[Federal Register Volume 84, Number 229 (Wednesday, November 27, 2019)]
[Rules and Regulations]
[Pages 65524-65606]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24931]



  Federal Register / Vol. 84 , No. 229 / Wednesday, November 27, 2019 / 
Rules and Regulations  

[[Page 65524]]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Subchapter E

[CMS-1717-F2]
RIN 0938-AU22


Medicare and Medicaid Programs: CY 2020 Hospital Outpatient PPS 
Policy Changes and Payment Rates and Ambulatory Surgical Center Payment 
System Policy Changes and Payment Rates. Price Transparency 
Requirements for Hospitals To Make Standard Charges Public

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule.

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SUMMARY: This final rule establishes requirements for hospitals 
operating in the United States to establish, update, and make public a 
list of their standard charges for the items and services that they 
provide. These actions are necessary to promote price transparency in 
health care and public access to hospital standard charges. By 
disclosing hospital standard charges, we believe the public (including 
patients, employers, clinicians, and other third parties) will have the 
information necessary to make more informed decisions about their care. 
We believe the impact of these final policies will help to increase 
market competition, and ultimately drive down the cost of health care 
services, making them more affordable for all patients.

DATES: This final rule is effective on January 1, 2021.

FOR FURTHER INFORMATION CONTACT: 
    Price Transparency of Hospital Standard Charges, contact Dr. Terri 
Postma or Elizabeth November, (410) 786-8465 or via email at 
[email protected].
    Quality Measurement Relating to Price Transparency, contact Dr. 
Reena Duseja or Dr. Terri Postma via email at 
[email protected].

SUPPLEMENTARY INFORMATION:  Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. We 
post all comments received before the close of the comment period on 
the following website as soon as possible after they have been 
received: http://www.regulations.gov/. Follow the search instructions 
on that website to view public comments.

Current Procedural Terminology (CPT) Copyright Notice

    Throughout this final rule, we use CPT codes and descriptions to 
refer to a variety of services. We note that CPT codes and descriptions 
are copyright 2018 American Medical Association. All Rights Reserved. 
CPT is a registered trademark of the American Medical Association 
(AMA). Applicable Federal Acquisition Regulations (FAR) and Defense 
Federal Acquisition Regulations (DFAR) apply.

Table of Contents

I. Summary and Background
    A. Executive Summary
    B. Statutory Basis and Current Guidance
II. Requirements for Hospitals To Make Public a List of Their 
Standard Charges
    A. Introduction and Overview
    B. Definition of ``Hospital'' and Hospitals Regarded as Having 
Met Requirements
    C. Definition of ``Items and Services'' Provided by Hospitals
    D. Definitions for Types of ``Standard Charges''
    E. Requirements for Public Disclosure of All Hospital Standard 
Charges for All Items and Services in a Comprehensive Machine-
Readable File
    F. Requirements for Displaying Shoppable Services in a Consumer-
Friendly Manner
    G. Monitoring and Enforcement of Requirements for Making 
Standard Charges Public
    H. Appeals Process
III. Comments Received in Response To Request for Information: 
Quality Measurement Relating to Price Transparency for Improving 
Beneficiary Access to Provider and Supplier Charge Information
IV. Collection of Information Requirements
    A. Response to Comments
    B. ICR for Hospital Price Transparency
V. Regulatory Impact Analysis
    A. Statement of Need
    B. Overall Impact
    C. Anticipated Effects
    D. Alternatives Considered
    E. Accounting Statement and Table
    F. Regulatory Reform Analysis Under E.O. 13771
    G. Conclusion

Regulation Text

I. Summary and Background

A. Executive Summary

1. Purpose
    In this final rule, we establish requirements for all hospitals 
(including hospitals not paid under the Medicare Outpatient Prospective 
Payment System (OPPS)) in the United States for making hospital 
standard charges available to the public pursuant to section 2718(e) of 
the PHS Act, as well as an enforcement scheme under section 2718(b)(3) 
of the PHS Act to enforce those requirements. These requirements, as 
well as the enforcement scheme, are additionally authorized by section 
1102(a) of the Social Security Act.
    This final rule also addresses comments we received on our 
proposals to implement section 2718(b) and (e), as well as a request 
for information on quality measurement relating to price transparency 
included in the ``Medicare Program; Proposed Changes to Hospital 
Outpatient Prospective Payment and Ambulatory Surgical Center Payment 
Systems and Quality Reporting Programs; Price Transparency of Hospital 
Standard Charges; Proposed Revisions of Organ Procurement Organizations 
Conditions of Coverage; Proposed Prior Authorization Process and 
Requirements for Certain Covered Outpatient Department Services; 
Potential Changes to the Laboratory Date of Service Policy; Proposed 
Changes to Grandfathered Children's Hospitals-Within-Hospitals'' (84 FR 
39398 through 39644), herein referred to as the ``CY 2020 OPPS/ASC 
proposed rule,'' which was displayed in the Federal Register on July 
29, 2019, with a comment period that ended on September 27, 2019.
    The final rule with comment period titled ``Medicare Program: 
Changes to Hospital Outpatient Prospective Payment and Ambulatory 
Surgical Center Payment Systems and Quality Reporting Programs; 
Revisions of Organ Procurement Organizations Conditions of Coverage; 
Prior Authorization Process and Requirements for Certain Covered 
Outpatient Department Services; Potential Changes to the Laboratory 
Date of Service Policy; Changes to Grandfathered Children's Hospitals-
Within-Hospitals; Notice of Closure of Two Teaching Hospitals and 
Opportunity to Apply for Available Slots,'' referred to hereinafter as 
the ``CY 2020 OPPS/ASC final rule with comment period,'' was displayed 
in the Federal Register on November 1, 2019. In that final rule with 
comment period, we explained our intent to summarize and respond to 
public comments on the proposed requirements for hospitals to make 
public their standard charges in a forthcoming final rule. This final 
rule is being published as a supplement to the CY 2020 OPPS/ASC final 
rule with comment period.
2. Summary of the Major Provisions
    We are adding a new Part 180--Hospital Price Transparency to Title 
45 of the Code of Federal Regulations (CFR) that will codify our 
regulations on price transparency that implement section

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2718(e) of the PHS Act. In this final rule, we are finalizing the 
following policies: (1) A definition of ``hospital''; (2) definitions 
for five types of ``standard charges'' (specifically, gross charges and 
payer-specific negotiated charges, as proposed, plus the discounted 
cash price, the de-identified minimum negotiated charge, and the de-
identified maximum negotiated charge) that hospitals would be required 
to make public; (3) a definition of hospital ``items and services'' 
that would include all items and services (both individual and 
packaged) provided by the hospital to a patient in connection with an 
inpatient admission or an outpatient department visit; (4) federally 
owned/operated facilities are deemed to have met all requirements; (5) 
requirements for making public a machine-readable file that contains a 
hospital's gross charges and payer-specific negotiated charges, as 
proposed, plus discounted cash prices, the de-identified minimum 
negotiated charge, and the de-identified maximum negotiated charge for 
all items and services provided by the hospital; (6) requirements for 
making public payer-specific negotiated charges, as proposed, plus 
discounted cash prices, the de-identified minimum negotiated charge, 
and the de-identified maximum negotiated charge, for 300 ``shoppable'' 
services that are displayed and packaged in a consumer-friendly manner, 
plus a policy to deem hospitals that offer internet-based price 
estimator tools as having met this requirement; (7) monitoring hospital 
noncompliance with requirements for publicly disclosing standard 
charges; (8) actions that would address hospital noncompliance, which 
include issuing a written warning notice, requesting a corrective 
action plan (CAP), and imposing civil monetary penalties (CMPs) on 
noncompliant hospitals and publicizing these penalties on a CMS 
website; and (9) appeals of CMPs.
3. Summary of Costs and Benefits
    We estimate the total burden for hospitals to review and post their 
standard charges for the first year to be 150 hours per hospital at 
$11,898.60 per hospital for a total burden of 900,300 hours (150 hours 
x 6,002 hospitals) and total cost of $71,415,397 ($11,898.60 x 6,002 
hospitals), as discussed in section V of this final rule. We estimate 
the total annual burden for hospitals to review and post their standard 
charges for subsequent years to be 46 hours per hospital at $3,610.88 
per hospital for a total annual burden for subsequent years of 276,092 
hours (46 hours x 6,002 hospitals) and total annual cost of $21,672,502 
($3,610.88 x 6,002 hospitals).

B. Statutory Basis and Current Guidance

    Section 1001 of the Patient Protection and Affordable Care Act 
(ACA) (Pub. L. 111-148), as amended by section 10101 of the Health Care 
and Education Reconciliation Act of 2010 (Pub. L. 111-152), amended 
Title XXVII of the PHS Act, in part, by adding a new section 2718(e) of 
the PHS Act. Section 2718 of the PHS Act, entitled ``Bringing Down the 
Cost of Health Care Coverage,'' requires each hospital operating within 
the United States for each year to establish (and update) and make 
public a list of the hospital's standard charges for items and services 
provided by the hospital, including for diagnosis related groups (DRGs) 
established under section 1886(d)(4) of the Social Security Act (SSA).
    In the FY 2015 inpatient prospective payment system (IPPS)/long-
term care hospital (LTCH) prospective payment system (PPS) proposed and 
final rules (79 FR 28169 and 79 FR 50146, respectively), we reminded 
hospitals of their obligation to comply with the provisions of section 
2718(e) of the PHS Act and provided guidelines for its implementation. 
At that time, we required hospitals to either make public a list of 
their standard charges or their policies for allowing the public to 
view a list of those charges in response to an inquiry. In addition, we 
stated that we expected hospitals to update the information at least 
annually, or more often as appropriate, to reflect current charges. We 
also encouraged hospitals to undertake efforts to engage in consumer-
friendly communication of their charges to enable consumers to compare 
charges for similar services across hospitals and to help consumers 
understand what their potential financial liability might be for items 
and services they obtain at the hospital.
    In the FY 2019 IPPS/LTCH PPS proposed rule and final rule (83 FR 
20164 and 83 FR 41144, respectively), we again reminded hospitals of 
their obligation to comply with the provisions of section 2718(e) of 
the PHS Act and updated our guidelines for its implementation. The 
announced update to our guidelines became effective January 1, 2019, 
and took one step to further improve the public accessibility of 
standard charge information. Specifically, we updated our guidelines to 
require hospitals to make available a list of their current standard 
charges via the internet in a machine-readable format and to update 
this information at least annually, or more often as appropriate. We 
subsequently published two sets of Frequently Asked Questions (FAQs) 
\1\ that provided additional guidance to hospitals, including a FAQ 
clarifying that while hospitals could choose the format they would use 
to make public a list of their standard charges, the publicly posted 
information should represent their standard charges as reflected in the 
hospital's chargemaster. We also clarified that the requirement applies 
to all hospitals operating within the United States and to all items 
and services provided by the hospital.
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    \1\ Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/AcuteInpatientPPS/Downloads/FAQs-Req-Hospital-Public-List-Standard-Charges.pdf and https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ProspMedicareFeeSvcPmtGen/Downloads/Additional-Frequently-Asked-Questions-Regarding-Requirements-for-Hospitals-To-Make-Public-a-List-of-Their-Standard-Charges-via-the-internet.pdf.
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II. Requirements for Hospitals To Make Public a List of Their Standard 
Charges

A. Introduction and Overview

1. Background
    As healthcare costs continue to rise, healthcare affordability has 
become an area of intense focus. Healthcare spending is projected to 
consume almost 20 percent of the economy by 2027.\2\ One reason for 
this upward spending trajectory is the lack of transparency in 
healthcare pricing.3 4 5 6 Numerous studies suggest that 
consumers want greater healthcare pricing transparency. For example, a 
study of high deductible health plan enrollees found that respondents 
wanted additional healthcare price information so they could make more 
informed decisions about where to seek

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care based on price.\7\ Health economists and other experts state that 
significant cost containment cannot occur without widespread and 
sustained transparency in provider prices.\8\ We believe there is a 
direct connection between transparency in hospital standard charge 
information and having more affordable healthcare and lower healthcare 
coverage costs. We believe healthcare markets could work more 
efficiently and provide consumers with higher-value healthcare if we 
promote policies that encourage choice and competition.\9\ As we have 
stated on numerous occasions, we believe that transparency in 
healthcare pricing is critical to enabling patients to become active 
consumers so that they can lead the drive towards value.\10\
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    \2\ CMS. National Health Expenditures Projections, 2018-2027: 
Forecast Summary. Available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/ForecastSummary.pdf.
    \3\ Scheurer D. Lack of Transparency Plagues U.S. Health Care 
System. The Hospitalist. 2013 May; 2013(5). Available at: https://www.the-hospitalist.org/hospitalist/article/125866/health-policy/lack-transparency-plagues-us-health-care-system.
    \4\ Bees J. Survey Snapshot: Is Transparency the Answer to 
Rising Health Care Costs? New England Journal of Medicine Catalyst. 
March 20, 2019. Available at: https://catalyst.nejm.org/health-care-cost-transparency-answer/.
    \5\ Wetzell S. Transparency: A Needed Step Towards Health Care 
Affordability. American Health Policy Institute. March, 2014. 
Available at: http://www.americanhealthpolicy.org/Content/documents/resources/Transparency%20Study%201%20-%20The%20Need%20for%20Health%20Care%20Transparency.pdf.
    \6\ Robert Wood Johnson Foundation. How Price Transparency Can 
Control the Cost of Health Care. March 1, 2016. Available at: 
https://www.rwjf.org/en/library/research/2016/03/how-price-transparency-controls-health-care-cost.html.
    \7\ Sinaiko AD, et al. Cost-Sharing Obligations, High-Deductible 
Health Plan Growth, and Shopping for Health Care: Enrollees with 
Skin in the Game. JAMA Intern Med. March 2016; 176(3), 395-397. 
Available at: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2482348.
    \8\ Boynton A, and Robinson JC. Appropriate Use Of Reference 
Pricing Can Increase Value. Health Affairs. July 7, 2015. Available 
at: https://www.healthaffairs.org/do/10.1377/hblog20150707.049155/full/.
    \9\ Azar AM, Mnuchin ST, and Acosta A. ``Reforming America's 
Healthcare System Through Choice and Competition.'' December 3, 
2018. Available at: https://www.hhs.gov/sites/default/files/Reforming-Americas-Healthcare-System-Through-Choice-and-Competition.pdf.
    \10\ Bresnick J. Verma: Price Transparency Rule a ``First Step'' 
for Consumerism. January 11, 2019. Available at: https://healthpayerintelligence.com/news/verma-price-transparency-rule-a-first-step-for-consumerism.
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    Many empirical studies have investigated the impact of price 
transparency on markets, with most research, consistent with 
predictions of standard economic theory, showing that price 
transparency leads to lower and more uniform prices.\11\ Traditional 
economic analysis suggests that if consumers were to have better 
pricing information for healthcare services, providers would face 
pressure to lower prices and provide better quality care.\12\ Falling 
prices may, in turn, expand consumers' access to healthcare.\13\
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    \11\ Congressional Research Service Report for Congress: Does 
Price Transparency Improve Market Efficiency? Implications of 
Empirical Evidence in Other Markets for the Healthcare Sector, July 
24, 2007 (updated April 29, 2008). Available at: https://crsreports.congress.gov/product/pdf/RL/RL34101.
    \12\ Ibid.
    \13\ Ibid.
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    Presently, however, the information that healthcare consumers need 
to make informed decisions based on the prices of healthcare services 
is not readily available. The Government Accountability Office (GAO) 
report (2011), ``Health Care Price Transparency: Meaningful Price 
Information is Difficult for Consumers to Obtain Prior to Receiving 
Care,'' \14\ found that healthcare price opacity, coupled with the 
often wide pricing disparities for particular procedures within the 
same market, can make it difficult for consumers to understand 
healthcare prices and to effectively shop for value. The report 
references a number of barriers that make it difficult for consumers to 
obtain price estimates in advance for healthcare services. Such 
barriers include the difficulty of predicting healthcare service needs 
in advance, a complex billing structure resulting in bills from 
multiple providers, the variety of insurance benefit structures, and 
concerns related to the public disclosure of rates negotiated between 
providers and third party payers. The GAO report goes on to explore 
various price transparency initiatives, including tools that consumers 
could use to generate price estimates in advance of receiving a 
healthcare service. The report notes that pricing information displayed 
by tools varies across initiatives, in large part due to limits 
reported by the initiatives in their access or authority to collect 
certain necessary price data. According to the GAO report, transparency 
initiatives with access to and integrated pricing data from both 
providers and insurers were best able to provide reasonable estimates 
of consumers' complete costs.
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    \14\ GAO. Health Care Price Transparency: Meaningful Price 
Information Is Difficult for Consumers to Obtain Prior to Receiving 
Care. Publicly released October 24, 2011. Available at: https://www.gao.gov/products/GAO-11-791.
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    The concept of making healthcare provider charges and insurance 
benefit information available to consumers is not new; some States have 
required disclosure of pricing information by providers and payers for 
a number of years. More than half of the States have passed legislation 
establishing price transparency websites or mandating that health 
plans, hospitals, or physicians make price information available to 
consumers.\15\ As of early 2012, there were 62 consumer-oriented, 
State-based healthcare price comparison websites.\16\ Half of these 
websites were launched after 2006, and most were developed and funded 
by a State government agency (46.8 percent) or hospital association 
(38.7 percent).\17\ Most websites report prices of inpatient care for 
medical conditions (72.6 percent) or surgeries (71.0 percent). 
Information about prices of outpatient services such as diagnostic or 
screening procedures (37.1 percent), radiology studies (22.6 percent), 
prescription drugs (14.5 percent), or laboratory tests (9.7 percent) 
are reported less often.\18\
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    \15\ Desai S, et al. Association Between Availability of a Price 
Transparency Tool and Outpatient Spending. JAMA. 2016;315(17):1874-
1881. Available at: https://jamanetwork.com/journals/jama/fullarticle/2518264.
    \16\ Kullgren JT, et al. A census of state health care price 
transparency websites. JAMA. 2013;309(23):2437-2438. Available at: 
https://jamanetwork.com/journals/jama/fullarticle/1697957.
    \17\ Ibid.
    \18\ Ibid.
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    Since the early 2000s, California-licensed hospitals have been 
required to annually submit to the State, for public posting on a State 
website: The charge description master (CDM, also known as a 
``chargemaster''); a list of the hospital's average charges for at 
least 25 common outpatient procedures, including ancillary services; 
and the estimated percentage increase in gross revenue due to price 
changes.\19\ The information is required to be submitted in plain 
language using easily understood terminology.\20\ In 2012, 
Massachusetts began requiring insurers to provide, upon request, the 
estimated amount insured patients will be responsible to pay for 
proposed admissions, procedures, or services based upon the information 
available to the insurer at the time, and also began requiring 
providers to disclose the charge for the admission, procedure, or 
service upon request by the patient within 2 working days.\21\ Since 
2015, Oregon has offered pricing data for the top 100 common hospital 
outpatient procedures and top 50 common inpatient procedures on its 
OregonHospitalGuide.org website, which displays the median negotiated 
amount of the procedure by hospital and includes patient paid amounts 
such as deductibles and copayments. The data are derived from State-
mandated annual hospital claims collection by the State's all payer 
claims database (APCD) and represent the service package cost for each 
of the procedures, including ancillary services and elements related to 
the procedure, with the exception of professional fees which are billed 
separately.\22\ More recently, in 2018, Colorado began requiring 
hospitals to post the prices of the 50 most used DRG codes and the 25 
most used outpatient CPT codes or healthcare services

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procedure codes with a ``plain-English description'' of the service, 
which must be updated at least annually.\23\
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    \19\ Available at: https://oshpd.ca.gov/data-and-reports/cost-transparency/hospital-chargemasters/2018-chargemasters/.
    \20\ Jenkins K. CMS Price Transparency Push Trails State 
Initiatives. The National Law Review. February 8, 2019. Available 
at: https://www.natlawreview.com/article/cms-price-transparency-push-trails-state-initiatives.
    \21\ Ibid.
    \22\ Available at: http://oregonhospitalguide.org/ and http://oregonhospitalguide.org/understanding-the-data/procedure-costs.html.
    \23\ Jenkins K. CMS Price Transparency Push Trails State 
Initiatives. The National Law Review. February 8, 2019. Available 
at: https://www.natlawreview.com/article/cms-price-transparency-push-trails-state-initiatives.
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    Not only have States taken an interest in price transparency, but 
insurers and self-funded employers have also moved in this direction. 
For example, some self-funded employers are using price transparency 
tools to incentivize their employees to make cost-conscious decisions 
when purchasing healthcare services. Most large insurers have embedded 
cost estimation tools into their member websites, and some provide 
their members with comparative cost and value information, which 
includes rates that the insurers have negotiated with in-network 
providers and suppliers.
    Research suggests that making such consumer-friendly pricing 
information available to the public can reduce healthcare costs for 
consumers. Specifically, recent research evaluating the impact of New 
Hampshire's price transparency efforts reveals that providing insured 
patients with information about prices can have an impact on the out-
of-pocket costs consumers pay for medical imaging procedures, not only 
by helping users of New Hampshire's website choose lower-cost options, 
but also by leading to lower prices that benefited all patients, 
including those in the State that did not use the 
website.24 25
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    \24\ Brown ZY. What would happen if hospitals openly shared 
their prices? The Conversation. January 30, 2019. Available at: 
https://theconversation.com/what-would-happen-if-hospitals-openly-shared-their-prices-110352.
    \25\ Brown ZY. An Empirical Model of Price Transparency and 
Markups in Health Care. August 2019. Available at: http://www-
personal.umich.edu/~zachb/
zbrown_empirical_model_price_transparency.pdf.
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    Despite the growing consumer demand and awareness of the need for 
healthcare pricing data, there continues to be a gap in easily 
accessible pricing information for consumers to use for healthcare 
shopping purposes. Specifically, there is inconsistent (and many times 
nonexistent) availability of provider charge information, among other 
limitations to understanding data made available or barriers to use of 
the data. We believe this information gap can, in part, be filled by 
the new requirements we are finalizing in this final rule, under 
section 2718(e) of the PHS Act, as described below. As we explained in 
the CY 2020 OPPS/ASC proposed rule, we believe that ensuring public 
access to hospital standard charge data will promote and support 
current and future price transparency efforts. We believe that this, in 
turn, will enable healthcare consumers to make more informed decisions, 
increase market competition, and ultimately drive down the cost of 
healthcare services, making them more affordable for all patients.
2. Summary of Proposals and General Comments
    In the CY 2020 OPPS/ASC proposed rule (84 FR 39398), we indicated 
that health care consumers continue to lack the meaningful pricing 
information they need to choose the healthcare services they want and 
need despite our prior requirements for hospitals to publicly post 
their chargemaster rates online. Based on feedback from hospitals and 
consumers following the January 1, 2019 implementation of the revised 
guidelines, and in accordance with President's Executive Order on 
``Improving Price and Quality Transparency in American Healthcare to 
Put Patients First'' (June 24, 2019), we proposed an expansion of 
hospital charge display requirements to include charges and information 
based on negotiated rates and for common shoppable items and services, 
in a manner that is consumer-friendly. We also proposed to establish a 
mechanism for monitoring and the application of penalties for 
noncompliance.
    Specifically, we proposed to add a new Part 180--Hospital Price 
Transparency to title 45 CFR which would contain our regulations on 
price transparency for purposes of section 2718(e) of the PHS Act. We 
made proposals related to: (1) A definition of ``hospital''; (2) 
different reporting requirements that would apply to certain hospitals; 
(3) definitions for two types of ``standard charges'' (specifically, 
gross charges and payer-specific negotiated charges) that hospitals 
would be required to make public, and a request for public comment on 
other types of standard charges that hospitals should be required to 
make public; (4) a definition of hospital ``items and services'' that 
would include all items and services (both individual and packaged) 
provided by the hospital to a patient in connection with an inpatient 
admission or an outpatient department visit; (5) requirements for 
making public a machine-readable file that contains a hospital's gross 
charges and payer-specific negotiated charges for all items and 
services provided by the hospital; (6) requirements for making public 
payer-specific negotiated charges for select hospital-provided items 
and services that are ``shoppable'' and that are displayed and packaged 
in a consumer-friendly manner; (7) monitoring for hospital 
noncompliance with requirements for publicly disclosing standard 
charges; (8) actions that would address hospital noncompliance, which 
include issuing a written warning notice, requesting a CAP, and 
imposing CMPs on noncompliant hospitals and publicizing these penalties 
on a CMS website; and (9) appeals of CMPs.
    Comment: Commenters included individual consumers, patient 
advocates, hospitals and health systems, private insurers, employers, 
medical associations, health benefits consultants, health information 
technology (IT) organizations and organizations with price transparency 
expertise, and academic institutions, among others. The majority of 
commenters expressed broad support for our proposed policies (in whole 
or in part) or agreed with the objectives we seek to accomplish through 
these requirements. Many of these commenters stated that the disclosure 
of hospital standard charges would serve to increase competition, drive 
down healthcare prices, and allow consumers to compare healthcare costs 
across facilities and to have better control over their budgets and the 
financing of their healthcare needs.
    Many commenters shared personal stories and examples of their 
experiences, illustrating their desire to shop and learn healthcare 
service prices in advance, and expressed frustration at their current 
inability to prospectively access medical costs. Commenters also 
provided specific examples of the ways that knowledge of healthcare 
pricing in advance would benefit consumers and empower them to make 
lower cost choices. Many commenters stated that consumers have a 
``right to know'' or ``right to understand'' healthcare costs in 
advance of receiving treatment.
    Individual consumers that submitted comments generally praised the 
proposals. One commenter stated it is the ``best attempt [thus] far to 
provide price transparency to the American public.'' But other 
commenters who supported hospital disclosure of charge information as a 
necessary first step also recognized that such disclosure would still 
fall, as one commenter stated, ``far short of the full price and cost 
transparency we need in every part of our healthcare system.''
    By contrast, many organizations, including those representing 
hospitals and insurers, that submitted comments expressed strong 
concerns with the proposals and generally questioned

[[Page 65528]]

whether hospital charge disclosures would effectively reduce healthcare 
costs. Many of these entities commented on the practicalities and 
usefulness of displaying hospital standard charges and asserted that 
the proposal would not ``directly'' and ``materially'' serve the stated 
interest of improving consumer access to healthcare pricing information 
to help drive down healthcare costs.
    Commenters that objected to the proposals also pointed out that 
disclosure of hospital charges would be insufficient to permit a 
consumer to obtain an out-of-pocket estimate in advance because 
consumers with insurance need additional information from payers. Some 
commenters generally indicated that the proposed disclosures would be 
of little benefit or use to consumers. Further, several commenters 
suggested that, for patients with health insurance, insurers, not 
hospitals, should be the primary source of price information, and that 
insurers should inform and educate their members on potential out-of-
pocket costs in advance of elective services. Some expressed concerns 
that patients could be confused by hospital charge information and 
misinterpret the standard charge data the hospital is required to 
display.
    Response: We thank the many commenters for their support of CMS' 
price transparency initiative in general, and our proposals to require 
hospitals to make public their standard charge information in 
particular, which, for reasons articulated in the CY 2020 OPPS/ASC 
proposed rule, we agree can improve consumer knowledge of the price of 
healthcare items and services in advance. For example, disclosure of 
payer-specific negotiated charges can help individuals with high 
deductible health plans (HDHPs) or those with co-insurance determine 
the portion of the negotiated charge for which they will be responsible 
for out-of-pocket. We believe that regulations we are finalizing in 
this final rule, implementing section 2718(e) of the PHS Act, requiring 
hospitals make public standard charges, are imperative for several 
reasons, including that consumers currently do not have the information 
they need in a readily usable way or in context to inform their 
healthcare decision-making. Further, we believe that greater 
transparency will increase competition throughout the market and 
address healthcare costs. For instance, disclosure of pricing 
information will allow providers, hospitals, insurers, employers and 
patients to begin to engage each other and better utilize market forces 
to address the high cost of medical care in a more widespread fashion.
    While we understand the commenters' concerns that disclosure of 
hospital standard charges may not be used by all consumers, we disagree 
that the availability of such data would be of little benefit to 
consumers generally. We continue to believe there is a direct 
connection between transparency in hospital standard charge information 
and having more affordable healthcare and lower healthcare coverage 
costs. We believe healthcare markets could work more efficiently and 
provide consumers with higher-value healthcare if we promote policies 
that encourage choice and competition. As we noted in the CY 2020 OPPS/
ASC proposed rule, and restated in section II.A.2 of this final rule, 
numerous studies suggest that consumers want greater transparency and 
price information so that they can make more informed decisions about 
where to seek care based on price (84 FR 39572).
    We do, however, agree with commenters who indicated that disclosure 
of hospital charge information alone may be insufficient or does not go 
far enough for consumers to know their out-of-pocket costs in advance 
of receiving a healthcare service. As we indicated in the CY 2020 OPPS/
ASC proposed rule (84 FR 39574), there are many barriers to obtaining 
an out-of-pocket estimate in advance and to make price comparisons for 
healthcare services, including that the data necessary for such an 
analysis are not available to the general public for personal use. 
Necessary data to make out-of-pocket price comparisons depends on an 
individual's circumstances. For example, a self-pay individual may 
simply want to know the amount a healthcare provider will accept in 
cash (or cash equivalent) as payment in full, while an individual with 
health insurance may want to know the charge negotiated between the 
healthcare provider and payer, along with additional individual 
benefit-specific information such as the amount of cost-sharing, the 
network status of the healthcare provider, how much of a deductible has 
been paid to date, and other information. We therefore agree with 
commenters who recognize that these policies to require hospitals to 
make public their standard charges are merely a necessary first step. 
We discuss the importance and necessity of specific types of hospital 
standard charges in section II.D of this final rule.
    In response to commenters suggesting that insurers should be the 
primary source of price information, we disagree that insurers alone 
should bear the complete burden or responsibility for price 
transparency. At least one key reason that insurers cannot alone bear 
the burden is that, in numerous instances, they are not participants in 
the transaction; for example, as discussed in section II.D of this 
final rule, self-pay patients and insured patients who are considering 
paying in cash have an interest in understanding hospitals' cash 
prices, or for employers who want to contract directly with hospitals. 
We also note that the proposed rule entitled Transparency in Coverage 
(file code CMS-9915-P) would place complementary transparency 
requirements on most individual and group market health insurance 
issuers and group health plans.
    Comment: A few commenters asked CMS not to move forward with the 
final rule, stating that price transparency should be done only at the 
state level. These commenters expressed concern that CMS moving forward 
in this area would either limit price transparency to a ``one size fits 
all'' approach or complicate or undercut efforts already ongoing in 
several states. These commenters suggested that instead of federal 
mandates, CMS could work with hospitals to provide meaningful 
information to patients about their out-of-pocket costs for their 
hospital care by improving financial counseling, or provide grant 
dollars for states to improve their own price transparency programs.
    More generally, many commenters asserted that several hospitals 
already respond to consumer requests for actionable healthcare pricing 
information in advance of receiving care, such as through existing 
tools, publicizing how and from whom patients can obtain price 
estimates, providing individualized financial counseling, or a 
combination of these methods.
    Response: We believe it is appropriate to promulgate regulations 
pursuant to section 2718(e) of the PHS Act.
    We further believe that transparency in pricing is a national 
issue, which Congress has recognized by enacting hospital price 
transparency statutory requirements.
    We appreciate the commenters' concerns about the possible 
interactions between new federal requirements for hospitals to make 
public standard charges and existing State price transparency 
initiatives, or hospital initiatives. As we discussed in the CY 2020 
OPPS/ASC proposed rule, we have sought ways to ensure sufficient 
flexibility in the new requirements, particularly around the form and

[[Page 65529]]

manner of making public hospital price information, as well as the 
frequency of making public this information. As with the proposed 
requirements, we continue to believe that the requirements we are 
finalizing in this final rule will align with and enhance ongoing State 
and hospital efforts for the display of hospital charge information. We 
note that while many States have made progress in promoting price 
transparency, most State efforts continue to fall short. For example, a 
group that tracks State progress found in their most recent report that 
all but seven States scored an ``F'' on price transparency.\26\ States 
that excel at promoting price transparency (for example, New Hampshire 
and Maine, the only two States to receive an ``A'' rating) are also 
States where the price of shoppable services has reportedly decreased 
\27\ or fostered a more competitive market.\28\ We believe these final 
rules will provide a national framework upon which States can either 
begin or continue to build.
---------------------------------------------------------------------------

    \26\ de Brantes F, et al. Price Transparency & Physician Quality 
Report Card 2017. Catalyst for Payment Reform. Available at: https://www.catalyze.org/wp-content/uploads/2017/11/Price-Transparency-and-Physician-Quality-Report-Card-2017_0-1.pdf.
    \27\ Brown ZY. Equilibrium Effects of Health Care Price 
Information. The Review of Economics and Statistics. Published 
October 2019; 101:4, 699-712. Available at: http://www-
personal.umich.edu/~zachb/zbrown_eqm_effects_price_transparency.pdf.
    \28\ Gudiksen KL, et al. The Secret of Health Care Prices: Why 
Transparency Is in the Public Interest. California Health Care 
Foundation. July 2019. Available at: https://www.chcf.org/wp-content/uploads/2019/06/SecretHealthCarePrices.pdf.
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    We commend those hospitals that are already publicly releasing 
their standard charges and providing patients individualized assistance 
to help them understand their projected costs in advance of receiving 
care. However, not all hospitals are prioritizing providing such 
assistance. Moreover, we do not believe that such existing hospital 
initiatives diminish the need to, and benefits of, establishing 
consistent, nationwide requirements for hospitals to make public 
standard charges. We encourage efforts to provide consumers with 
additional price information (beyond the requirements established in 
this final rule) and for hospitals to continue to educate and provide 
prospective out-of-pocket information to patients. By doing so, 
hospitals can help consumers gain an understanding of hospital standard 
charge information and thereby support consumers in making cost 
conscious decisions regarding their care in advance.
    Comment: Some commenters generally indicated that the proposals for 
hospitals to disclose their standard charges would be very burdensome 
to implement. Several commenters also suggested that the proposed price 
transparency requirements are contrary to the Patients over Paperwork 
initiative, which is a CMS initiative that aims to remove regulatory 
obstacles that get in the way of providers spending time with patients.
    Response: The Patients over Paperwork initiative is in accord with 
President Trump's Executive Order that directs federal agencies to 
``cut the red tape'' to reduce burdensome regulations. Through 
``Patients over Paperwork,'' CMS established an internal process to 
evaluate and streamline regulations with a goal to reduce unnecessary 
burden, to increase efficiencies, and to improve the beneficiary 
experience.\29\ Generally, we believe the final requirements will 
increase transparency in hospital charge information and will achieve 
one of our primary goals of putting patients first and empowering them 
to make the best decisions for themselves and their families.\30\ 
Efficiencies could also be gained through implementation of these 
requirements for markets, providers and patients.31 32 33 To 
implement section 2718(e) of the PHS Act and to achieve these goals, 
some burden on hospitals is necessary. However, we have sought through 
rulemaking to minimize the burden wherever possible.
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    \29\ CMS.gov website, Patients Over Paperwork, at https://www.cms.gov/Outreach-and-Education/Outreach/Partnerships/PatientsOverPaperwork.html.
    \30\ CMS.gov, Patients Over Paperwork webpage, available at 
https://www.cms.gov/About-CMS/story-page/patients-over-paperwork.html; see also 84 FR 27021 (RFI describing CMS' top 
priority as putting patients first and empowering them to make the 
best decisions for themselves and their families).
    \31\ Kim M. The Effect of Hospital Price Transparency in Health 
Care Markets. 2011. Available at: https://repository.upenn.edu/dissertations/AAI3475926/.
    \32\ CRS Report to Congress: Does Price Transparency Improve 
Market Efficiency? Implications of Empirical Evidence in Other 
Markets for the Health Sector. July 24, 2007. Available at: https://fas.org/sgp/crs/secrecy/RL34101.pdf.
    \33\ Santa J. The Healthcare Imperative: Lowering Costs and 
Improving Outcomes: Workshop Series Summary. 2010. Available at: 
https://www.ncbi.nlm.nih.gov/books/NBK53921/.
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    We acknowledge commenters' concerns related to burden. However, we 
believe that the burdens placed on hospitals to make public their 
standard charge data is outweighed by the benefit that the availability 
of these data will have in informing patients regarding healthcare 
costs and choices and improving overall market competition. Since we 
believe that transparency is necessary to improve healthcare value and 
empower patients, we believe the need justifies the additional burden. 
While the burdens hospitals may incur to implement these requirements 
might be administrative in nature, we believe that the benefits to 
consumers, and to the public as a whole, justify this regulatory action 
and that we are thereby prioritizing patients through this regulatory 
action.
    Comment: A few commenters offered suggestions for how to improve 
hospital price transparency in general, including the following:
     Presenting pricing data with quality, health outcomes, and 
other relevant data.
     Encouraging shared decision-making and cost of care 
conversations between patients and clinicians at the point of care.
     Addressing unexpected costs of care and providing consumer 
protections from unexpected and unnecessary out-of-pocket spending, 
such as those resulting from incidents where the patient is billed at 
rates that are inconsistent with publicly posted prices for their payer 
(referred to by a few commenters as ``price surprise''), or billed by 
out-of-network providers that provided treatment at an in-network 
facility, or the practice where the provider bills the patient for the 
balance between the amount the patient's health insurance plan covers 
and the amount that the provider charges (``balance billing'').
    Response: We acknowledge that additional barriers have to be 
overcome to allow consumers to identify appropriate sites of care for 
needed healthcare services, determine out-of-pocket costs in advance, 
and utilize indicators of quality of care to make value-based 
decisions. As we have previously described, we believe the policies we 
are finalizing in this final rule requiring hospitals to make public 
standard charges are a necessary and important first step in ensuring 
transparency in healthcare prices for consumers, but that the release 
of hospital standard charge information is not sufficient by itself to 
achieve our ultimate goals for price transparency. We also note that 
our final policies do not preclude hospitals from undertaking 
additional transparency efforts beyond making public their standard 
charges. HHS continues to explore other authorities to further advance 
the Administration's goal of enhancing consumers' ability to choose the 
healthcare that is best for them, to make fully informed decisions 
about their healthcare, and to access both useful price and quality 
information and

[[Page 65530]]

provide incentives to find low-cost, high-quality care.
    We agree that cost-of-care conversations at the point of care are 
important. National surveys show that a majority of patients and 
physicians want to have these conversations, but often the information 
necessary for actionable conversations is unavailable.\34\ A recent 
supplemental issue of the Annals of Internal Medicine \35\ highlighted 
this issue and identified best practices for integrating cost-of-care 
conversations at the point of care. We believe that disclosure of 
hospital standard charges along with the disclosure of payer 
information is the first step to ensuring patients and practitioners 
have actionable data to support meaningful cost-of-care conversations. 
We encourage these conversations and the disclosure of additional 
relevant information to support patient decisions about their care.
---------------------------------------------------------------------------

    \34\ University of Utah Health website, Let's Talk About Money, 
https://uofuhealth.utah.edu/value/lets-talk-about-money.php.
    \35\ Fostering Productive Health Care Cost Conversations: 
Sharing Lessons Learned and Best Practices. May 2019 Vol: 170, Issue 
9_Supplement. Annals of Internal Medicine. Available at: https://annals.org/aim/issue/937992.
---------------------------------------------------------------------------

    We also agree that ``surprise billing'' is an issue of great 
concern to consumers and of great interest to both federal and state 
lawmakers. The policies finalized in this final rule will not resolve 
that issue entirely, although it is possible that disclosure of 
hospital standard charges could help mitigate some surprise billing 
experienced by consumers.
    Comment: One commenter suggested that Medicare and Medicaid 
beneficiaries need an easy way to report fraud and balance billings by 
providers.
    Response: There already exist multiple avenues by which anyone 
suspecting healthcare fraud, waste, or abuse in Medicare and/or 
Medicaid may readily report it to oversight authorities. For example, 
the HHS Office of Inspector General (OIG) Hotline accepts tips and 
complaints from all sources about potential fraud, waste, abuse, and 
mismanagement in HHS' programs (see https://oig.hhs.gov/FRAUD/REPORT-FRAUD/INDEX.ASP for instructions). Additionally, anyone wishing to 
report instances of potential Medicare fraud may contact Medicare's 
toll-free customer service operations at 1-800-MEDICARE (1-800-633-
4227), and obtain additional information at www.medicare.gov/fraud. 
Anyone suspecting Medicaid fraud, waste, or abuse is encouraged to 
report it to the Program Integrity contact of the respective State 
Medicaid Agency (see https://www.medicaid.gov/about-us/contact-us/contact-state-page.html for the 50 United States, the District of 
Columbia, the US Virgin Islands, and Puerto Rico).

B. Definition of ``Hospital'' and Hospitals Regarded as Having Met 
Requirements

1. Definition of ``Hospital''
    Section 2718(e) of the PHS Act does not define ``hospital.'' 
Initially, we considered proposing to adopt a definition of 
``hospital'' that is used either in other sections of the PHS Act or in 
the SSA, but we found that no single or combined definition was 
suitable because those other definitions were applicable to specific 
programs or Medicare participation and therefore had program-specific 
requirements that made them too narrow for our purposes. For example, 
we considered referencing the definition of ``hospital'' at section 
1861(e) of the SSA because that definition is well understood by 
institutions that participate as hospitals for purposes of Medicare. 
However, we were concerned that doing so could have had the 
unintentional effect of limiting the institutions we believe should be 
covered by section 2718(e) of the PHS Act. Even so, we believe that the 
licensing requirement described at section 1861(e)(7) of the SSA 
captures the institutions that we believe should be characterized as 
hospitals for purposes of this section.
    Accordingly, we proposed to define a ``hospital'' as an institution 
in any State in which State or applicable local law provides for the 
licensing of hospitals and that is: (1) Licensed as a hospital pursuant 
to such law; or (2) approved, by the agency of such State or locality 
responsible for licensing hospitals, as meeting the standards 
established for such licensing (which we proposed to codify in new 45 
CFR 180.20).
    We believe this proposed definition is the best way to ensure that 
section 2718(e) of the PHS Act applies to each hospital operating 
within the United States. First, in addition to applying to all 
Medicare-enrolled hospitals (that, by definition, must be licensed by a 
State as a hospital, or otherwise approved by the State or local 
licensing agency as meeting hospital licensing standards), the proposed 
definition would also capture any institutions that are, in fact, 
operating as hospitals under State or local law, but might not be 
considered hospitals for purposes of Medicare participation. As 
discussed in section XVI.A.2. of the CY 2020 OPPS/ASC proposed rule (84 
FR 39572 through 39573), many States have promoted price transparency 
initiatives, and some require institutions they license as hospitals to 
make certain charges public as a part of those initiatives. Therefore, 
defining a hospital by its licensure (or by its approval by the State 
or locality as meeting licensing standards) may carry the advantage of 
aligning the application of Federal and State price transparency 
initiatives to the same institutions.
    We also proposed that, for purposes of the definition of 
``hospital,'' a State includes each of the several States, the District 
of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and 
the Northern Mariana Islands. We stated that this proposed definition 
of State would be consistent with how that term is defined under 
section 2791(d)(14) of the PHS Act. We further stated that we believed 
that adopting this definition of ``State'' for purposes of section 
2718(e) of the PHS Act is appropriate because, unlike the other 
provisions in section 2718 which apply to health insurance issuers, 
section 2718(e) applies to hospitals. Therefore, it is distinguishable 
from the approach outlined in the July 2014 letters \36\ to the 
Territories regarding the PHS Act health insurance requirements 
established or amended by Public Law 111-148 and Public Law 111-152.
---------------------------------------------------------------------------

    \36\ The July 2014 letters are available at: https://www.cms.gov/CCIIO/Resources/Letters/index.html#Health%20Market%20Reforms.
---------------------------------------------------------------------------

    Our proposed definition focused on whether or not the institution 
is licensed by the State or under applicable local law as a hospital, 
or is approved, by the agency of such State or locality responsible for 
licensing hospitals, as meeting the standards established for such 
licensing. As such, a ``hospital'' under our proposed definition 
includes each institution that satisfies the definition, regardless of 
whether that institution is enrolled in Medicare or, if enrolled, 
regardless of how Medicare designates the institution for its purposes. 
Thus, we noted that the proposed definition includes critical access 
hospitals (CAHs), inpatient psychiatric facilities (IPFs), sole 
community hospitals (SCHs), and inpatient rehabilitation facilities 
(IRFs), which we previously identified in our guidelines as being 
hospitals for the purposes of section 2718(e) of the PHS Act,\37\ as 
well as any other type of institution, so long as it is licensed as

[[Page 65531]]

a hospital (or otherwise approved) as meeting hospital licensing 
standards.
---------------------------------------------------------------------------

    \37\ Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ProspMedicareFeeSvcPmtGen/Downloads/Additional-Frequently-Asked-Questions-Regarding-Requirements-for-Hospitals-To-Make-Public-a-List-of-Their-Standard-Charges-via-the-internet.pdf.
---------------------------------------------------------------------------

    Finally, we noted that the proposed definition of ``hospital'' did 
not include entities such as ambulatory surgical centers (ASCs) or 
other non-hospital sites-of-care from which consumers may seek 
healthcare items and services. We discussed that, for example, non-
hospital sites may offer ambulatory surgical services, laboratory or 
imaging services, or other services that are similar or identical to 
the services offered by hospital outpatient departments. In the 
interest of increasing opportunities for healthcare consumers to 
compare prices for similar services and promoting widespread 
transparency in healthcare prices, we encouraged non-hospital sites-of-
care to make public their lists of standard charges in alignment with 
the proposed requirements so that consumers could make effective 
pricing comparisons.
    We invited public comments on our proposed definition of 
``hospital,'' which we proposed to codify at 45 CFR 180.20.
    Comment: A few commenters requested that CMS finalize the 
definition of hospital as proposed and applauded the agency's effort to 
provide a standard definition of hospital for the purposes of making 
standard charges public. One commenter agreed that the definition of 
hospital should not be limited to only those hospitals that participate 
in Medicare.
    Several commenters suggested that the proposed definition of 
hospital is too limited, and suggested that CMS expand the definition 
to include other providers, such as physicians, ASCs, clinics, 
community health centers, and skilled nursing facilities, in order to 
better educate consumers on prices for services furnished by all 
provider types. A few commenters generally suggested that CMS extend 
price transparency policies to all service providers and all places of 
service, not just hospitals or hospital settings. One commenter 
suggested that CMS expand the definition of hospital to include any 
facility that conducts surgery with anesthesia.
    In particular, a few commenters explained the need for ASCs to be 
transparent with their prices. One commenter noted that federally 
mandated payment and other policies continue to emphasize patients 
obtaining care in an outpatient setting instead of an inpatient acute 
care hospital and therefore the definition of hospital should reflect 
the greater role ASCs are taking in the healthcare system. Commenters 
also noted that ASCs provide similar services to hospitals and may 
therefore compete with hospitals. On the other hand, one commenter 
urged CMS to apply price transparency standards to ASCs to minimize 
incentives for hospitals to defer surgeries to new ASCs formed for the 
purpose of circumventing disclosure of the hospital's charges.
    Commenters took diverging positions on whether IRFs should be 
required to make public standard charges. A few commenters urged that 
IRFs be included among the entities required to make public standard 
charges. On the other hand, as described and addressed in Section 
II.B.2 of this final rule, a few commenters suggested that IRFs be 
exempt from the reporting requirements.
    Response: We thank the commenters that supported our proposed 
definition of hospital. We believe that our proposed definition of 
hospital, which we are finalizing, is a broad definition that will 
encompass all institutions recognized by a State as a hospital. Because 
section 2718(e) of the PHS Act applies to each hospital operating 
within the United States, we do not believe we have the authority to 
apply the price transparency requirements to non-hospital sites of 
care. For this reason, we decline to adopt commenters' suggestions that 
we expand the definition of hospital to include all service providers 
and places of service, including to all places of service that provide 
surgical services requiring anesthesia. We also decline the commenters' 
suggestions to narrow the scope of the definition of hospital, for 
instance to exclude IRFs where the IRFs otherwise meet the definition 
of hospital we are finalizing. We believe such an approach would not be 
consistent with section 2718(e) of the Act, which applies to each 
hospital operating in the United States. Given the importance of making 
public standard charge data to inform consumer healthcare decision-
making, we believe it is important to not overly constrict the 
definition of hospital, which might permit subsets of hospitals that 
meet the definition we are finalizing to avoid public disclosure of 
their standard charges.
    We defer to States' or localities' hospital licensing standards for 
the determination of whether an entity falls within the definition of 
hospital for the purposes of new 45 CFR part 180. Any facility licensed 
by a State or locality as a hospital, or that is approved by the agency 
of such State or locality responsible for licensing hospitals, as 
meeting the standards established for such licensing, would be 
considered a ``hospital'' for the purposes of section 2718(e) of the 
Act and therefore required to comply with the requirements to make 
public their standard charges in the form and manner required by this 
final rule. For this reason, we cannot provide an exhaustive list of 
institution types encompassed within State or locality hospital 
licensing laws.
    Regarding specific types of entities, however, we note that 
healthcare providers such as ASCs, physicians, or community health 
centers would not likely satisfy our specified definition of 
``hospital'' since they are not likely to be licensed by a State or 
locality as a hospital or to be approved by the agency of such State or 
locality responsible for licensing hospitals as meeting the standards 
established for such licensing. We recognize that ASCs provide many of 
the same services as hospitals and note that many ASCs already engage 
in price transparency efforts of their own. We have no knowledge that 
existing price transparency initiatives (those in states that already 
require hospitals to make public standard charges and our existing 
guidance that hospitals make public standard charges pursuant to 
section 2718(e) of the PHS Act) have engendered any shifts in business 
between hospitals and ASCs. However, we believe it is reasonable to 
assume that shifts to the most appropriate care setting may occur as 
referring providers and their patients seek out the highest value 
setting for their care.
    Comment: A few commenters requested clarification on how the 
requirements to make standard charges public and CMS compliance actions 
would apply to hospital outpatient services that are provided off-
campus, or in hospital-affiliated or hospital-owned clinics. One 
commenter asked whether all hospital locations under one CMS 
Certification Number (CCN) are a single hospital for the purpose of the 
proposal or whether they are considered separate locations. The 
commenter expressed concern that there is an absence of any connection 
between the CY 2020 OPPS/ASC proposed rule's definition of ``hospital'' 
and the CCN. The commenter expressed concern that this lack of clarity 
would hinder compliance with the proposal if finalized and lessen the 
impact of the proposed penalty.
    Response: We did not propose to define the term ``hospital'' with 
reference to the CCN, which is the hospital identification system we 
use for purposes of Medicare and Medicaid. As we discussed in the CY 
2020 OPPS/ASC proposed rule, we declined to base the definition of 
hospital on Medicare participation, as the statute states all hospitals 
operating within the United

[[Page 65532]]

States must make available a list of their standard charges.
    As discussed in section II.E.6 of this final rule, each hospital 
location operating under a single hospital license (or approval) that 
has a different set of standard charges than the other location(s) 
operating under the same hospital license (or approval) must separately 
make public the standard charges applicable to that location, as stated 
in 45 CFR 180.50. All hospital location(s) operating under the same 
hospital license (or approval), such as a hospital's outpatient 
department located at an off-campus location (from the main hospital 
location) operating under the hospital's license, are subject to the 
requirements in this rule.
    Final Action: We are finalizing our proposal to define ``hospital'' 
to mean an institution in any State in which State or applicable local 
law provides for the licensing of hospitals, that is licensed as a 
hospital pursuant to such law, or is approved, by the agency of such 
State or locality responsible for licensing hospitals, as meeting the 
standards established for such licensing. For purposes of this 
definition, a State includes each of the several States, the District 
of Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, and 
the Northern Mariana Islands. We are finalizing our proposal to set 
forth the definition of ``hospital'' in the regulations at new 45 CFR 
180.20.
2. Special Requirements That Apply to Certain Hospitals
    In the CY 2020 OPPS/ASC proposed rule (84 FR 39575 through 39576), 
we proposed that hospital standard charge disclosure requirements would 
not apply to federally-owned or operated hospitals, including Indian 
Health Service (IHS) facilities (including Tribally-owned and operated 
facilities), Veterans Affairs (VA) facilities, and Department of 
Defense (DOD) Military Treatment Facilities (MTFs), because, with the 
exception of some emergency services, these facilities do not provide 
services to the general public and the established payment rates for 
services are not subject to negotiation. Instead, each of these 
facility types is authorized to provide services only to patients who 
meet specific eligibility criteria. For example, individuals must meet 
the requirements enumerated at 42 CFR 136.22 through 136.23 to be 
eligible to receive services from IHS and Tribal facilities. Similarly, 
under 38 CFR 17.43 through 17.46, VA hospitals provide hospital, 
domiciliary, and nursing home services to individuals with prior 
authorization who are discharged or retiring members of the Armed 
Forces and, upon authorization, beneficiaries of the PHS, Office of 
Workers' Compensation Programs, and other Federal agencies (38 CFR 
17.43). In addition, federally-owned or operated hospitals such as IHS 
and Tribal facilities \38\ impose no cost-sharing, or, in the case of 
VA hospitals \39\ and DOD MTFs,\40\ little cost-sharing. With respect 
to such facilities where there is cost-sharing, the charges are 
publicized through the Federal Register, Federal websites, or direct 
communication and therefore known to the populations served by such 
facilities in advance of receiving healthcare services. Only emergency 
services at federally-owned or operated facilities are available to 
non-eligible individuals. Because these hospitals do not treat the 
general public, their rates are not subject to negotiation, and the 
cost sharing obligations for hospital provided services are known to 
their patients in advance, we believe it is appropriate to establish 
different requirements that apply to these hospitals.
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    \38\ Section 1680r(b) of the Indian Health Care Improvement Act 
(25 U.S.C. 1680r).
    \39\ VA cost-sharing information available at: https://www.va.gov/HEALTHBENEFITS/cost/copays.asp.
    \40\ MTF cost-sharing information available at: https://tricare.mil/Costs/Compare and https://comptroller.defense.gov/Portals/45/documents/rates/fy2019/2019_ia.pdf.
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    Specifically, we proposed to deem federally owned or operated 
hospitals that do not treat the general public (except for emergency 
services) and whose rates are not subject to negotiation, to be in 
compliance with the requirements of section 2718(e) of the PHS Act 
because their charges for hospital provided services are publicized to 
their patients (for example, through the Federal Register) (proposed 
new 45 CFR 180.30(b)). We also requested public comments on whether 
exceptions to our proposed requirements might be warranted for 
hospitals (for example, hospitals located in rural areas, CAHs, or 
hospitals that treat special populations) that are not federally owned 
or operated, while also ensuring that charges for the services provided 
by such hospitals are available to the public.
    Comment: Commenters diverged as to whether additional exceptions 
should be made for providers that meet the proposed definition of 
``hospital,'' such that these providers would not be required to make 
standard charges public. One commenter strongly recommended that CMS 
not allow any exceptions to requirements for entities that meet the 
proposed definition of ``hospital.''
    Other commenters requested that CMS exempt CAHs, rural hospitals, 
and SCHs from part or all requirements to make standard charges public. 
The commenters stated that the requirements would be challenging for 
small facilities and cited several justifications for this possible 
exemption, including that CAHs are already at a disadvantage when 
negotiating rates with third-party payers; they lack the implementation 
resources due to their size and reimbursement structure; and the 
likelihood of their experiencing operational disruptions as a result of 
diverting staff time and other resources to comply with the proposed 
requirements. On the other hand, one commenter specified that patients 
receiving care in CAHs and rural hospitals deserve to know how much 
services cost in advance.
    A few commenters argued that LTCHs and IRFs ought to be excluded or 
exempted from the requirement of having to make public their standard 
charges for a variety of reasons, including: (1) Commenters' belief 
that patients are unable to schedule LTCH and IRF services in advance; 
(2) patients treated in LTCHs and IRFs are there for follow-up care 
after a short-term acute stay in a hospital and the critical nature of 
the patients' condition, and the need for tailored treatment plans for 
complex conditions, would not lend itself to being shoppable; (3) 
imposing price transparency requirements on LTCHs will not serve the 
objectives of increased market competition or quality improvement since 
sometimes there is only one LTCH in a single market and there are fewer 
than 400 total LTCHs nationwide.
    One commenter requested that CMS exempt institutions and hospitals 
that are not enrolled in Medicare and which are not reimbursed under a 
prospective payment system.
    Response: Our definition of ``hospital'' is any institution in any 
State in which State or applicable local law provides for the licensing 
of hospitals, that is licensed as a hospital pursuant to such law or is 
approved, by the agency of such State or locality responsible for 
licensing hospitals, as meeting the standards established for such 
licensing. As we explained in section II.B.1 of this final rule, we 
defer to States' or localities' hospital licensing standards for the 
determination of whether an entity falls within the definition of 
hospital for the purposes of new 45 CFR part 180. We continue to 
believe this definition provides the best way to ensure that section 
2718(e) of the PHS Act applies to each hospital operating

[[Page 65533]]

within the United States. It also may help align the application of 
these requirements with State price transparency initiatives to the 
same institutions.
    We appreciate the operational, resource, and other concerns raised 
by commenters, however, to the extent that IRFs, CAHs, LTCHs, rural 
hospitals, and SCHs (among others) fall within our proposed definition 
of hospital, we believe this is appropriate because patients, or their 
caregivers, should have the opportunity to know in advance (as their 
circumstances permit) standard charges for these entities' items and 
services, to inform their healthcare decision-making. We decline to 
either exempt such hospitals from making public standard charges, or 
deem such hospitals as having met requirements for making public their 
standard charges.
    We recognize that some small hospitals, and rural hospitals, 
including CAHs and SCHs may face challenges in implementing these 
requirements, but we do not believe that such challenges are 
insurmountable.
    We also disagree with the commenters that suggest that services 
provided by LTCHs and IRFs are not shoppable. Patients, and their 
caregivers, seeking long term care or rehabilitation services may have 
the opportunity to shop for these services in advance, and we believe 
patients and caregivers should have access to consumer-friendly charge 
information for such facilities. We believe that such information could 
be used by patients or their caregivers to better inform their 
decision-making when a patient transfers from an acute care facility 
(that falls within our definition of ``hospital'') to a post-acute care 
facility (that also falls within our definition of ``hospital'').
    Further, we believe that patients with complex conditions, their 
caregivers, or both, may have a particular interest in using price data 
to inform healthcare decision-making. We believe that the data we are 
requiring hospitals to make public could inform healthcare decision-
making by patients with complex conditions, their caregivers, or both, 
even though they may require additional, or specialized treatment.
    We do not believe that the absence of competition for items or 
services in a market should excuse hospitals from making public 
standard charges that consumers may need to inform the cost of their 
care. We believe transparency in hospital prices is important to 
consumers' healthcare decision-making, regardless of the number of 
facilities in a particular market or nationwide.
    We also decline the commenter's suggestion to exempt institutions 
and hospitals from the requirements to make public standard charges if 
they are not enrolled in Medicare. As we explained in the CY 2020 OPPS/
ASC proposed rule, we believe that such an approach would unduly limit 
the applicability of the policies for hospitals to make public standard 
charges under section 2718(e) of the PHS Act (84 FR 39575).
    Final Action: We are finalizing as proposed to specify at 45 CFR 
180.30 provisions on the applicability of the requirements for making 
public standard charges. We are finalizing as proposed to specify in 45 
CFR 180.30(a) that the requirements to make public standard charges 
apply to hospitals as defined at 45 CFR 180.20.
    We received no comments on our proposal to deem federally owned or 
operated hospitals to be in compliance with the requirements to make 
public standard charges. Therefore, we are finalizing, as proposed, to 
specify in 45 CFR 180.30(b) that federally owned or operated hospitals 
are deemed by CMS to be in compliance with the requirements for making 
public standard charges, including but not limited to:
     Federally owned hospital facilities, including facilities 
operated by the U.S. Department of VA and MTF operated by the U.S. 
Department of Defense.
     Hospitals operated by an Indian Health Program as defined 
in section 4(12) of the Indian Health Care Improvement Act.
    We received no comments on our proposal that hospital charge 
information must be made public electronically via the internet. We are 
finalizing this requirement as proposed at 45 CFR 180.30(c).

C. Definition of ``Items and Services'' Provided by Hospitals

    Section 2718(e) of the PHS Act requires that hospitals make public 
a list of the hospital's standard charges for items and services 
provided by the hospital, including for DRGs. We proposed that, for 
purposes of section 2718(e) of the PHS Act, ``items and services'' 
provided by the hospital are all items and services, including 
individual items and services and service packages, that could be 
provided by a hospital to a patient in connection with an inpatient 
admission or an outpatient department visit for which the hospital has 
established a standard charge. Examples of these items and services 
include, but are not limited to, supplies, procedures, room and board, 
use of the facility and other items (generally described as facility 
fees), services of employed physicians and non-physician practitioners 
(generally reflected as professional charges), and any other items or 
services for which a hospital has established a charge.
    Our proposed definition included both individual items and services 
as well as ``service packages'' for which a hospital has established a 
charge. Every hospital maintains a file system known as a chargemaster, 
which contains all billable procedure codes performed at the hospital, 
along with descriptions of those codes and the hospitals' own list 
prices. The format and contents of the chargemaster vary among 
hospitals, but the source codes are derived from common billing code 
systems (such as the AMA's CPT system). Chargemasters can include tens 
of thousands of line items, depending on the type of facility, and can 
be maintained in spreadsheet or database formats.\41\ For purposes of 
section 2718(e) of the PHS Act, we proposed to define ``chargemaster'' 
to mean the list of all individual items and services maintained by a 
hospital for which the hospital has established a standard charge (at 
proposed new 45 CFR 180.20). Each individual item or service found on 
the hospital chargemaster has a corresponding ``gross'' charge (84 FR 
39578 through 39579). Each individual item or service may also have a 
corresponding negotiated discount, because some hospitals negotiate 
with third party payers to establish a flat percent discounted rate off 
the gross charge for each individual item and service listed on the 
chargemaster; for example, a hospital may negotiate a 50 percent 
discount off all chargemaster gross rates with a third party payer.
---------------------------------------------------------------------------

    \41\ Tompkins C, et al. The Precarious Pricing System For 
Hospital Services. Health Affairs. January/February 2006; 25(1). 
Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.25.1.45.
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    In contrast to the chargemaster, or so-called ``fee-for-service'' 
(FFS) price list, hospitals also routinely negotiate rates with third 
party payers for bundles of services, or ``service packages,'' in lieu 
of charging for each and every imaging study, laboratory test, or 
alcohol swab found on the chargemaster.\42\ Such service packages may 
have charges established on, for example, the basis of a common 
procedure or patient characteristic, or may have an established per 
diem rate that includes all individual items and services furnished 
during an inpatient stay. Some hospitals present ``self-pay package 
pricing'' for prompt same-day payment from healthcare consumers.

[[Page 65534]]

The hospital's billing and accounting systems maintain the negotiated 
charges for service packages which are commonly identified in the 
hospital's billing system by recognized industry standards and codes. 
For example, a DRG system may be used to define a hospital product 
based on the characteristics of patients receiving similar sets of 
[itemized] services.\43\ Medicare and some commercial insurers have 
adopted DRG classifications as a method of inpatient hospital payment. 
Other codes (for example, payer-specific codes, CPT or Healthcare 
Common Procedure Coding System (HCPCS) codes) are used by hospitals and 
payers to identify service packages based on procedures.
---------------------------------------------------------------------------

    \42\ Nichols LM, and O'Malley AS. Hospital Payment Systems: Will 
Payers Like The Future Better Than The Past? Health Affairs. 
January/February 2006; 25(1). Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.25.1.81.
    \43\ Mistichelli J. Diagnosis Related Groups (DRGs). Georgetown 
University. June, 1984. Available at: https://repository.library.georgetown.edu/handle/10822/556896.
---------------------------------------------------------------------------

    For purposes of section 2718(e) of the PHS Act, we proposed to 
define a ``service package'' to mean an aggregation of individual items 
and services into a single service with a single charge (proposed new 
45 CFR 180.20). In the CY 2020 OPPS/ASC proposed rule, we explained our 
belief that this was appropriate and consistent with section 2718(e) of 
the PHS Act because we believe the inclusion of DRGs as an item or 
service in section 2718(e) recognizes that hospital services can be 
provided, and charges billed, based on the service's individual 
component parts or as a more inclusive service package. While section 
2718(e) of the PHS Act specifically includes items and services grouped 
into DRGs as an example of the items and services for which hospitals 
must list their standard charges, we explained that our proposed 
definition of ``items and services'' should include not just all DRGs 
(as established under 1886(d)(4) of the SSA) but also all other service 
packages provided by the hospital, including, for example, service 
packages the hospital provides in an outpatient setting for which a 
hospital may have established a standard charge. Therefore, our 
proposed definition of ``items and services'' includes both individual 
items and services and service packages.
    We also included in our proposed definition of ``items and 
services'' provided by the hospital the services furnished by 
physicians and non-physician practitioners who are employed by the 
hospital. We explained our belief that the services the hospital 
provides through its employed physicians and non-physician 
practitioners are items and services provided by the hospital because 
such clinicians are employed by the hospital specifically so it can 
offer such services to its patients. In addition, the hospital 
establishes and negotiates the charges for the employed physician and 
non-physician services and then bills and retains the payment for the 
professional services of employed physicians and non-physician 
practitioners. We therefore proposed to include these services in our 
proposed definition of items and services provided by the hospital 
under section 2718(e) of the PHS Act, and for hospitals to make public 
the charges for the services of their employed physicians and non-
physician practitioners.
    We also considered including in our proposed definition of items 
and services the services provided by physicians and non-physician 
practitioners who are not employed by the hospitals, but who provide 
services at a hospital location. For example, a procedure performed in 
a hospital setting may involve anesthesiology services provided by a 
non-employed physician who has established his or her own charge for 
the service provided at a hospital location. These physicians and non-
physician practitioners may send a bill that is separate from the 
hospital bill, or they may elect to reassign their billing rights to 
the hospital that will send a single bill that includes both hospital 
charges and professional service charges. Often, healthcare consumers 
are not expecting an additional charge or are otherwise surprised when 
they receive bills from entities other than the hospital, or when 
charges for non-employed physicians and non-physician practitioners are 
higher than expected (for example, when a non-employed physician is 
out-of-network and the consumer's third party payer declines payment 
for those services for that reason). We explained our belief that the 
provision of such additional charge information would be exceptionally 
valuable to give consumers a more complete picture of the total amount 
they might be charged in connection with an inpatient admission or an 
outpatient department visit at a hospital location, potentially helping 
to address the widely recognized ``surprise billing'' issue. However, 
because physicians and non-physician practitioners who are not employed 
by the hospital are practicing independently, establish their own 
charges for services, and receive the payment for their services, we 
indicated we did not believe their charges for their services would 
fall within the scope of section 2718(e) of the PHS Act as they are not 
services ``provided by the hospital.''
    We welcomed comments on these proposals.
    Comment: A few commenters agreed with the proposed definition of 
``items and services'' including service packages. Many commenters, 
however, questioned the feasibility of providing standard charges for 
service packages, as they believe that it is neither feasible, nor 
technically possible, for a hospital to report data from its 
chargemaster as service packages. A few commenters also expressed 
concern that pricing for service packages as proposed presents a 
challenge because service packages are often unique to each payer, and 
the reimbursements negotiated with payers are not necessarily 
associated with a HCPCS code, DRG, National Drug Code (NDC), or 
Ambulatory Payment Classification (APC) as the proposed regulation 
anticipates.
    A few commenters stated that they believe CMS needs to provide 
guidance or a framework to help hospitals define outpatient service 
packages and attribute ancillary services to specific primary services. 
Another commenter asked if the definition of ``items and services'' was 
flexible enough to allow for different payment models ranging from 
episodic care that has a guarantee of follow-up care being included if 
a complication happens, to care models that include subscription-based 
contracts.
    Response: We thank commenters for their input on the proposal. We 
are finalizing the definition of ``items and services'' as proposed.
    As we explained in the CY 2020 OPPS/ASC proposed rule, some 
hospitals routinely negotiate rates with third party payers for bundles 
of services or ``service packages.'' We agree with commenters that the 
standard charge for a service package is not typically found on the 
hospital's chargemaster, which simply lists out all the individual 
items and services. Standard charges for service packages are 
negotiated between the hospital and payer and are identified by common 
billing codes (for example, DRGs or APCs) or other payer-specific 
identifiers that provide context to the type and scope of 
individualized items and services that may be included in the package. 
As explained in more detail in section II.D.3 of this final rule, the 
payer-specific charge the hospital has negotiated for a service package 
(also referred to as the `base rate') can be found in other parts of 
the hospital billing and accounting systems than the chargemaster, or 
in rate tables or the rate sheets found in hospital in-network

[[Page 65535]]

contracts with third party payers indicating the agreed upon rates for 
the provision of various hospital services.
    We decline to define outpatient service packages and attributed 
ancillary services because we believe this would be too prescriptive 
and each hospital may provide different outpatient service packages and 
ancillary services. We note, however, that we provide some additional 
guidance for how hospitals should display of payer-specific negotiated 
charges for hospital items and services (including service packages) 
and their ancillary services, as applicable, in sections II.F of this 
final rule.
    We also note that the definition of items and services that we are 
finalizing gives hospitals flexibility to display their standard 
charges for service packages that are unique to each of their payer-
specific contracts. Thus, a service package that has been negotiated 
with a third party payer to include treatment for complications or 
follow up care is included in our definition of hospital items and 
services.
    Comment: One commenter sought clarification on whether CMS is 
retaining the requirement in current CMS guidelines that PPS hospitals 
post a list of their standard charges for each Medicare Severity (MS)-
DRG.
    Response: We are finalizing policies that would supersede the 
current guidance, and require hospitals to make public their payer-
specific charges for items and services, including service packages as 
identified by DRG, APC, or other common billing code. CMS previously 
issued guidelines specifying that only hospitals paid under the 
Medicare IPPS (referred to as subsection (d) hospitals) would be 
required to establish (and update) and make public a list of their 
standard charges for each DRG established under section 1886(d)(4) of 
the SSA.\44\ In retrospect, we recognize that this guidance 
unnecessarily limited the reporting of DRGs by hospitals according to 
section 2718(e) of the PHS Act, which specifies that a hospital make 
public a list of the hospital's standard charges for items and services 
provided by the hospital, including for DRGs established under section 
1886(d)(4) of the SSA. As indicated in our proposed definition of 
``items and services,'' we interpret the statute to apply to not just 
individualized items and services, but also to service packages. We 
believe such service packages are identified by common billing codes 
(for example, DRG or APCs), not just MS-DRGs. We are therefore 
implementing new policies in these regulations. Additionally, as 
discussed in more detail in section II.D.3, we clarify that the 
standard charge associated with the DRG would be the base rate the 
hospital has negotiated with third party payers.
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    \44\ Available at: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/ProspMedicareFeeSvcPmtGen/Downloads/Additional-Frequently-Asked-Questions-Regarding-Requirements-for-Hospitals-To-Make-Public-a-List-of-Their-Standard-Charges-via-the-internet.pdf.
---------------------------------------------------------------------------

    Comment: A few commenters supported a definition of items and 
services that would include services of employed physicians and non-
physician practitioners (generally reflected as professional charges). 
A few commenters supported a more expansive definition of items and 
services that would require hospitals to post charges for all 
practitioners who affiliate with a hospital. Commenters who favored 
this approach typically stated that CMS should place hospitals in a 
position to be fully responsible for transparency around the entire 
bill, citing concerns about surprise billing where patients received a 
separate bill from medical practitioners not employed by the hospital.
    Response: We appreciate commenters support for the proposed 
definition of items and services which would include services of 
employed physicians and non-physician practitioners (generally 
reflected as professional charges). We also appreciate comments 
encouraging the adoption of an even broader definition of items and 
services that includes services for physicians and non-physician 
practitioners who are affiliated with the hospital. As stated in the CY 
2020 OPPS/ASC proposed rule, because physicians and non-physician 
practitioners who are not employed by the hospital are practicing 
independently, establish their own charges for services, and receive 
the payment for their services, we do not believe the charges for their 
services fall within the scope of section 2718(e) of the PHS Act as 
they are not services ``provided by the hospital.'' We note that in 
section II.F.2 of this final rule, we require hospitals to display 
their standard charges for shoppable services in a consumer-friendly 
manner, and we provided an example template for the format hospitals 
could use for this purpose. In section II.F of this final rule, we 
require hospitals to group the primary shoppable service with the 
ancillary services customarily provided by the hospital. We also 
strongly encourage and recommend that hospitals, for the sake of 
consumer-friendly presentation, indicate any additional ancillary 
services that are not provided by the hospital but that the patient is 
likely to experience as part of the primary shoppable service. We 
recommend and encourage hospitals to indicate that such services may be 
billed separately by other entities involved in the patient's care. We 
believe such disclosure may be helpful to enable consumers to identify 
when services of physicians or non-physician practitioners not employed 
by the hospital may be separately charged.
    Comment: Several commenters sought clarification on the term 
``employment,'' noting there are various relationships and employment 
arrangements (including, for example, full time employment by a 
hospital, or independent contractor arrangements). A few commenters 
described these arrangements. For example, one commenter stated that 
large academic medical centers may have faculty who are housed in a 
business entity affiliated with the hospital, but not necessarily 
employed by that hospital. The commenter also stated there may be 
instances where independent practices assign billing rights to the 
hospitals entity, but those practitioners are not considered employed 
by the hospital. A few commenters explained that in many instances, the 
employment of physicians and non-physician practitioners represent 
complicated legal organizational structures. Another commenter 
explained that it could be difficult to understand in what scenarios 
physicians are employed based on looking at the billing entity for 
professional services.
    Response: We appreciate the commenters' suggestions identifying 
examples of the variation and complexity in employment models and 
possible contracting relationships that may exists between hospitals 
and physicians, or entities employing physicians. Given such variation 
and complexity, we believe it is important to preserve flexibility for 
hospitals to identify employed physicians or non-physician 
practitioners under their organizational structure, and we decline at 
this time to codify a definition of ``employment.''
    Comment: Several commenters disagreed that services provided by 
physicians and non-physician practitioners employed by hospitals should 
be included in the definition of items and services. These commenters 
suggested that, under the proposed approach, hospitals that employ 
physicians and non-physician practitioners would be providing 
displaying prices that would not be comparable with prices of hospitals 
that do not employ, and therefore need not disclose, physician and non-
physician practitioner prices, and expressed

[[Page 65536]]

concern that this would result in consumer confusion. A few commenters 
believed hospitals that employ physicians and non-physician 
practitioners would be at a disadvantage under the proposed definition 
of ``items and services,'' as their standard charges would appear 
higher than hospitals that do not. One comment suggested that an 
unanticipated consequence of requiring price transparency only for 
employed providers could be hospitals moving capital and services into 
``partnerships'' in order to take advantage of the hidden pricing that 
such a partnership would enable.
    Response: We disagree with commenters who suggest that services for 
employed physicians should be excluded from the definition of items and 
services as we believe this information will be valuable to give 
consumers a complete picture of the total amount they might be charged 
by a hospital.
    We disagree with comments suggesting that hospital price 
transparency requirements would disadvantage those hospitals that 
employ physicians and non-physician practitioners as compared to 
hospitals that do not. As further discussed in section II.F. of this 
final rule, with respect to the requirement to make public certain 
standard charges for shoppable services in a consumer-friendly format, 
hospital employed physicians' and non-physician practitioners' services 
may be charged as ancillary services to a primary shoppable service. 
Under such circumstances, hospitals would list such ancillary services 
separately from the primary shoppable service. In Table 2, in section 
II.F of this final rule, we include an example for how hospitals could 
format and display their shoppable services. We also note that our 
final policies require that the standard charges for each shoppable 
service (including ancillary services) be listed separately, not summed 
(see section II.F. of this final rule). We therefore believe consumers, 
comparing shoppable services for multiple hospitals, will be able to 
distinguish whether or not the hospital standard charges include 
charges for services of physicians and non-physician practitioners.
    We also do not have sufficient information to conclude that a 
requirement for hospitals to disclose standard charges for services of 
employed physicians and non-physician practitioners is likely to result 
in a systematic change from the practice of employing physicians and 
non-physician practitioners to favoring other types of partnerships and 
employment arrangements. In developing our proposals for hospital price 
transparency, we drew from similar requirements of States and we are 
not aware that such price transparency requirements altered the mode by 
which hospitals employ physicians and non-physician practitioners.
    Comment: A few commenters suggested that CMS lacked the legal basis 
to establish a definition of hospital items and services that includes 
services of employed physicians and non-physician practitioners.
    Response: Section 2718(e) of the PHS Act requires hospitals to make 
public the hospital's standard charges for items and services provided 
by the hospital, including for DRGs. The term ``standard charges for 
items and services'' is not defined in section 2718. We believe the 
Secretary has the authority to define ``items and services.'' Since 
hospitals charge patients for the services of their employed physicians 
and non-physician practitioners, we believe it is reasonable for the 
Secretary to define items and services as including their services.
    Comment: One commenter expressed concern with requiring hospitals 
to make public standard charges for services of employed emergency room 
physicians, urging a cautious approach so as to not undermine the 
patient protections in place under the Emergency Medical Treatment and 
Labor Act (EMTALA). The commenter explained that EMTALA stipulates that 
a hospital may not place any signs in the emergency department 
regarding the prepayment of fees or payment of co-pays and deductibles 
that may have the chilling effect of dissuading patients from coming to 
the emergency department. That, the commenter said, could lead patients 
to leave prior to receiving a medical screening examination and 
stabilizing treatment without regard to financial means or insurance 
status. The commenter expressed concern that if the hospital attempts 
to provide pricing information to patients prior to stabilizing them, 
it would not only constitute an EMTALA violation, but it could also 
potentially cause the patient's health to deteriorate since it could 
delay the patient from receiving critical care. While the commenter 
noted that the penalties for violating EMTALA are steep, their larger 
concern was that if price transparency for emergency care is not 
approached carefully, a hospital could inadvertently put patients in 
the position of making life-or-death healthcare decisions based on 
costs.
    Several other commenters stressed how important it is that 
consumers know the cost of emergency services in non-life threatening 
circumstances. One commenter explained that he or she might have used 
price data (if available) to determine which hospital emergency room to 
go to for treatment of a non-life threatening condition. One commenter 
noted that in the case of an emergency, people would not have time for 
comparison of shoppable healthcare services.
    Response: We appreciate the comment expressing concern about 
potential interaction between EMTALA, or section 1867 of the SSA (42 
U.S.C. 1395dd), and the requirements for hospitals to make public 
standard charges under section 2718(e) of the PHS Act. However, we 
believe that the policies we finalize here that require hospitals to 
make public standard charges online are distinct from EMTALA's 
requirements and prohibitions and that the two bodies of law are not 
inconsistent and can harmoniously co-exist. To be clear, the price 
transparency provisions that we are finalizing do not require that 
hospitals post any signage or make any statement at the emergency 
department regarding the cost of emergency care or any hospital 
policies regarding prepayment of fees or payment of co-pays and 
deductibles. But we do believe that the policies we are finalizing, for 
hospitals to make public standard charges, offer consumers 
opportunities for informed decision-making by providing them with 
information about the cost of care which, for example, they might 
consider prior to visiting a hospital emergency department for 
treatment of a non-life threatening condition.
    Comment: One commenter believed that there should be better patient 
education to go along with the requirements for listing standard 
charges related to items and services and service packages.
    Response: We note that this rule does not preclude hospitals from 
taking additional measures to educate their patient populations on the 
data they make publicly available.
    Final Action: We are finalizing, as proposed, the meaning of 
``items and services'' at new 45 CFR 180.20. In the CY 2020 OPPS/ASC 
proposed rule, we had included several examples of items and services 
within the definition; for clarity, we are finalizing a technical 
change to enumerate these examples at 45 CFR part 180.20.
    Accordingly, items and services means all items and services, 
including individual items and services and service packages, that 
could be provided by a hospital to a patient in connection

[[Page 65537]]

with an inpatient admission or an outpatient department visit for which 
the hospital has established a standard charge. Examples include, but 
are not limited to the following:
    (1) Supplies and procedures.
    (2) Room and board.
    (3) Use of the facility and other items (generally described as 
facility fees).
    (4) Services of employed physicians and non-physician practitioners 
(generally reflected as professional charges).
    (5) Any other items or services for which a hospital has 
established a standard charge.

D. Definitions for Types of ``Standard Charges''

1. Overview and Background
    Under our current guidelines related to section 2718(e) of the PHS 
Act (as discussed in the FY 2019 IPPS/LTCH PPS proposed rule and final 
rule (83 FR 20164 and 41144, respectively)), a hospital may choose the 
format it uses to make public a list of its standard charges, so long 
as the information represents the hospital's current standard charges 
as reflected in its chargemaster.
    As we explained in the CY 2020 OPPS/ASC proposed rule, we received 
feedback from several commenters in response to the 2018 requests for 
information (RFIs), including hospitals and patient advocacy 
organizations, who indicated that gross charges as reflected in 
hospital chargemasters may only apply to a small subset of consumers; 
for example, those who are self-pay or who are being asked to pay the 
chargemaster rate because the hospital is not included in the patient's 
insurance network. We explained that stakeholders also noted that the 
charges listed in a hospital's chargemaster are typically not the 
amounts that hospitals actually charge to consumers who have health 
insurance because, for the insured population, hospitals charge amounts 
reflect discounts to the chargemaster rates that the hospital has 
negotiated with third party payers. Further, with respect to patients 
who qualify for financial assistance or who pay in cash, commenters on 
the RFIs pointed out that some hospitals will charge lower amounts than 
the rates that appear on the chargemaster. Adding to the complexity, a 
few commenters noted that hospitals often package items and services 
and charge a single discounted negotiated amount for the packaged 
service. For example, as discussed in II.C. of this final rule, instead 
of itemizing and charging for each individual hospital item or service 
found on the chargemaster, a hospital may identify a primary common 
condition or procedure and charge a single negotiated or ``cash'' 
amount for the primary common condition or procedure that includes all 
associated items and services that are necessary for treatment of the 
common condition or to perform the procedures. We stated that we 
believed these comments illustrated a fundamental challenge of making 
healthcare prices transparent in general, and specifically with respect 
to the issue of how we should best implement section 2718(e) of the PHS 
Act; simply put, hospitals do not offer all consumers a single 
``standard charge'' for the items and services they furnish. Rather, 
the ``standard charge'' for an item or service (including service 
packages) varies depending on the circumstances particular to the 
consumer (84FR 39577 through 39578).
    As discussed in the CY 2020 OPPS/ASC proposed rule, in developing 
our proposals in this rulemaking we took into account the comments we 
received from the 2018 RFIs responding to our question about how 
``standard charges'' should be defined. We indicated in the CY 2020 
OPPS/ASC proposed rule that we believed the variety of suggested 
definitions reflected and supported our assessment that hospitals can 
have different standard charges for various groups of individuals. We 
stated that, in general, for purposes of 2718(e) of the PHS Act, we 
believed a standard charge could be identified as a charge that is the 
regular rate established by the hospital for the items and services 
provided to a specific group of paying patients. Therefore, we 
considered what types of standard charges may reflect certain common 
and identifiable groups of paying patients and we proposed to define 
standard charges to mean ``gross charges'' and ``payer-specific 
negotiated charges,'' and to codify this definition in proposed new 45 
CFR 180.20. As explained in the CY 2020 OPPS/ASC proposed rule, our 
proposal to define standard charges as gross charges and payer-specific 
negotiated charges reflects the fact that a hospital's standard charge 
for an item or service is not typically a single fixed amount, but, 
rather, depends on factors such as who is being charged for the item or 
service, and particular circumstances that apply to an identifiable 
group of people, including, for example, healthcare consumers that are 
insured members of third party insurance products and plans that have 
negotiated a rate on its members' behalf.
    Further, in the CY 2020 OPPS/ASC proposed rule, we acknowledged 
that the proposed definition of hospital ``standard charges'' would be 
limited to only two of the many possibilities that exist for defining 
types of hospital ``standard charges,'' and we discussed other 
potential definitions that we considered, and sought public input and 
comment on the alternatives and additional types of standard charges 
that may be useful to consumers.
    Comment: Many commenters, in particular, individuals and those 
representing independent medical practices, expressed frustration 
related to the opacity of healthcare prices, stating that hospital 
charges are often unreasonable. Commenters described hospital billing 
practices as a ``shell game'' and asserted that the use of overly 
inflated chargemaster rates to negotiate with payers is an unfair 
practice that leads patients to get ``gouged.'' One commenter noted 
that the ``lack of price transparency circumvents market forces that 
seek to keep prices within reasonable limits [which has] resulted in 
the creation of a dysfunctional market with rapidly increasing and 
excessive charges for which the consumer is ultimately responsible.'' 
Others similarly asserted that the lack of availability of healthcare 
costs leads to ``predatory pricing'' on the part of hospitals and 
insurance companies, and noted that millions of Americans have gone 
bankrupt because they get ``stuck with bills that are beyond 
reasonable.''
    Many commenters asserted that hospital disclosure of standard 
charges would be critical to bring accountability and increased value 
to the healthcare industry; however, many other commenters stated that 
they believed the movement toward value-based care could or would be 
harmed by hospital disclosure of standard charges, specifically, as a 
result of disclosure of payer-specific negotiated charges.
    Many commenters were highly supportive of our proposals and, in 
particular, of the proposals to require hospitals to make public both 
gross and payer-specific negotiated charges. Many commenters asserted 
that such disclosure is informative and necessary for consumers and 
will improve the value of healthcare for consumers. For example, 
commenters indicated that knowing the rate the insurer had negotiated 
on their behalf would be essential for patients with co-insurance and 
HDHPs to help determine their out-of-pocket cost estimates in advance. 
Other commenters indicated that the gross charge or cash rate was 
important for self-pay patients (with or without insurance) to compare 
facility prices.
    Many other commenters, however, disagreed with our proposals,

[[Page 65538]]

questioning the legal authority for requiring disclosure of more than 
one type of hospital standard charge as proposed, with objections 
focused mainly on the proposed definition and requirement to disclose 
payer-specific negotiated charges.
    Many commenters supported the addition of, or offered alternative 
suggestions for, necessary types of standard charges such as the 
discounted cash price and variations of the de-identified minimum, 
median, or maximum negotiated charge.
    Response: Hospital bills can be mystifying, even to those who have 
been in healthcare-related professions for years; some hospital charges 
are market-based, while others are not. There are three broad types of 
hospital rates, depending on the patient and payer: (1) Medicaid and 
Medicare FFS rates; (2) Negotiated rates with private insurers or 
health plans; and (3) Uninsured or self-pay.
    Medicaid FFS rates are dictated by each State and tend to be at the 
lower end of market rates. Medicare FFS rates are determined by CMS and 
those rates tend to be higher than Medicaid rates within a state. 
Privately negotiated rates vary with the competitive structure of the 
geographic market and usually tend to be somewhat higher than Medicare 
rates, but in some areas of the country the two sets of rates tend to 
converge.
    Chargemaster (gross) rates charged to self-pay individuals bear 
little relationship to market rates, are usually highly inflated,\45\ 
and tend to be an artifact of the way in which Medicare used to 
reimburse hospitals. Under the old system, the more services a hospital 
provided and longer a patient's stay, the greater the reimbursement. 
Congress, recognizing that the reimbursement system created 
disincentives to provide efficient care, enacted in 1983 a prospective 
payment system. The primary objective of the prospective payment system 
is to create incentives for hospitals to operate efficiently and 
minimize unnecessary costs while at the same time ensuring that 
payments are sufficient to adequately compensate hospitals for their 
legitimate costs in delivering necessary care to Medicare 
beneficiaries.
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    \45\ Richman BD, et al. Battling the Chargemaster: A Simple 
Remedy to Balance Billing for Unavoidable Out-of-Network Care. Am J 
Manag Care. 2017;23(4):e100-e105. Available at: https://www.ajmc.com/journals/issue/2017/2017-vol23-n4/battling-the-chargemaster-a-simple-remedy-to-balance-billing-for-unavoidable-out-of-network-care.
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    To partly compensate hospitals for certain overly costly 
hospitalizations, hospitals may receive an ``outlier'' payment which is 
based on the hospital's billed charges, adjusted to cost, in comparison 
to the payment that would otherwise be received and an outlier 
threshold. See 42 CFR 412.84. To determine whether an individual case 
would qualify for an outlier payment, the hospital's cost-to-charge 
ratio is applied to the covered charges to estimate the costs of the 
case. In the late 1990s, many hospitals began manipulating or gaming 
that ratio to make it easier to qualify for outlier payments. The 
larger the charges, the smaller the ratio, but it takes time for the 
ratio to be updated. Thus, by way of example, if a hospital had a cost-
to-charge ratio 1 to 5, or 20 percent, then a pill which cost the 
hospital $1 to purchase might be billed to a patient at $5. However if 
the hospital doubled the charge to the patient to $10, the 
corresponding change in its ratio would take time to be updated. Its 
costs might look like $2 instead of $1 in the interim. Rule changes 
have reduced such manipulation. Nevertheless, some hospitals' charges 
do not reflect market rates, and these can come into play when a 
hospital bills a self-pay patient. Hospital bills that are generated 
off these chargemaster rates can be inherently unreasonable when judged 
against prevailing market rates.
    As premiums under the ACA have become less affordable,\46\ many 
individuals, both with and without insurance, have large unpaid 
hospital bills. Some hospitals, including some that are categorized as 
charitable, have responded by instituting collection actions against 
those patients. As the number of these suits have proliferated, many 
states courts have had to grapple with hospital charging systems in 
order to judge whether a given set of charges was reasonable. There are 
several potential metrics for assessing reasonableness of a hospital's 
charge in a given case as an alternative to the chargemaster (gross) 
rates described above. These include the rate Medicare would have paid 
for those same services, the amount hospitals are supposed to charge 
needy patients who lack insurance ``not more than the amounts generally 
billed to individuals who have insurance covering such care'' (see IRC 
501(r)(5)(A) or the amounts billed consistent with the financial 
assistance policy each non-profit hospital is requires to have (see IRC 
501(r)(4)).
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    \46\ NCSL website, Health Insurance: Premiums and Increases, at 
http://www.ncsl.org/research/health/health-insurance-premiums.aspx.
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    We continue to believe that the public posting of hospital standard 
charge information will be useful to the public, including consumers 
who need to obtain items and services from a hospital, consumers who 
wish to view hospital prices prior to selecting a hospital, clinicians 
who use the data at the point of care when making referrals, and other 
members of the public who may develop consumer-friendly price 
transparency tools or perform analyses and make policy to drive value-
based care. In the CY 2020 OPPS/ASC proposed rule, we stated that we 
believed these proposed requirements would represent an important step 
towards putting healthcare consumers at the center of their healthcare 
and ensuring they have access to the hospital standard charge 
information they need. Additionally, as stated in the CY 2020 OPPS/ASC 
proposed rule, we believe that requiring transparency of hospital 
charges will drive competition, which, in turn, may have the effect of 
not only lowering hospital charges for the most vulnerable consumers 
and those with the least market power to negotiate prices, but also for 
consumers who have access to charges negotiated on their behalf by a 
third party payer.
    We also continue to believe that price transparency will lead to 
lower costs for consumers and better quality of care. As stated in the 
CY 2020 OPPS/ASC proposed rule, many empirical studies have 
investigated the impact of price transparency on markets, with most 
research showing that price transparency leads to lower and more 
uniform prices, consistent with predictions of standard economic 
theory. Further, evidence shows that healthcare quality is not often 
correlated with price.\47\ Traditional economic analysis suggests that 
if consumers have better pricing information for healthcare services, 
providers would face pressure to either lower prices or to provide 
better quality of care for the prices they charge.\48\ Much of the 
research evidence we considered in the development of these 
requirements and in the CY 2020 OPPS/ASC proposed rule are reprised in 
sections II.A, II.D.3, and in our Regulatory Impact Analysis (RIA) 
(section V). Because the drive towards value depends on access to both 
quality and cost information, we believe that disclosure of hospital 
standard charges fully aligns with and supports our drive

[[Page 65539]]

toward value care as one half of the value proposition. In other words, 
whereas hospital quality information is readily available to the 
public,49 50 hospital standard charge information is not. 
Disclosure of hospital standard charge information will therefore 
complement quality information so that consumers can make high value 
decisions about their care.
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    \47\ Hussey P, et al. The Association Between Health Care 
Quality and Cost A Systematic Review. Ann Intern Med. January 2013; 
158(1): 27-34. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4863949/.
    \48\ Ginsburg P. Shopping For Price In Medical Care. Health 
Affairs. 2007. Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.26.2.w208.
    \49\ https://www.medicare.gov/hospitalcompare/search.html.
    \50\ AHRQ website, Comparative Reports on Hospitals, at https://www.ahrq.gov/talkingquality/resources/comparative-reports/hospitals.html.
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    Section 2718 of the PHS Act provides authority to require 
disclosure of hospital standard charges. Specifically, section 2718(e) 
of the PHS Act requires each hospital operating within the United 
States for each year to establish (and update) and make public a list 
of the hospital's standard charges for items and services provided by 
the hospital, including for diagnosis-related groups established under 
section 1886(d)(4) of the SSA. In addition to section 2718(e) and 
section 2718(b)(3) (regarding enforcement), section 1102 of the SSA 
supports the requirements in this rule. Section 1102(a) of the SSA 
requires the Secretary to ``make and publish such rules and 
regulations, not inconsistent with this Act, as may be necessary to the 
efficient administration of the functions with which [he or she] is 
charged'' under the SSA. By its terms, this provision authorizes 
regulations that the Secretary determines are necessary to administer 
these programs. In our view, as discussed further below, there is a 
direct connection between transparency in hospital standard charge 
information and having more affordable healthcare and lower healthcare 
coverage costs. In addition, these requirements also promote the 
efficient administration of the Medicare and Medicaid programs.
    Since the PHS Act does not define ``standard charges'' for purposes 
of implementation of section 2718(e) of the PHS Act, we proposed to 
define standard charges by the regular rate established by the hospital 
for an item or service provided to a specific group of paying patients. 
The term ``rate'' is defined in the Oxford dictionary as ``a fixed 
price paid or charged for something, especially goods or services.'' We 
therefore use the terms ``rate'' and ``charge'' interchangeably 
throughout this final rule. We believe that reading the statute to 
permit disclosure of several types of charges (or ``rates'') that are 
standard for different identifiable groups of people is reasonable for 
several reasons. First, while there is a definition of ``charge'' in 
the SSA that is used for purposes of Medicare (as commenters noted and 
as discussed in more detail in II.D.2), there is not a definition of 
`standard charges' in either the PHS Act or the SSA. We believe that 
had Congress intended us to use the SSA definition of ``charges,'' 
Congress would have referenced that definition of ``charges'' and 
included this provision in the SSA, as opposed to the PHS Act. 
Alternatively, Congress could have indicated that hospitals make public 
their ``charges'' and not qualified the term by inserting ``standard'' 
in front of it. Moreover, we believe the statute contemplates 
disclosure of changes other than the hospital chargemaster rates 
because the statute requires hospitals to disclose their ``standard 
charges'' for items and services, including for diagnosis related 
groups (italicized for emphasis). This suggests that the statute 
contemplates disclosure of charges other than the list prices as found 
in the hospital chargemaster because the hospital chargemaster contains 
only list prices for individual items and services. Hospital 
chargemasters do not include list prices for service packages 
represented by common billing codes such as DRGs. Instead, ``standard 
charges'' for service packages are determined as a result of 
negotiations with third party payers.\51\ For these reasons and others 
articulated in the CY 2020 OPPS/ASC proposed rule, we believe the term 
``standard charges'' for purposes of implementing section 2718(e) of 
the PHS Act may be defined to mean the standard charges as they relate 
to different identifiable groups of people and to include charges other 
than those found in the hospital chargemaster.
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    \51\ Office of Attorney General, Commonwealth of Massachusetts. 
Examination of Health Care Cost Trends and Cost Drivers Pursuant to 
G.L. c. 12C, Sec.  17. (October 11, 2018). Available at: https://www.mass.gov/files/documents/2018/10/11/AGO%20Cost%20Trends%20Report%202018.pdf.
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    As there are many different identifiable groups of paying patients 
(some that are self-pay and others that are members of third party 
payer insurance plans), in the CY 2020 OPPS/ASC proposed rule, we 
defined two types of standard charges, specifically, the gross 
(chargemaster) charges and the payer-specific negotiated charges. As 
explained in section II.A. of this final rule, we continue to believe 
that gross charges found in the chargemaster as well as negotiated 
charges are both informative and necessary for consumers to understand 
their potential out-of-pocket cost obligations, but such information is 
not readily available to consumers. These two specific types of 
standard charges have the potential to inform two large identifiable 
groups of healthcare consumers who do not currently have ready access 
to hospital charge information, specifically those who have limited 
power to negotiate charges (for example, self-pay individuals) and 
those who rely on third party payers to negotiate charges on their 
behalf. We also continue to believe that hospital face only a limited 
burden to make publicly available these types of standard charges 
because good business practices necessitate that these charges be 
available, maintained, and in use in hospital billing and accounting 
systems.
    Section 2719 of the PHS Act requires non-grandfathered plans and 
issuers to provide a notice of adverse benefit determination \52\ 
(commonly referred to as an explanation of benefits (EOB)) to 
participants, beneficiaries, and enrollees after healthcare items or 
services are furnished and claims for benefits are adjudicated. We note 
that presentation of both gross charges and payer-specific negotiated 
charges is consistent with the standard charges found in a patient's 
EOB that health insurance plans are required to provide to patients 
following a healthcare service. EOBs include such data points as: The 
type of service provided; the amount the hospital billed for the 
service (which we define as the gross charge for purposes of 
implementing section 2718(e) of the PHS Act); any discount the patient 
received for using an in-network provider (which we define as the 
payer-specific negotiated charge for purposes of implementing section 
2718(e) of the PHS Act) or the allowed amount for out-of-network 
providers; the portion or amount the plan paid the hospital; and the 
remaining amount owed out-of-pocket and any portion of that amount 
applied toward the deductible. It is evident that while the first two 
sets of charge data are necessary for a consumer to understand their 
out-of-pocket obligations, that data are insufficient as the consumer 
must obtain additional information from his or her third party payer 
related to the circumstances of their particular insurance plan (for 
example, what portion of the payer-specific negotiated charges would be 
paid by the plan and

[[Page 65540]]

other plan dependencies such as the patient's co-insurance obligations 
or where the patient is in their deductible for the year). Both gross 
charges and payer-specific negotiated charges are therefore necessary 
starting points for patients with third party payer insurance to 
understand their out-of-pocket cost obligations, and hospitals have 
ready access to both. By making these two important types of standard 
charges public, consumers could have the information necessary to 
create what could be considered an EOB in advance of a service, rather 
than having to wait for months after services were rendered to 
understand the extent of their healthcare costs. We address the gross 
charges as a type of standard charge in section II.D.2 of this final 
rule. We address the payer-specific negotiated charge in section II.D.3 
of this final rule.
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    \52\ An adverse benefit determination means an adverse benefit 
determination as defined in 29 CFR 2560.503-1, as well as any 
rescission of coverage, as described in 29 CFR 2590.715-2712(a)(2) 
(whether or not, in connection with the rescission, there is an 
adverse effect on any particular benefit at that time). See 26 CFR 
54.9815-2719, 29 CFR 2590.715-2719 and 45 CFR 147.136. Plans subject 
to the requirements of ERISA (including grandfathered health plans) 
are also subject to a requirement to provide an adverse benefit 
determination under 29 CFR 2560.503-1.
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    Finally, we appreciate commenter support and suggestions for 
alternative types of standard charges and are finalizing three 
additional types of standard charges in response to comments. 
Specifically, we are finalizing the discounted cash price (as discussed 
in section II.D.4.c of this final rule), as well as the de-identified 
minimum negotiated charge and the de-identified maximum negotiated 
charge which are discussed in section II.D.4.d of this final rule.
    Final Action: After considering the public comments, we are 
finalizing as proposed our definition of standard charges at 45 CFR 
180.20 to mean the regular rate established by the hospital for an item 
or service provided to a specific group of paying patients. We are also 
finalizing two types of standard charges, gross charges and payer-
specific negotiated charges (as discussed in more detail in sections 
II.D.2 and II.D.3 of this final rule). Further, as a result of broad 
stakeholder support for the discounted cash price as an alternative 
type of standard charge because of its greater applicability to self-
pay individuals, we are adding the discounted cash price as a third 
type of standard charge (as discussed in more detail in section 
II.D.4.c of this final rule). In response to the many commenters who 
supported variations of the de-identified minimum, median and maximum 
negotiated charges, we are finalizing modifications to define the de-
identified minimum negotiated charge, and de-identified maximum 
negotiated charge as a fourth and fifth type of standard charge (as 
discussed in more detail in section II.D.4.d of this final rule). Each 
of these types of standard charges (the gross charge, the payer-
specific negotiated charge, the discounted cash price, the de-
identified minimum negotiated charge, and the de-identified maximum 
negotiated charge) and the comments received are discussed in more 
detail in sections II.D.2, II.D.3, and II.D.4.c and II.D.4.d of this 
final rule, respectively.
2. Definition of ``Gross Charges'' as a Type of Standard Charge
    We proposed that, for purposes of the first type of ``standard 
charge,'' a ``gross charge'' would be defined as the charge for an 
individual item or service that is reflected on a hospital's 
chargemaster, absent any discounts (at new 45 CFR 180.20). As we 
explained in the CY 2020 OPPS/ASC proposed rule (84 FR 39576 through 
39577), the hospital chargemaster contains a list of all individual 
items and services the hospital provides. The gross charges reflected 
in the chargemaster often apply to a specific group of individuals who 
are self-pay, but do not reflect charges negotiated by third party 
payers. We also noted that the chargemaster does not include charges 
that the hospital may have negotiated for service packages, such as per 
diem rates, DRGs or other common payer service packages, and therefore 
this type of standard charge would not include standard charges for 
service packages.
    We proposed to require hospitals to make public their gross charges 
because, in addition to applying to a specific group of individuals, 
based on research and stakeholder input, we believe gross charges are 
useful to the general public, necessary to promote price transparency, 
and necessary to drive down premium and out-of-pocket costs for 
consumers of healthcare services. For example, studies suggest that the 
gross charge plays an important role in the negotiation of prices with 
third party insurance products that are subsequently sold to 
consumers.\53\ Specifically, as hospital executives and others familiar 
with hospital billing cycles often note, hospitals routinely use gross 
charges as a starting point for negotiating discounted rates with third 
party payers, and higher gross charges have been found to be associated 
with both higher negotiated rates and, in turn, higher premiums and 
out-of-pocket costs for insured individuals.54 55 As such, 
gross charges are relevant to all consumers, including those with 
insurance coverage. We stated in the CY 2020 OPPS/ASC proposed rule 
that we believe that requiring transparency of hospital gross charges 
may drive competition, which, in turn, might have the effect of not 
only lowering hospital charges for the most vulnerable consumers and 
those with the least market power to negotiate prices, but also for 
consumers who have access to charges negotiated on their behalf by a 
third party payer.
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    \53\ Bai G and Anderson GF. Market Power: Price Variation Among 
Commercial Insurers for Hospital Services. Health Affairs. Oct 2018; 
37(10): 1615-1622. Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.2018.0567.
    \54\ Bai G and Anderson GF. Extreme Markup: The Fifty US 
Hospitals With The Highest Charge-To-Cost Ratios. Health Affairs. 
Jun 2015; 34(6): 922-928. Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.2014.1414.
    \55\ Batty M and Ippolito B. Mystery of The Chargemaster: 
Examining The Role Of Hospital List Prices in What Patients Actually 
Pay. Health Affairs. April 2017; 36(4): 689-696. Available at: 
https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.0986.
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    Additionally, we indicated in the CY 2020 OPPS/ASC proposed rule 
that third party developers of consumer price transparency tools can 
use gross charges in conjunction with additional information (such as 
an individual's specific insurance and benefit information and quality 
data) to develop and make available consumer-friendly out-of-pocket 
cost estimates that allow consumers to compare healthcare service 
prices across hospitals and other nonhospital settings of care. 
Moreover, we noted in the CY 2020 OPPS/ASC proposed rule (84 FR 39572 
through 39573) that research suggests that making such consumer-
friendly information available to the public has been demonstrated to 
reduce consumer healthcare costs. As such, we concluded that public 
access to hospital gross charges is critical to inform all patients 
(both self-pay and insured) of their choices and drive transparency in 
prices and proposed to codify the proposed definition of ``gross 
charges'' at new 45 CFR 180.20. We invited public comment on our 
proposal to define a type of ``standard charge'' as a ``gross charge'' 
and on our proposed definition of ``gross charge.''
    Comment: Several commenters specifically agreed with our proposal 
to include gross charges as a type of standard charges. A few 
commenters also stated that they believed gross charges should be the 
only definition of ``standard charge.'' Several commenters, however, 
disagreed with the proposed inclusion of gross charges as a type of 
standard charge due to their belief that the definition conflicts with 
the definition of ``charges'' used in CMS's Provider Reimbursement 
Manual Part 1 (PRM1). Several commenters emphasized the importance of 
CMS remaining consistent with its definitions of ``charges'' due to 
their belief that deviating from these definitions would undermine the 
accuracy of hospital cost

[[Page 65541]]

reports which is fundamental to the Medicare rate-setting process.
    Response: We thank commenters for their support of a definition of 
the first type of standard charge to be the ``gross charge'' and 
disagree with commenters who state that the gross charge should be the 
only standard charge. As further explained in section II.D.1 of this 
final rule, we believe the statute contemplates standard charges other 
than those found in the hospital chargemaster. Additionally, we sought 
comment last year on a definition of ``standard charges'' and, as a 
result of comments, we were persuaded a singular ``standard'' that 
applies to all identifiable groups of patients is not possible because 
groups of patients with third party payer insurance have different 
standard charges that apply to them than do patients without third 
party payer coverage. We therefore decline to adopt the several 
commenters' suggestions that we finalize the gross charge as the only 
type of hospital standard charge.
    Further, we do not believe our proposed definition of ``gross 
charges'' for purposes of implementing section 2718(e) of the PHS Act 
conflicts with definitions of ``charges'' found in the PRM1, which 
states ``Charges refer to the regular rates established by the provider 
for services rendered to both beneficiaries and to other paying 
patients. Charges should be related consistently to the cost of the 
services and uniformly applied to all patients whether inpatient or 
outpatient. All patients' charges used in the development of 
apportionment ratios should be recorded at the gross value; i.e., 
charges before the application of allowances and discounts 
deductions.'' \56\ In fact, we believe our definition of ``gross 
charge'' as the charge for an individual item or service that is 
reflected on a hospital's chargemaster, absent any discounts, is the 
same as the charges referenced in the PRM1 and that hospitals use to 
create cost reports for Medicare purposes. We further do not believe 
that the term ``charges'' as used in the PRM is in conflict because the 
term is defined for a specific purpose and use, that is, for purposes 
of Medicare cost reporting. For this reason, we disagree with 
commenters that our definition of ``gross charges'' as a type of 
standard charge in any way undermines the accuracy of hospital Medicare 
cost reports.
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    \56\ Part I, Chapter 22, Section 2202.4 of the Medicare Provider 
Reimbursement Manual https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Paper-Based-Manuals-Items/CMS021929.html.
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    Additionally, gross charges may also sometimes be referred to as 
``billed charges'' or ``billed amounts'' and appear on a patient's EOB 
as the first charge listed, and are the first step in explaining the 
patient's out-of-pocket obligations. When the consumer has no insurance 
and is self-pay, there is no EOB and the hospital often applies the 
gross charges to the consumer if no other pre-arrangement has been 
worked out (for example, if the consumer has not taken advantage of a 
discounted cash price offered by the hospitals).
    Comment: Regarding the need for and usefulness of gross charges as 
a type of standard charge, several commenters asserted that gross 
charge data would be meaningful to the public and necessary for full 
price transparency. A few commenters emphasized the positive difference 
this information would make if people had the ability to see 
information, for example one commenter stated that they would like to 
see the different levels of room charges on a list, stating that it 
would make a big difference for most people. A few commenters added 
that by seeing costs up front they could make an informed decision 
before receiving care, in order to both anticipate their bill and 
potentially shop around. A few commenters also expressed that by seeing 
all charges up front, consumers could determine whether ``self-pay'' 
would be a better deal for them than paying the insurance copay and 
deductible. By contrast, several commenters disagreed that gross 
charges would be applicable or useful to the public, because they 
believe that they do not represent what most consumers would actually 
pay (particularly those with third party payer coverage) and would not 
be meaningful to the public. One commenter stated that even in the 
hands of app developers, this data may have little relevance to insured 
individuals because the data wouldn't be presented in the context of 
the individual's health plan. One commenter disagreed with hospitals 
posting gross charges because they believe that in rural areas, the 
appearance of high prices may deter a consumer from seeking care.
    Response: We thank the commenters for their input. We agree with 
stakeholders who suggested that while the gross charge may be 
applicable to some self-paying patients, it is not the standard charge 
that applies to groups of insured patients. Even some self-paying 
patients may find that some hospitals offer a cash discounted price off 
their chargemaster rates (as discussed in more detail in section 
II.D.4.c of this final rule). Because of this, we are finalizing 
definitions for several types of standard charges that would be 
applicable to both self-pay patients as well as consumers with third 
party payer coverage. As we outlined in more detail in the CY 2020 
OPPS/ASC proposed rule (84 FR 39578 through 39579), research suggests 
that gross charges appear to play an important role in prices paid by 
consumers with third-party insurance products because higher gross 
charges are associated with higher negotiated rates, premiums, and 
consumer out-of-pocket costs. For consumers who are self-pay or who 
lack insurance, such information can be useful in advance of selecting 
a provider of healthcare services to help patients determine potential 
out-of-pocket cost obligations. This information may also have high 
value for researchers and other academics who can assess regional and 
national cost trends to determine the effectiveness of price 
transparency efforts, and for lawmakers to determine policy 
improvements that are necessary to drive toward value in healthcare. As 
noted in II.D.1 in this final rule, the presentation of gross charges 
is the starting point for insured patient's EOBs, which contain 
multiple charge and other data points necessary for patients to 
understand their out-of-pocket cost obligations. We therefore believe 
that disclosure of gross charges are useful to the general public and 
necessary to promote price transparency and reduce premiums and out-of-
pocket costs for consumers of healthcare.
    We recognize the unique challenges that rural hospitals face, but 
disagree that rural hospitals making standard charges public would 
deter patients from seeking necessary care, especially where there is 
already minimal competition with a CAH or sole community hospital. We 
believe instead that this information would allow consumers to include 
price considerations in their treatment plan for elective procedures, 
which may result in selecting the most appropriate setting for their 
care and increased patient satisfaction.
    Final Action: At new 45 CFR 180.20, we are finalizing as proposed a 
definition of gross charge, as a type of standard charge, to mean the 
charge for an individual item or service that is reflected on a 
hospital's chargemaster, absent any discounts.
3. Definition of ``Payer-Specific Negotiated Charge'' as a Type of 
Standard Charge
    As noted in section II.D.1. of this final rule, in general, for 
purposes of 2718(e), we believe a standard charge can be identified as 
a regular rate established

[[Page 65542]]

by the hospital for the items and services provided to a specific group 
of paying patients. We proposed that, for purposes of the second type 
of ``standard charge,'' the ``payer-specific negotiated charge'' would 
be defined as the charge that the hospital has negotiated with a third 
party payer for an item or service. We further proposed to define 
``third party payer'' for purposes of section 2718(e) of the PHS Act as 
an entity that, by statute, contract, or agreement, is legally 
responsible for payment of a claim for a healthcare item or service, 
and to codify this definition at new 45 CFR 180.20. As the reference to 
``third party'' suggests, this definition excludes an individual who 
pays for a healthcare item or service that he or she receives (such as 
self-pay patients).
    We proposed to focus on a second type of ``standard charge'' 
related to negotiated rates because most consumers (over 90 percent 
\57\) rely on a third party payer to cover a portion or all of the cost 
of healthcare items and services, including a portion or all of the 
cost of items and services provided by hospitals (in accordance with 
the terms and conditions of the third party payer's contract agreement 
with that consumer). Some third party payers (for example, FFS Medicare 
and Medicaid) currently make public the maximum rate they pay for a 
hospital item or service. However, many third party payers do not 
reveal their negotiated rates, even to individuals on behalf of whom 
they pay. Additionally, many contracts between third party payers and 
hospitals contain so-called ``gag clauses'' that prohibit hospitals 
from disclosing the rates they have negotiated with third party 
payers.\58\ Because consumers are not generally part of the 
negotiations or privy to the resulting negotiated rates, consumers 
often find it difficult to learn in advance of receiving a healthcare 
service the rate their third party payers may pay and subsequently what 
the individual's portion of the cost will be. Having insight into the 
charges negotiated on one's behalf is necessary for insured healthcare 
consumers to determine and compare their potential out-of-pocket 
obligations prior to receipt of a healthcare service. For example, if a 
healthcare consumer knows that he or she will be responsible for a co-
pay of 20 percent of the charges for a hospital service, he or she can 
compare the charges that the third party negotiated with hospital A and 
hospital B and, from that, the consumer can determine his or her 
expected out-of-pocket costs at hospital A versus hospital B.
---------------------------------------------------------------------------

    \57\ Berchick E, et al. Health Insurance Coverage in the United 
States: 2017. United States Census Bureau, September 2018. Available 
at: https://www.census.gov/content/dam/Census/library/publications/2018/demo/p60-264.pdf.
    \58\ King JS, Muir MA, Alessi SA. Clarifying Costs Can Increased 
Price Transparency Reduce Healthcare Spending? 4 William & Mary 
Policy Review 319 (2013). Available at: https://pdfs.semanticscholar.org/f604/1a0484c65c593525d0c07e040cf655697f2d.pdf.
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    In the CY 2020 OPPS/ASC proposed rule, we explained that knowing a 
negotiated charge is also important because a growing number of insured 
healthcare consumers are finding that some services are more affordable 
if the consumer chooses to forego utilizing their insurance product and 
simply pays out-of-pocket. For example, stakeholders and reports 
indicate that an increasing number of consumers are discovering that 
sometimes providers' cash discounts can mean paying lower out-of-pocket 
costs than paying the out-of-pocket costs calculated after taking into 
account a third party payer's higher negotiated 
rate.59 60 61 62 However, consumers cannot make such 
determinations without knowing the rate their third party payer has 
negotiated.
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    \59\ Beck M. How to Cut Your Health-Care Bill: Pay Cash. The 
Wall Street Journal. February 15, 2016. Available at: https://www.wsj.com/articles/how-to-cut-your-health-care-bill-pay-cash-1455592277.
    \60\ Rosato D. How Paying Your Doctor in Cash Could Save You 
Money. Consumer Reports. May 4, 2018. Available at: https://www.consumerreports.org/healthcare-costs/how-paying-your-doctor-in-cash-could-save-you-money/.
    \61\ Terhune C. Many hospitals, doctors offer cash discount for 
medical bills. Los Angeles Times. March 27, 2012. Available at: 
https://www.latimes.com/business/healthcare/la-fi-medical-prices-20120527-story.html.
    \62\ Weissmann D. `An Arm And A Leg': Can You Shop Around For A 
Lower-Priced MRI? Kaiser Health News. June 19, 2019. Available at: 
https://khn.org/news/an-arm-and-a-leg-can-you-shop-around-for-a-lower-priced-mri/.
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    For the reasons discussed above, we indicated that we agreed with 
2018 RFI commenters that gross charges (as a type of standard charge) 
could be applicable to one identifiable group of consumers (for 
example, self-pay) but are not enough for another large and 
identifiable group of consumers (for example, those with third party 
insurance) to know their charges for hospital items. Thus, we proposed 
that a type of ``standard charge'' is the ``payer-specific negotiated 
charge'' that would be defined as the charge (or rate) that a hospital 
has negotiated with a third party payer for an item or service. We 
stated that we decided to focus on negotiated rates rather than all 
payer rates because charges that are not negotiated (for example, FFS 
Medicare or Medicaid rates) are often already publicly available.
    In the CY 2020 OPPS/ASC proposed rule, we stated that it is clear 
that such data is necessary for consumers to be able to determine their 
potential out-of-pocket costs in advance, and that we believe the 
release of such data would help drive down healthcare costs (as 
discussed above and supported by recent price transparency research). 
However, we also stated we recognized that the impact resulting from 
the release of negotiated rates is largely unknown and that some 
stakeholders had expressed concern that the public display of 
negotiated rates, at least without additional legislative or regulatory 
efforts, may have the unintended consequence of increasing healthcare 
costs of hospital services in highly concentrated markets or as a 
result of anticompetitive behaviors.\63\
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    \63\ King JS, Muir MA, Alessi SA. Clarifying Costs Can Increased 
Price Transparency Reduce Healthcare Spending? 4 William & Mary 
Policy Review 319 (2013). Available at: https://pdfs.semanticscholar.org/f604/1a0484c65c593525d0c07e040cf655697f2d.pdf.
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    Moreover, we recognized in the CY 2020 OPPS/ASC proposed rule that 
requiring release of all payer-specific negotiated charges for all 
hospital items and services (both individual items and services as well 
as service packages) would mean releasing a large amount of data. To 
get a sense for the number of potential negotiated rates a hospital may 
have, we conducted an internal analysis of plans in the regulated 
individual and small group insurance markets under the ACA. Our 
analysis indicated that the number of products or lines of service per 
rating area ranges from approximately 1 to 200 in the individual market 
(averaging nearly 20 products or lines of service in each rating area), 
while in the small market group, the number ranges from 1 to 400 
(averaging nearly 40 products or lines of service in each rating area). 
We further noted our belief that most, if not all, hospitals maintain 
such data electronically because these data are used routinely for 
billing, and concluded that disclosure of such large amounts of charge 
information would present little burden for a hospital to 
electronically pull and display online in a machine-readable format (as 
discussed in more detail in the CY 2020 OPPS/ASC proposed rule at 84 FR 
39581 through 39585). We went on to explain that ensuring display of 
such a large amount of data in a consumer-friendly manner may pose 
greater challenges.
    In the CY 2020 OPPS/ASC proposed rule, we noted that, in displaying 
the payer-specific negotiated charges, hospitals would display all 
negotiated charges, including, for example, charges

[[Page 65543]]

negotiated with Medicare Advantage plans because such rates are 
negotiated. Conversely, hospitals would not include payment rates that 
are not negotiated, such as rates set by certain healthcare programs 
that are directly government-financed, for example, those set by CMS 
for FFS Medicare. We indicated, however, that we believed the display 
of a non-negotiated rate (for example, display of a Medicare and 
Medicaid FFS rate for an item or service) in conjunction with the gross 
charge and the payer-specific negotiated charges for the same item or 
service could be informative for the public and that the proposals 
would not preclude hospitals from displaying them.
    Finally, we proposed to codify the definition of ``payer-specific 
negotiated charge'' and ``third party payer'' at new 45 CFR 180.20. We 
invited public comment on our proposal to define a type of ``standard 
charge'' as a ``payer-specific negotiated charge.'' We also sought 
public comment on whether and how the release of such specific charge 
information could result in unintended consequences and on whether and 
how there may be different methods for making such information 
available to individuals who seek to understand what their out-of-
pocket cost obligations may be in advance of receiving a healthcare 
service.
    Comment: Many individual commenters and organizations, including 
patient/consumer advocates, IT and tool developers, medical 
associations, and small business plan entities, were strongly in favor 
of the release of payer-specific negotiated charges, indicating that 
such information is essential for individual decision-making. One 
commenter stated that the Administration's goal to improve the value of 
care relies on the disclosure of negotiated rates.
    By contrast, many commenters, including commenters from hospitals 
and large insurers, indicated that the release of gross charges or 
payer-specific negotiated charges would not be helpful or meaningful to 
consumers who want to know their individual out-of-pocket estimates. 
Many commenters noted that the release of gross and payer-negotiated 
charges is not sufficient by itself, highlighting consumers' need for 
additional information (such as co-pay, deductible, etc.) to get an 
individualized out-of-pocket estimate. Several commenters stated their 
belief that identification of the payer was not necessary for 
negotiated charges to be useful to the public. Several commenters 
raised concern related to the potential for patient confusion over the 
posting of negotiated charges, including if they try to determine how 
it impacts their financial obligation or over potential discrepancies 
between the amount the hospital makes public and the amount the insurer 
indicates to the patient in EOBs sent after the fact. Many commenters 
stated that they do not believe consumers will use this information.
    Response: We appreciate the response from stakeholders who 
expressed support for our proposed definition of a type of standard 
charge as the payer-specific negotiated charge. We agree for the policy 
reasons indicated in the CY 2020 OPPS/ASC proposed rule (84 FR 39579 
through 39580) and by commenters that public disclosure of payer-
specific negotiated charge (also known as negotiated rates) is 
essential for insured individuals' decision-making. For the reasons we 
have indicated, we disagree with commenters who indicated that payer-
specific negotiated charges are meaningless to consumers, but we do 
agree that a payer-specific negotiated charge does not, in isolation, 
provide a patient with an individualized out-of-pocket estimate. As 
explained in the GAO report we describe in section II.A. of this final 
rule, payer-specific negotiated charges are a critical piece of 
information necessary for patients to determine their potential out-of-
pocket cost estimates in advance of a service. As explained in section 
II.D.1 of this final rule, EOBs are designed to communicate provider 
charges and resulting patient cost obligations, taking third party 
payer insurance into account, and the payer-specific negotiated charge 
is a standard and critical data point found on patient's EOB. When a 
consumer has access to payer-specific negotiated charge information 
prior to receiving a healthcare service (instead of sometimes weeks or 
months after the fact when the EOB arrives), in combination with 
additional information from payers, it can help him or her determine 
potential out-of-pocket cost. Knowing a negotiated charge is also 
important because a growing number of insured healthcare consumers are 
finding that some services are more affordable when they elect to 
forego utilizing their health insurance product and, instead, pay out-
of-pocket. We further agree that consumers may be able to get a general 
sense of the cost of healthcare services by viewing de-identified 
negotiated rates, and we address this issue in more detail in section 
II.D.4.d of this final rule. However, we believe that having hospitals 
disclose payer-specific negotiated charges would provide consumers with 
more specific information for their particular circumstance and 
insurance plan.
    We disagree that there will be confusing discrepancies between the 
posted hospital charges and the patient's EOB because payer-specific 
negotiated rates are agreed upon, and, therefore, known in advance by 
both hospitals and third party payers. We suggest that hospitals access 
and review the rate sheets (also referred to as rate tables or fee 
schedules) that are typically included in the contracts hospitals have 
with third party payers in order to ensure the information they make 
public is consistent with their contracted rates.
    Finally, based on the multitude of comments we received from 
patient advocates and individual consumers, we believe that patients 
will use the charge information that hospitals make public. 
Additionally, hospital charge information can inform shared decision-
making and patient-centric referrals at the point of care. Recent 
research suggests that an increasing number of patients are seeking 
information from their providers about the anticipated costs of 
healthcare services. For example, in a recent national survey, a 
majority of patients, physicians, and employers are ready, or feel a 
responsibility, to have cost of healthcare conversations.\64\ Such 
conversations depend on the availability of standard charge 
information.
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    \64\ University of Utah Health website, Let's Talk About Money, 
https://uofuhealth.utah.edu/value/lets-talk-about-money.php.
---------------------------------------------------------------------------

    Comment: Many commenters, including hospital associations and large 
insurers, questioned CMS' legal authority to require disclosure of 
payer-specific negotiated charges. For example, many commenters 
believed that payer-specific negotiated rates are proprietary and 
requiring their disclosure would infringe upon intellectual property 
rights recognized by Congress through the Defend Trade Secrets Act of 
2016 (DTSA).\65\ A few commenters indicated that disclosure of payer-
specific negotiated charges was likely limited under the Freedom of 
Information Act (FOIA). Commenters argued that the FOIA protects trade 
secrets and confidential commercial or financial information against 
broad public disclosure. These commenters further asserted that the 
requirement to disclose payer-specific negotiated charges would violate 
the First Amendment, and, therefore, compelling disclosure would be 
unconstitutional. Several commenters pointed out that

[[Page 65544]]

some contracts between hospitals and payers include non-disclosure 
clauses, prohibiting the hospital from disclosing the rates they 
negotiated with third party payers.
---------------------------------------------------------------------------

    \65\ 18 U.S.C. 1836.
---------------------------------------------------------------------------

    Response: We believe that we have authority to define ``standard 
charges'' to mean the regular rate established by the hospital for an 
item or service provided to a specific group of paying patients, and 
that one type of standard charges is payer-specific negotiated charges. 
As explained in section II.D.2 of this final rule, the term ``standard 
charges'' is not defined in either the SSA or the PHS Act. We are also 
not aware of any historical usage of the term by the industry, and note 
that its association with the rates in a hospital chargemaster appears 
to have originated with our guidelines that took effect on January 1, 
2019. Additionally, we note that many stakeholders (including 
hospitals) have provided feedback that our current guidelines are 
neither sufficient to inform consumers (particularly those with 
insurance) what their charges for a hospital item or service will be, 
nor reflective of the financial liability that they will actually 
incur. We therefore concluded it would be reasonable to define payer-
specific negotiated charges as a type of ``standard charge.''
    We do not believe that the payer-specific negotiated charges 
hospitals would be required to disclose are proprietary or would 
constitute trade secrets. To the contrary, this information is already 
generally disclosed to the public in a variety of ways, for example, 
through State databases and patient EOBs. For example, New Hampshire 
has released payer and provider specific negotiated rates in its state 
operated HealthCost database. Maine has also been releasing negotiated 
rate information for over a decade. Additionally, the rates are 
routinely available to patients through EOBs. As noted elsewhere, that 
presentation of both gross charges and payer-specific negotiated 
charges is consistent with the standard charges found in a patient's 
EOBs that health insurance plans are required to provide to patients 
following a healthcare service. EOBs include such data points as: The 
type of service provided; the amount the hospital billed for the 
service (which we define as the gross charge for purposes of these 
requirements); any in-network discount an insured patient received 
(which we define as the payer-specific negotiated charge for purposes 
of these requirements); and the remaining amount owed out-of-pocket and 
any portion of that amount applied toward the patient's deductible. 
Additionally, negotiated rates are relatively easy to access, for 
example, by competitors in a local market, by price transparency 
vendors who use reverse engineering to determine negotiated rates for 
their tools, and by private entities that use crowdsourcing efforts to 
collect the standard charge information found on EOBs and display them 
online to assist the public in price shopping.\66\
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    \66\ https://clearhealthcosts.com/pricecheck-share-form/.
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    With respect to the Defend Trade Secrets Act of 2016, we do not 
believe it is applicable here, as it applies only to trade secrets that 
are ``misappropriated,'' which is defined by reference to, among other 
things, ``improper means,'' where there was a ``duty to maintain the 
secrecy,'' or ``accident or mistake.'' We do not believe any of the 
meanings of the term ``misappropriation'' under the Defend Trade 
Secrets Act apply to a circumstance where an agency rule requires 
disclosure of certain information. 18 U.S.C. 1836 et seq.
    Finally, to the extent commenters intended to cite the Trade 
Secrets Act, we note that it applies only to disclosures ``not 
authorized by law,'' in contrast to the circumstance here, where this 
final rule requires disclosure of certain information. 18 U.S.C. 1905. 
We would also note that, as a threshold matter, the Trade Secrets Act 
contemplates disclosure by a federal actor (``an officer or employee of 
the United States or of any department or agency thereof . . . ''), and 
not disclosures by private entities, as contemplated by this final 
rule.
    Consistent with price transparency and economics research 
(discussed in section II.D.1 and elsewhere in this final rule), we 
believe that the disclosure of payer-specific negotiated charges would 
serve a greater public interest and that ``concealing negotiated price 
information serves little purpose other than protecting dominant 
providers' ability to charge above-market prices and insurers' ability 
to avoid paying other providers those same elevated rates.'' \67\ For 
Maine, one State official indicated that ``to date, there is no 
evidence that the release of [Maine Health Data Organization] claims 
data has resulted in an anticompetitive market. In fact, quite the 
opposite. Transparency is what fosters a competitive market.'' \68\ 
Similarly, disclosure of claims data in New Hampshire has resulted in 
increased competition and reduced prices for healthcare services.\69\ 
Additionally, even if a contract between a hospital and a payer 
contained a provision prohibiting the public disclosure of its terms, 
it is our understanding that such contracts typically include 
exceptions where a particular disclosure is required by Federal law.
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    \67\ Catalyst for Payment Reform. ``Report Card on State Price 
Transparency Laws,'' July 2015. Available at: https://www.catalyze.org/wp-content/uploads/woocommerce_uploads/2017/04/2015-Report-Card-on-State-Price-Transparency-Laws.pdf.
    \68\ Gudiksen KL, et al. The Secret of Health Care Prices: Why 
Transparency Is in the Public Interest. California Health Care 
Foundation. July 2019. Available at: https://www.chcf.org/wp-content/uploads/2019/06/SecretHealthCarePrices.pdf.
    \69\ Brown ZY. Equilibrium Effects of Health Care Price 
Information. The Review of Economics and Statistics. Published 
October 2019; 101:4, 699-712. Available at: http://www-
personal.umich.edu/~zachb/zbrown_eqm_effects_price_transparency.pdf.
---------------------------------------------------------------------------

    With respect to FOIA, while Exemption 4 does protect confidential 
trade secrets or confidential commercial information, it does not apply 
to disclosures by private entities such as hospitals as contemplated by 
this rule.
    Finally, requiring hospitals to make public standard charges is 
consistent with First Amendment jurisprudence. Rules, such as this one, 
that require certain factual commercial disclosures pass muster under 
the First Amendment where the disclosure advances a government interest 
and does not unduly burden speech. When the government requires 
accurate disclosures in the marketing of regulated products under 
appropriate circumstances, it does not infringe on protected First 
Amendment interests. As the United States Supreme Court recognized in 
Zauderer v. Office of Disciplinary Counsel, 471 U.S. 626 (1985) and 
recently confirmed in Nat'l Inst. of Family and Life Advocates v. 
Becerra, 138 S. Ct. 2361, 2372, 2376 (2018) (``NIFLA''), required 
disclosures of factual, noncontroversial information in commercial 
speech may be subject to more deferential First Amendment scrutiny. 
Under the approach articulated in Zauderer, courts have upheld required 
disclosures of factual information in the realm of commercial speech 
where the disclosure requirement reasonably relates to a government 
interest and is not unjustified or unduly burdensome such that it would 
chill protected speech.\70\ As further discussed below, and cited 
elsewhere in this final rule, the required disclosures here advance the

[[Page 65545]]

government's substantial interest in providing consumers with factual 
price information to facilitate more informed health care decisions, as 
well as the government's substantial interest in lowering healthcare 
costs, as further discussed below.\71\ As discussed elsewhere in this 
final rule, each of the standard charges we have chosen specifically 
because they are relevant to a specific group of consumers. For 
example, the negotiated charges are directly relevant to patients 
covered by a payer's specific insurance product. We note that hospitals 
regularly use their payer-specific negotiated charges to determine 
insured patient out-of-pocket costs, and payer-specific negotiated 
charges are also regularly supplied to consumers on EOBs.
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    \70\ See Zauderer, 471 U.S. at 651; Milavetz v. United States, 
559 U.S. 229, 250, 252-53 (2010); NIFLA, 138 S. Ct. at 2376 (``[W]e 
do not question the legality of . . . purely factual and 
uncontroversial disclosures about commercial products.'').
    \71\ See generally, Pharm. Care Mgmt. Ass'n v. Rowe, 429 .3d 
294, 310 (1st Cir. 2005) (recognizing that the government interest 
in cost-effective health care justified disclosure of financial 
interests of pharmacy benefit managers); N.Y. State Rest. Ass'n v. 
N.Y. City Bd. Of Health, 556 F.3d 114, 134 (2d Cir. 2009) 
(recognizing that the government interest in ``promot[ing] informed 
consumer decision-making'' justified posting of calories on menus in 
chain restaurants).
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    Furthermore, these disclosures would neither ``drown[ ] out the 
[speaker's] own message'' or ``effectively rule[ ] out'' a mode of 
communication.\72\ Indeed, the requirement to provide standard charge 
information is not unduly burdensome where, as here, the hospital has 
the ability to convey other information of its choosing in the 
remainder of the website and other interactions with the public.
---------------------------------------------------------------------------

    \72\ NIFLA, 138 S. Ct. at 2378.
---------------------------------------------------------------------------

    Some comments assert that the rule should be evaluated under the 
intermediate scrutiny test for commercial speech articulated in Central 
Hudson Gas & Elec. Corp. v. Pub. Serv. Comm'n, 447 U.S. 557 (1980). 
Under that test, agencies can regulate speech where the regulation 
advances a substantial government interest and the regulation is no 
more extensive than necessary to serve that interest. Although many of 
these comments failed to offer any explanation as to why the more 
deferential review under Zauderer would not apply, one comment asserted 
that the Zauderer test is limited to disclosures that appear in 
advertising. We disagree. ``Although the Court in Zauderer may have 
referred repeatedly to advertising . . . , these references were 
contextual and not the sine qua non of Zauderer's reasoning. Zauderer 
did not base its holding on any notion of estoppel or equity, but on 
the lack of a significant constitutional interest in not disclosing 
factual and noncontroversial information to consumers.'' CTIA--Wireless 
Ass'n v. City of Berkeley, 158 F. Supp. 3d 897, 903 (N.D. Cal. 2016), 
aff'd, 928 F.3d 832, 842 (9th Cir. 2019).
    In any event, although we believe that Zauderer provides the 
appropriate framework for review, the rule also satisfies the elements 
of the Central Hudson test. The government interest here is clear. As 
discussed above, the required disclosures here advance the government's 
substantial interest in providing consumers with factual price 
information to facilitate more informed health care decisions. In 
addition, these disclosures advance the government's substantial 
interest in lowering healthcare costs. Healthcare costs continue to 
rise, and healthcare spending is projected to consume almost 20 percent 
of the economy by 2027.\73\ Hospital spending accounts for a 
substantial share of overall healthcare spending, and hospital charges 
for similar procedures can vary significantly from hospital to 
hospital. It is well-documented that the lack of transparency in 
hospital prices is a barrier that prevents consumers from understanding 
what their financial liability will be for hospital items and services, 
and that lack of knowledge not only affects their ability to shop for 
value, but also gives them no ability to proactively make decisions 
that could impact that financial liability. Additionally, as discussed 
in section II.D.1, these rising costs impact the Medicare Trust Funds 
and the amount paid to hospitals by Medicare.
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    \73\ CMS. National Health Expenditures Projections, 2018-2027: 
Forecast Summary. Available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/NationalHealthExpendData/Downloads/ForecastSummary.pdf.
---------------------------------------------------------------------------

    We note further that public comments received for this rule, 
healthcare consumers resoundingly expressed support for having access 
to hospital pricing information. This public sentiment is echoed in 
numerous studies and surveys show that consumers are concerned about 
the high cost of healthcare, want to be able to know prices prior to 
purchasing a healthcare service, and are frustrated by the lack of 
access to information on medical costs before receiving medical 
services.74 75 76 77 
78 Employers are also actively seeking healthcare pricing 
information for initiatives that drive reductions in healthcare 
costs79 80 81 and once they have 
access, they are able to drive healthcare value.\82\
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    \74\ Sinha SL, et al. ``The Demographics of Healthcare Price 
Transparency.'' Accenture Consulting, 2017. Available at: https://www.accenture.com/_acnmedia/pdf-69/accenture-health-the-demographics-of-healthcare-price-transparency-infographic.pdf.
    \75\ Foundation for Government Accountability. ``Poll: Voters 
Want The Right To Shop For Health Care.'' January 29, 2018. 
Available at: https://thefga.org/poll/right-to-shop-poll/.
    \76\ Schleifer D, et al. ``Still Searching: How People Use 
Health Care Price Information in the United States.'' Public Agenda, 
April 2017. Available at: https://www.publicagenda.org/wp-content/uploads/2019/09/PublicAgenda_StillSearching_Brief_2017.pdf.
    \77\ ``News Reports about a Weakening Economy Impacting How Some 
Patients Seek Medical Treatment.'' TransUnion. September 17, 2019. 
Available at: https://newsroom.transunion.com/news-reports-about-a-weakening-economy-impacting-how-some-patients-seek-medical-treatment/.
    \78\ Shih YT, and Chien C. A review of cost communication in 
oncology: Patient attitude, provider acceptance, and outcome 
assessment. Cancer, 123: 928-39. Available at: https://onlinelibrary.wiley.com/doi/full/10.1002/cncr.30423.
    \79\ Livingston S. Setting the bar for hospital prices: NC aims 
to tie reimbursement to Medicare for state employees. Modern 
Healthcare. March 2, 2019. Available at: https://www.modernhealthcare.com/hospitals/setting-bar-hospital-prices.
    \80\ Prager E. Consumer Responsiveness to Simple Health Care 
Prices: Evidence from Tiered Hospital Networks. September 21, 2017. 
Available at: https://pdfs.semanticscholar.org/053e/218f13dcd7f21002c623268151918fa708f0.pdf?_ga=2.190709035.1212076034.1563994376-1742025875.1563994376.
    \81\ Wu S, et al. Price Transparency for MRIs Increased Use Of 
Less Costly Providers And Triggered Provider Competition. Health 
Affairs. August 2014; 33(8). Available at: https://doi.org/10.1377/hlthaff.2014.0168.
    \82\ Sachdev G, et al. Self-Insured Employers Are Using Price 
Transparency To Improve Contracting With Health Care Providers: The 
Indiana Experience. Health Affairs. October 7, 2019. Available at: 
https://www.healthaffairs.org/do/10.1377/hblog20191003.778513/full/.
---------------------------------------------------------------------------

    The rule is also narrowly tailored to achieve the government's 
interest because there is a direct connection between the disclosure of 
hospital standard charge information and reduced healthcare costs and 
increased patient satisfaction. As we have described elsewhere in this 
final rule, we believe the regulations we are establishing are an 
important first step in providing information to consumers to support 
their healthcare decision-making. Although some States have made 
progress in promoting price transparency, most State efforts fall 
short. Further, existing hospital initiatives to make public their 
gross charges are not sufficient to provide insured consumers with the 
information applicable to them. Specifically, insured consumers need to 
understand the rates third party payers have negotiated (payer-specific 
negotiated charges) on their behalf for hospital items and services. 
There is emerging evidence that when healthcare consumers use 
healthcare pricing information, cost savings results for both inpatient 
and outpatient care without sacrificing

[[Page 65546]]

quality.83 84 85 86 
87 Moreover, cost savings drive competition 88 
89 and create a `spillover' effect benefitting all regional 
consumers.90 91 92 Additionally, 
providers are discovering that providing price estimates ahead of a 
healthcare service results in fewer billing-related complaints, 
decreased revenue losses for the provider, and overall increased 
patient satisfaction.93 94 Finally, we are not 
aware of any alternatives to the policies in this final rule that would 
be as effective in achieving these results. As discussed above and 
elsewhere in this final rule, hospital chargemaster disclosures do not 
include the charges applicable to insured consumers; and relying on 
individual hospitals for voluntary disclosures may not allow consumers 
to make comparisons between hospitals or sufficiently drive competition 
or create ``spillover'' effects. Similarly, relying on state-by-state 
initiatives would only benefit consumers in some states.
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    \83\ Robinson JC and Brown TT. Increases In Consumer Cost 
Sharing Redirect Patient Volumes And Reduce Hospital Prices For 
Orthopedic Surgery. Health Affairs. August 2013; 32(8). Available 
at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2013.0188.
    \84\ Blase B. ``How Price Transparency Would Revolutionize 
Healthcare.'' New York Post. October 12, 2019. Available at: https://nypost.com/2019/10/12/how-price-transparency-would-revolutionize-healthcare/.
    \85\ Rhoads J. Right to Shop for Public Employees: How Health 
Care Incentives are Saving Money in Kentucky. Foundation for 
Government Accountability. March 8, 2019. Available at: https://thefga.org/wp-content/uploads/2019/03/RTS-Kentucky-HealthCareIncentivesSavingMoney-DRAFT8.pdf
    \86\ Lieber EMJ. ``Does It Pay to Know Prices in Health Care?'' 
American Economic Journal. 2017, 9(1): 154-179. Available at: 
https://pubs.aeaweb.org/doi/pdfplus/10.1257/pol.20150124.
    \87\ Whaley C, et al. ``Association Between Availability of 
Health Service Prices and Payments for These Services.'' JAMA. 2014; 
312(16):1670-1676. Available at https://jamanetwork.com/journals/jama/fullarticle/1917438.
    \88\ Boynton A, and Robinson JC. Appropriate Use Of Reference 
Pricing Can Increase Value. Health Affairs. July 7, 2015. Available 
at: https://www.healthaffairs.org/do/10.1377/hblog20150707.049155/full/.
    \89\ Wu S, et al. Price Transparency for MRIs Increased Use Of 
Less Costly Providers And Triggered Provider Competition. Health 
Affairs. August 2014; 33(8). Available at: https://doi.org/10.1377/hlthaff.2014.0168.
    \90\ Brown ZY. Equilibrium Effects of Health Care Price 
Information. The Review of Economics and Statistics. Published 
October 2019; 101:4, 699-712. Available at: http://www-
personal.umich.edu/~zachb/zbrown_eqm_effects_price_transparency.pdf.
    \91\ Wu S, et al. Price Transparency for MRIs Increased Use Of 
Less Costly Providers And Triggered Provider Competition. Health 
Affairs. August 2014; 33(8). Available at: https://doi.org/10.1377/hlthaff.2014.0168.
    \92\ Blase B. ``How Price Transparency Would Revolutionize 
Healthcare.'' New York Post. October 12, 2019. Available at: https://nypost.com/2019/10/12/how-price-transparency-would-revolutionize-healthcare/.
    \93\ Otero HJ, et al. The Cost-Estimation Department: A Step 
Toward Cost Transparency in Radiology. JACR. February 2019; 16(2): 
194-95. Available at: https://www.jacr.org/article/S1546-1440(18)30981-5/fulltext.
    \94\ Hammer DC. ``Adapting customer service to consumer-directed 
health care: by implementing new tools that provide greater 
transparency in billing, hospitals can decrease collection costs 
while improving consumer satisfaction.'' Healthcare Financial 
Management. September 2006; 60(9). Available at: https://go.galegroup.com/ps/anonymous?id=GALE%7CA151440927&sid=googleScholar&v=2.1⁢=r&linkaccess=abs&issn=07350732&p=AONE&sw=w.
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    Comment: Many commenters expressed confusion related to the term 
payer-specific negotiated charge, indicating that such a hospital 
charge does not exist, or that the term is in conflict with terminology 
used within the healthcare industry, such as ``negotiated rates'' or 
the ``allowed amount.'' Several commenters asserted that hospitals do 
not negotiate ``payment rates,'' ``methodologies'' or ``allowed 
amounts'' with third party payers. Additionally, many commenters 
suggested in general usage (and according to one commenter, as defined 
by dictionary.com), the definition of ``standard'' means ``usual, 
common, or customary'' and asserted that payer-specific negotiated 
charges are not usual, common, or customary because they vary from 
payer to payer.
    Other commenters seemed to suggest that payer-specific charges 
could not be identified because, as one commenter noted, rates 
associated with DRGs can have three levels of payments based on the 
types of co-morbidities and can change based on change in a patient's 
condition or treatment plan.
    Response: As explained in the CY 2020 OPPS/ASC proposed rule, we 
could not identify an existing definition of ``standard charges,'' nor 
do we believe that a single ``standard charge'' can be identified for 
purposes of implementing section 2718(e) of the PHS Act, since factors 
such as insured status and the particular third-party payer plan drive 
the hospital charges borne by consumers. Therefore, we proposed a new 
definition for ``standard charges'' (which can also be called 
``rates'') that could apply to certain identifiable groups of 
individuals--specifically, individuals that are self-pay and 
individuals that have third party payer coverage. Thus, the charges the 
hospital has negotiated with a specific payer for a hospital item or 
service are the standard charges that apply to consumers with a 
specific plan through a specific insurer--in other words, the rate is 
the usual or common rate for the members of that plan. Therefore, one 
type of ``standard charge'' is the gross rate or charge found in the 
hospital chargemaster (which aligns with the PRM1's definition of 
``charges'') while another ``standard charge'' is the charge or rate 
that the hospital has negotiated with a third party payer for an item 
or service.
    When hospitals contract with a third party payer to be included in 
the plan's network, the hospital and insurer agree to specific, often 
discounted, prices that will apply to items or services furnished by 
the hospital. Best practice according to healthcare financial 
management experts and revenue cycle managers dictates that these 
payer-specific negotiated charges should be included in hospital 
contracts and listed in associated rate sheets (also called rate tables 
or fee schedules). Rate sheets include a list of all hospital items and 
services for which the hospital and payer have established regular 
rates (for example, the payer-specific negotiated charges that apply to 
hospital items and services). Hospitals also routinely keep and 
maintain such rate sheets to police and validate their reimbursements 
from payers as part of their revenue management cycle, holding payers 
accountable for the rates they have negotiated with the hospital. Such 
rates tables are also used by hospitals to compare against benchmarks 
(such as Medicare FFS rates) to determine where it is advantageous to 
renegotiate for higher amounts at the next opportunity. The contracted 
rate, sometimes called the ``negotiated rate,'' ``in-network amount,'' 
``allowed charges'' or ``negotiated discount'' can be significantly 
lower than what the hospital would charge an individual who did not 
have an insurance company negotiating discounts on his or her behalf, 
and this contracted rate is reflected in the patient's EOB after the 
healthcare service has been provided. As such, we do not believe the 
term ``payer-specific negotiated charges'' conflicts with any 
particular defined industry term or with the term ``charges'' as 
defined by Medicare. We further clarify that the payer-specific 
negotiated charge is the charge the hospital has negotiated with a 
third party for an item or service and does not refer to the amount the 
hospital is ultimately paid by the insurer or patient for an item or 
service. We believe that it is unlikely such amounts could be 
considered hospital standard charges and that it would prove very 
difficult for a hospital to make such amounts public in advance, given 
that, as commenters point out, the actual paid amounts are dependent on 
information that the hospital does not have without

[[Page 65547]]

contacting the insurer to determine the specifics of the patient's 
obligations under the patient's contract with the insurer.
    We note that the payer-specific negotiated charge for a DRG is the 
rate the hospital has negotiated for the DRG as a service package. We 
clarify that the requirement to make public the payer-specific 
negotiated charge for a DRG would mean the base rate that is negotiated 
by the hospital with the third party payer, and not the adjusted or 
final payment received by the hospital for a packaged service.
    Comment: In response to CMS' request for comment on the potential 
unintended consequences of releasing payer-specific charge information, 
many commenters asserted such disclosure would be confusing or even 
harmful to patients. For example, many commenters raised patient-
specific concerns that the policy would impact patients negatively by 
creating reliance on published rates when they could potentially be 
required to pay a higher out-of-pocket amount after the service, or 
could impact their health by confusing them or causing them to seek out 
cheaper care rather than the most effective or best quality care. One 
commenter expressed concern that display of payer-specific negotiated 
charges would shift the burden of understanding the costs of care from 
the hospitals/payers to consumers.
    Response: We thank the commenters for their input. We continue to 
believe that the public posting of hospital standard charge information 
will be beneficial to healthcare consumers who need to obtain items and 
services from a hospital, healthcare consumers who wish to view 
hospital prices prior to selecting a hospital, clinicians who use the 
data at the point of care when making referrals, and other members of 
the public who may develop consumer-friendly price transparency tools. 
This belief is supported by the many commenters who asserted the desire 
to have better access to, and understanding of, hospital charges. While 
we cannot discount the possibility that some consumers may find 
required hospital data disclosures confusing, we believe that the vast 
majority will find the increased availability of data, especially as it 
may be reformatted in consumer-friendly price transparency tools, 
overwhelmingly beneficial. Additionally as noted in section II.D.1 of 
this final rule, patients already receive this information in the form 
of EOBs, so we do not believe that advance notice of such standard 
charges would cause confusion beyond the confusion and frustration that 
currently exists for lack of such knowledge as expressed by commenters 
who feel they are ``flying blind.'' We also note that nothing in this 
final rule would prevent a hospital from engaging in patient education 
or otherwise assisting patients in understanding potential hospital 
charges in advance of receiving a hospital service, including 
articulating factors that may influence ultimate patient out-of-pocket 
costs or displaying quality information along with hospital charge 
information.
    Moreover, we strongly disagree that the display of payer-specific 
negotiated charges would effect some shift from hospitals/payers to 
consumers of the burden of understanding the costs of care, and we 
pointedly note that research,\95\ vast amounts of media reports,\96\ as 
well as many commenters to the CY 2020 OPPS/ASC proposed rule make 
clear that consumers already bear, and are exceptionally frustrated at 
the lack of publicly available data to help ease, that burden. We 
believe that requiring disclosure of hospital standard charges is a 
necessary first step to begin to alleviate consumers' frustration in 
understanding their potential cost of care in advance of the receipt of 
services.
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    \95\ Aliferis L. Variation in Prices for Common Medical Tests 
and Procedures. JAMA Intern Med. 2015; 175(1):11-12. Available at: 
https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/1935935.
    \96\ CBS News, Medical Price Roulette: CBS News investigates the 
lack of transparency in America's health care system. September 20, 
2019. Available at: https://www.cbsnews.com/news/medical-price-roulette-cbs-news-investigates-the-lack-of-transparency-in-americas-health-care-system/.
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    Finally, as noted by commenters, knowing the payer-specific 
negotiated charges can be highly beneficial for consumers in HDHPs and 
in plans where the consumer is responsible for a percentage (that is, 
co-insurance) of the negotiated rate. The most common coinsurance 
arrangement is 20/80 where the consumer is responsible for 20 percent 
of the payer-negotiated charges and the insurer covers the remaining 80 
percent. Both HDHPs and co-pays are becoming more common 
97 98 and create a great deal of uncertainty for consumers 
who can't access the rates hospitals and insurers have negotiated.
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    \97\ Cohen RA, et al. Health Insurance Coverage: Early Release 
of Estimates From the National Health Interview Survey, January-
March 2018. National Center For Health Statistics. Available at: 
https://www.cdc.gov/nchs/data/nhis/earlyrelease/Insur201808.pdf.
    \98\ Miller EG, et al. High-Deductible Health Plan Enrollment 
Increased From 2006 To 2016, Employer-Funded Accounts Grew In 
Largest Firms. Health Affairs. August 2018. Available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2018.0188.
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    Comment: Many commenters cautioned that disclosure of payer-
specific negotiated charges would increase, not decrease, healthcare 
costs in certain markets due to anticompetitive behaviors or increases 
in prices as a result of hospital knowledge of better rates negotiated 
by neighboring hospitals. Specifically, many commenters stated that 
disclosure of payer-specific negotiated charges could encourage price 
fixing and facilitate hospital collusion, causing prices to rise and 
thus harming consumers. Others raised concerns that publicly displaying 
insurer contract information would make it easier for insurers to 
circumvent antitrust safeguards, negatively affecting competition. 
Several commenters also argued that the inclusion of payer-specific 
negotiated charges as a standard charge would result in adverse market 
impacts on published rates and hamper hospitals' ability to negotiate 
fair and competitive payment rates with payers. One commenter more 
specifically argued that if all payer rates are disclosed, then every 
payer paying above the lowest rate would renegotiate to the lowest rate 
for every service, leaving hospitals with very little power to object. 
One commenter specifically suggested that CMS conduct a pilot study in 
only a few markets to determine the impact of the policy on negotiated 
prices before finalizing.
    Response: As indicated in our literature review and Economic 
Analyses (84 FR 39630 through 84 FR 39634), we concluded that 
implementing our proposals, most of which we are finalizing in this 
final rule, would yield many benefits with particular benefits for 
consumers who we believe have a right to know the cost of hospital 
services before committing to them and to be able to shop for the best 
value care and for employers who purchase healthcare for their 
employees.
    In general, our belief that accessible pricing information would 
reduce healthcare costs by encouraging providers to offer more 
competitive rates is consistent with predictions of standard economic 
theory.\99\ Economists have long concluded that markets work best when 
consumer prices reflect the actual cost to create and deliver the 
product.\100\ And a number of empirical

[[Page 65548]]

studies on price transparency in other markets shows that transparency 
initiatives tend to lead to more consistent, lower 
prices.101 102 However, some economists do not believe that 
healthcare price transparency will prevent rising costs due to the 
unique characteristics of the healthcare market.\103\
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    \99\ CRS Report for Congress: Does Price Transparency Improve 
Market Efficiency? Implications of Empirical Evidence in Other 
Markets for the Healthcare Sector. July 24, 2007. Available at: 
https://fas.org/sgp/crs/secrecy/RL34101.pdf.
    \100\ Murray R. Setting Hospital Rates to Control Costs and 
Boost Quality: The Maryland Experience. Health Affairs. September/
October 2009; 28(5). Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.28.5.1395.
    \101\ CRS Report for Congress: Does Price Transparency Improve 
Market Efficiency? Implications of Empirical Evidence in Other 
Markets for the Healthcare Sector. July 24, 2007. Available at: 
https://fas.org/sgp/crs/secrecy/RL34101.pdf.
    \102\ Kim M. The Effect of Hospital Price Transparency in Health 
Care Markets. 2011. Available at: https://repository.upenn.edu/dissertations/AAI3475926/.
    \103\ King JS, Muir MA, Alessi SA. Clarifying Costs Can 
Increased Price Transparency Reduce Healthcare Spending? 4 William & 
Mary Policy Review 319 (2013). Available at: https://pdfs.semanticscholar.org/f604/1a0484c65c593525d0c07e040cf655697f2d.pdf.
---------------------------------------------------------------------------

    In our discussion of available research and market impacts (84 FR 
39579 through 84 FR 39580, we took into account the potential for 
unintended consequences. Specifically, we noted that at minimum, our 
policy to require disclosure of payer-specific negotiated charges would 
release data necessary to better understand how the level of price 
dispersion in various healthcare markets impacts healthcare spending 
and consumer out-of-pocket costs. As noted in the CY 2020 OPPS/ASC 
proposed rule, negotiated charges for various procedures varies widely 
within and across geographic regions on the United States.\104\ Some 
factors associated with the level of hospital price dispersion in a 
geographic area are the hospital's size, healthcare demand, labor 
costs, and technology, although it was the hospital's market power 
(level of competition) that was most positively associated with high 
price dispersion.105 106 One researcher found that variation 
in prices across hospital referral regions is the primary driver of 
variation in spending per enrollee for those privately insured, while 
the quantity of care provided across hospital referral regions is the 
primary driver of variation in spending per beneficiary for 
Medicare.\107\ One major barrier to fully understanding healthcare 
price variation (and understanding the impact of transparency of 
healthcare pricing in general) is the lack of availability of 
negotiated charges to researchers and the public.\108\ We noted that 
our proposals would make hospital charge information available, which 
would generate a better understanding of (1) hospital price dispersion, 
and (2) the relationship between hospital price dispersion and 
healthcare spending. Understanding these relationships through release 
of pricing data could lead to downward price pressure on healthcare 
prices and reductions in overall spending system-wide, particularly in 
markets where there is insurer and hospital competition,\109\ or to 
considerable spending reductions and reduction of price 
dispersion.\110\
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    \104\ Kennedy K, et al. Health Care Cost Institute. Past the 
Price Index: Exploring Actual Prices Paid for Specific Services by 
Metro Area. Healthy Marketplace Index. April 30, 2019. Available at: 
https://www.healthcostinstitute.org/blog/entry/hmi-2019-service-prices.
    \105\ Cooper Z, et al. The Price Ain't Right? Hospital Prices 
and Health Spending on the Privately Insured. The Quarterly Journal 
of Economics. December 2015. Available at: https://pdfs.semanticscholar.org/cb9c/f90786cc39ddac6d88f3ba1074a7c2d5f0a5.pdf.
    \106\ Bai G and Anderson GF. Market Power: Price Variation Among 
Commercial Insurers For Hospital Services. Health Affairs. Oct 2018; 
37(10): 1615-1622. Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.2018.0567.
    \107\ Cooper Z, et al. The Price Ain't Right? Hospital Prices 
and Health Spending on the Privately Insured. The Quarterly Journal 
of Economics. December 2015. Available at: https://pdfs.semanticscholar.org/cb9c/f90786cc39ddac6d88f3ba1074a7c2d5f0a5.pdf.
    \108\ Ibid.
    \109\ Ho K and Lee RS. Insurer Competition and Negotiated 
Hospital Prices. August 2013. Available at: https://pdfs.semanticscholar.org/b6e9/11d7e171d3074b473439f93d377f4a4202bf.pdf.
    \110\ Brown ZY. An Empirical Model of Price Transparency and 
Markups in Health Care. August 2019. Available at: http://www-
personal.umich.edu/~zachb/
zbrown_empirical_model_price_transparency.pdf.
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    In their comprehensive analysis of the impact of regulations across 
more than 30 States requiring public access to the prices of hospital 
procedures, some researchers found that regulations lowered the price 
of shoppable procedures such as hip replacements by approximately five 
percent overall compared to prices for non-shoppable procedures such as 
appendectomies. They further found that half of the observed price 
reduction in charges was due to hospitals lowering their prices to 
remain competitive. This was particularly true for high priced 
hospitals and for hospitals in competitive urban areas.\111\ Research 
has also indicated that price transparency initiatives can decrease 
prices paid by consumers and insurers. One study found that following 
the introduction of a State-run website providing out-of-pocket costs 
for a subset of shoppable outpatient services reduced the charges for 
these procedures by approximately 5 percent for consumers, in part by 
shifting demand to lower cost providers.\112\ In addition, the study 
found that, following the introduction of the website, insurers over 
time experienced a 4-percent reduction in administrative costs for 
imaging services.
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    \111\ Christensen HB, Floyd E, and Maffett M. ``The Effects of 
Price Transparency Regulation on Prices in the Healthcare 
Industry.'' Available at: https://www.bakerinstitute.org/media/files/event/01ce2e80/HPF-paper-AHEC-Floyd.pdf.
    \112\ Brown ZY. Equilibrium Effects of Health Care Price 
Information. The Review of Economics and Statistics. Published 
October 2019; 101:4, 699-712. Available at: http://www-
personal.umich.edu/~zachb/zbrown_eqm_effects_price_transparency.pdf.
---------------------------------------------------------------------------

    Another possibility we considered was that transparency in payer-
specific negotiated charges could narrow the dispersion of prices in a 
market, meaning that knowledge of payer-specific charges may not only 
result in lowering prices for payers currently paying rates above the 
median, but could also increase prices for payers that are currently 
paying rates below the median. We considered whether making payer-
specific negotiated prices public could risk disrupting the ability for 
certain payers to extract aggressive discounts in the future, 
especially from providers in markets with limited competition. For 
example, a hospital providing an aggressive discount to a particular 
payer may become motivated to withdraw such discount to avoid divulging 
such information to other payers with whom they contract.
    Several studies of mandated price transparency in non-healthcare 
commodity markets have shown suppliers can use the information to their 
advantage in maximizing the prices they can charge in markets with 
limited competition or where commodities are not easily transferable 
across geographies.\113\ We noted that although there are no definitive 
conclusions on the effects of price transparency on markets, one study 
found that it can either increase or decrease prices depending on the 
strength of the bargainers and the size of the market.\114\ While price 
transparency gives buyers and sellers important information about the 
value of items and services, the effect may result in price increases 
by changing the incentives for buyers and sellers may also enable 
traders to observe deviations

[[Page 65549]]

from collusive practices. Allowing weaker bargainers to see prices 
negotiated by stronger bargainers will change incentives facing buyers 
and sellers, and can lead to price increases.
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    \113\ See for example, Congressional Research Service Report for 
Congress: Does Price Transparency Improve Market Efficiency? 
Implications of Empirical Evidence in Other Markets for the Health 
Sector. July 24, 2007. Available at: https://fas.org/sgp/crs/secrecy/RL34101.pdf.
    \114\ Congressional Research Service Report for Congress: Does 
Price Transparency Improve Market Efficiency? Implications of 
Empirical Evidence in Other Markets for the Health Sector. July 24, 
2007. Available at: https://fas.org/sgp/crs/secrecy/RL34101.pdf.
---------------------------------------------------------------------------

    In the absence of a national model, we looked to two States that 
previously enacted price transparency laws, California and New 
Hampshire. California enacted a requirement for hospitals to post their 
CDM in 2004, and in 2003, New Hampshire created an all-payer claims 
database, later publishing the data in 2007 in a statewide, web-based 
price transparency comparison tool. Studies assessing the impact of the 
New Hampshire State law have found that the efforts focused on the wide 
variation of provider prices, which in turn created opportunities for 
new benefit design that incentivized consumer choice of lower costs 
providers and sites of service.\115\ In California, the link between 
hospital chargemaster data and patient cost was validated through a 10-
year study of the chargemaster data which found that each dollar in a 
hospital's list price was associated with an additional 15 cents in 
payment to a hospital for privately insured patients (versus publicly 
insured patients).\116\ We indicated that this effort to improve the 
availability of charge data could open up the possibility to States to 
further regulate hospital charges--examples seen in both California and 
New Hampshire that took further legislative action to reduce price 
dispersion, reduce surprise billing and to place limits on charges for 
the uninsured and for out-of-network providers.
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    \115\ Tu H, and Gourevitch R. California HealthCare Foundation 
and Robert Wood Johnson Foundation. Moving Markets, Lessons from the 
New Hampshire Price Transparency Experiment. April 2014. Available 
at: https://www.chcf.org/wp-content/uploads/2017/12/PDF-MovingMarketsNewHampshire.pdf.
    \116\ Batty M and Ippolito B. Mystery Of The Chargemaster: 
Examining The Role Of Hospital List Prices In What Patients Actually 
Pay. Health Affairs. April, 2017; 36(4): 689-696. Available at: 
https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.0986.
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    In addition to economic effects described above, we analyzed 
consumer impact and concluded that consumers may feel more satisfied 
with their care when they are empowered to make decisions about their 
treatment. A recent survey \117\ indicated a strong desire for price 
transparency and openness. Eighty-eight percent of the population 
polled, demanded improved transparency with respect to their total 
financial responsibility, including co-pays and deductibles. Another 
study suggests that improving a patient's financial experience served 
as the biggest area to improve overall customer satisfaction.\118\ 
According to a 2011 GAO report, transparent healthcare price 
information may help consumers anticipate their healthcare costs, 
reduce the possibility of unexpected expenses, and make more informed 
choices about their care, including for both shoppable services as 
defined in this rule and other hospital items and services in both 
outpatient and inpatient settings.\119\
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    \117\ See Gruessner V. Consumer Satisfaction Dips When Payers 
Lack Price Transparency. Private Payers News (October 3, 2016). 
Available at: https://healthpayerintelligence.com/news/consumer-satisfaction-dips-when-payers-lack-price-transparency.
    \118\ Experian Health, Improve the healthcare financial journey. 
Patient Engagement (June 21, 2018). Available at: https://www.experian.com/blogs/healthcare/2018/06/healthcare-financial-journey/.
    \119\ Government Accountability Office. September 2011. Health 
Care Price Transparency: Meaningful Price Information Is Difficult 
for Consumers to Obtain Prior to Receiving Care. Available at: 
https://www.gao.gov/assets/590/585400.pdf.
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    A large part of the literature on consumer use of price information 
comes from studies of price transparency tools, particularly those 
offered by third party payers and for shoppable services. Some studies 
of consumer use of price information through web-based tools, such as 
those offered by self-insured employers or plans, indicate that they 
may help consumers save money on shoppable services. One study examined 
consumer use of an employer-sponsored, private price transparency tool 
and its impact on claims payments for three common medical services: 
Laboratory tests; advanced imaging services; and clinician office 
visits.\120\ That study found that those who used the tool had lower 
claims payments by approximately 14 percent for laboratory tests; 13 
percent for advanced imaging services; and approximately 1 percent for 
office visits compared to those who did not use the tool. Another study 
found that those employed by a large corporation who used a healthcare 
price transparency tool were able to reduce their costs by 10 to 17 
percent compared to nonusers.\121\ Those using the tool mainly searched 
for information on shoppable services and also tended to have more 
limited insurance coverage. However, one study of the use of price 
transparency tools by consumers with an employer-based, high deductible 
health plan found that consumers' likely perception that higher price 
is a proxy for higher quality care may lead them to select higher-cost 
options.\122\ This study found a spending drop between 11.8 and 13.8 
percent occurring across the spectrum of healthcare service categories 
at the health plan level; the majority of spending reductions were due 
to consumer quantity reductions across a broad range of services, 
including both high and low value care. Another study of the use of 
price transparency tools by consumers found that only 10 percent of 
consumers who were offered a tool with price information utilized it, 
and that there was a slight relative increase in their out-of-pocket 
health spending on outpatient services compared to the patient group 
that was not offered the tool.\123\
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    \120\ Whaley C, et al. ``Association Between Availability of 
Health Service Prices and Payments for These Services.'' JAMA. 2014; 
312(16):1670-1676. Available at https://jamanetwork.com/journals/jama/fullarticle/1917438.
    \121\ Lieber EMJ. ``Does It Pay to Know Prices in Health Care?'' 
American Economic Journal. 2017, 9(1): 154-179. Available at: 
https://pubs.aeaweb.org/doi/pdfplus/10.1257/pol.20150124.
    \122\ Brot-Goldberg ZC, et al. What Does a Deductible Do? The 
Impact of Cost-Sharing on Health Care Prices, Quantities, and 
Spending Dynamics. Cambridge, MA: National Bureau of Economic 
Research; Working Paper, October 2015. Available at: https://www.nber.org/papers/w21632.pdf.
    \123\ Desai S, et al. Association between availability of a 
price transparency tool and outpatient spending. JAMA. 
2016;315(17):1874-1881. doi:10.1001/jama.2016.4288. Available at: 
https://jamanetwork.com/journals/jama/fullarticle/2518264.
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    Although we are not requiring that hospitals develop a price 
comparison tool, we encourage innovation in this area by making 
standard charges available in a machine-readable format to third-party 
tool developers as well as the general public. We continue to believe 
that the use of a third-party tool would enhance public access to 
pricing data, but we do not believe the absence of one would cause 
confusion among consumers on how to use the available standard charge 
data made public by the hospital because we are also proposing 
requirements for hospitals to make public their payer-specific charges 
for a set of shoppable services in a consumer-friendly manner. A large 
part of consumer buy-in and understanding may depend on providers' 
willingness and ability to make public, and to have conversations with 
consumers about, their standard charge data to allow for price 
comparison and decisions about upcoming medical treatment. As 
consumers' healthcare costs continue to rise, clinicians are in a 
unique position to discuss the financial impacts of healthcare 
decisions with their patients. One study found that patients will often 
choose services based on clinician referral rather than consideration 
of

[[Page 65550]]

cost.\124\ We believe that the pricing information made available as a 
result of this final rule will help ensure that clinicians have 
relevant pricing data to counsel patients on financial options. A 
systematic review found that clinicians and their patients believe 
communication about healthcare costs is important and that they have 
the potential to influence health and financial outcomes, but that 
discussions between clinicians and patients about costs are not 
common,\125\ even though a majority of patients and physicians express 
a desire to have such cost-of-care conversations.\126\ In our review, 
we found evidence that physicians were open to having these 
conversations, and that they were occurring more frequently, but 
providers have also identified the need for price information as a 
barrier to discussing costs with patients.127 128 In 
addition, a literature review of 18 studies measuring the effects of 
charge display on cost and practice patterns found that having 
prospective access to prices for radiology and laboratory services 
changed physician's ordering behavior, and in 7 of the 9 studies on 
cost reported statistically significant cost reduction when charges 
were displayed.\129\
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    \124\ Chernew M, et al. ``Are Health Care Services Shoppable? 
Evidence from the Consumption of Lower-Limb MRI Scans.'' National 
Bureau of Economic Research, Working Paper No. 24869. Issued July 
2018, revised January 2019. Available at: https://www.nber.org/papers/w24869.
    \125\ Meluch AL, and Oglesby WH. (2015). Physician-patient 
communication regarding patients' healthcare costs in the US: A 
systematic review of the literature. Journal of Communication in 
Healthcare, 8(2), 151-160. Available at: https://www.tandfonline.com/doi/full/10.1179/1753807615Y.0000000010?scroll=top&needAccess=true.
    \126\ University of Utah: The State of Value in U.S. Healthcare. 
Available at: https://uofuhealth.utah.edu/value/.
    \127\ Schiavoni KH, et al. How Primary Care Physicians Integrate 
Price Information into Clinical Decision-Making, J Gen Intern 
Medicine. 2017 January; 32(1): 81-87. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5215149/.
    \128\ Alexander GC, et al. Barriers to Patient-physician 
Communication About Out-of-pocket Costs, J Gen Intern Med. 2004 
August; 19(8): 856-860. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1492500/.
    \129\ Goetz C, et al. The effect of charge display on cost of 
care and physician practice behaviors: a systematic review, Journal 
Gen Intern Med. 2015 Jun; 30(6):835-42. Available at: https://www.ncbi.nlm.nih.gov/pubmed/25691240.
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    Employers can also benefit from transparency in provider pricing 
and disclosure of payer-specific negotiated charges in particular. Some 
employers are seeking and implementing innovative ways using 
transparency in healthcare pricing to reduce healthcare costs and are 
using healthcare pricing information effectively to do so.\130\ Some 
employers, particularly self-insured employers, are using knowledge of 
payer-specific negotiated charges in their discussions with providers 
and health plans to drive referrals to high value care settings which 
is driving down the cost of healthcare for both employer and employee. 
For example, self-insured employers in Indiana are effectively using 
knowledge of hospital charges to improve contracting with 
providers.131 132 Additionally, based on our review of 
economics research, we believe the healthcare market will become more 
effective and efficient as a result of transparency in healthcare 
pricing. For example, one study found that when the State of California 
adopted a reference pricing model for their employees, usage of lower 
priced facilities increased by 9 to 14 percent and facilities in 
California responded by reducing their prices by 17 to 21 percent.\133\ 
The California and the New Hampshire initiatives (described earlier) 
were both demonstrated to produce ``spillover'' effects, meaning that 
changing market prices as a result of consumer shopping benefited even 
those who were not actively shopping.\134\
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    \130\ Woods L, et al. Employers are fixing health care. Harvard 
Business Review. March 2019. Available at: https://hbr.org/cover-story/2019/03/how-employers-are-fixing-health-care.
    \131\ Sachdev G. Using RAND 2.0 Hospital Pricing Report to 
Achieve High Value. Employers' Forum of Indiana. July 31, 2019. 
Available at: https://employersforumindiana.org/media/2019/07/Using-RAND-2.0-Hospital-Prices-to-Achieve-Value-presented-by-Gloria-Sachdev-7-31-19.pdf.
    \132\ Sachdev G, et al. Self-Insured Employers Are Using Price 
Transparency To Improve Contracting With Health Care Providers: The 
Indiana Experience. Health Affairs. October 7, 2019. Available at: 
https://www.healthaffairs.org/do/10.1377/hblog20191003.778513/full/
    \133\ Robinson JC and Brown TT. Increases In Consumer Cost 
Sharing Redirect Patient Volumes And Reduce Hospital Prices For 
Orthopedic Surgery. Health Affairs. August 2013; 32(8). Available 
at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2013.0188.
    \134\ Blase B. Transparent Prices Will Help Consumers and 
Employers Reduce Health Spending. Galen Institute. September 27, 
2019. Available at: https://galen.org/assets/Blase_Transparency_Paper_092719.pdf.
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    In summary, we concluded that transparency in pricing is necessary 
and can be effective to help bring down the cost of healthcare 
services, reduce price dispersion, and benefit consumers of healthcare 
services, including patients and employers. In light of this, we do not 
believe additional testing needs to be done prior to finalizing this 
rule. We further note that the federal government has laws and 
processes to investigate and act when entities engage in collusive or 
other anticompetitive practices.
    Comment: Many commenters indicated that it would be a challenge and 
burden for hospitals to access and display their payer-specific 
negotiated charges. For example, many commenters asserted that such 
information is either ``non-existent'' (specifically that it does not 
exist in hospital accounting systems) or is not available to be 
reported by hospitals without significant manual effort, while several 
others indicated that consumers should pursue information on out-of-
pocket obligations from insurers as opposed to hospitals. Several 
others indicated that the data is not available electronically and 
would require manual entry or require hospitals to purchase 
prohibitively expensive software. Several commenters stated that 
charges on the chargemaster are not always associated with negotiated 
charges due to billing complexities such as per diem rates and bundled 
payment arrangements and that the CY 2020 OPPS/ASC proposed rule relied 
on the mistaken assumption that payer-specific rates can be expressed 
in a static matrix. One commenter explained that hospital managed care 
agreements do not typically set forth simple dollar amounts for each 
service; instead, they specify payment methodologies, which are in 
essence negotiated payment algorithms rather than static matrices. The 
commenter also noted that the appropriate payment amount for a 
particular service package cannot be calculated until the delivery of 
care, and the assignment of any dollar amount prior to the delivery of 
care would risk overstating or understating the applicable payment 
amount for that case.
    Response: As noted above, hospital payer-specific negotiated 
charges or rates can be found within the in-network contracts that 
hospitals have signed with third party payers. Such contracts often 
include rates sheets that contain a list of hospital items and services 
(including service packages) and the corresponding negotiated rates. If 
the rate sheets are not in electronic form, we suggest that the 
hospital request an electronic copy of their contract and corresponding 
rate sheet from the third party payer. Additionally, we note that we 
are concurrently issuing a proposed rule entitled Transparency in 
Coverage (file code CMS-9915-P) that would require most issuers of 
individual and group market health insurance and group health plans to 
make public, in an electronic machine-readable format, negotiated rate 
and unique out-of-network allowed amount information that hospitals, 
including

[[Page 65551]]

CAHs, and others could use. Access to these data may be a benefit to 
less resourced hospitals which indicated that payers may take advantage 
of small hospitals that don't diligently maintain their contracts or 
contracted rates.
    We agree that payer-specific negotiated charges are not found in a 
hospital's chargemaster because such charges are typically found in 
other parts of the hospital's billing and accounting systems or in 
their payer contracts. We also agree that such charges are often 
negotiated for service packages rather than for individualized items 
and services as listed in the hospital chargemaster, and that 
negotiated contracts often include methodologies that would apply to 
payment rates, often leading to payments to hospitals that are 
different than the base rates negotiated with insurers for hospital 
items and services. However, we do not agree that these issues 
represent barriers to making public payer-specific negotiated charges 
because as clarified above, the negotiated rates we are requiring to be 
made public are the base rates, not the payment received. Additionally, 
we offer suggestions for developing the comprehensive machine-readable 
file in section II.E of this final rule and the display of payer-
specific charges for the set of shoppable services in a low-cost 
consumer-friendly format in section II.F of this final rule.
    Finally, we recognize that some hospitals may have negotiated 
charges with many payers representing hundreds of plans. We believe the 
burden to hospitals for making public all payer-specific negotiated 
charges is outweighed by the public's need for access to such 
information. However, after consideration of the comments received, we 
are responding to concerns about burden by finalizing a policy to delay 
the effective date of these final rules to January 1, 2021 (see section 
II.G.3 of this final rule for more details). We believe that by 
extending this final rule effective date, hospitals will have 
sufficient time to collect and display the standard charge information 
as required under this rule. Additionally, we are finalizing a policy 
to regard hospitals that offer internet-based price estimator tools as 
having met the requirements for making public their consumer-friendly 
list of shoppable services (section II.F.5 of this final rule) which 
will relieve some burden for hospitals that are already displaying 
consumer-friendly charge information.
    Comment: Several commenters specifically noted that although the CY 
2020 OPPS/ASC proposed rule exempts the publication of Medicaid FFS 
arrangements, payer-specific negotiated charges would include Medicaid 
managed care organizations (MCOs) and the information published would 
have little value to Medicaid beneficiaries since their out-of-pocket 
obligations are limited by federal and state cost-sharing requirements 
and the information may intimidate families from seeking necessary care 
due to the confusion caused by the charges.
    Response: Under this final rule, hospitals would be required to 
make public their standard charges for payer-specific negotiated 
charges. As noted by commenters and as we explained in the proposed 
rule, such payer-specific negotiated charges would not include non-
negotiated payment rates (such as those payment rates for FFS Medicare 
or Medicaid). However, hospitals will be required to make public the 
payer-specific negotiated charges that they have negotiated with third 
party payers, including charges negotiated by third party payer managed 
care plans such as Medicare Advantage plans, Medicaid MCOs, and other 
Medicaid managed care plans. Based on research cited previously, as 
well as patient and patient advocate comments, we disagree that the 
display of payer-specific negotiated rates will have little value to 
individuals enrolled in Medicaid MCOs or other Medicaid managed care 
plans in which third parties negotiate charges with hospitals. We 
believe that all consumers, including, for example, beneficiaries 
enrolled in Medicaid MCOs, should have the advantage of a full line of 
sight into their healthcare pricing. We are therefore finalizing as 
proposed our definition of payer-specific negotiated charges which 
would include Medicare and Medicaid plans managed by third party payers 
who negotiate charges with providers.
    Final Action: We are finalizing as proposed a definition of payer-
specific negotiated charge as a type of standard charge at new 45 CFR 
180.20 to mean the charge that a hospital has negotiated with a third 
party payer for an item or service. We are also finalizing as proposed 
a definition of ``third party payer'' for purposes of section 2718(e) 
of the PHS Act as an entity that, by statute, contract, or agreement, 
is legally responsible for payment of a claim for a healthcare item or 
service.
4. Alternative Definitions for Types of Standard Charges That We 
Considered
    In addition to the two types of standard charges (gross charges and 
payer-specific negotiated charges) that we proposed and are finalizing 
for purposes of section 2718(e) of the PHS Act, we sought public 
comment on whether we should instead, or additionally, require the 
disclosure of other types of charges as standard charges. We considered 
several alternatives for types of standard charges related to groups of 
individuals with third party payer coverage and also for types of 
standard charges that could be useful to groups of individuals who are 
self-pay.
a. Volume-Driven Negotiated Charge
    As a variant of the definition of the ``payer-specific negotiated 
charge,'' we considered defining a type of ``standard charge'' based on 
the volume of patients to whom the hospital applies the standard 
charge. Specifically, we considered defining a type of ``standard 
charge'' as the ``modal negotiated charge.'' The mode of a distribution 
represents the number that occurs most frequently in a set of numbers. 
Here, we considered defining ``modal negotiated charge'' as the most 
frequently charged rate across all rates the hospital has negotiated 
with third party payers for an item or service. We indicated that we 
believed that this definition could provide a useful and reasonable 
proxy for payer-specific negotiated charges and decrease burden for the 
amount of data the hospital would have to make public and display in a 
consumer-friendly format. We sought public comment on whether the modal 
negotiated charge would be as informative to consumers with insurance 
and whether it should be required as an alternative or in addition to 
the payer-specific negotiated charges.
    Comment: A few commenters supported volume-driven negotiated 
charges, such as the modal-negotiated charge, or a similar variation of 
such a charge based on volume, as a type of standard charge, stating 
that hospitals should publish chargemaster and negotiated amounts based 
on the billing volume. One commenter noted that developing and 
communicating a volume-driven average charge could be challenging, 
given that hospitals and insurers often negotiate charges for non-
standardized bundled services and service packages. A few commenters 
disagreed with further defining negotiated charges based on volume, 
stating that they believe the information would be both incorrect and 
confusing to consumers and onerous for hospitals required to report the 
information. Additionally, one commenter strongly objected to use of a 
volume-driven charge, stating that they believe such an alternative 
standard charge would perpetuate the idea that insurers have been able 
to drive prices lower based on volume-driven negotiations.

[[Page 65552]]

    Response: After consideration of the comments received, we agree 
with the commenters who stated that volume-driven charge information 
could be confusing to consumers, and we believe it is less useful than 
the types of standard charges we are finalizing. Because the modal 
negotiated rate, or similar volume-driven variations, would combine 
rates the hospital has negotiated with all third party payers for all 
items or services and weigh that number based on the volume of patients 
(a number unknown to the public), we agree it could be misleading for 
consumers who are trying to combine the volume-driven rate with their 
specific benefit information to determine their potential out-of-pocket 
obligations in advance, as it does not represent what their specific 
payer has negotiated. This type of standard charge may have utility in 
certain circumstances, however, after consideration of the public 
comments we received, we are not defining ``modal negotiated charges'' 
as a type of volume-driven ``standard charge'' at this time.
b. All Allowed Charges
    We also considered defining a type of ``standard charge'' as the 
charges for all items and services for all third party payer plans and 
products, including charges that are non-negotiated (such as FFS 
Medicare rates), which we would call ``all allowed charges.'' As we 
explained in the CY 2020 OPPS/ASC proposed rule, this option would have 
required hospitals to provide the broadest set of charge information 
for all individuals with health insurance coverage because it would 
have the advantage of including all identified third party payer 
charges (including third party payer rates that are not negotiated). 
Additionally, every consumer would have access to charge information 
specific to his or her insurance plan. We considered, but did not 
propose, this alternative because we stated we believed consumers with 
non-negotiated healthcare coverage already have adequate and 
centralized access to non-negotiated charges for hospital items and 
services and are largely protected from out-of-pocket costs which may 
make them less sensitive to price shopping. However, we sought public 
comment on whether increasing the data hospital would be required to 
make public would pose a burden, particularly for smaller or rural 
hospitals that may not keep such data electronically available.
    Comment: We received a few comments related to all allowed charges. 
One commenter supported the inclusion of the ``Medicare allowable'' 
charge in particular as a type of standard charge in order to provide a 
meaningful benchmark using existing data. One commenter objected to 
including all allowed charges as a type of standard charges due to 
their belief that consumers whose insurance plans are non-negotiated 
already have access to the information that would be required.
    Response: We agree with commenters who indicated there is no need 
to include all allowed charges because the allowed amounts of plans 
that are not negotiated (for example, FFS Medicare and Medicaid) are 
already publicly disclosed. Moreover, such publicly disclosed allowed 
amounts make a benchmark available to those who wish to use it; nothing 
in this final rule would prevent a hospital or third party payer from 
displaying a Medicare FFS rate as a benchmark. However, we believe it 
would be redundant to require hospitals to re-disclose already public 
rates and create an unnecessary burden. After consideration of the 
public comments we received, we are not finalizing a requirement for 
hospitals to re-disclose ``all allowed charges'' at this time.
c. Definition of Discounted Cash Price as a Type of ``Standard Charge''
    As discussed in the CY 2020 OPPS/ASC proposed rule (84 FR 39577 
through 39579), hospital gross charge information may be most directly 
relevant to a group of self-pay consumers who do not have third party 
payer insurance coverage or who seek care out-of-network. Such 
consumers would not need information in addition to hospital gross 
charges in order to determine their potential out-of-pocket cost 
obligations because the gross charge would represent the totality of 
their out-of-pocket cost estimate. However, stakeholders have indicated 
that hospitals often offer discounts off the gross charge or make other 
concessions to individuals who are self-pay. Thus, we considered 
defining a type of ``standard charge'' as the ``discounted cash 
price,'' defined as the price the hospital would charge individuals who 
pay cash (or cash equivalent) for an individual item or service or 
service package. We considered this alternative definition because 
there are many consumers who pay in cash (or cash equivalent) for 
hospital items and services.
    As we explained in the CY 2020 OPPS/ASC proposed rule, the first 
subgroup of self-pay consumers that we believed could benefit from 
knowing the discount cash price would be those who are uninsured. The 
number of uninsured individuals in the United States rose to 27.4 
million in 2017.\135\ These individuals' need for hospital price 
transparency differs from patients with insurance who generally are 
otherwise shielded from the full cost of hospitalization and hospital 
items and services. Uninsured individuals do not have the advantage of 
having access to a discounted group rate that has been negotiated by a 
third party payer. Therefore, individuals without insurance may face 
higher out-of-pocket costs for healthcare services.
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    \135\ Kaiser Family Foundation. The Number of Uninsured People 
Rose in 2017, Reversing Some of the Coverage Gains Under the 
Affordable Care Act. December 2018. Available at: https://www.kff.org/uninsured/press-release/the-number-of-uninsured-people-rose-in-2017-reversing-some-of-the-coverage-gains-under-the-affordable-care-act/.
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    The second subgroup of self-pay consumers we indicated may benefit 
from knowing the discounted cash price are those who may have some 
healthcare coverage but who still bear the full cost of at least 
certain healthcare services. For example, these may be individuals who: 
Have insurance but who go out of network; have exceeded their insurance 
coverage limits; have high deductible plans but have not yet met their 
deductible; prefer to pay through a health savings account or similar 
vehicle; or seek non-covered and/or elective items or services. We 
noted that many hospitals offer discounts to these groups of 
individuals, either as a flat percentage discount off the chargemaster 
rate or at the insurer's negotiated rate, while some hospitals offer 
consumers a cash discount if they pay in full on the day of the 
service.\136\ Other hospitals have developed and offer standardized 
cash prices for service packages for certain segments of the population 
that traditionally pay in cash for healthcare services.\137\ We 
recognized that currently, it is difficult for most consumers to 
determine in advance of receiving a service what discount(s) the 
hospital may offer an individual because cash and financial need 
discounts and policies can vary widely among hospitals.
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    \136\ Beck M. How to Cut Your Health-Care Bill: Pay Cash. The 
Wall Street Journal. February 15, 2016. Available at: https://www.wsj.com/articles/how-to-cut-your-health-care-bill-pay-cash-1455592277.
    \137\ Hempstead K and White C. Plain Talk about Price 
Transparency. Health Affairs. March 25, 2019. Available at: https://www.healthaffairs.org/do/10.1377/hblog20190319.99794/full/.
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    We therefore specifically considered an option that would require 
hospitals to make public the cash discount that would apply for 
shoppable services and service packages that would include all 
ancillary services, similar to our proposals for consumer-friendly 
display

[[Page 65553]]

of payer-specific negotiated charges (84 FR 39585 through 39591). In 
this case, the discounted cash price would represent the amount a 
hospital would accept as payment in full for the shoppable service 
package from an individual. Such charges could be lower than the rate 
the hospital negotiates with third party payers because it would not 
require many of the administrative functions that exist for hospitals 
to seek payment from third party payers (for example, prior 
authorization and billing functions). However, we recognized that many 
hospitals have not determined or maintain, a standard cash discount 
that would apply uniformly to all self-pay consumers for each of the 
items and services provided by the hospital or for service packages, 
unlike they do for negotiated charges. We sought comment on this 
option, specifically, how many shoppable services for which it would be 
reasonable to require hospitals to develop and maintain, and make 
public a discounted cash price.
    In addition, in the CY 2020 OPPS/ASC proposed rule we noted that 
many hospitals offer cash discounts on a sliding scale according to 
financial need. In such instances, we acknowledged that it may be 
difficult for a hospital to establish and make public a single 
standardized cash rate for such groups of consumers. For this reason, 
we also considered a different definition that would take sliding scale 
cash discounts into account by defining a standard charge as the median 
cash price. The median cash price would be the midpoint of all cash 
discounts offered to consumers, including prices for self-pay patients 
and those qualifying for financial assistance. We indicated that for 
uninsured patients who may qualify for financial assistance, the value 
of making a median cash price public could raise awareness of their 
available options, including the ability to apply for financial 
assistance, however, we also stated that we believed such a rate would 
be less useful to the public than a single standard cash price that the 
hospital would accept as payment in full as discussed above.
    Comment: Many commenters, including individual consumers, patient 
advocates, clinicians, and insurers, strongly supported including a 
definition of standard charges to reflect the discounted cash price 
that would be offered to a self-pay consumer because they believe this 
information would be beneficial and relevant to consumers, including 
consumers with third party payer coverage. A few commenters suggested 
that CMS redefine this type of ``standard charge'' as hospital walk-in 
rates, meaning the rates a hospital will typically charge to a patient 
without insurance, and one commenter suggested that hospitals post the 
``Amounts Generally Billed,'' an IRS-defined term for the maximum 
amount individuals under a hospital's financial assistance plan would 
pay.
    By contrast, several commenters, mostly hospital representatives, 
disagreed with defining standard charges as the discounted cash price 
due to their belief that the cash price is often reflective of after-
the-fact charity discounts due to the patient's inability to pay or as 
a result of lack of insurance. One commenter disagreed with defining a 
cash rate as a type of standard charge because they believe CMS cannot 
require or force hospitals to have discounted cash prices, and 
therefore cannot require their disclosure.
    Response: We thank the commenters for their strong support and 
their input on the utility of the discounted cash price for all 
consumers. We considered this alternative definition because there are 
many consumers who may wish to pay in cash (or cash equivalent) for 
hospital items and services, whether insured or uninsured, for a 
variety of reasons. We agree with commenters who indicated that the 
discounted cash price is important for many self-pay consumers. Many 
hospitals have already developed and offer standardized cash prices for 
service packages for certain segments of the population who 
traditionally pay in cash for healthcare services and who pay cash (or 
cash equivalent) in advance of receiving a healthcare service.\138\ 
Such prices and services are typically offered as a consumer-friendly 
packaged service that negates the need for hospitals to expend 
administrative time and resources billing third party payers and 
resubmitting charges when payment is denied.\139\ Moreover, we agree 
with commenters who indicated that up-front knowledge of pricing can 
increase patient satisfaction and reduce bad debt and could help 
mitigate ``surprise billing.''
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    \138\ Hempstead K and White C. Plain Talk about Price 
Transparency. Health Affairs. March 25, 2019. Available at: https://www.healthaffairs.org/do/10.1377/hblog20190319.99794/full/.
    \139\ Bai G, et al. Providing Useful Hospital Pricing 
Information To Patients: Lessons From Voluntary Price Disclosure. 
Health Affairs. April 2019. Available at: https://www.healthaffairs.org/do/10.1377/hblog20190416.853636/full/.
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    As discussed in the CY 2020 OPPS/ASC proposed rule, we made a 
distinction between the discounted cash price (the price a hospital 
agrees to accept from a self-pay consumer as payment in full) versus a 
median cash price that would take into account any and all cash prices 
accepted by hospitals, including cash payments accepted following 
sliding scale discounts as a result of charity care. We clarify that 
the ``discounted cash price'' would reflect the discounted rate 
published by the hospital, unrelated to any charity care or bill 
forgiveness that a hospital may choose or be required to apply to a 
particular individual's bill. Thus, the discounted cash price is a 
standard charge offered by the hospital to a group of individuals who 
are self-pay. The discounted cash price may be generally analogous to 
the ``walk-in'' rate referred to by commenters, however, we do not want 
to take a position as to whether it is the same as the cash discount 
price because the cash discounted price would apply to all self-pay 
individuals, regardless of insurance status.
    We are therefore finalizing a definition of discounted cash price 
as a type of standard charge. We note that we agree with commenters who 
indicate that some hospitals may not have determined a discounted cash 
price for self-pay consumers. For some hospitals, the cash price is the 
undiscounted gross charges as reflected in the hospital chargemaster as 
previously discussed. In that case, under our definition of discounted 
cash price, the hospital's discounted cash price would simply be its 
gross charges as reflected in the chargemaster.
    Final Action: We are finalizing the definition of discounted cash 
price that we discussed in the CY 2020 OPPS/ASC proposed rule. 
Specifically, we are finalizing a definition of cash discounted price 
to mean the charge that applies to an individual who pays cash (or cash 
equivalent) for a hospital item or service. Hospitals that do not offer 
self-pay discounts may display the hospital's undiscounted gross 
charges as found in the hospital chargemaster. We are finalizing this 
definition at 45 CFR 180.20.
d. Definitions of ``De-Identified Minimum Negotiated Charge'' and ``De-
Identified Maximum Negotiated Charge'' as Two Types of Standard Charges
    In the CY 2020 OPPS/ASC proposed rule, we also considered defining 
a type of ``standard charge'' as the de-identified minimum, median, and 
maximum negotiated charge. Under this definition, the hospital would be 
required to make public the lowest, median, and highest charges of the 
distribution of all negotiated charges across all third party payer 
plans and products. We indicated that this

[[Page 65554]]

information could provide healthcare consumers with an estimate of what 
a hospital may charge, because it conveys the range of charges 
negotiated by all third party payers. We also indicated that as a 
replacement for the payer-specific negotiated charge, this definition 
had the advantage of lowering reporting burden and could relieve some 
concerns by stakeholders related to the potential for increased 
healthcare costs in some markets as a result of the disclosure of third 
party payer negotiated charges. At the time, we did not propose to 
define the de-identified minimum, median, and maximum negotiated 
charges as types of standard charges because we believed the payer-
specific negotiated charges would provide much more useful and specific 
information for consumers. However, we sought comment on this issue as 
an alternative type of standard charge.
    Comment: Many commenters supported a definition of standard charges 
to require hospitals to post a de-identified range of negotiated rates, 
including the minimum, median, and maximum negotiated rates or all-
inclusive range, quartiles or a median range (that is, the 25th and 
75th percentile or the 25th through the 75th percentiles), another 
specific percentile within the range of negotiated charges, ``usual and 
customary'' (which are based on a regional percentile), or average 
rate. Commenters supported these alternatives in addition to payer-
specific negotiated charges because they believe de-identified 
negotiated rate information would be relevant and beneficial to 
consumers. Commenters noted that many consumer-facing price 
transparency tools display the minimum and maximum negotiated charges 
for healthcare services already, or display regional average charges. 
One commenter stated that providing such alternative charges in 
addition to providing the payer-specific negotiated charges can be 
helpful as it provides a ``meaningful anchor'' for the patient when 
they are comparing options. Other commenters echoed this sentiment, 
indicating that such charges, in addition to payer-specific negotiated 
charges, are useful for consumers such as patients and employers.
    Several commenters indicated they believed these types of standard 
charges could provide a suitable substitute for the payer-specific 
negotiated charges. A few commenters indicated that the substitution 
could protect the identification of individual payers in smaller 
markets which they said would reduce any legal or market risk that 
could be associated with compelling the release of negotiated rates, 
although one commenter expressed concern that display of a de-
identified maximum may have an adverse effect on the ability to 
negotiate lower rates. By contrast, patient advocates and consumers 
strongly opposed the substitution of any type of de-identified 
negotiated charge, stating such charges would provide a far less 
accurate indicator of a patient's potential financial obligations 
compared to knowledge of the consumer's own payer-specific negotiated 
charges. For example, one commenter said that substitution for payer-
specific negotiated charges for a more general or informational charge 
may leave patients feeling misled and delays the country from moving 
closer to a patient-focused system. Another indicated that limiting 
standard charge information to a median or range would reduce utility 
of the information and serve to frustrate innovators who seek to 
provide consumers with an unbiased view of provider cost and quality.
    Several commenters specifically indicated that a range (for 
example, the minimum and maximum negotiated charges) of de-identified 
charges would be useful to the public because it would make it easier 
for consumers to quickly understand the range of prices across all 
insurance plans that might apply. One commenter noted that requiring 
hospitals to make public a range instead of all payer-specific 
negotiated charges would not likely reduce burden.
    Additionally, a few commenters recommended the use of regional or 
market averages or median rates, or the ``usual and customary'' which 
stated that displaying a market (not hospital) median, or the ``usual 
and customary'' which is defined by the National Council of Insurance 
Legislators (NCIL) as the 80th percentile of physician charges in a 
geographic region based on an independent unbiased benchmarking charge 
database. One commenter noted that such rates would serve as a basic 
benchmark for vendors and prevent the prices paid by insurers from 
being known.
    A few commenters, however, disagreed with defining a standard 
charge based on the hospital's minimum, median, and maximum negotiated 
rate (or a variation of these) due to their belief that this data would 
be of limited value or not be beneficial to consumers and may cause 
confusion. One commenter specifically requested that the median cash 
price not be finalized as a type of standard charge.
    Response: We thank commenters for their support and innovative 
suggestions on variations of the potential definition of a type of 
``standard charge'' as the de-identified minimum, median, and maximum 
negotiated charge. We agree with commenters that information related to 
several types of de-identified negotiated rates could be useful and 
beneficial to consumers in conjunction with payer-specific negotiated 
charges, together as a range, or as separate types of standard charges.
    First, we agree with commenters who suggested that the de-
identified minimum negotiated charge and the de-identified maximum 
negotiated charge could each provide a benchmark for determining the 
value of a hospital item or service for referring providers or 
employers. For example, for a consumer with insurance who is obligated 
to pay a percentage of the negotiated charge, knowing the maximum would 
be more helpful and informative than not having any reference point at 
all and would relieve consumers of the fear and uncertainty due to the 
lack of knowledge. Disclosure of the minimum de-identified negotiated 
charge by itself could also provide a benchmark that could have an 
impact on market forces, as some commenters suggested. Therefore, we 
believe that each value, independent of the other, could be helpful in 
providing some standard hospital charge information to consumers.
    We further agree with commenters who asserted that knowing both the 
minimum and the maximum (that is, the range) of negotiated rates could 
benefit consumers. As noted by commenters, many consumer facing pricing 
tools make use of ranges in their displays. For example, consumers 
without third party payer coverage could use the range to negotiate a 
charge with the hospital that is more reasonable than the gross charges 
a hospital might otherwise bill them. The range would also be useful 
for consumers with insurance, for example, someone obligated to pay a 
percentage of the negotiated rate would be able to determine both their 
minimum and maximum financial obligation for an item or service to 
compare across hospital settings.
    Finally, however, we agree with commenters who indicated that the 
most beneficial hospital standard charge information for consumers 
(including patients and employers) would include requiring disclosure 
of payer-specific negotiated charges along with disclosure of the de-
identified minimum negotiated charges and de-identified maximum 
negotiated charges. We agree with commenters who indicated that this 
set of information, taken together, can provide consumers with an even 
more complete picture of hospital

[[Page 65555]]

standard charges and drive value. For example, by knowing one's payer-
specific negotiated charges in addition to the minimum and maximum 
negotiated charges for a hospital item or service, consumers with third 
party payer coverage could determine whether their insurer has 
negotiated well on their behalf by assessing where their payer-specific 
negotiated charge falls along the range. Such information would serve 
to promote value choices in obtaining a healthcare services, and may 
also promote value choices in obtaining a healthcare insurance product. 
Additionally, we agree with commenters that presenting such information 
aligns with current consumer-friendly tools and displays and supports 
innovation.
    We are therefore finalizing with modification to define a fourth 
type of standard charge as the ``de-identified minimum negotiated 
charge'' to mean the lowest charge that a hospital has negotiated with 
all third party payers for an item or service. We are also finalizing 
with modification to define a fifth type of standard charge as the 
``de-identified maximum negotiated charge'' to mean the highest charge 
that a hospital has negotiated with all third party payers for an item 
or service. To identify the minimum negotiated charge and the maximum 
negotiated charge, the hospital considers the distribution of all 
negotiated charges across all third party payer plans and products for 
each hospital item or service. We note that this distribution would not 
include non-negotiated charges with third party payers. The hospital 
must then select and display the lowest and highest de-identified 
negotiated charge for each item or service the hospital provides.
    We appreciate the many additional innovative suggestions for how a 
range of de-identified negotiated charges could be displayed by a 
hospital. We note that we have interpreted section 2718(e) of the PHS 
Act to require each hospital to disclose its own standard charges, and 
not the charges that are standard in a particular region or market as 
some commenters suggested. However, if commenters believe such data to 
be valuable, nothing would prevent hospitals or other users of the 
information to include such ranges when presenting it to consumers.
    Final Action: We are therefore finalizing with modification to 
define a fourth and fifth type of standard charge as the ``de-
identified minimum negotiated charge'' to mean the lowest charge that a 
hospital has negotiated with all third party payers for an item or 
service. We are also finalizing with modification to define a fifth 
type of standard charge as the ``de-identified maximum negotiated 
charge'' to mean the highest charge that a hospital has negotiated with 
all third party payers for an item or service. In response to comments 
and in the interest of minimizing hospital burden, we are not 
finalizing the inclusion of the median negotiated charge as a type of 
standard charge. We are finalizing these definitions at 45 CFR 180.20. 
As discussed above, we believe these additional types of standard 
charges could be useful and beneficial to consumers.
    We intend for the de-identified minimum negotiated charge and de-
identified maximum negotiated charge to be severable, one from the 
other, and from payer-specific negotiated charge, such that each of 
these three types of standard charges could stand-alone as a type of 
standard charge.
    We believe it is reasonable to consider the de-identified minimum 
negotiated charge and the de-identified maximum negotiated charge as 
severable from payer-specific negotiated charge because these values 
represent the lowest or highest charge (along a distribution) that a 
hospital has negotiated across all third party payers for an item or 
service, and do not identify the third party payer with which these 
rates are negotiated. We also believe these types of standard charges 
are severable from each other because the de-identified minimum 
negotiated charge and the de-identified maximum negotiated charge are 
separate values in the distribution.
    Further, we believe it is feasible for hospitals to separately 
identify each type of ``standard charge'', which according to the 
definition we are finalizing in 45 CFR 180.20 includes: Gross charge, 
payer-specific negotiated charge, de-identified minimum negotiated 
charge, de-identified maximum negotiated charge, and discounted cash 
price. As discussed elsewhere in section II.D of this final rule, we 
believe each type of standard charge is a reasonable, and necessary 
aspect of hospital price transparency, to ensure consumers have as 
complete information as possible to inform their healthcare decision-
making. We therefore believe that all five charges (gross charge, 
payer-specific negotiated charge, de-identified minimum negotiated, 
charge, de-identified maximum negotiated charge, and discounted cash 
price) provide value to consumers for the reasons discussed in this 
section. Accordingly, we intended for all five definitions to be 
severable, such that if a court were to invalidate the inclusion of an 
individual definition, the remaining definitions would remain defined 
as types of standard charges.
    We believe, when made public in combination (according to the 
requirements we are finalizing), these types of standard charges will 
be most effective in achieving meaningful transparency in prices of 
hospital items and services. We also recognize that each type of 
standard charge alone, if made public nationwide, could also further 
hospital price transparency in the United States.

E. Requirements for Public Disclosure of All Hospital Standard Charges 
for All Items and Services in a Comprehensive Machine-Readable File

1. Overview
    Section 2718(e) of the PHS Act requires hospitals to make their 
standard charges public in accordance with guidelines developed by the 
Secretary. Therefore, we proposed that hospitals make public their 
standard charges in two ways: (1) A comprehensive machine-readable file 
that makes public all standard charge information for all hospital 
items and services (84 FR 39581 through 39585), and (2) a consumer-
friendly display of common ``shoppable'' services derived from the 
machine-readable file (84 FR 39585 through 39591). In the CY 2020 OPPS/
ASC proposed rule, we explained our belief that these two different 
methods of making hospital standard charges public are necessary to 
ensure that such data is available to consumers where and when it is 
needed (for example, via integration into price transparency tools, 
electronic health records (EHRs), and consumer apps), and also directly 
available and useful to consumers that search for hospital-specific 
charge information without use of a developed price transparency tool.
    For purposes of displaying all standard charges for all items and 
services in a comprehensive machine-readable file, we proposed 
requirements for the file format, the content of the data in the file, 
and how to ensure the public could easily access and find the file. We 
agree with commenters who indicate that the machine-readable file would 
contain a large amount of data, however, we believe that a single data 
file would be highly useable by the public because all the data would 
be in one place. By ensuring accessibility to all hospital standard 
charge data for all items and services, these data will be available 
for use by the public in price transparency tools, to be integrated 
into EHRs for purposes of clinical decision-making and referrals, or to 
be used by

[[Page 65556]]

researchers and policy officials to help bring more value to 
healthcare.
    Comment: A few commenters (particularly hospitals) noted concerns 
that the chargemaster data they already make public online appears to 
be accessed less by consumers and more by insurance brokers, 
competitors, and reporters. Additionally, many commenters believed that 
the proposed data to be made public would be too complex, voluminous, 
and time consuming for consumers to navigate and understand. 
Specifically, commenters expressed concern that: The data files would 
be comprised of thousands of lines of data that consumers would have to 
sift through; the volume of files could crash personal computers; the 
information could add to confusion for consumer who may not understand 
a chargemaster, coding, or the differences between ancillary services, 
gross charges, and payer-specific negotiated charges; providing large 
and complex datasets (even if standardized) would not achieve CMS's 
stated goal of transparency; and consumers may not be able to derive 
actual costs from standard charge information. Some commenters 
indicated that the machine-readable file should be made consumer-
friendly and searchable.
    Response: We believe that requiring hospitals to make public all 
standard charges for all items and services they provide is consistent 
with the mandate of section 2718(e) of the PHS Act. We agree with 
commenters who indicate that the machine-readable file would contain a 
large amount of data, however, we believe that a single data file would 
be highly useable by the public because all the data would be in one 
place. By ensuring accessibility to all hospital standard charge data 
for all items and services, these data will be available for use by the 
public in price transparency tools, to be integrated into EHRs for 
purposes of clinical decision-making and referrals, or to be used by 
researchers and policy officials to help bring more value to 
healthcare. In order to ensure hospital standard charge data is more 
directly useful to the average patient, we proposed and are finalizing 
an additional requirement for hospitals to make a public standard 
charges for a set of shoppable services in a consumer-friendly manner 
(see section II.F of this final rule). We believe the shorter data set 
presented in a consumer-friendly manner is more likely to be directly 
useful to consumers who seek to compare costs for common shoppable 
services hospital-by-hospital.
    We note that many machine-readable data sets that are made 
available for public use can be quite large. For example, Medicare 
Provider Utilization and Payment Data files include information for 
common inpatient and outpatient services, all physician and other 
supplier procedures and services, and all Part D prescriptions.\140\ 
These files are freely available to the public and contain hundreds of 
thousands of data points in .xlsx and .csv format. We therefore believe 
it is possible for hospitals to make public all their standard charges 
for all the items and services they provided in a similar manner. 
Additionally, we have not heard that large Medicare data files of data 
derived from claims causes any confusion for healthcare consumers, and 
healthcare consumers do not typically use the information in the data 
files directly. Instead, voluminous Medicare data is used by a variety 
of stakeholders, some of whom take the information and present it to 
users in a consumer-friendly manner.\141\ Similarly, we do not believe 
that making public a comprehensive machine-readable file with all 
standard charges for all items and services would create patient 
confusion. Finally, we note that by definition, machine-readable files 
are searchable.
---------------------------------------------------------------------------

    \140\ CMS.gov website, Medicare Provider Utilization and Payment 
Data. Available at: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/index.html.
    \141\ Wei S, et al. Surgeon Scorecard. ProPublica. Updated July 
15, 2015. Available at: https://projects.propublica.org/surgeons/.
---------------------------------------------------------------------------

2. Standardized Data Elements for the Comprehensive Machine-Readable 
File
    In the CY 2020 OPPS/ASC proposed rule (84 FR 39582 through 39583), 
we proposed that hospitals disclose their list of standard charges for 
all items and services online in a single digital file that is machine-
readable. Without specifying a minimum reporting standard for the 
machine-readable file, the standard charges data made publicly 
available by each hospital could vary, making it difficult for the 
users of the data to compare items and services. For example, some 
hospitals currently post a single column of gross charges without any 
associations to CPT or HCPCS codes or other identifying descriptions of 
the items and services to which the gross charge applies. A similar 
example would be a hospital that displays a list of gross charges that 
is correlated with a list of item numbers that are meaningful to the 
hospital billing personnel, but not understandable to the general 
public. By contrast, some hospitals list their gross charges along with 
a brief description of the item or service to which each gross charge 
applies and the corresponding standardized identifying codes (typically 
HCPCS or CPT codes).
    We expressed our concern that the lack of uniformity leaves the 
public unable to meaningfully use, understand, and compare standard 
charge information across hospitals. Therefore, for the comprehensive 
machine-readable file of all standard charges for all items and 
services, we made proposals to ensure uniformity of the data made 
publicly available by each hospital. To inform these proposals, we 
considered the data elements that are typically included in a 
hospital's billing system and which of those elements would result in 
hospital standard charge data being most transparent, identifiable, 
meaningful, and comparable. Specifically, we proposed that the list of 
hospital items and services include the following corresponding 
information, as applicable, for each item and service:
     Description of each item or service (including both 
individual items and services and service packages).
     The corresponding gross charge that applies to each 
individual item or service when provided in, as applicable, the 
hospital inpatient setting and outpatient department setting.
     The corresponding payer-specific negotiated charge that 
applies to each item or service (including charges for both individual 
items and services as well as service packages) when provided in, as 
applicable, the hospital inpatient setting and outpatient department 
setting. Each list of payer-specific charges must be clearly associated 
with the name of the third party payer.
     Any code used by the hospital for purposes of accounting 
or billing for the item or service, including, but not limited to, the 
CPT code, HCPCS code, DRG, NDC, or other common payer identifier.
     Revenue code, as applicable.
    We proposed to codify these requirements at proposed new 45 CFR 
180.50(b). We stated that we believe that these elements would be 
necessary to ensure that the public would be able to compare standard 
charges for the same or similar items and services provided by 
different hospitals.
    We proposed that hospitals associate each standard charge with a 
CPT or HCPCS code, DRG, NDC, or other common payer identifier, as 
applicable, because hospitals uniformly understand them and commonly 
use them for billing items and services (including both individual 
items and services and service packages). We also proposed

[[Page 65557]]

that hospitals include item descriptions for each item or service. In 
the case of items and services that are associated with common billing 
codes (such as HCPCS codes), the hospital could use the code's 
associated short text description.
    In addition, based on stakeholder feedback suggesting hospital 
charge information should include revenue codes to be comparable, we 
proposed to require that the hospital include a revenue code where 
applicable and appropriate. Hospitals use revenue codes to associate 
items and services to various hospital departments. When a hospital 
charges differently for the same item or service in a different 
department, we proposed that the hospital associate the charge with the 
department represented by the revenue code, providing the public some 
additional detail about the charges they may expect for hospital 
services provided in different hospital departments.
    In developing this proposal, we also considered whether the 
following data elements, which are commonly included in hospital 
billing systems, might be useful to the public:
     Numeric designation for hospital department.
     General ledger number for accounting purposes.
     Long text description.
     Other identifying elements.
    However, we determined that, for various reasons, these data 
elements may not be as useful as the data elements that we proposed to 
require hospitals to make public. For example, data elements such as 
general ledger numbers are generally relevant to the hospital for 
accounting purposes but may not add value for the public, while data 
elements such as alternative code sets (such as International 
Statistical Classification of Diseases and Related Health Problems, 
10th revision (ICD-10) codes) or long text descriptions associated with 
CPT codes, while useful, might be difficult to associate with a single 
item or service or be otherwise difficult to display in a file that is 
intended mainly for further computer processing. Because of this, we 
stated that while long text descriptions might benefit healthcare 
consumers and be appropriate for the consumer-friendly display of 
shoppable services (as discussed in the CY 2020 OPPS/ASC proposed rule, 
84 FR 39585 through 39591), we believe they may add unnecessary burden 
for hospitals when such descriptions are not readily electronically 
available, or when the display of such data is not easily formatted 
into a machine-readable file. Therefore, we did not propose to require 
these additional elements for the machine-readable data file that 
contains a list of all standard charges for all hospital items and 
services. We invited public comment on the proposed data elements for 
the comprehensive machine-readable file of all standard charges for all 
items and services that hospitals would be required to make public. We 
also sought public comment on the other data elements that, as we 
detail above, we considered but did not propose to require, and on any 
other standard charge data elements that CMS should consider requiring 
hospitals to make public.
    Comment: A few commenters sought clarification on how to make 
public charges for various hospital items and services. For example, 
one commenter stated that gross charges are not established for several 
codes using surgical procedure codes, but rather are listed as unit of 
time. Others pointed out that charges for hospitals and physicians may 
be maintained separately, with some indicating that employed physician 
charges are not included in their hospital chargemaster.
    Response: In its comprehensive machine-readable file, the hospital 
must include all standard charges for all items and services for which 
it has established a charge, which includes time-based gross charges. 
For items and services and associated gross charges found in the 
hospital chargemaster, the hospital could list, for example, the gross 
charge associated with supplies or amount charges per unit of time. An 
example of how a hospital could list its time-based gross charges for 
various items and services can be viewed in Table 1.
    We understand that some hospitals may have several locations 
operating under a consolidated hospital license, and each location may 
have its own chargemaster. Some hospitals may have a chargemaster for 
hospital items and services (for example, supplies, procedures, or room 
and board charges) and one for hospital services provided by employed 
professionals, although more often all gross charges for all items and 
services provided by the hospital (including services of employed 
practitioners) are kept in a single hospital chargemaster. Moreover, we 
agree with commenters that often the charges for employed practitioners 
are not associated with specific CPT/HCPCS codes until after a service 
has been provided to a patient. However, the gross charge for the 
employed professional would still be present in the chargemaster. The 
last several rows of Table 1 illustrates one way a hospital could 
incorporate standard charges for professional services into their 
comprehensive machine-readable file. Additionally, we note that gross 
charges for some supplies, such as gauze pads, found in the hospital 
chargemaster may not have a corresponding common billing code. 
Therefore, we clarify that that common billing codes as a required data 
element be included as applicable.

[[Page 65558]]



                                 Table 1--Sample Display of Gross Charges \142\
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Hospital XYZ Medical Center
                                                                               ---------------------------------
Prices Posted and Effective [month/day/year]
Notes: [insert any clarifying notes]
----------------------------------------------------------------------------------------------------------------


 
                                                                                            OP/Default      IP/ER gross
               Description                        CPT/HCPCS code                NDC        gross charge       charge            ERx Charge quantity
--------------------------------------------------------------------------------------------------------------------------------------------------------
HB IV INFUS HYDRATION 31-60 MIN.........  96360.........................  ..............       $1,000.13       $1,394.45  ..............................
HB IV INFUSION HYDRATION ADDL HR........  96361.........................  ..............          251.13          383.97  ..............................
HB IV INFUSION THERAPY 1ST HR...........  96365.........................  ..............        1,061.85        1,681.80  ..............................
HB ROOM CHARGE 1:5 SEMI PRIV............  ..............................  ..............  ..............        2,534.00  ..............................
HB ROOM CHG 1:5 OB PRIV DELX............  ..............................  ..............  ..............        2,534.00  ..............................
HB ROOM CHG 1:5 OB DELX 1 ROOM..........  ..............................  ..............  ..............        2,534.00  ..............................
HB ROOM CHG 1:5 OB DELX 2 ROOMS.........  ..............................  ..............  ..............        2,534.00  ..............................
SURG LEVEL 1 1ST HR 04..................  Z7506.........................  ..............  ..............        3,497.16  ..............................
SURG LEVEL 1 ADDL 30M 04................  Z7508.........................  ..............  ..............        1,325.20  ..............................
SURG LEVEL 2 1ST HR 04..................  Z7506.........................  ..............  ..............        6,994.32  ..............................
PROMETHAZINE 50 MG PR SUPP..............  J8498.........................     00713013212          251.13          383.97  12 Each.
PHENYLEPHRINE HCL 10% OP DROP...........  ..............................     17478020605          926.40        1,264.33  5 mL.
MULTIVITAMIN PO TABS....................  ..............................     10135011501            0.00            0.00  100 Each.
DIABETIC MGMT PROG, F/UP VISIT TO MD....  S9141.........................  ..............          185.00  ..............  ..............................
GENETIC COUNSEL 15 MINS.................  S0265.........................  ..............           94.00  ..............  ..............................
DIALYSIS TRAINING/COMPLETE..............  90989.........................  ..............          988.00  ..............  ..............................
ANESTH, PROCEDURE ON MOUTH..............  170...........................  ..............           87.00  ..............  ..............................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Comment: One commenter provided a chart as an example of how to 
disclose price transparency information broken down by Medicare, 
Medicaid, commercial non-contracted in-network and commercial non-
contracted out-of-network providers. Another commenter recommended that 
any publicly-available report of hospital negotiated prices be preceded 
by efforts to create standardized data definitions and formats across 
hospitals and ensure alignment with insurer reporting standards, which 
is critical to achieving consumer-friendly, useful, ``apples-to-
apples'' information.
---------------------------------------------------------------------------

    \142\ Note that this example shows only one type of standard 
charge (specifically the gross charges) that a hospital would be 
required to make public in the comprehensive machine-readable file. 
Hospitals must also make public the payer-specific negotiated 
charges, the de-identified minimum negotiated charges, the de-
identified maximum negotiated charges, and the discounted cash 
prices for all items and services.
---------------------------------------------------------------------------

    Response: We appreciate these comments and agree that 
standardization is important to ensure that hospital charge information 
can be compared across and between hospitals. Based on a review of 
state requirements and a sampling of hospitals that are currently 
making their charges public, we chose the specific data elements we are 
finalizing, which are included in hospital billing and accounting 
systems, as the ones that would result in hospital standard charge data 
being transparent, identifiable, meaningful, and comparable. For 
example, we believe that the billing codes present a common data 
element that provides an adequate cross-walk between hospitals for 
their items and services. Such codes serve as a common language between 
providers and payers to describe the medical, surgical and diagnostic 
services provided by the healthcare community.
    We agree that defining elements in a data dictionary or more 
specificity in data file formats could make it easier for IT personnel 
to use hospital charge data and will take it under consideration for 
future rulemaking.
    For reasons we discussed earlier in section II.D.3. of this final 
rule, data on FFS Medicare and Medicaid is not included as a type of 
standard charge and would not be required to be included in the 
comprehensive machine-readable file. Because such data is publicly 
available, however, it could readily be included by a hospital that so 
chooses, or it could be added by those who use the hospital standard 
charge information. We further agree that additional data related to 
commercial non-contracted in-network and commercial non-contracted out-
of-network providers could be useful for consumers and note that we are 
concurrently publishing a price transparency proposed rule entitled 
Transparency in Coverage (file code CMS-9915-P) focused on disclosure 
of negotiated rates and unique out-of-network allowed amounts from most 
individual and group market health insurance issuers and group health 
plans. We believe that by doing so we are aligning expectations and 
incentives across the healthcare system and helping to ensure alignment 
with reporting standards applicable to issuers and group health plans.
    Comment: A few commenters expressed concern that this proposal 
falls short of achieving its goal of informing patients about the cost 
of care in a meaningful way to choose among hospital providers. One 
commenter asserted that even when hospitals use the same or similar 
terminology to describe specific services, some services can be very 
specific in ways that patients may not understand and associated out-
of-pocket costs can vary a great deal, and that unless patients are 
familiar with coding and standard descriptors, it is likely that many 
will compare cost estimates for services that are substantially 
different from what they will receive. Several commenters asserted that 
hospitals do not have adequate, timely health plan information related 
to patient benefit plans, bundled payments, and adjudication rules to 
provide patients with accurate out-of-pocket cost estimates prior to 
services. One commenter expressed concern with the ability for an 
accurate estimate to be ``published in a file'' due to the myriad ways 
that payers structure and adjudicate providers' claims. The commenter 
noted that third-party payers have processing systems that determine 
``allowables'', adjustments, payments, patient responsibility, etc., 
and that address unique plan design constructs (at the employer's 
discretion) based on each unique contract. Another commenter asserted 
that there is significant complexity in negotiated contracts and many 
other nuances in

[[Page 65559]]

contract arrangements that would means that each hospital would need to 
provide data on literally thousands of service bundle combinations.
    Response: We are clarifying the requirements for making public all 
standard charges for all items and services in a comprehensive machine-
readable file and have included an example of the format and structure 
the list of gross charges could take (see Table 1). We agree that 
standardization in some form is important to ensure high utility for 
users of the hospital standard charge information, and we have proposed 
and are finalizing certain requirements (such as the data elements and 
file formats) that would be standardized across hospitals. We decline 
at this time to be more prescriptive in our approach; however, we may 
revisit these requirements in future rulemaking should we find it is 
necessary to make improvements in the display and accessibility of 
hospital standard charge information for the public. Regarding the 
display of payer-specific negotiated charges, we recommend hospitals 
consult their rate sheets or rate tables within which the payer-
specific negotiated charges are often found. Such rate sheets typically 
contain a list of common billing codes for items and services provided 
by the hospital along with the associated payer-specific negotiated 
charge or rate. We believe it is possible to make this information 
public in a single comprehensive machine-readable file by, for example, 
using multiple tabs in an XML format. For example, one tab could show a 
list of individualized items and services and associated gross charges 
derived from the hospital's chargemaster while another tab could 
display the individualized items and services and service packages for 
a specific payer's plan based on the rate sheet derived from the 
hospital's contract with the payer. We also note that service packages 
can often be associated with a common billing code such as a DRG or APC 
or other payer modifier that is identified on the rate sheet. We 
clarify that for service packages, we do not intend each and every 
individual item or service within the service package to be separately 
listed. For example, if a hospital has a payer-specific negotiated 
charge (base charge) for a DRG code, the hospital would list that 
payer-specific negotiated charge and associated DRG code as a single 
line-item on its machine-readable file.
    Further, as described in more detail in section II.D.1 of this 
final rule, we disagree with commenters who indicated that standard 
charges are meaningless to consumers. We agree, however, that for 
insured patients, the payer-specific negotiated charge does not in 
isolation provide a patient with an individualized out-of-pocket 
estimate. Because the additional details of a consumer's benefit 
structure (for example, the copay or deductible) are not standard 
charges maintained by hospitals, we did not propose that hospitals 
would be required to make these data elements public. However, as we 
explained, the hospital standard charges, specifically, the gross 
charge and the payer-specific negotiated charges, are critical data 
points found on patient EOBs which are designed to communicate provider 
charges and resulting patient cost obligations, taking third party 
payer insurance into account. When a patient has access to payer-
specific negotiated charge information prior to obtaining a healthcare 
service (instead of sometimes weeks or months after the fact when the 
EOB arrives), combined with additional information the patient can get 
from payers, it can help the individual determine his or her potential 
out-of-pocket information for a hospital item or service in advance. As 
previously noted, we agree with commenters who indicate that the 
machine-readable file would contain a large amount of data, however, we 
believe that a single data file would be highly useable by the public 
because all the data would be in one place. By ensuring accessibility 
to all hospital standard charge data for all items and services, these 
data will be available for use by the public in price transparency 
tools, to be integrated into EHRs for purposes of clinical decision-
making and referrals, or to be used by researchers and policy officials 
to help bring more value to healthcare.
    Comment: One commenter suggested that the machine-readable file 
include the ``claim allowable,'' which is comprised of the sum of the 
co-pay, coinsurance, deductible and health insurance company payment. A 
few commenters indicated CPT codes and ICD procedure codes should be 
included to facilitate apples-to-apples comparisons and ensure so 
inpatient facilities do not have a way to extend charges to cash-pay 
patients and inflate patient charges.
    Response: We thank the commenters for their input. We believe the 
``claim allowable'' referred to by the commenter is analogous to the 
payer-specific negotiated charge, which is the rate negotiated by 
hospitals that includes both the payer and patient portion. In other 
words, as explained in section II.D.3 of this final rule, the payer-
specific negotiated charge is the discounted rate that the hospital has 
negotiated with the third party payer and is typically displayed as the 
second charge listed on the patient's EOB. As expressed by commenters, 
additional information from the payer is necessary to determine how the 
``negotiated rate'' or ``allowed amount'' is apportioned between the 
payer and the patient. As explained in the CY 2020 OPPS/ASC proposed 
rule, we do not believe that ICD procedure codes should be included 
because, while useful, such information might be difficult to associate 
with a single item or service or be otherwise difficult to display in a 
file that is intended mainly for further computer processing. In 
summary, we believe the proposed data elements represent the necessary 
elements (standard charges, service description, and code) to ensure 
hospital charge information is relevant to consumers, usable, and 
comparable, so we are finalizing as proposed.
    Comment: Several commenters stated that there can be multiple 
revenue codes for a single service, leading to consumer confusion and 
repetitive information. One commenter recommended that CMS eliminate 
revenue code as a standardized data element because some procedures 
have the same charge, but the revenue code differs.
    Response: We believe the revenue code is an important data element 
for the reasons described in the CY 2020 OPPS/ASC proposed rule, but we 
are sympathetic to commenters who indicated that including such a code 
may exponentially increase the number of fields in the comprehensive 
machine-readable file and make the file difficult to manage. We believe 
the commenter indicated this because the revenue center code is 
specific to each hospital department which may offer the same or 
similar items and services to other hospital departments. If a hospital 
were to list out each item or service provided in each revenue center 
separately, the list of items and services could be replicated many 
times over. We are therefore not finalizing this data element as a 
requirement, but continue to encourage its inclusion and use by 
hospitals where appropriate to improve the public's understanding of 
hospital standard charges. For example, if an item or service has a 
different charge when provided in a different revenue center (that is, 
department), the hospital could list just that one item twice--once for 
the revenue center that has the different standard charge and once for 
the standard charge that applies to all other revenue centers.
    Comment: Several commenters suggested alternatives to the standard

[[Page 65560]]

data elements for reporting all items and services. For example, some 
suggested including ICD-10 procedure codes, one suggested posting 
separate charges for administrative cost of government and insurance 
regulations, and another suggested hospitals make public the costs 
related to cost-shifting and uncompensated care, the availability of 
providers, whether the provider takes all forms of payment. One 
commenter suggested leveraging a group of various stakeholders to 
develop and validate these standards. One commenter also suggested that 
a healthcare consumer should have the right to view a line itemized 
medical bill before and after the time of service, which would contain 
the full name (no abbreviations) of each medical test as spelled out in 
the AMA CPT manual for which a medical provider wants paid accompanied 
by the five (5) digit CPT billing code as per the AMA CPT manual. Two 
commenters asserted that failure to provide an easy to understand fee 
schedule in advance, combined with hospitals failure to provide an 
itemized bill, results in the unfair and unethical practice known as 
surprise medical billing.
    Response: We appreciate the commenters' alternative suggestions and 
interest in reducing the risk of surprise billing by providing 
consumers with an advance itemized bill of each medical service. We 
note that this final rule would not constrain hospitals from providing 
an itemized bill in advance, ICD-10 codes, or other information that 
consumers may find helpful to understand the cost of their care. At 
this time, however, we believe that the common data requirements we are 
finalizing provide sufficient information for consumers to compare 
hospital standard charges.
    Final Action: We are finalizing with modifications our proposals 
for common data elements that must be included in the comprehensive 
machine-readable file that contains all standard charges for all items 
and services provided by the hospital. Specifically, we are finalizing 
a requirement that the machine-readable list of hospital items and 
services include the following corresponding information, as 
applicable, for each item and service:
     Description of each item or service (including both 
individual items and services and service packages).
     The corresponding gross charge that applies to each 
individual item or service when provided in, as applicable, the 
hospital inpatient setting and outpatient department setting.
     The corresponding payer-specific negotiated charge that 
applies to each item or service (including charges for both individual 
items and services as well as service packages) when provided in, as 
applicable, the hospital inpatient setting and outpatient department 
setting. Each payer-specific negotiated charge must be clearly 
associated with the name of the third party payer and plan.
     The corresponding de-identified minimum negotiated charge 
that applies to each item or service (including charges for both 
individual items and services as well as service packages) when 
provided in, as applicable, the hospital inpatient setting and 
outpatient department setting.
     The corresponding de-identified maximum negotiated charge 
that applies to each item or service (including charges for both 
individual items and services as well as service packages) when 
provided in, as applicable, the hospital inpatient setting and 
outpatient department setting.
     The corresponding discounted cash price that applies to 
each item or service (including charges for both individual items and 
services as well as service packages) when provided in, as applicable, 
the hospital inpatient setting and outpatient department setting.
     Any code used by the hospital for purposes of accounting 
or billing for the item or service, including, but not limited to, the 
CPT code, HCPCS code, DRG, NDC, or other common payer identifier.
    We are codifying these requirements at new 45 CFR 180.50(b). We 
believe that these elements are necessary to ensure that the public can 
compare standard charges for similar or the same items and services 
provided by different hospitals. We are not finalizing the revenue 
center code as a required data element, but we continue to encourage 
its inclusion and use by hospitals where appropriate to improve the 
public's understanding of hospital standard charges.
3. Machine-Readable File Format Requirements
    To make public their standard charges for all hospital items and 
services, we proposed to require that hospitals post the charge 
information in a single digital file in a machine-readable format. We 
proposed to define a machine-readable format as a digital 
representation of data or information in a file that can be imported or 
read into a computer system for further processing. Examples of 
machine-readable formats include, but are not limited to, .XML, .JSON 
and .CSV formats. A Portable Document Format (PDF) would not meet this 
definition because the data contained within the PDF file cannot be 
easily extracted without further processing or formatting. We proposed 
to codify these format requirements at proposed new 45 CFR 180.50(c) 
and the definition of machine-readable at proposed new 45 CFR 180.20. 
We explained our belief that making public such data in a machine-
readable format would pose little burden on hospitals because many, if 
not all, hospitals already keep these data in electronic format in 
their accounting systems for purposes of, for example, ensuring 
accurate billing. However, we sought comment on this assumption and the 
burden associated with transferring hospital charge data into a 
machine-readable format.
    As an alternative, we considered proposing to require that 
hospitals post their list of all standard charges for all items and 
services using a single standardized file format, specifically .XML 
only, because this format is generally easily downloadable and readable 
for many healthcare consumers, and it could simplify the ability of 
price transparency tool developers to access the data. However, we did 
not want to be overly prescriptive in our requirements for formatting. 
We sought public comments on whether we should require that hospitals 
use a specific machine-readable format, and if so, which format(s). 
Specifically, we sought public comment on whether we should require 
hospitals to make all standard charge data for all items and services 
available as an .XML file only.
    In addition, we considered formats that could allow direct public 
access to hospital standard charge information and we sought public 
comment from all stakeholders, particularly hospitals and innovative IT 
vendors, regarding such technologies or standards that could facilitate 
public access to real-time updates in a format to make it easier for 
information to be available when and where consumers want to use it. We 
specifically sought public comment on adopting a requirement that 
hospitals make public their standard charges through an open standards-
based Application Programming Interface (API) (sometimes referred to as 
an ``open'' API) through which they would disclose the standard charges 
and associated data elements discussed in section XVI.E.2 of the CY 
2020 OPPS/ASC proposed rule (84 FR 39582 through 39583). We also sought 
public comment on the additional burden that may be associated with a 
requirement that hospitals make public their standard charges through a 
standards-based API.

[[Page 65561]]

    Comment: Several commenters supported the use of API-based methods 
to access pricing information, noting that APIs are largely efficient 
and not burdensome to implement. A few commenters believed this would 
also encourage the development of an innovative health ecosystem that 
would facilitate the most user-friendly interface for consuming and 
presenting the information to patients. A few commenters supported the 
development of industry-wide API standard or requiring a standards-
based API, which would leverage widely-recognized, national standards. 
One commenter suggested that CMS require all stakeholders in the 
healthcare industry to adopt standardized data exchange methods for 
pricing information to allow the primary care or other referring 
physician to be able to have the price conversation with the patient as 
decisions are made. Another commenter urged the use of APIs to be able 
to export a complete health record with both price and clinical 
information. One commenter recommended that CMS use consensus-based 
data standards for the posting of machine-readable files, as stated in 
the June 24, 2019 Executive Order on Improving Price and Quality 
Transparency in American Healthcare to Put Patients First.
    Response: We appreciate comments on this issue. We believe that 
standardizing exchange of hospital standard charge and other data is an 
important goal, but we believe that finalizing our requirement that 
hospitals make their standard charge information available to the 
public online in a machine-readable format is a good initial step. We 
continue to work on policies designed to advance the use of APIs to 
support interoperability in collaboration with other federal partners, 
such as the Office of the National Coordinator (ONC). As hospital 
disclosure of standard charges matures, and Fast Healthcare 
Interoperability Resources (FHIR) or other consensus-based standards 
for data pricing endpoints develop, we may revisit the issue and 
consider proposing in future rulemaking approaches using API or other 
technology.
    Final Action: We are finalizing as proposed the requirement that 
hospitals post their standard charge information in a single digital 
file in a machine-readable format. We are finalizing our definition of 
machine-readable format as a digital representation of data or 
information in a file that can be imported or read into a computer 
system for further processing. Examples of machine-readable formats 
include, but are not limited to, .XML, .JSON and .CSV formats. A PDF 
would not meet this definition because the data contained within the 
PDF file cannot be easily extracted without further processing or 
formatting. We are finalizing these format requirements at new 45 CFR 
180.50(c) and the definition of machine-readable at new 45 CFR 180.20.
4. Location and Accessibility Requirements for the Comprehensive 
Machine-Readable File
    In the CY 2020 OPPS/ASC proposed rule, we explained that we 
reviewed how hospitals are currently implementing our updated 
guidelines, which took effect on January 1, 2019, and we expressed 
concern that some charge information made public by hospitals may be 
difficult for the public to locate. For example, information may be 
difficult to locate if the public is required to click down several 
levels in order to find the information. We also expressed our concern 
about barriers that could inhibit the public's ability to access the 
information once located. For example, we indicated that we were aware 
that some hospitals require consumers to set up a username and 
password, or require consumers to submit various types of other 
information, including, but not limited to, their email address, in 
order to access the data. We expressed concern that these requirements 
might deter the public from accessing hospital charge information.
    Accordingly, we proposed that a hospital would have discretion to 
choose the internet location it uses to post its file containing the 
list of standard charges so long as the comprehensive machine-readable 
file is displayed on a publicly-available web page, it is displayed 
prominently and clearly identifies the hospital location with which the 
standard charges information is associated, and the standard charge 
data are easily accessible, without barriers, and the data can be 
digitally searched. For purposes of these proposed requirements: (1) 
``displayed prominently'' would mean that the value and purpose of the 
web page \143\ and its content \144\ is clearly communicated, there is 
no reliance on breadcrumbs \145\ to help with navigation, and the link 
to the standard charge file is visually distinguished on the web page; 
\146\ (2) ``easily accessible'' would mean that standard charge data 
are presented in a single machine-readable file that is searchable and 
that the standard charges file posted on a website can be accessed with 
the fewest number of clicks; \147\ and (3) ``without barriers'' would 
mean the data can be accessed free of charge, users would not have to 
input information (such as their name, email address, or other 
personally identifying information (PII)) or register to access or use 
the standard charge data file. We proposed to codify this requirement 
at proposed new 45 CFR 180.50(d).
---------------------------------------------------------------------------

    \143\ https://webstandards.hhs.gov/guidelines/49.
    \144\ Nielsen J. (2003, November 9). The ten most violated 
homepage design guidelines. Alertbox. Available at: http://www.useit.com/alertbox/20031110.html.
    \145\ https://webstandards.hhs.gov/guidelines/78.
    \146\ https://webstandards.hhs.gov/guidelines/88.
    \147\ https://webstandards.hhs.gov/guidelines/181.
---------------------------------------------------------------------------

    We encouraged hospitals to review the HHS Web Standards and 
Usability Guidelines (available at: https://webstandards.hhs.gov/), 
which are research-based and are intended to provide best practices 
over a broad range of web design and digital communications issues.
    We also requested public comments on an alternative we considered, 
which would have required hospitals to submit a link to the standard 
charges file to a CMS-specified central website, or submit a link to 
the standard charge file to CMS that would be made public on a CMS web 
page. Such a method could have allowed the public to access standard 
charge information for their purposes in one centralized location. We 
stated that we believed this could reduce potential confusion about 
where to find standard charge information and potentially allow 
standard charge information to be posted alongside CMS hospital quality 
information. It could also assist in the assessment of hospital 
compliance with section 2718(e) of the PHS Act. In spite of these 
possible benefits, we did not propose to require hospitals to submit or 
upload a link to their standard charge information to a CMS-specified 
centralized website because we believed such an effort could be 
unnecessarily duplicative of ongoing State and private sector efforts 
to centralize hospital pricing information and potentially confuse 
consumers who may reasonably look to a hospital website directly for 
charge information. However, we stated that because we appreciate the 
advantages of having all data available through a single site, we 
considered this alternative and sought public comments. We sought 
comment on this alternative option, specifically, whether the burden 
outweighs the advantages.
    Finally, we sought public comments on potential additional 
requirements, including easily-searchable file naming

[[Page 65562]]

conventions and whether we should specify the website location for 
posting rather than our proposed requirement that would permit 
hospitals some flexibility in choosing an appropriate website. Current 
instances of machine-readable charge files posted on hospital websites 
contain variable file types, file names, and locations on each website. 
Standardizing file name or website location information could provide 
consumers with a standard pathway to find the information and would 
provide uniformity, making it easier for potential software to review 
information on each website. Specific requirements for file naming 
conventions and locations for posting on websites could also facilitate 
the monitoring and enforcement of the requirement. Therefore, we sought 
public comments on whether we should propose to adopt these additional 
requirements or other requirements related to these issues.
    Comment: A few commenters supported the development and use 
centralized price transparency websites. For example, two commenters 
noted that the use of a centralized posting repository would aid in 
monitoring to ensure hospital compliance. One commenter agreed that the 
information should be required to be placed in a standardized location, 
such as a standardized ``pricing'' uniform resource locator (URL), 
expressing a belief that it would go a long way toward simplifying the 
presently time-consuming and confusing process when attempting to 
comparison shop for healthcare. The commenter indicated that, when 
combined with the machine-readability requirements, such a standardized 
location would enable a wide variety of benchmarking and comparison-
shopping services that are not possible today. One commenter supported 
the alternative concept for centralizing the standard charge data from 
each hospital into a CMS website to which hospitals would link from 
their respective websites, and quality data would be posted alongside 
the charge information. Another commenter did not support a central 
location that would contain all the links, expressing a belief that the 
requirement to make the charge information ``displayed prominently'' on 
the hospitals website would be sufficient. A few commenters suggested 
that CMS host a centralized list of machine-readable pricing websites 
and recommended that these websites be incorporated into the existing 
CMS National Plan and Provider Enumeration System (NPPES). Another 
commenter suggested that CMS launch and maintain a centralized data 
portal, similar to CMS' Hospital Compare website, with tightly defined 
file constructs in order to ensure the submission of consistent 
information by providers so that comparisons could be made. A few 
commenters suggested that CMS leverage existing price transparency 
efforts by states, including requirements to report pricing information 
or publish instructions on hospital websites to facilitate consumer 
access to pricing information. One commenter noted that states with 
APCDs and price transparency websites centralize and compare costs/
prices and other attributes across providers and payers, providing a 
platform for disseminating standardized information. The commenter 
suggested that CMS leverage this experience, invest in 
interoperability, and advance this work across states to support 
consumers. Several commenters suggested alternative approaches to 
enable public access to price transparency information. One commenter 
recommended the development of a transparency website that incorporates 
a radius-distance search tool to view and compare hospital charges. The 
commenters noted that CMS shares the contents of the NPPES database on 
a regular basis as public use files due to the inevitability of FOIA 
requests. A few commenters supported the use of an independent third-
party online database, with one commenter noting that this approach 
would not increase burden on hospitals or clinicians, in alignment with 
CMS' stated policy goals.
    Response: We appreciate the many suggestions from stakeholders 
related to ensuring public access to hospital standard charge 
information. We agree with stakeholders that centralizing the standard 
charges information disclosed by hospitals could have many advantages 
for finding the files and for monitoring to ensure compliance. We 
decline to finalize such a policy at this time, however, we will 
continue to consider a requirement for hospitals to submit to CMS their 
files, or a link to where such files may be located on the internet, 
for future rulemaking. We agree with commenters that a naming 
convention could assist in locating hospital charge data files and are 
therefore finalizing a requirement that hospitals use a CMS-specified 
naming convention, which, as discussed in the CY 2020 OPPS/ASC proposed 
rule, we believe will help stakeholders more easily locate the 
comprehensive machine-readable file that contains all hospital standard 
charge information. We are finalizing the following naming convention 
that must be used for the file: __standardcharges.[json[verbar]xml[verbar]csv] in which the EIN is 
the Employer Identification Number of the hospital, followed by the 
hospital name, followed by ``standardcharges'' followed by the 
hospital's chosen file format.
    CMS thanks the commenters for their input on the use of APCDs. We 
note that this rule does not require hospitals to contribute data to an 
APCD, but recognize that States with APCDs may seek to integrate the 
publication of hospital standard charge data and negotiated charges 
with ongoing price transparency and interoperability efforts. Moreover, 
we are finalizing our policy to permit hospitals to choose an 
appropriate public facing website and web page on which to make public 
its comprehensive machine-readable list of all standard charges for all 
items and services.
    Comment: A few commenters agreed with our proposals for data 
accessibility, specifically that accessing the hospital charge 
information would not require consumers to input information (such as 
their name, email address, or other personal identifying information) 
or register. One commenter suggested, however, that this requirement 
does not appear to be in alignment with Medicare.gov, which the 
commenter notes requires visitors to provide personal, identifying 
information (such as date of birth) when reviewing options for Medicare 
health plans.
    Response: We thank commenters for their support for barrier free 
access to consumer cost comparison information and are finalizing as 
proposed the requirement hospitals provide barrier-free access to their 
machine-readable file of hospital standard charges for all items and 
services provided by the hospital. The comment about access to 
Medicare.gov is inaccurate; the public may review and compare plans and 
pricing anonymously--with or without a drug list--without signing into 
anything or providing personal information. The website requires only a 
zip code entry in order to narrow down the available plans. Even if the 
website did require submission of some personal information, we do not 
believe it is a good analogy for access to a data file. A better 
analogy might be access to CMS public use file data. Such data is also 
made public online in a machine-readable format and does not require 
users to create an account or enter PII to download. In contrast, 
beneficiary access to a personalized online portal containing or using 
personalized information (such as would allow a patient to review and 
select a Medicare

[[Page 65563]]

Advantage health plan or to access one's own claims data) would seem to 
us to be very different. We are therefore finalizing our proposals for 
barrier-free access as proposed.
    Final Action: We are finalizing, with modifications, our proposals 
related to location and accessibility of the comprehensive machine-
readable file of all hospital standard charges for all items and 
services it provides. Specifically, we are finalizing that a hospital 
would have discretion to choose the internet location it uses to post 
its file containing the list of standard charges so long as the 
comprehensive machine-readable file is displayed on a publicly-
available website, it is displayed prominently and clearly identifies 
the hospital location with which the standard charges information is 
associated (Sec.  180.50(d)(1) and (2)). We are finalizing as proposed 
that the hospital must ensure the standard charge data are easily 
accessible and without barriers, including but not limited to that the 
data can be accessed free of charge, without having to establish a user 
account or password, and without having to submit PII (Sec.  
180.50(d)(3)). We are also finalizing our policy that the data must be 
able to be digitally searched (Sec.  180.50(d)(4)). Finally, we are 
finalizing a modification to also require that the hospital must use a 
CMS-specified naming convention for the file (Sec.  180.50(d)(5)). The 
naming convention for the file must be: __standardcharges.[json[verbar]xml[verbar]csv].
5. Frequency of Machine-Readable File Updates
    The statute requires hospitals to establish, update, and make 
public their standard charges for each year. Therefore, we proposed to 
require hospitals to make public and update their file containing the 
list of all standard charges for all items and services at least once 
annually (proposed new 45 CFR 180.50(e)). As explained in the CY 2020 
OPPS/ASC proposed rule, we recognize that hospital charges may change 
more frequently and therefore we encouraged, but did not propose to 
require, that hospitals update this file more often, as appropriate, so 
that the public could access the most up-to-date charge information. We 
also recognized that hospitals may update their charges at different 
times during the year and may also have various State price 
transparency reporting requirements that require updates. For purposes 
of these proposed requirements, we explained that updates that would 
occur at least once in a 12-month period would satisfy our proposed 
requirement to update at least once annually, and also serve to reduce 
reporting burden for hospitals. In other words, we indicated that the 
hospital could make public and update its list of standard charges at 
any point in time during the year, so long as the update to the charge 
data would occur no more than 12 months after posting.
    We also proposed to require hospitals to clearly indicate the date 
of the last update they made to the standard charge data, and permitted 
some discretion as to where the hospital indicated the date of the last 
update. For example, we stated that if a hospital chose to make public 
its list of standard charges in .XML format, the first row of the 
spreadsheet could indicate the date the file was last updated. We also 
stated that the hospital could alternatively choose to indicate the 
date the file was last updated in text associated with the file on the 
web page on which it was posted, or could indicate the date in some 
other way, as long as that date was clearly indicated and associated 
with the file or location containing the standard charge information.
    Comment: A few commenters expressed concern that requiring updates 
to the data only once every 12 months may mean the data posted will not 
be useful to consumers because the information posted may be outdated 
depending on the frequency and timing of contract renegotiation. A few 
commenters also noted that updating the database on a continual basis 
during the year would be a significant burden to hospitals, while 
another commenter suggested that price information should be updated 
more frequently, whenever the prices are changed. One commenter 
specifically supported the requirement to update the standard charge 
information annually. A few commenters recommended that the web page 
indicate the date of last update. One commenter asked for clarification 
regarding the process for price disclosure when new medical information 
is discovered that ``changes the care plan'' and whether hospitals need 
to update patients if pricing information has already been provided.
    Response: We thank commenters for their support and 
recommendations. The statute requires hospitals to annually update its 
list of standard charges, and we believe our proposed requirement for 
hospitals to update their comprehensive machine-readable list of 
standard charges at least once in a 12 month period (which we are 
finalizing) is consistent with its plain language. We recognize the 
challenges inherent in annual posting of a flat file containing all 
hospital standard charges for all items in services. Specifically, we 
recognize that such data may, for various reasons, become outdated over 
the course of a 12 month period, but we also recognize that it may be 
burdensome for a hospital to continually update its standard charge 
information. We believe our final policy strikes a balance between 
consumer need to plan and compare prices when seeking care with 
hospital disclosure burden. We note that in the CY 2020 OPPS/ASC 
proposed rule we sought comment on alternative mechanisms (such as 
requiring data to be presented in an API format) that could allow for 
access to continuously updated hospital charge information. As noted in 
section II.E.3 of this final rule, we will continue to consider this 
option for future rulemaking. We encourage hospitals to make more 
frequent updates, at their discretion and commend hospitals that choose 
to go beyond these requirements to more frequently update the standard 
charge information they make online, or that provide additional 
consumer-specific estimates based on consumer care plans.
    Final Action: At a new 45 CFR 180.50(e), we are finalizing as 
proposed the requirement for hospitals to make public and update their 
file containing the list of all standard charges for all items and 
services at least once annually. For purposes of assessing compliance, 
such updates must occur at least once in a 12-month period. We are also 
finalizing the requirement for hospitals to clearly indicate the date 
of the last update they have made to the standard charge data, with 
some discretion as to where the date of the last update is indicated, 
so long as that date is clearly indicated either within the file or 
otherwise clearly associated with the file.
6. Requirements for Making Public Separate Machine-Readable Files for 
Different Hospital Locations
    As explained in the CY 2020 OPPS/ASC proposed rule, we indicated 
our understanding that some hospitals may have different locations 
operating under a consolidated or single State license, and that 
different hospital locations may offer different services that have 
different associated standard charges. To address this circumstance, we 
proposed at new 45 CFR 180.50(a)(2) that the requirements for making 
public the machine-readable file containing all standard charges for 
all items and services would separately apply to each hospital location 
such that each hospital location would be required to make

[[Page 65564]]

public a separate identifiable list of standard charges.
    Comment: One commenter supported clearly indicating which hospital 
location is covered if the hospital is part of a health system. One 
commenter expressed concern that because academic and teaching 
institutions have expansive campuses, requiring each health system to 
fulfill the requirements separately for each hospital location would 
increase their burden significantly.
    Response: We clarify that a hospital need not post separate files 
for each clinic operating under a consolidated state hospital license; 
it would be sufficient for a hospital to post a single file of standard 
charges for a single campus location, if the file includes charges for 
all items and services offered at the single campus location.
    In cases where such off-campus and affiliated sites operate under 
the same license (or approval) as a main location but have different 
standard charges or offer different items and services, these locations 
would separately make public the standard charges for such locations.
    Final Action: We are finalizing as proposed at new 45 CFR 
180.50(a)(2) (with technical edits for clarity) that the requirements 
for making public the machine-readable file containing all standard 
charges for all items and services apply to each hospital location such 
that a separate identifiable list of all standard charges applicable to 
each hospital location would also would have to be made public.

F. Requirements for Displaying Shoppable Services in a Consumer-
Friendly Manner

1. Background and Overview
    In the CY 2020 OPPS/ASC proposed rule we indicated our belief that 
requiring hospitals to post on the internet a machine-readable file 
containing a list of all standard charges for all items and services 
would be a good first step for driving transparency in healthcare 
pricing because the access to such data would allow integration into 
price transparency tools or into EHR systems for use at the point of 
care or otherwise where and when the information is necessary to help 
inform patients. As a result of the January 1, 2019 update to our 
guidance, we received feedback that long lists of charges in a file 
posted online in a machine-readable format may not be immediately or 
directly useful for many healthcare consumers because the amount of 
data could be overwhelming or not easily understood by consumers. 
Because of this, we considered ways of requiring or encouraging 
hospitals to make public standard charges for frequently provided 
services in a form and manner that would be more directly accessible 
and consumer friendly. Therefore, in addition to including all their 
standard charges for all items and services in the machine-readable 
file, we proposed that hospitals must make public their payer-specific 
negotiated charges for common services for which consumers may have the 
opportunity to shop, in a consumer-friendly manner.
    First, we proposed requirements for hospitals to display a list of 
payer-specific negotiated charges for a specified set and number of 
``shoppable'' services. We stated that we believed doing so would 
enable consumers to make comparisons across hospital sites of care. 
Second, we made proposals intended to ensure the charge information for 
``shoppable'' services would be presented in a way that is consumer-
friendly, including presenting the information as a service package. 
Third, we made proposals related to location, accessibility, and timing 
for updates.
    We explained our belief that the proposals related to consumer-
friendly display of hospital charge information would align with and 
enhance many ongoing State and hospital efforts. We sought comment from 
hospitals regarding the extent to which our proposals are duplicative 
of such ongoing efforts, and how best to ensure consistency of 
consumer-friendly data display across hospital settings. We further 
sought comment from consumers regarding their potential engagement with 
a list of ``shoppable'' hospital items and services, including whether 
our proposals would provide for a useful amount of data and data 
elements that allow for actionable comparisons of ``shoppable'' 
hospital provided items and services.
2. Definition of ``Shoppable Service''
    We proposed that for purposes of this requirement, a ``shoppable 
service'' would be defined as a service package that can be scheduled 
by a healthcare consumer in advance. Shoppable services are typically 
those that are routinely provided in non-urgent situations that do not 
require immediate action or attention to the patient, thus allowing 
patients to price shop and schedule a service at a time that is 
convenient for them. We proposed this definition because it is 
consistent with definitions proposed by policy experts or used by 
researchers who identify a service as ``shoppable'' if a patient is 
able to determine where and when they will receive services and can 
compare charges for multiple providers.\148\ Since hospitals may not 
have insight into whether a particular service is available across 
multiple providers or where a consumer will ultimately determine where 
to receive a particular service, we focused our proposed definition on 
the first aspect, that is, whether or not a service offered by the 
hospital could be scheduled by the consumer in advance.
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    \148\ White C, and Eguchi M. Reference Pricing: A Small Piece of 
the Health Care Price and Quality Puzzle. National Institute for 
Health Care Reform Research Brief Number 18 (2014). Available at: 
https://www.mathematica.org/our-publications-and-findings/publications/reference-pricing-a-small-piece-of-the-health-care-price-and-quality-puzzle.
---------------------------------------------------------------------------

    Additionally, we proposed that the charges for such services be 
displayed as a grouping of related services, meaning that the charge 
for the primary shoppable service would be displayed along with charges 
for ancillary items and services the hospital customarily provides as 
part of or in addition to the primary shoppable service. We proposed 
that hospitals would make public the payer-specific negotiated charge 
for a primary shoppable service that is grouped together with charges 
for associated ancillary services because we believe charge information 
displayed in such a way is consumer-friendly and patient-focused. In 
other words, we believe that consumers want to see and shop for 
healthcare services in the way they experience the service. We proposed 
to define an ``ancillary service'' as an item or service a hospital 
customarily provides as part of or in conjunction with a shoppable 
primary service (proposed new 45 CFR 180.20). Ancillary items and 
services may include laboratory, radiology, drugs, delivery room 
(including maternity labor room), operating room (including post-
anesthesia and postoperative recovery rooms), therapy services 
(physical, speech, occupational), hospital fees, room and board 
charges, and charges for employed professional services. Ancillary 
services may also include other special items and services for which 
charges are customarily made in addition to a routine service charge. 
For example, an outpatient procedure may include many services that are 
provided by the hospital, for example, local and/or global anesthesia, 
services of employed professionals, supplies, facility and/or ancillary 
facility fees, imaging services, lab services and pre- and post-op 
follow up. To the extent that a hospital customarily provides (and 
bills for) such ancillary services as a part of or in conjunction with 
the primary service, we stated the hospital should group the ancillary 
service

[[Page 65565]]

charges along with the other payer-specific negotiated charges that are 
displayed for the shoppable service. We indicated that we believed such 
a practice would be consumer-friendly by presenting standard charge 
information in a way that reflects how a patient experiences the 
service.
    Examples of primary shoppable services may include certain imaging 
and laboratory services, medical and surgical procedures, and 
outpatient clinic visits. The emphasis on shoppable services aligns 
with various State price transparency efforts and is consistent with 
stakeholder feedback. Further, this emphasis is consistent with 
research demonstrating that improving price transparency for shoppable 
services can have an impact on driving down the cost of healthcare. We 
proposed to add this definition to our regulations at proposed new 45 
CFR 180.20.
    Comment: Many commenters generally supported the requirement for 
hospitals to make public their standard charges for shoppable services, 
stating that consumers need the ability to shop and compare common 
hospital services prior to purchase. In particular, one commenter 
commended CMS for the focus on non-emergency services, for which 
patients have an opportunity to shop in advance.
    Some commenters indicated that the ability to schedule a service in 
advance alone is not enough to ensure the healthcare service is 
shoppable. For example, one commenter stated that patients need to have 
multiple providers available in their insurer's network that provide 
the service. One commenter argued that there are no healthcare services 
that could be considered shoppable because beneficiaries are limited to 
the coverage options in their health plan.
    Additionally, commenters suggesting limiting the scope of shoppable 
services based on individual consumer circumstances, for example, one 
commenter suggested that the definition of shoppable services be 
limited to non-covered, non-medically necessary services such as 
elective cosmetic surgery; otherwise, patients may believe that a 
shoppable service is not a necessary service. One commenter urged CMS 
to ensure that the definition of ``shoppable services'' will always 
clearly exclude emergency department services and that CMS never 
introduce a definitional change that could in any way be misconstrued 
to include them so that patients would not be deterred from seeking 
emergency care. One commenter suggested that CMS focus price 
transparency efforts on some prescription drugs and diagnostic imaging 
only. A few commenters argued that certain service such as vaginal 
delivery and cancer treatments would be excluded from being posted as 
shoppable services because they believe such services are unpredictable 
and unable to be scheduled in advance.
    Response: Our proposed definition for a shoppable service aligns 
with scholarly sources indicating that the ability to schedule in 
advance is a key concept for determining the shoppability of a 
healthcare service. As we explained in the CY 2020 OPPS/ASC proposed 
rule, we believe it is reasonable to define a service as ``shoppable'' 
when a consumer can schedule it in advance and not by additional 
criteria or concepts that could enhance or reduce the shoppability of a 
particular service in an individual circumstance. For example, a 
service may be medically necessary for some patients but not others. A 
service may be provided in an emergency situation for some patients but 
not others. A patient may or may not have a plan or insurance network 
that permits them to receive a service from more than one provider in 
their region or insurance network. However, such issues are specific to 
individual circumstances, and are not necessarily the case for all 
individuals who may have the opportunity to schedule a particular 
healthcare service from a hospital in advance. We therefore think it is 
reasonable to use only the first commonly used criterion for the 
definition of a shoppable service (that the service can be scheduled in 
advance), as using additional criteria may unduly limit the types of 
services that may be shoppable for some patients. Moreover, as we noted 
in the CY 2020 OPPS/ASC proposed rule, we limited the definition of 
shoppable service to the first commonly used definition (that the 
service can be scheduled in advance) and did not expand to other 
commonly used definitions (such as whether or not there is more than 
one provider in a market) because we are finalizing requirements that 
apply to hospitals, and hospitals may not be able to determine whether 
a service is shoppable under other criteria, for example, a hospital 
may not be aware of whether or not there are other providers of the 
service available to their patients.
    We disagree with stakeholders who asserted that services provided 
for delivery of babies or that cancer treatments are not able to be 
scheduled in advance and therefore not shoppable. In most instances, 
the location for the delivery of a baby is planned well in advance; at 
least one analysis of a price transparency tool for non-elderly 
patients found that vaginal deliveries are one of the most commonly 
shopped healthcare services.\149\ Similarly, patients who receive a 
cancer diagnosis often seek information about providers that are 
available to treat them before committing to a treatment course by a 
particular provider. By ensuring the release of hospital standard 
charge information, we seek to improve consumer knowledge for the cost 
side of the value proposition. Nothing in this rule would prohibit 
hospitals from displaying quality information along with standard 
charge information, and we encourage hospitals to provide consumers 
with both cost and quality information in a consumer-friendly manner.
---------------------------------------------------------------------------

    \149\ Sinaiko AD, and Rosenthal MB. Examining A Health Care 
Price Transparency Tool: Who Uses It, And How They Shop For Care. 
Health Affairs. April 2016. Available at: https://www.healthaffairs.org/doi/full/10.1377/hlthaff.2015.0746.
---------------------------------------------------------------------------

    Comment: One commenter disagreed with the focus on shoppable 
services entirely, citing a study that found that no more than 43 
percent of hospital spending is attributable to items and services that 
can reasonably be scheduled in advance, and suggested CMS focus on 
other hospital services to impact consumer shopping behavior.
    Response: Our research has shown that there is great interest among 
consumers in taking price into consideration when deciding on treatment 
options and choice of provider. For example, studies have found that 
more than 40 percent of healthcare services are potentially shoppable 
by consumers 150 151 but such services are typically lower 
cost services such as laboratory tests, imaging, and office visits, 
along with some higher-cost procedures such as joint replacements. 
Researchers estimate that approximately $36 billion could be saved when 
consumers are given the ability to shop and compare prices for common 
shoppable services.\152\ As the

[[Page 65566]]

commenter notes, at least one study indicates that approximately 43 
percent of the $524 billion spend on healthcare by individuals with 
employer-sponsored insurance in 2011 was spent on shoppable 
services.\153\ We believe these studies taken together support our 
focus on shoppable services; however, we agree that many non-shoppable 
hospital and emergency services can be very expensive and account for 
much of the healthcare spending in the United States.
---------------------------------------------------------------------------

    \150\ White C, and Eguchi M. Reference Pricing: A Small Piece of 
the Health Care Price and Quality Puzzle. National Institute for 
Health Care Reform Research Brief Number 18 (2014). Available at: 
https://www.mathematica.org/our-publications-and-findings/publications/reference-pricing-a-small-piece-of-the-health-care-price-and-quality-puzzle.
    \151\ Frost A, and Newman D. Spending on Shoppable Services in 
Health Care. Health Care Cost Institute Issue Brief No. 11 (2016). 
Available at http://www.healthcostinstitute.org/files/Shoppable%20Services%20IB%203.2.16_0.pdf.
    \152\ Coluni B. White Paper: Save $36 Billion in U.S. Healthcare 
Spending Through Price Transparency. Truven Health Analytics, 2012. 
Available at: http://www.akleg.gov/basis/get_documents.asp?session=30&docid=14495.
    \153\ Health Care Cost Institute. Spending on Shoppable Services 
in Health Care. Issue Brief #11. March 2016. Available at: https://www.healthcostinstitute.org/images/easyblog_articles/110/Shoppable-Services-IB-3.2.16_0.pdf.
---------------------------------------------------------------------------

    Comment: One commenter agreed with the necessity of displaying 
ancillary items and services in conjunction with the primary service to 
give consumers ``true line of sight'' into their potential costs, but 
suggested that CMS use Medicare claims data to identify the highest 
volume and highest cost ancillary services associated with the 70 
proposed CMS-specified shoppable services, and then provide this 
mapping of service codes in the final rule. Another commenter similarly 
suggested a ``numeric standard'' for determining the list of all 
associated ancillary services by averaging all the required charges 
associated with the primary services, since in some cases only a small 
minority of patients who receive the primary service also receive the 
ancillary services.
    Several commenters requested that CMS clarify how hospitals would 
determine which services they ``customarily'' provide to meet the 
requirements for displaying ancillary services with the primary 
shoppable service. A few commenters expressed concern that the 
definition for ancillary services is not adequately clear, and, as a 
result, hospitals may not interpret ancillary services consistently and 
ultimately cause confusion for consumers. One commenter suggested that 
since complex service packages are difficult to unbundle and shop for 
in isolation, truly shoppable services should be limited to those that 
can be grouped into a reliable service package or are typically only 
administered as an independent service (which the commenter suggests be 
referred to as discrete services). A few other commenters suggested 
that in their hospitals, all supplies, drugs, ancillary tests, 
anesthesia, and recovery are charged separately by contracted 
clinicians or facilities apart from the primary service and therefore 
their hospital could not meet the proposed display requirements for 
standard charges for shoppable services.
    Response: We believe that each hospital should be able to query its 
administrative billing system or EHR system by CPT code to determine 
what other services or line items from other departments (laboratory, 
radiology, etc.) are typically billed with the primary shoppable 
service and present this in a consumer-friendly manner to prospective 
patients. Although this information may differ across hospitals, we 
anticipate this effort will be beneficial to consumers who wish to 
understand their likely cost of care, the items and services that are 
included, and how each might vary by hospital. We further believe that 
hospitals should have flexibility to determine how best to display the 
primary shoppable service as well as the associated ancillary services 
in a manner that is consumer-friendly. We note that many hospitals and 
hospital price estimator tools are already making this information 
available and suggest that hospitals unfamiliar with such efforts look 
to such tools and displays for suggestions on how to display such 
information in a consumer-friendly manner. Further, including ancillary 
services and presenting them together as a shoppable service package 
conforms with recommended best practice for displaying to consumers 
prices for shoppable services.\154\
---------------------------------------------------------------------------

    \154\ Catalyst for Payment Reform. The State of the Art of Price 
Transparency Tools and Solutions. November 2013. Available at: 
https://www.catalyze.org/wp-content/uploads/2017/04/2013-The-State-of-the-Art-of-Price-Transparency-Tools-and-Solutions.pdf.
---------------------------------------------------------------------------

    Further, we appreciate the suggestions made by commenters on 
opportunities for hospitals to report ancillary services by highest 
volume, frequency, and cost. Since, as the commenter noted, the 
availability of these services varies by hospital, we decline to impose 
a standard for the number and types of ancillary services provided.
    We appreciate the comment about limiting shoppable services only to 
those that can be reliably bundled into service package and to include 
individual services only when they are always offered as an individual 
service. We recognize that these practices may differ from hospital to 
hospital. Each hospital, therefore, must determine whether it 
customarily provides ancillary services in conjunction with the primary 
shoppable service and if so, how best to communicate and display them. 
We offer in Table 2 an example template for a display of shoppable 
service packages which communicates the standard charge for the primary 
service along with standard charges for ancillary services customarily 
provided by the hospital. We note that our final rules would require a 
hospital to display the primary shoppable service charges along with 
the charges for the ancillary services it provides and hospitals are 
not required to indicate other ancillary services that are typically 
furnished by other providers involved in the primary shoppable service. 
However, for sake of consumer-friendly presentation, we strongly 
encourage and recommend that the hospital indicate all ancillary 
services the customer may expect as part of the primary shoppable 
service, and to indicate they may be billed separately by other 
entities involved in their care for such services.
    Finally, we agree that hospitals may not customarily provide 
ancillary services with some shoppable services. Such services may be 
``simple'' or ``discrete'' as described by commenters, meaning that 
they are typically experienced by the consumer and billed for by the 
hospital in the same way--as a single service. In this case, as in the 
example in Table 2, such services would be listed as a single shoppable 
service. As a result, we are finalizing a modification to our 
definition of ``shoppable services'' to remove the reference to a 
``service package.'' We believe removing the term ``package'' from the 
definition is necessary to clarify that not every shoppable service is 
a service package. In certain instances, a primary ``shoppable 
service'' may be an individual item or service or a service package. 
Additionally, not all shoppable services are necessarily associated 
with additional ancillary services. We believe this will help clarify 
and simplify the definition. In so doing, however, we do not intend to 
imply that the display of ancillary services is no longer needed or 
important; we are still finalizing our policy that hospitals display 
the ancillary services along with each primary shoppable service, as 
applicable.

[[Page 65567]]



                                Table 2--Sample of Display of Shoppable Services
----------------------------------------------------------------------------------------------------------------
 
----------------------------------------------------------------------------------------------------------------
Hospital XYZ Medical Center
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Prices Posted and Effective [month/day/year]
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Notes: [insert any clarifying notes or disclaimers]
----------------------------------------------------------------------------------------------------------------


 
                                              Primary service and                           [Standard charge for
            Shoppable service                 ancillary services         CPT/HCPCS code            Plan X]
----------------------------------------------------------------------------------------------------------------
Colonoscopy.............................  primary diagnostic                        45378                  $750
                                           procedure.
                                          anesthesia (medication                [code(s)]                  $122
                                           only).
                                                                     -------------------------------------------
                                          physician services........    Not provided by hospital (may be billed
                                                                                      separately)
                                          pathology/interpretation      Not provided by hospital (may be billed
                                           of results.                                separately)
                                                                     -------------------------------------------
                                          facility fee..............            [code(s)]                  $500
Office Visit............................  New patient outpatient                    99203                   $54
                                           visit, 30 min.
Vaginal Delivery........................  primary procedure.........                59400                   [$]
                                          hospital services.........            [code(s)]                   [$]
                                                                     -------------------------------------------
                                          physician services........    Not provided by hospital (may be billed
                                                                                      separately)
                                          general anesthesia........    Not provided by hospital (may be billed
                                                                                      separately)
                                          pain control..............    Not provided by hospital (may be billed
                                                                                      separately)
                                                                     -------------------------------------------
                                          two day hospital stay.....            [code(s)]                   [$]
                                          monitoring after delivery.            [code(s)]                   [$]
----------------------------------------------------------------------------------------------------------------

    Comment: Several hospital commenters expressed concern that the 
volume of plans, in some cases more than 100, with which they have 
contracted rates would present a challenge with respect to collecting 
and posting ancillary items and services for each primary service.
    Response: In the CY 2020 OPPS/ASC proposed rule, we proposed that 
hospitals make public their payer-specific negotiated charges for at 
least 300 shoppable services in a consumer-friendly manner. We are 
finalizing this policy because we believe it is necessary to present 
hospital standard charge information in a more consumer-friendly manner 
than simply to make all standard charges for all items and services 
public in a comprehensive machine-readable file. We did not propose 
that hospitals display their gross charges in a consumer-friendly 
format because, as many hospitals commented on the FY 2019 IPPS/LTCH 
PPS rule in which we updated our guidance to require hospitals to make 
public their chargemaster rates online in a machine-readable format, 
such charges are not relevant to most consumers, even to self-pay 
consumers who are often provided discounted rates by the hospital. As 
discussed in more detail in section II.D of this final rule, we are 
also finalizing three additional types of standard charges: (1) The 
discounted cash price, (2) the de-identified minimum negotiated charge, 
and (3) the de-identified maximum negotiated charge. We believe these 
types of standard charges are important and relevant to consumers and 
therefore will include these types of standard charges in the data 
elements hospitals must display in a consumer-friendly manner. We 
discuss this in more detail in section II.F.4 of this final rule.
    We recognize that hospitals will be presenting much of their 
standard charge data in a manner that has historically not been made 
available to the public. For many hospitals, particularly large 
hospitals, this may involve display of data for potentially many dozens 
of payers and plan products. This rule will not require hospitals to 
change any of their charging or billing practices, but, rather, to 
provide their standard charge information to the public in a consumer-
friendly manner, that is, in a way that more closely approximates 
hospital provided services as they are experienced by the consumer. A 
detailed assessment of the estimated burden on hospitals may be found 
in section V of this final rule.
    We note that the final rules, as discussed in more detail in II.F.5 
of this final rule, provide hospitals with flexibility to determine the 
format they wish to use in order to make these data consumer-friendly 
and readily accessible. For hospitals that lack resources, flat files 
posted online may be the simplest and least expensive option. In such 
cases, we believe it would be reasonable and permissible under our 
final rules related to the consumer-friendly display of shoppable 
services for a hospital to post one file of shoppable services for each 
set of standard charges displayed. For example, the hospital could post 
one consumer-friendly file for each list of the payer-specific 
negotiated charges the hospital has established with each payer for its 
list of 300 shoppable services, a stand-alone consumer-friendly file of 
discounted cash prices for shoppable services, and a stand-alone 
consumer-friendly file of the de-identified minimum and maximum 
negotiated charges for each of the shoppable services. In this way, 
consumers could search for and review only the charges that are 
standard for their particular insurance plan for 300 shoppable services 
provided by the hospital in a consumer-friendly format. Self-pay 
individuals could search for and review a file focused on providing 
them with discounted cash price information for each of the shoppable 
services.

[[Page 65568]]

    Final Action: We are modifying the definition of ``shoppable 
service'' to remove the phrase ``shoppable service package'' and 
finalizing a definition of ``shoppable services'' to mean a service 
that can be scheduled by a healthcare consumer in advance. We are 
finalizing that when the shoppable service is customarily accompanied 
by the provision of ancillary services, the hospital must present the 
shoppable service as a grouping of related services, meaning that the 
charge for the primary shoppable service (whether an individual item or 
service or service package) is displayed along with charges for 
ancillary services. We finalize our definition of ``ancillary service'' 
for purposes of section 2718(e) of the PHS Act to mean an item or 
service a hospital customarily provides as part of or in conjunction 
with a shoppable primary service (new 45 CFR 180.20). As explained in 
the CY 2020 OPPS/ASC proposed rule, ancillary items and services may 
include laboratory, radiology, drugs, delivery room (including 
maternity labor room), operating room (including post-anesthesia and 
postoperative recovery rooms), therapy services (physical, speech, 
occupational), hospital fees, room and board charges, and charges for 
employed professional services. Ancillary services may also include 
other special items and services for which charges are customarily made 
in addition to a routine shoppable service charge. For example, an 
outpatient procedure may include additional services that are provided 
by the hospital, for example, local and/or global anesthesia, services 
of employed professionals, supplies, facility and/or ancillary facility 
fees, imaging services, lab services, and pre- and post-op follow up.
3. Selected Shoppable Services
    We proposed to require hospitals to make public a list of their 
payer-specific negotiated charges for as many of the 70 shoppable 
services that we identify in Table 3 that are provided by the hospital, 
and as many additional shoppable services selected by the hospital as 
are necessary to reach a combined total of at least 300 shoppable 
services (new 45 CFR 180.60(a)).
    In a study of 2011 claims by autoworkers, researchers identified a 
set of 350 frequently billed healthcare services that consumers could 
schedule in advance and for which there was variation in charges across 
providers.\155\ Hospitals that are early adopters of price transparency 
have suggested that it is possible to initially identify and display 
good-faith individualized price estimates for at least 350 shoppable 
healthcare services identified by primary billing codes (including 
prices for ancillary services) with more sophisticated price 
transparency tool developers creating and being able to display 
individualized pricing estimates for at least 1000 shoppable services. 
In contrast, most States that require hospital posting of shoppable 
services range in requiring 25-50 shoppable services, with California 
being the only State that requires the corresponding charge information 
to include ancillary services. In the CY 2020 OPPS/ASC proposed rule, 
we indicated that since these rules would apply to all hospitals 
operating in the United States, some of which may not have any 
experience in displaying charges for shoppable services, we believed it 
would be reasonable to propose a starting point of at least 300 
shoppable services for which hospitals would be required to display 
payer-specific negotiated charges. We further indicated that we 
anticipated that we would increase this number over time as hospitals 
become accustomed to displaying charge information to consumers as a 
grouping of related charges and as such data is more routinely used by 
consumers.
---------------------------------------------------------------------------

    \155\ White C. and Eguchi M. Reference Pricing: A Small Piece of 
the Health Care Price and Quality Puzzle. National Institute for 
Health Care Reform Research Brief Number 18 (2014). Available at: 
https://www.mathematica.org/our-publications-and-findings/publications/reference-pricing-a-small-piece-of-the-health-care-price-and-quality-puzzle.
---------------------------------------------------------------------------

    We also indicated that we believed it would be reasonable to 
require a portion of the 300 shoppable services to be CMS-specified in 
order to ensure standardization that would provide consumers with the 
ability to compare prices across hospital settings. We stated that we 
further believed it would be prudent to permit hospitals to select a 
portion of the shoppable services themselves, recognizing that some 
hospitals may specialize in certain services (for example, specialized 
procedures) or may serve populations that utilize other shoppable 
services with more frequency or are more relevant than the ones we have 
identified for purposes of the CMS-specified services.
    The proposed list of 70 shoppable services were selected based on 
an analysis of shoppable services that are currently made public under 
State price transparency requirements, a review of services that 
frequently appear in web-based price transparency tools, an analysis of 
high volume services and high cost procedures derived from External 
Data Gathering Environment (EDGE) server data,\156\ and a review by CMS 
medical officers. In other words, we used a combination of quantitative 
analysis of the EDGE server claims data, a qualitative review of 
commonly selected services for State and hospital price transparency 
initiatives and tools, and clinician review to ensure such services 
could be scheduled in advance in order to identify our list of 70 CMS-
specified shoppable services.
---------------------------------------------------------------------------

    \156\ Consistent with 45 CFR 153.700, in States where HHS is 
operating the risk adjustment program, issuers must submit 
enrollment, claims, and encounter data for risk adjustment-covered 
plans in the individual and small group markets through the External 
Data Gathering Environment (EDGE) servers. Issuers upload enrollee, 
pharmaceutical claim, medical claim, and supplemental diagnosis 
information from their systems to an issuer-owned and controlled 
EDGE server.
---------------------------------------------------------------------------

    In addition to the proposed 70 CMS-specified shoppable services, we 
also proposed that each hospital would select, at minimum, 230 
additional shoppable services, identified by a primary HCPCS, CPT, DRG 
(or other widely used industry code, as applicable) and make publicly 
available a list of its payer-specific negotiated charges for each of 
those shoppable services, including the payer-specific negotiated 
charges for the shoppable service in both the inpatient setting and the 
outpatient setting, if different. We further proposed that hospitals 
select such services based on the utilization or billing rate of the 
services in the past year. We stated that we believed that enabling 
hospitals to select most of the shoppable services for which they make 
their payer-specific negotiated charges available would permit them to 
tailor their list of shoppable services to their specific patient 
populations and area of expertise. For example, a children's hospital 
could select additional shoppable services that are predominantly 
provided to children.
    Although we indicated that we believed that most hospitals would 
provide the 70 CMS-specified shoppable services (which are very common 
and frequently billed by hospitals based on our analysis of claims) it 
is possible that some hospitals may not offer all of them (for example, 
specialty hospitals). Therefore, we proposed that hospitals would make 
public a list of their payer-specific negotiated charges for as many of 
the 70 shoppable services specified by CMS that are provided by the 
hospital, plus as many additional shoppable services as would be 
necessary to reach a total of at least 300 shoppable services.
    We articulated an alternative option by which we would specify a 
larger set of shoppable services and allow

[[Page 65569]]

hospitals to select up to 70 CMS-specified shoppable services from the 
larger list for which it would make its payer-specific negotiated 
charges publicly available. The hospital would then select an 
additional 230 shoppable services for a total of 300 shoppable 
services. But we did not propose this because we believe most hospitals 
provide the 70 CMS-specified shoppable services and because we were 
concerned that more discretion would erode our desire to ensure 
consumers can get hospital charge information for a minimum 
standardized set of services.
    We sought public comments on the 70 CMS-specified shoppable 
services we proposed. We indicated we were particularly interested in 
feedback regarding the specific services we identified as shoppable 
services and whether other services should be included because they are 
more common, more shoppable, or both. We also indicated we were 
interested in feedback on whether we should require more or less than a 
total of 300 shoppable services. Specifically, we sought comment from 
hospitals and consumers on whether a list of 100 shoppable services (or 
less) would be a reasonable starting point. We also sought public 
comment on whether we should identify more specific requirements 
related to hospital-selected shoppable services; for example, requiring 
hospitals to select their most frequently billed shoppable services 
(that are not included in the CMS-specified list).
    Comment: Many commenters provided opinions about the number of 
shoppable services that hospitals would be required to display. Several 
commenters indicated the total number of shoppable services should be 
increased to more than 300. For example, one commenter suggested that 
the list of shoppable services be as robust as necessary, using an 
example of some price transparency platforms that include up to 8,000-
9,000 procedures. One commenter suggested that CMS expand on the 
required list of 70 and leverage the experience of states to add more 
services. One commenter suggested that all hospital services should be 
displayed because any non-emergent service provided by the hospital 
could be scheduled in advance. In contrast, many commenters supported 
decreasing the total number of shoppable services, arguing that a lower 
number would be more manageable and less burdensome for hospitals. For 
example, one commenter stated that the list of shoppable services 
should be limited to the 70 that CMS initially provided without 
expanding. Several commenters argued that requiring a total of 300 
shoppable services is excessive, especially for small rural hospitals 
and CAHs that do not provide surgical, magnetic resonance imaging 
(MRI), or obstetric care, with one commenter suggesting that 75-100 
total items and services would be more reasonable. One commenter 
suggested reducing the number of shoppable services to reflect the 
small number of inpatient services provided by LTCHs. One commenter 
specifically suggested that rather than selecting 230 shoppable 
services, hospitals should select 100 total services distributed evenly 
across the 25 highest price inpatient services, the 25 highest dollar 
value inpatient services (calculated using price per service multiplied 
by the number of services provided), the 25 highest price outpatient 
services, and the 25 highest dollar value outpatient services.
    Response: As we indicated in the CY 2020 OPPS/ASC proposed rule, we 
believe that 300 shoppable services is a reasonable number based on 
research,\157\ discussions with hospital executives who are early 
adopters and indicated it is possible to initially identify and display 
good-faith individualized price estimates for at least 350 shoppable 
healthcare services identified by primary billing codes (including 
prices for ancillary services), and discussions with more sophisticated 
price transparency tool developers who identify and display more than 
1,000 shoppable services. By contrast, we recognized that most States 
that require hospital posting of shoppable services require 25-50 
shoppable services, with California being the only State that requires 
the corresponding charge information to include ancillary services. 
Thus, we determined that 300 shoppable services would be a reasonable 
starting point. While we agree that nearly all hospital items and 
services could be considered ``shoppable'' because nearly all could be 
scheduled in advance, we continue to believe that a total of 300 
services strikes a balance between the need for consumer-friendly 
presentation of shoppable services and hospital burden and are 
therefore finalizing as proposed our requirement that hospitals make 
public 70 CMS-specified shoppable services along with an additional 230 
hospital-selected shoppable services for a total of 300 shoppable 
services.
---------------------------------------------------------------------------

    \157\ White C. and Eguchi M. Reference Pricing: A Small Piece of 
the Health Care Price and Quality Puzzle. National Institute for 
Health Care Reform Research Brief Number 18 (2014). Available at: 
https://www.mathematica.org/our-publications-and-findings/publications/reference-pricing-a-small-piece-of-the-health-care-price-and-quality-puzzle.
---------------------------------------------------------------------------

    Further, as indicated in the CY 2020 OPPS/ASC proposed rule, we 
recognized that some hospitals may not offer all 70 CMS-specified 
services. Therefore, we proposed and are finalizing a requirement that 
hospitals would make public their list of standard charges for as many 
of the 70 shoppable services specified by CMS that are provided by the 
hospital, plus as many additional shoppable services as would be 
necessary to reach a total of at least 300 shoppable services. We agree 
with commenters that selecting shoppable services based on the highest 
price and highest dollar value inpatient and outpatient services are 
good examples of criteria for hospitals to consider as they determine 
their hospital-selected 230 shoppable services, however, many such 
services are not as common as other shoppable services provided by the 
hospital. We believe that hospitals should make final determinations 
based on how commonly such services are provided to their patient 
population, and thus we are finalizing as proposed our requirement that 
hospitals select such services based on the utilization or billing rate 
of the services in the past year. In other words, the hospital must 
take into consideration the frequency with which they provide services 
that meet the definition of `shoppable' to the patient population they 
serve when determining the hospital-selected shoppable services. We 
note that nothing would preclude a hospital from taking additional 
information (such as the cost of the services) into consideration as 
they develop their list of 230 shoppable services.
    In light of commenters that asserted that some small or specialty 
hospitals may not offer 300 services that could be scheduled by 
consumers in advance, we are modifying our requirements to finalize a 
policy that in cases where a hospital does not provide 300 services 
that could be scheduled by consumers in advance, the hospital must list 
as many of the services it provides that could be scheduled by patients 
in advance (that is, the hospital must list as many shoppable services 
as it provides).
    Comment: Several commenters cited the need for uniformity in 
hospital selection of shoppable services. A few commenters agreed that 
shoppable services should be standardized to allow for comparability 
for consumers. A few commenters argued that patients would not be able 
to adequately compare pricing information for the items and services in 
70 CMS-identified shoppable services that are performed in non-

[[Page 65570]]

hospital settings. One commenter suggested that CMS define a specific 
CPT code range to clarify which procedures are required among the list 
of shoppable services to ensure uniformity and accuracy. One commenter 
suggested that these requirements be phased in gradually, starting with 
a requirement to post standard charges for ``simpler'' visits 
initially, and then include surgeries, DRGs, and services that are more 
complicated. A few commenters expressed concerns that the variability 
in how hospitals bundle items and services would not yield accurate 
consumer comparisons for shoppable services.
    Response: To ensure some degree of uniformity in the shoppable 
services hospitals make public in a consumer-friendly manner, we 
proposed and are finalizing 70 CMS-specified hospital services 
identified by CPT and other commonly used billing codes. As we stated 
in the CY 2020 OPPS/ASC proposed rule, the list of 70 shoppable 
services were selected based on an analysis of shoppable services that 
are currently made public under State price transparency requirements, 
a review of services that frequently appear in web-based price 
transparency tools, an analysis of high volume services and high cost 
procedures derived from EDGE server data,\158\ and a review by CMS 
medical officers. In other words, we used a combination of quantitative 
analysis of the EDGE server claims data, a qualitative review of 
commonly selected services for State and hospital price transparency 
initiatives and tools, and clinician review to ensure such services 
could be scheduled in advance in order to identify our list of 70 CMS-
specified shoppable services. Based on this analysis, we believe that 
these 70 CMS-specified shoppable services are commonly provided by 
hospitals and we believe hospital display of these services will ensure 
consumers have access to standard charges for a minimum set of 
shoppable services.
---------------------------------------------------------------------------

    \158\ Consistent with 45 CFR 153.700, in States where HHS is 
operating the risk adjustment program, issuers must submit 
enrollment, claims, and encounter data for risk adjustment-covered 
plans in the individual and small group markets through the External 
Data Gathering Environment (EDGE) servers. Issuers upload enrollee, 
pharmaceutical claim, medical claim, and supplemental diagnosis 
information from their systems to an issuer-owned and controlled 
EDGE server.
---------------------------------------------------------------------------

    We recognize that many of the shoppable services included on the 
list of 70 CMS-specified services are provided by settings other than 
hospitals; however, our requirements apply only to hospitals (as 
defined at 45 CFR 180.20), and not when they are provided by non-
hospital sites of care. Therefore this information is useful to 
consumers when they are comparing services across hospital settings. 
While non-hospital sites of care are not subject to these regulations 
we are finalizing, we encourage non-hospital sites of care that offer 
the same shoppable services to standardize their displays of charges so 
that consumers have more options and information available to them.
    We appreciate that beginning with ``simpler'' shoppable services 
could provide a phased pathway for hospitals to make public their 
shoppable services; however, we decline to adopt this approach because 
some of the more ``complex'' shoppable services are those for which 
consumers routinely shop (for example, colonoscopy or vaginal 
delivery). We recognize that there may be some variability in the 
method used by hospitals to establish and display standard charges for 
shoppable primary services and associated ancillary services, and we 
encourage hospitals to communicate in consumer-friendly ways what is or 
is not included in the hospital's prices for a shoppable service and 
its ancillary services.
    Comment: Several commenters offered comments related to the 
services included on the CMS-specified list of 70 shoppable services. 
For example, one commenter provided a list of 23 services they 
suggested removing from the 70 CMS-specific shoppable services due to 
their variability in cost, charge structure, charge amounts, and 
associated complexity for providers to develop a sound ``proposed 
rate.'' The list provided by the commenter included procedures 
identified by DRG that are typically divided into those with and 
without major comorbid conditions or complications (MCC).
    A few commenters indicated their belief that the services provided 
by cancer hospitals are not shoppable, and one commenter argued that 
the list of 70 CMS-specified shoppable services are irrelevant to 
cancer hospitals because cancer hospitals do not offer standalone 
services (such as imaging, laboratory or surgical services). Instead, 
such hospitals provide integrated disease management with disease-
specific financial counseling. One commenter indicated that specialty 
hospitals (such as children's hospitals, orthopedic, or cancer 
facilities) should have customized lists of shoppable services.
    A few commenters requested that Evaluation and Management (E&M) 
services be removed from the list because E&M services are billed by 
providers in an office setting and not hospitals. A few commenters 
requested that laboratory testing be removed from the list with one 
commenter requesting that CMS remove 14 routine laboratory tests 
included in the required list of 70 shoppable items and services 
because they are among the least costly services and are less central 
to patients' economic and site of care decisions, and suggested that 
CMS replace them with higher cost procedures more likely to be 
separately paid when performed in a hospital setting. One commenter 
stated that the list of shoppable services is too long and includes 
codes that are not billed by many hospitals and rarely scheduled in 
advance, for example, laboratory tests and CPT code 93000 for 
electrocardiogram. By contrast, one commenter encouraged CMS to include 
clinical laboratory test pricing as part of the standard charge 
information hospitals are required to post, and requested that CMS 
ensure the requirements under this rule are consistent with the type of 
data required to be reported to CMS under section 216(a) of the 
Protecting Access to Medicare Act (PAMA).
    One commenter requested clarification on whether posting an average 
charge based on historical cases would be sufficient if the hospital 
does not charge based on the specific CMS-specified CPT or DRG codes. 
Another commenter pointed out that the standard DRG codes in the list 
of 70 CMS-specified shoppable services correspond to MS-DRGs and not to 
DRGs used by third party payers (for example, All Patients Refined 
(APR)-DRGs). One commenter requested clarification on how the 70 CMS-
specified shoppable services would be categorized asking whether it 
would be DRG for all inpatient services only, and if so, what is the 
packaging type for ambulatory services.
    Response: We appreciate that specialty hospitals offer services 
that are different from most hospitals, however, we do not believe that 
should be an impediment to specialty hospitals displaying their charges 
for shoppable services. Similarly, we believe our requirements have 
addressed situations in which a hospital does not provide one or more 
of the 70 CMS-specified shoppable services. Specifically, we proposed 
and are finalizing a requirement that if a hospital does not provide 
some of the 70 CMS-specified services, then the hospital would identify 
enough shoppable services that it commonly provides to its unique 
patient population so that the total number of shoppable services is at 
least 300. We believe this policy will ensure that the shoppable 
services posted are standardized as much as possible across

[[Page 65571]]

all hospitals while also ensuring specialty hospital have flexibility 
to make public the most relevant shoppable services for their unique 
patient populations.
    The 70 CMS-specified shoppable services are found in Table 3 and 
are divided into four broad categories: E&M Services, Laboratory and 
Pathology Services, Radiology Services, Medicine and Surgery Services. 
While some such services (for example, E&M or laboratory services) may 
not be the most expensive hospital services, our analysis indicates 
they are commonly billed and are healthcare services that are commonly 
shopped. Such services may be billed by a hospital as part of a 
hospital inpatient or outpatient visit. As noted above, to the extent 
such services are not provided by a hospital, the hospital may select 
additional shoppable services that are relevant to its patient 
population.
    We appreciate commenters who pointed out that the codes numbers 
listed for DRG procedures are MS-DRG codes and not APR-DRGs or other 
third party payer service package codes. We recognize this could also 
be the case for other CMS-specified services that are routinely 
negotiated by hospitals with third party payers as packaged services. 
For example, the same or similar shoppable service may be paid as a 
service package by two different payers that use two different common 
billing codes (for example, an MS-DRG by Medicare versus an APR-DRG by 
another third party payer). As such, we will permit hospitals to make 
appropriate substitutions and cross-walks as necessary to allow them to 
display their standard charges for the shoppable services across all 
their third party payers. Average charges based on prior years would 
not be acceptable as an average charge is not one of the types of 
standard charges we are finalizing in this rule.
    Section 1834A of the SSA, as established by section 216(a) of the 
PAMA, required significant changes to how Medicare pays for clinical 
diagnostic laboratory tests under the Clinical Laboratory Fee Schedule. 
Laboratories, including independent laboratories, physician office 
laboratories and hospital outreach laboratories, that meet the 
definition of an applicable laboratory are required to report 
applicable information, which generally includes each private payor 
rate for each clinical diagnostic laboratory test for which final 
payment has been made during the data collection period, the associated 
volume of tests performed corresponding to each private payor rate, and 
the specific HCPCS code associated with the test. We do not believe 
that any of the provisions under this rule conflict with or duplicate 
the requirements under section 1834A of the SSA. While consumer-
friendly display of shoppable laboratory services may include similar 
data (such as payer-specific negotiated charges), the requirement under 
this rule is to provide that information in a consumer-friendly format 
to which consumers have easy access.
    We decline to make any changes in our list of CMS-specified 
shoppable services. As explained in the CY 2020 OPPS/ASC proposed rule, 
we used a combination of quantitative analysis of the EDGE server 
claims data, a qualitative review of commonly selected services for 
State and hospital price transparency initiatives and tools, and 
clinician review to ensure such services could be scheduled in advance 
in order to identify our list of 70 CMS-specified shoppable services. 
We are therefore finalizing the 70 CMS-specified shoppable services as 
proposed.
    Final Action: We are finalizing as proposed our requirement for 
hospitals to make public their standard charges for as many of the 70 
shoppable services that we identify in Table 3 that are provided by the 
hospital, and as many additional shoppable services selected by the 
hospital as is necessary for a combined total of at least 300 shoppable 
services (new Sec.  180.60(a)). In response to comments, we are adding 
a requirement that if a hospital does not provide 300 shoppable 
services, the hospital must list as many shoppable services as they 
provide. These requirements will be finalized at 45 CFR 180.60(a). We 
will also permit hospitals to make appropriate coding substitutions and 
cross-walks as necessary to be able to display their standard charges 
for the 70 CMS-specified services across third party payers.
    We are further finalizing as proposed that in selecting a shoppable 
service, a hospital must consider the rate at which it provides and 
bills for that shoppable service. In other words, the shoppable 
services selected for display by the hospital should be commonly 
provided to the hospital's patient population. We note that this 
proposal, which discussed in the CY 2020 OPPS/ASC proposed rule (84 FR 
39589) was inadvertently omitted from the proposed regulation text but 
we are including it at new 45 CFR 180.60(a).
    Finally, we clarify that hospitals should cross-walk and use, as 
applicable, an appropriate payer-specific billing code (for example, an 
APR-DRG code) in place of the MS-DRG code indicated for the five 
procedures in the list of 70 CMS-specified shoppable services that are 
identified by MS-DRG codes 216, 460, 470, 473, and 743.

       TABLE 3--Final List of 70 CMS-Specified Shoppable Services
------------------------------------------------------------------------
                                                       2020 CPT/HCPCS
         Evaluation & management services               primary code
------------------------------------------------------------------------
Psychotherapy, 30 min.............................                90832
Psychotherapy, 45 min.............................                90834
Psychotherapy, 60 min.............................                90837
Family psychotherapy, not including patient, 50                   90846
 min..............................................
Family psychotherapy, including patient, 50 min...                90847
Group psychotherapy...............................                90853
New patient office or other outpatient visit,                     99203
 typically 30 min.................................
New patient office of other outpatient visit,                     99204
 typically 45 min.................................
New patient office of other outpatient visit,                     99205
 typically 60 min.................................
Patient office consultation, typically 40 min.....                99243
Patient office consultation, typically 60 min.....                99244
Initial new patient preventive medicine evaluation                99385
 (18-39 years)....................................
Initial new patient preventive medicine evaluation                99386
 (40-64 years)....................................
------------------------------------------------------------------------


[[Page 65572]]


 
                                                       2020 CPT/HCPCS
          Laboratory & pathology services               primary code
------------------------------------------------------------------------
Basic metabolic panel.............................                80048
Blood test, comprehensive group of blood chemicals                80053
Obstetric blood test panel........................                80055
Blood test, lipids (cholesterol and triglycerides)                80061
Kidney function panel test........................                80069
Liver function blood test panel...................                80076
Manual urinalysis test with examination using            81000 or 81001
 microscope.......................................
Automated urinalysis test.........................       81002 or 81003
PSA (prostate specific antigen)...................          84153-84154
Blood test, thyroid stimulating hormone (TSH).....                84443
Complete blood cell count, with differential white                85025
 blood cells, automated...........................
Complete blood count, automated...................                85027
Blood test, clotting time.........................                85610
Coagulation assessment blood test.................                85730
------------------------------------------------------------------------


 
                                                       2020 CPT/HCPCS
                Radiology services                      primary code
------------------------------------------------------------------------
CT scan, head or brain, without contrast..........                70450
MRI scan of brain before and after contrast.......                70553
X-Ray, lower back, minimum four views.............                72110
MRI scan of lower spinal canal....................                72148
CT scan, pelvis, with contrast....................                72193
MRI scan of leg joint.............................                73721
CT scan of abdomen and pelvis with contrast.......                74177
Ultrasound of abdomen.............................                76700
Abdominal ultrasound of pregnant uterus (greater                  76805
 or equal to 14 weeks 0 days) single or first
 fetus............................................
Ultrasound pelvis through vagina..................                76830
Mammography of one breast.........................                77065
Mammography of both breasts.......................                77066
Mammography, screening, bilateral.................                77067
------------------------------------------------------------------------


 
                                                       2020 CPT/HCPCS
           Medicine and surgery services                primary code
------------------------------------------------------------------------
Cardiac valve and other major cardiothoracic                        216
 procedures with cardiac catheterization with
 major complications or comorbidities.............
Spinal fusion except cervical without major                         460
 comorbid conditions or complications (MCC).......
Major joint replacement or reattachment of lower                    470
 extremity without major comorbid conditions or
 complications (MCC)..............................
Cervical spinal fusion without comorbid conditions                  473
 (CC) or major comorbid conditions or
 complications (MCC)..............................
Uterine and adnexa procedures for non-malignancy                    743
 without comorbid conditions (CC) or major
 comorbid conditions or complications (MCC).......
Removal of 1 or more breast growth, open procedure                19120
Shaving of shoulder bone using an endoscope.......                29826
Removal of one knee cartilage using an endoscope..                29881
Removal of tonsils and adenoid glands patient                     42820
 younger than age 12..............................
Diagnostic examination of esophagus, stomach, and/                43235
 or upper small bowel using an endoscope..........
Biopsy of the esophagus, stomach, and/or upper                    43239
 small bowel using an endoscope...................
Diagnostic examination of large bowel using an                    45378
 endoscope........................................
Biopsy of large bowel using an endoscope..........                45380
Removal of polyps or growths of large bowel using                 45385
 an endoscope.....................................
Ultrasound examination of lower large bowel using                 45391
 an endoscope.....................................
Removal of gallbladder using an endoscope.........                47562
Repair of groin hernia patient age 5 years or                     49505
 older............................................
Biopsy of prostate gland..........................                55700
Surgical removal of prostate and surrounding lymph                55866
 nodes using an endoscope.........................
Routine obstetric care for vaginal delivery,                      59400
 including pre-and post-delivery care.............
Routine obstetric care for cesarean delivery,                     59510
 including pre-and post-delivery care.............
Routine obstetric care for vaginal delivery after                 59610
 prior cesarean delivery including pre-and post-
 delivery care....................................
Injection of substance into spinal canal of lower           62322-62323
 back or sacrum using imaging guidance............
Injections of anesthetic and/or steroid drug into                 64483
 lower or sacral spine nerve root using imaging
 guidance.........................................
Removal of recurring cataract in lens capsule                     66821
 using laser......................................
Removal of cataract with insertion of lens........                66984
Electrocardiogram, routine, with interpretation                   93000
 and report.......................................
Insertion of catheter into left heart for                         93452
 diagnosis........................................
Sleep study.......................................                95810
Physical therapy, therapeutic exercise............                97110
------------------------------------------------------------------------


[[Page 65573]]

4. Required Corresponding Data Elements
    We proposed that the consumer-friendly charge information the 
hospital makes available to the public online for the CMS and hospital-
selected shoppable services must include certain corresponding data 
elements in order to ensure that consumers understand the hospital's 
payer-specific negotiated charge for each shoppable service and can use 
that information to make comparisons across hospitals. Specifically, we 
proposed that the consumer-friendly display of payer-specific 
negotiated charge information contain the following corresponding 
information for each of the 70 CMS-specified and at least 230 hospital-
selected shoppable services:
     A plain-language description of each shoppable service. 
For example, hospitals would not be required, but are invited, to 
review and use the Federal plain language guidelines.\159\
---------------------------------------------------------------------------

    \159\ See Federal plain language guidelines, available at 
https://plainlanguage.gov/guidelines/.
---------------------------------------------------------------------------

     The payer-specific negotiated charge that applies to each 
shoppable service. If the hospital does not provide one or more of the 
CMS-specified shoppable services, the hospital may indicate ``N/A'' for 
the corresponding charge or otherwise make it clear that the service is 
not provided by the hospital. Each payer-specific charge must be 
clearly associated with the name of the third party payer.
     A list of all the associated ancillary items and services 
that the hospital provides with the shoppable service, including the 
payer-specific negotiated charge for each ancillary item or service.
     The location at which each shoppable service is provided 
by the hospital (for example, Smithville Campus or XYZ Clinic), 
including whether the payer-specific negotiated charge for the 
shoppable service applies at that location to the provision of that 
shoppable service in the inpatient setting, the outpatient department 
setting, or both. If the payer-specific negotiated charge for the 
shoppable service varies based upon location or whether the hospital 
provides the shoppable service in the inpatient versus the outpatient 
setting, the hospital would be required to identify each payer-specific 
negotiated charge.
     Any primary code used by the hospital for purposes of 
accounting or billing for the shoppable service, including, but not 
limited to, the CPT code, the HCPCS code, the DRG, or other commonly 
used service billing code.
    We proposed that hospitals make public the payer-specific 
negotiated charge for a shoppable service in a manner that groups the 
payer-specific negotiated charge for the primary shoppable service 
along with charges for associated ancillary services because we believe 
charge information displayed in such a way is consumer-friendly and 
patient-focused. In other words, we believe that consumers want to see 
and shop for healthcare services in the way they experience the 
service. We recognized that not all hospitals will customarily provide 
exactly the same ancillary items or services with a primary shoppable 
service and therefore we believe it is important for hospitals to 
display a list of which ancillary services are included in conjunction 
with or as part of the primary shoppable service.
    We proposed to codify these proposed required data elements at 
proposed new 45 CFR 180.60(b). We sought public comments on these data 
elements and whether there are additional data elements that should be 
displayed to the public in a consumer-friendly manner. We emphasized 
that nothing in our proposal was meant to inhibit or restrict hospitals 
from including additional data elements that would improve the ability 
of healthcare consumers to understand the hospital's charges for 
shoppable services.
    Comment: Some commenters offered suggestions on specific data 
elements they felt would be necessary to provide consumers with 
accurate understanding of the shoppable services provided by hospitals. 
For example, one commenter suggested that CMS specifically require that 
hospitals list both their technical and professional fees to provide a 
more accurate picture of potential costs. The commenter argued that 
including such charges would reduce the likelihood of surprise billing 
as these additional fees often come in the form of an additional charge 
or bill to consumers. The commenter cited a new state law in Minnesota 
requiring that all provider-based clinics that charge a separate 
facility fee for visits give notice to patients and publicly post a 
disclosure on their website stating that patients may receive a 
separate charge or billing for the facility component, which may result 
in a higher out-of-pocket expense. Another commenter suggested the 
consumer-friendly display of standard charges should take into account 
cost-shifting and uncompensated care, federal requirements such as 
EMTALA, the availability of providers for after-hours care, and whether 
the provider takes all forms of payment.
    A few commenters expressed concern that the proposal does not 
provide hospitals adequate specificity as to how the data should be 
formatted to ensure that information is meaningful and presented in a 
consumer-friendly manner. Many commenters stated that display of 
standard charges for shoppable services would be incomplete without 
corresponding data on healthcare quality to allow consumers to 
understand value. A few commenters recommended requiring hospitals to 
include quality information alongside price in a meaningful way, with 
one suggesting that we also draw on the large body of research on 
healthcare quality measures and presentation format, including volume 
information. The commenter, however, cautioned that if CMS took this 
route, procedure complications data would be difficult for consumers to 
interpret. The commenter recommended that leveraging key measures 
already being used in various quality efforts, in addition to aligning 
measures across public and private payers, could help reduce consumer 
confusion. One commenter urged CMS to establish a Health Quality 
Roadmap in reference to section 4 of the June 24, 2019 Executive Order 
on Improving Price and Quality Transparency to establish common quality 
measurements, align inpatient and outpatient measures, and eliminate 
low-value or counterproductive measures. The commenter suggested that 
quality and outcomes data is more valuable to patients than 
transparency of hospital charges, arguing that they provide information 
for patients to seek out providers with the best track record. The 
commenter stated that providing data on readmissions, frequency or 
revision surgery and mortality, and especially elective procedures such 
as total joint arthroplasty, would encourage providers to use the best 
protocols.
    Several commenters indicated that information on provider referrals 
as a required element would be necessary to decrease healthcare costs 
and to shift consumers to lower cost and higher quality options. One 
commenter stated that further outreach is necessary to determine what 
kinds of price information and which methods of display would influence 
consumer behavior.
    As noted in section II.D.4 of this final rule, several commenters 
supported including a definition of standard charges to reflect the 
discounted cash price that would be given to a self-pay consumer and 
the de-identified minimum and maximum negotiated charges because they 
believe this

[[Page 65574]]

information would be beneficial and relevant to consumers. A few 
commenters believed such standard charges could be confusing to 
consumers.
    Response: We recognize many state legislatures have undertaken 
efforts to reduce surprise billing and applaud such efforts. We are 
finalizing as proposed our requirement that hospitals make public and 
display all ancillary items and services they provide with the primary 
shoppable service as one of the required data elements. As part of our 
requirements, hospitals would be required to display facilities fees 
and fees for services of employed clinicians. However, in accordance 
with our final policies for defining hospital items and services 
(section II.C of this final rule) hospitals would not be required to 
make public the professional fees for all clinicians practicing in 
hospital-based clinics. We note that nothing in this rule would prevent 
hospitals from undertaking disclosure charges for all clinicians 
practicing in a hospital-based clinics, however, and encourage 
hospitals to do so as a way of improving price transparency for 
consumers.
    We thank commenters for their interest in improving consumer 
awareness of quality data. We agree that quality is a necessary 
consideration for consumers deciding on how and where to obtain the 
highest value medical items and services, however, section 2718(e) of 
the PHS Act does not require hospitals to disclose quality information. 
We note that comparative hospital quality information is readily 
available to the public \160\ and that nothing in this final rule would 
prohibit hospitals from posting quality information along with their 
standard charge information. We further note that we included an RFI in 
the CY 2020 OPPS/ASC proposed rule so as to gather feedback that we may 
consider for our ongoing price transparency and value-based 
initiatives.
---------------------------------------------------------------------------

    \160\ AHRQ website, Comparative Reports on Hospitals, at https://www.ahrq.gov/talkingquality/resources/comparative-reports/hospitals.html.
---------------------------------------------------------------------------

    Similarly, although data elements such as referrals, additional 
places of service, availability of the provider for after-hours care, 
and what form of payment the provider accepts are all important 
considerations in driving improvements in value care, we believe 
requiring hospital disclosure of these data elements is beyond the 
scope of section 2718(e) of the PHS Act. In addition, we believe our 
policies represent a balance between data elements that would be useful 
for the public while being sensitive to hospitals' burden in meeting 
requirements. We note, however, that nothing in this final rule would 
prevent a hospital from displaying additional data elements it believes 
the public would find useful.
    Finally, we are making several modifications to the list of data 
elements that hospitals would be required to make public for its 
consumer-friendly display of standard charges.
    First, we are modifying the list of data elements to align with and 
include the three new types of standard charges we finalized in section 
II.D of this final rule. Specifically, we will include the discounted 
cash price, the de-identified minimum negotiated charge, and the de-
identified maximum negotiated charge, along with other necessary 
conforming changes to the list of required data elements throughout. 
Specifically, we are finalizing the following as data elements:
     The payer-specific negotiated charge that applies to each 
shoppable service (and corresponding ancillary services, as 
applicable). We clarify that the hospital must identify and clearly 
associate each set of payer-specific negotiated charges with the name 
of the third party payer and plan. For example the hospital's list of 
payer-specific negotiated charges for Payer X's Silver Plan could be in 
one tab or column in a spreadsheet titled ``Payer X: Silver Plan'' 
while the list of payer-specific negotiated charges for Payer Y's Gold 
Plan could be in another tab or column titled or labeled as ``Payer Y: 
Gold Plan.''
     The discounted cash price that applies to each shoppable 
service (and corresponding ancillary services, as applicable). If the 
hospital does not offer a discounted cash price for one or more 
shoppable services (or corresponding ancillary services), the hospital 
must list its gross charge.
     The de-identified minimum negotiated charge that applies 
to each shoppable service (and corresponding ancillary services, as 
applicable).
     The de-identified maximum negotiated charge that applies 
to each shoppable service (and corresponding ancillary services, as 
applicable).
    Second, in the list of data elements related to the types of 
standard charges, we are finalizing a few clarifying edits to ensure 
hospital understanding that the requirement to display the standard 
charge for a shoppable service applies to each primary shoppable 
service and to each corresponding ancillary service (as applicable). In 
other words, the display of standard charges for the shoppable service 
grouping means display of each charge of the component parts of the 
shoppable service grouping (for example, the hospital must list the 
charge associated with the primary shoppable service plus the charge(s) 
for each ancillary service not already included in the primary 
shoppable service). In so doing, we are removing the separate 
requirement to list all the associated ancillary services and instead 
incorporating the requirement into the list of data elements related to 
the types of standard charges.
    Third, we are clarifying that if the hospital does not offer one or 
more of the 70 CMS-specified shoppable services, the hospital must 
clearly indicate that fact with respect to every type of standard 
charge required for consumer-friendly display. The hospital may use 
``N/A'' for the corresponding charge or use another appropriate 
indicator to communicate to the public that the service is not provided 
by the hospital. We are finalizing this requirement as a separate data 
element.
    Fourth, we are finalizing the requirement that the hospital include 
a plain-language description of each shoppable service, as proposed. 
For example, hospitals would not be required but are invited to review 
and use, the Federal plain language guidelines.\161\ Fifth, we are 
modifying the data element related to the location of each shoppable 
service in light of the additional types of standard charges that 
hospitals must list for the shoppable services to refer more broadly to 
the ``standard charges'' rather than to ``payer-specific negotiated 
charges'' in each instance it appears. Specifically, we are finalizing 
that the location at which each shoppable service is provided by the 
hospital (for example, Smithville Campus or XYZ Clinic), including 
whether the standard charges for the shoppable service applies at that 
location to the provision of that shoppable service in the inpatient 
setting, the outpatient department setting, or both. If the standard 
charge for the shoppable service varies based upon location or whether 
the hospital provides the shoppable service in the inpatient versus the 
outpatient setting, the hospital would be required to identify each set 
of standard charges.
---------------------------------------------------------------------------

    \161\ See Federal plain language guidelines, available at 
https://plainlanguage.gov/guidelines/.
---------------------------------------------------------------------------

    Finally, we are finalizing without modification the requirement to 
display any primary code used by the hospital for purposes of 
accounting or billing for the shoppable service and associated 
ancillary services, including, but not limited to, the CPT code, the 
HCPCS code, the DRG, or other commonly used

[[Page 65575]]

service billing code. We note that, as discussed in section II.F.3 of 
this final rule, hospitals may use, as applicable, an appropriate 
payer-specific billing code (for example, an APR-DRG code) in place of 
the MS-DRG code indicated for the five procedures in the list of 70 
CMS-specified shoppable services that are identified by MS-DRG codes 
216, 460, 470, 473, and 743.
    Comment: Several commenters raised concerns with the time, effort, 
and technical challenges for hospitals of posting billing and charge 
codes as part of the consumer-friendly display of standard charge data 
for shoppable services. One commenter stated that the coding elements 
and concepts required do not exist or are not maintained in hospital 
chargemasters, but flow to posted charges through other interfaces. 
Several commenters indicated they believed that the size and scope of 
the data that would need to be presented would be quite large, with 
commenters estimating that the resulting file could be 300 lines long 
with dozens of columns or could lead to 100,000 rows of data with 
millions of fields. One commenter indicated that the size and 
complexity of the data might crash the hospital's website. One 
commenter stated that in order to compile, display, and maintain 
service packages for the select shoppable services, a sophisticated 
relational database analysis with web-based display modules would be 
necessary unless the hospital has existing software. Similarly, another 
commenter stated that to comply with the new regulation, it would need 
to work with its web development team and EHR management system vendor 
to build a shopper functionality and benefits engine and hire 
additional vendors to maintain functionality and accuracy. One 
commenter recommended that CMS take additional time to ensure that 
posting data for shoppable services is fairly applied across provider 
types and does not require an abundance of resources. One commenter 
stated that presenting their standard charge information in a consumer-
friendly manner would be difficult for hospitals, for example, rural 
hospitals and CAHs that rely on cost-based reimbursement, that are 
unable to afford a vendor for software that would aid in the posting of 
standard charge data.
    Response: We acknowledge that not all data elements required for 
the display of hospital standard charges in a consumer-friendly manner 
can be derived solely from a hospital's chargemaster. The set of 
standard charges found in the hospital chargemaster are only one type 
of standard charges--the gross charges--which are the undiscounted 
rates for individual items and services; as pointed out by hospitals 
that submitted comments in the FY 2019 IPPS/LTCH PPS (83 FR 41686 
through 41688), the gross charge does not apply to most consumers of 
hospital services, for example, consumers with third party payer 
coverage. In other words, the gross charge is not a standard charge for 
approximately 90 percent of the hospital's customers who have third 
party payer coverage. The set of standard charges that applies to 
consumers with third party payer coverage are the payer-specific 
negotiated charges the hospital has established with the consumer's 
third party payer. Such charges are not a part of the hospital's 
chargemaster. Moreover, many payer-specific standard charges have been 
negotiated for service packages, as opposed to individual items and 
services that are listed in the hospital chargemaster. Thus, the data 
elements required for making public standard charges in a consumer-
friendly manner will require hospitals to look beyond their 
chargemasters and pull the relevant data out of their other accounting 
and billing systems.
    Additionally, we acknowledge that the benefits of compiling these 
data elements and presenting them in a consumer-friendly manner will 
likely require more thoughtful effort on the part of hospitals than 
simply making all their standard charge information public in a 
comprehensive machine-readable file. For example, identifying and 
listing the standard charges for ancillary services along with the 
primary shoppable service may take some thought and clinical input. 
Translating internal code descriptions into a consumer-friendly plain-
language description for items and services provided by the hospital 
may also require some thought. However, we disagree that consumer-
friendly display of hospital standard charge information would 
overwhelm or ``crash'' a hospital's website, or that the requirements 
would necessitate the development of an elaborate or expensive tool. As 
suggested in section II.F.3 of this final rule, we believe there are 
low-tech and inexpensive ways to compile hospital standard charge 
information in files posted online that are consumer-friendly, and, in 
Table 2, we have offered an example of how a hospital might consider 
making such information public.
    Additionally, we note that we are modifying our list of required 
data elements to align with and reflect the final policies related to 
the definition of ''standard charge'' as discussed in section II.D of 
this final rule. As such, the list of data elements would include the 
discounted cash price, the de-identified minimum negotiated charge, and 
the de-identified maximum negotiated charge for each of the 300 
shoppable services and their associated ancillary services. 
Accordingly, and in light of comments, we have increased our burden 
estimate (section V of this final rule) to reflect and recognize that 
hospitals may need to put more time and thought into ensuring that 
their standard charge information is presented in a consumer-friendly 
manner than we initially believed and to account for posting additional 
types of standard charges, specifically, the addition of the discounted 
cash price and the display of the de-identified minimum negotiated 
charge, and the de-identified maximum negotiated charge for each 
shoppable service and corresponding ancillary services.
    Final Action: We are specifying the data elements that hospitals 
must include in their online posting of shoppable services in order to 
ensure that consumers understand the hospital's standard charges for 
each shoppable service and can use that information to make comparisons 
across hospitals.
    As noted in responses to comments, we are making several clarifying 
edits and modifications to align with final policies including: (1) 
Modifications to align with and include the three new types of standard 
charges we are finalizing in section II.D of this final rule, (2) we 
are removing the separate requirement to list all the associated 
ancillary services and instead incorporating the requirement into the 
list of data elements related to the types of standard charges, (3) 
finalizing as a separate data element and clarifying that if a hospital 
does not offer one or more of the 70 CMS-specified shoppable services, 
the hospital must clearly indicate that fact with respect to every type 
of standard charge required for consumer-friendly display, and (4) 
modifying the data element related to the location of each shoppable 
service in light of the additional types of standard charges that 
hospitals must list for the shoppable services to refer more broadly to 
the three types of standard charges referred to in the section, rather 
than to ``payer-specific negotiated charges'' in each instance it 
appears.
    In summary, we are specifying in new 45 CFR 180.60(b) that 
hospitals must include, as applicable, all of the following 
corresponding data elements when displaying the three types of

[[Page 65576]]

standard charges for its list of shoppable services:
     A plain-language description of each shoppable service.
     An indicator when one or more of the CMS-specified 
shoppable services are not offered by the hospital.
     The payer-specific negotiated charge that applies to each 
shoppable service (and to each ancillary service, as applicable). Each 
list of payer-specific negotiated charges must be clearly associated 
with the name of the third party payer and plan.
     The discounted cash price that applies to each shoppable 
service (and corresponding ancillary services, as applicable). If the 
hospital does not offer a discounted cash price for one or more 
shoppable services (or corresponding ancillary services), the hospital 
must list its undiscounted gross charge.
     The de-identified minimum negotiated charge that applies 
to each shoppable service (and to each corresponding ancillary service, 
as applicable).
     The de-identified maximum negotiated charge that applies 
to each shoppable service (and to each corresponding ancillary service, 
as applicable).
     The location at which the shoppable service is provided, 
including whether the standard charges for the hospital's shoppable 
service applies at that location to the provision of that shoppable 
service in the inpatient setting, the outpatient department setting, or 
both.
     Any primary code used by the hospital for purposes of 
accounting or billing for the shoppable service, including, as 
applicable, the CPT code, the HCPCS code, the DRG, or other common 
service billing code.
    We note that, as discussed in section II.F.3 of this final rule, 
hospitals may use, as applicable, an appropriate payer-specific billing 
code (for example, an APR-DRG code) in place of the MS-DRG code 
indicated for the five procedures in the list of 70 CMS-specified 
shoppable services that are identified by MS-DRG codes 216, 460, 470, 
473, and 743.
5. Format of Display of Consumer-Friendly Information
    In the CY 2020 OPPS/ASC proposed rule, we indicated that we were 
aware that many hospitals are already communicating charge information 
to patients in a variety of ways. Some are already making public 
various types of standard charges for shoppable services available 
online in various formats. For example, some hospitals offer searchable 
price transparency tools on their website that offer estimated charges 
(averages or individualized out-of-pocket costs) or may display charges 
for shoppable services in brochures (both online and offline) that 
contain self-pay discounted prices for a service package. In the CY 
2020 OPPS/ASC proposed rule, we indicated that we believed many 
hospitals are already already meeting or exceeding our proposed 
requirements by offering, for example, patient-friendly price 
transparency tools that calculate individualized out-of-pocket cost 
estimates. We sought comment on whether offering such tools could 
qualify a hospital to be excepted from some of the proposed 
requirements, for example, the consumer-friendly display requirements 
(84 FR 39576).
    We further noted in the CY 2020 OPPS/ASC proposed rule that because 
there are a variety of consumer-friendly ways to display charges for 
hospital services and because we did not want to restrict hospitals 
from innovating or from having to duplicate efforts, we did not propose 
to require hospitals to use a specific format for making such data 
public online in a consumer-friendly manner. Specifically, unlike our 
proposals for the comprehensive machine-readable list of standard 
charges for all items and services (discussed in section II.E of this 
final rule), we did not propose to require that hospitals make payer-
specific charge data public in a single digital file posted online. 
Instead, we proposed that hospitals retain flexibility on how best to 
display the payer-specific negotiated charge data and proposed 
associated data elements to the public online, so long as the website 
is easily accessible to the public. We indicated that we believed this 
approach would permit some flexibility for hospitals to, for example, 
post one or more files online with a list of payer-specific charges for 
the shoppable services and associated data elements, or, for example, 
to integrate such data into existing price estimate tools.
    Additionally, we did not propose, but considered, an option that 
would require hospitals to make these data available in API format. As 
explained in more detail in section II.E.3. of this final rule, an API 
enabled format could allow consumers to access the data by searching 
for it directly when they do not have a computer by, for example, 
putting a CPT code in the URL path of the hospital to render in one's 
mobile phone browser the gross or payer-specific negotiated charge for 
the service. For example, a consumer searching for the price of a blood 
test for cholesterol (CPT code 80061) at fictional hospital ABC could 
look it up by inserting the URL path https://hospitalABC.com/api/80061.
    We further recognized not all consumers have access to the 
internet. Therefore, we proposed to require that hospitals make certain 
data elements available in a consumer-friendly manner offline (84 FR 
39589 through 39590). Specifically, we proposed that the hospital would 
provide a paper copy (for example, a brochure or booklet) of the 
information to consumers upon request within 72 hours of the request. 
We proposed to codify this provision at proposed new 45 CFR 180.60(c).
    Comment: A few commenters expressed concern that the proposal did 
not provide hospitals adequate specificity as to how the data should be 
formatted to ensure that information is meaningful and presented in a 
consumer-friendly manner.
    A few commenters indicated that the requirement to provide to the 
patient ``a paper copy (for example, a brochure or booklet)'' of the 
information is available to consumers upon request within 72 hours of 
the request'' would be challenging to implement because it would be 
costly and time consuming, and the volume of data would be enormous. 
Two commenters suggested hospitals should be able to charge a fee to 
cover the costs of printing a paper copy. One commenter suggested that 
if individuals do not have access to internet, public libraries provide 
free internet access to patrons. Two commenters suggested that CMS 
should permit hospitals to limit the size and contents of the patient-
requested paper equivalent (for example, limiting the response to the 
payer-specific negotiated charges that apply to the individual's 
circumstances).
    Response: In the CY 2020 OPPS/ASC proposed rule we indicated that, 
because there are a variety of consumer-friendly ways to display 
charges for hospital services and because we did not want to restrict 
hospitals from innovating or from having to duplicate efforts, we did 
not propose to require hospitals to use a specific format for making 
such data public online in a consumer-friendly manner. We therefore 
proposed and are finalizing a policy that hospitals retain flexibility 
on how best to display their standard charge data and proposed 
associated data elements to the public in a consumer-friendly manner 
online, so long as the online information is easily accessible to the 
public. We continue to believe that this approach would permit some 
flexibility for hospitals to, for example, post one or more files 
online with a list of payer-specific charges for

[[Page 65577]]

the shoppable services and associated data elements, or, for example, 
to integrate such data into existing price estimate tools. We have 
included a sample template in Table 2 as an example of the format that 
would meet our requirements, although hospitals are not required to use 
this template.
    Additionally, in light of our final policy to permit hospitals 
flexibility to choose an appropriate format, we are not finalizing the 
proposal that the hospital make available a paper copy. We generally 
agree with commenters who indicated that a paper format could be 
burdensome, however, if we determine that lack of a paper copy of 
hospital standard charges is preventing consumers from accessing 
hospital charge information, we may revisit this in future rulemaking.
    Comment: Commenters stated that they were concerned that consumer-
friendly display of standard charges for shoppable services might not 
provide the consumer with sufficient understanding of their actual 
costs, with several commenters expressing concern that the payer-
specific negotiated charge would differ significantly based on the 
severity of the patient's condition, leading to variation between the 
amount displayed in a consumer-friendly format and the amount received 
by the hospital from the third-party payer. Because of this, commenters 
suggested that, in order to display standard charges in a ``consumer-
friendly'' format, the information must include data on out-of-pocket 
costs, with several commenters stating that this information should be 
specific to the individual's health insurance plan.
    Response: We recognize the need and desire for consumers to 
anticipate their out-of-pocket costs. We believe understanding the 
payer-specific negotiated charge is a necessary first step towards 
consumers having insight into the cost of their healthcare and being in 
a better position to choose the healthcare coverage and setting that is 
most advantageous to them. We expect consumers will use the hospital 
standard charge information in conjunction and communication with their 
providers and carriers to understanding their unique cost sharing 
obligations. Further, we agree that a consumer-friendly online display 
of shoppable services that would return an immediate out-of-pocket 
price estimates is preferable to a flat file of standard charges posted 
online. For this reason we considered and are finalizing as described 
in more detail below, a policy to deem a hospital price estimator tool 
as meeting some of the requirements under 45 CFR 180.60. We agree with 
commenters who indicated that sometimes circumstances during the course 
of treatment can alter price estimates and because of this we encourage 
hospitals to continue to engage in patient education, communication, 
and heightened transparency regarding the cost estimates they provide.
    We further emphasize that hospitals are not precluded from 
providing customized one-on-one financial counseling to consumers, and 
we applaud hospitals that take the additional step to provide this 
information to consumers on an individual basis through financial 
counseling in addition to meeting the posting requirements for the 
public files.
    Comment: Many commenters indicated that many hospitals are already 
communicating financial obligations to consumers in advance in a 
variety of consumer-friendly ways. For example, several commenters 
stated that many hospitals provide good faith estimates, financial 
counseling services, or have available call centers and/or patient-
friendly pricing tools on their websites for use by patients. A few 
commenters asserted that providing patient-specific estimates, such as 
a patient's likely out-of-pocket costs based on data provided by the 
patient's insurer, is more helpful to consumers than sharing charges 
online as proposed because such information is personalized based on 
individual circumstances.
    Some commenters specifically requested relief from one or more of 
the requirements under this rule as a result of hospital efforts to 
communicate personalized out-of-pocket information. Specifically, a few 
commenters suggested that hospitals that already provide internet-based 
price estimator tools or good faith estimates to consumers (for 
brevity, we henceforth refer to such an application as a price 
estimator tool) be exempt from the requirements of the rule. For 
example, one commenter suggested that if hospitals offer tools that 
allow patients to obtain out-of-pocket estimates for 300 shoppable 
services (including the 70 specified by CMS), they should be considered 
to have met their obligations under the rule. This commenter further 
suggested that CMS could set the expectation that hospitals opting for 
this approach provide estimates for all payers with which they have 
negotiated rates. A few commenters suggested that this flexibility to 
provide consumer-friendly charge information in this manner would be 
beneficial for reasons such as mitigating the risk of disclosure of 
data that some regard as trade secret or confidential while providing 
the same baseline information (gross charges) as required under the 
rule as well as more accurate information about patients' out of cost 
based on personalized estimates from their plan specific information. 
Other commenters explained that a price estimator tool that provides 
meaningful cost information to patients would be more useful to 
patients than voluminous data sets. One commenter specifically 
requested that no hospital offering a pricing tool should be exempted 
from releasing the comprehensive machine-readable data.
    A few commenters noted that there are potential limitations 
associated with the information a patient receives through consumer-
friendly pricing tools because providers cannot always estimate what 
services a patient will need, how they will respond to treatment, and 
whether complications as a result of co-morbidities or other issues 
will arise that would require additional services. For example, one 
commenter noted that accurate price estimation may depend on data 
elements such as payer coverage/benefit information, hospital/payer 
contract information, physician order and diagnosis, which may be 
contained in the hospital's EHR system.
    Some commenters that supported an exemption for hospitals that have 
established a price estimator tool, indicated that if adopted, CMS 
should specify what qualifies as an acceptable price estimator tool and 
made specific suggestions for tool functionality, although in some 
cases these suggestions were made in the context of price estimator 
tools that could be offered by health insurers rather than hospitals. 
Suggestions for consumer-friendly tool functionality included:
     Provide users with an estimate of the overall cost and the 
out-of-pocket costs, including out-of-pocket costs based on an 
individual's insurance policy.
     Notify user of the availability of financial aid, payment 
plans, and assistance in enrolling for Medicaid or state program.
     Include a disclaimer about the limitation of the 
estimation, such as to advise the user to consult with their health 
insurer to confirm individual payment responsibilities, such as 
remaining deductible balances.
     Indicate quality of care in the healthcare setting.
     Do not require PII; users would not be required to use any 
form of account, username, or password to use the price estimator tool.

[[Page 65578]]

     Make estimates available in English, Spanish, and other 
languages as preferred.
     Offer an ad hoc service where a patient can obtain a cost 
estimate telephonically and/or via email.
     Be prominently featured on the hospital home page, and use 
plain and obvious language to help ensure that consumers can find it.
     Hospitals should advertise this tool to patients and 
generate interest.
    Several commenters generally encouraged CMS to take steps to 
facilitate the development and voluntary adoption of price estimator 
tools by convening stakeholders, including the Departments of Labor and 
Treasury, to identify best practices, recommending minimum standards 
for common features, and developing solutions to common technical 
barriers.
    Response: We appreciate commenters' careful consideration of and 
detailed suggestions for an approach for regarding hospitals as having 
met the requirement for making public their standard charge information 
in a consumer-friendly manner. In the CY 2020 OPPS/ASC proposed rule, 
we noted that as a result of the January 1, 2019 update to our 
guidance, we received feedback that long lists of charges in a file 
posted online in a machine-readable format may not be immediately or 
directly useful for many healthcare consumers because the amount of 
data could be overwhelming or not easily understood by consumers. We 
further recognized in the CY 2020 OPPS/ASC proposed rule that hospital 
standard charges, while necessary for consumers to understand their 
potential out-of-pocket obligations, are not sufficient in and of 
themselves. In section II.D of this final rule, we stated that we 
agree, for example, that the payer-specific negotiated charge does not, 
in isolation, provide a patient with an individualized out-of-pocket 
estimate. We referred to the GAO report \162\ we described in the CY 
2020 OPPS/ASC proposed rule which supports our assertion that payer-
specific negotiated charges are a critical piece of information 
necessary for patients to determine their potential out-of-pocket cost 
obligations. In other words, in order for an insured individual to 
determine an out-of-pocket estimate in advance of committing to a 
healthcare service with a particular provider, the insured individual 
must have several data points including the total charge (which is the 
payer-specific negotiated charge) for the item or service and their 
particular benefits under their insurance plan (for example, their co-
pay or deductible) in order to determine their personalize out-of-
pocket obligation. More often than not, patients see all this 
information after the service has been provided in the form of their 
EOBs. As explained in II.D of this final rule, EOBs are designed to 
communicate provider charges and resulting patient cost obligations, 
taking third party payer insurance into account. The payer-specific 
negotiated charge is a critical data point found on patient's EOB. We 
further explained that when a consumer has access to payer-specific 
negotiated charge information prior to receiving a healthcare service 
(instead of sometimes weeks or months after the fact when the EOB 
arrives), in combination with additional information from payers, it 
can help the patient estimate his or her potential out-of-pocket cost.
---------------------------------------------------------------------------

    \162\ GAO. Health Care Price Transparency: Meaningful Price 
Information Is Difficult for Consumers to Obtain Prior to Receiving 
Care. Publicly released October 24, 2011. Available at: https://www.gao.gov/products/GAO-11-791.
---------------------------------------------------------------------------

    Because of this, in the CY 2020 OPPS/ASC proposed rule, we 
considered ways of requiring or encouraging hospitals to make public 
standard charges for frequently provided services in a form and manner 
that would be more directly accessible and consumer friendly. 
Therefore, in addition to including all their standard charges for all 
items and services in the machine-readable file, we proposed that 
hospitals must make public their payer-specific negotiated charges for 
common services for which consumers may have the opportunity to shop, 
in a consumer-friendly manner. The intent of these provisions was to 
ensure that the hospital standard charges made public in the 
comprehensive machine-readable file would be more accessible to the 
average consumer so that consumers could use the information, combining 
it with additional necessary benefit information from their insurer, to 
estimate their individual out-of-pocket cost obligations in advance of 
receiving a healthcare service from the hospital.
    We are persuaded by commenters' suggestions that some hospitals 
offering online price estimator tools that provide real-time 
individualized out-of-pocket cost estimates should receive 
consideration and potential relief from some of the requirements for 
making public standard charges, particularly as it relates to our 
intent and goals for requiring that hospitals communicate their 
standard charges in a consumer-friendly manner. We believe voluntarily 
offering an online price estimator tool has merit because the hospital 
standard charges as defined in this final rule are used to develop the 
individual's out-of-pocket estimate in an even more consumer-friendly 
way than what we proposed within the limits of our statutory authority. 
We believe that price estimator tools pick up where our rule ends and 
take the additional steps that would otherwise be required by the 
consumer to determine their individualized out-of-pocket by combining 
hospital standard charge information with the individual's benefit 
information directly from the insurer. Thus, although some hospital 
price estimator tools may not display standard charge information in 
the consumer-friendly manner in the precise ways we proposed and are 
finalizing under this rule, they do appear to accomplish the goal and 
intent of ensuring such information is available in a consumer-friendly 
manner for purposes of individuals to directly determine their specific 
out-of-pocket costs in advance of committing to a hospital service. 
Thus, we believe it is possible that hospitals with price estimator 
tools could be considered as having accomplished the goals we intended 
to achieve by requiring hospitals to repackage and display their 
standard charge information for common shoppable services in a 
consumer-friendly manner. We emphasize, however, that hospitals would 
still be required to publish all standard charges in a machine-readable 
file consistent with the requirements we finalize in section II.E of 
this final rule.
    We are finalizing, as modifications to our proposal, in a new 45 
CFR 180.60, that a hospital may voluntarily offer an internet-based 
price estimator tool and thereby be deemed to have met our requirements 
to make public its standard charges for selected shoppable services in 
a consumer-friendly manner. We believe this accommodation is responsive 
to comments indicating that the requirements to make public shoppable 
services in a consumer-friendly format are duplicative of efforts by 
hospitals that offer individualized internet-based price estimator 
tools.
    We considered the minimum necessary functionality requirements a 
price estimator tool must embody to satisfy this new policy. As 
reflected in the comments we received on this topic, we recognize that 
different hospitals may maintain different types of internet-based 
healthcare cost price estimator tools, and that the market for, and 
technology behind, these applications is growing. Therefore, we believe 
it is important to ensure there is flexibility for the data elements, 
format, location and accessibility of a price estimator tool that would 
be considered to meet the requirements of 45 CFR 180.60. We

[[Page 65579]]

believe that the requirements we are establishing in this final rule, 
for certain minimum data and functionality of a price estimator tool 
for purposes of meeting the requirements under new 45 CFR 180.60, are a 
starting point. We appreciate and will consider the commenters' 
suggestions that we seek stakeholder input for future considerations 
related to the price estimator tool policies we are finalizing, 
including to identify best practices, common features, and solutions to 
overcoming common technical barriers.
    Therefore, we are finalizing a modification to our proposed policy 
to specify in new 45 CFR 180.60(a)(2) that a hospital that maintains an 
internet-based price estimator that meets certain criteria is deemed to 
have met our requirements at 45 CFR 180.60. The price estimator tool 
must:
     Allow healthcare consumers to, at the time they use the 
tool, obtain an estimate of the amount they will be obligated to pay 
the hospital for the shoppable service.
     Provide estimates for as many of the 70 CMS-specified 
shoppable services that are provided by the hospital, and as many 
additional hospital-selected shoppable services as is necessary for a 
combined total of at least 300 shoppable services.
     Is prominently displayed on the hospital's website and be 
accessible without charge and without having to register or establish a 
user account or password.
    To be clear, we believe that a price estimator tool would be 
considered internet-based if it is available on an internet website or 
through a mobile application. We considered the additional suggestions 
by commenters related to ensuring that price estimator tools are 
consumer-friendly. In our review of available online price estimator 
tools offered by hospitals, we observed that their look and feel are 
not uniform, so, in this final rule, and so as not to be overly 
proscriptive or restrict innovation, we are not at this time finalizing 
a specific definition of a consumer-friendly format for price estimator 
tools or any additional criteria. However, we encourage hospitals to 
take note of current estimator tool best practices and seek to ensure 
the price estimator tools they offer are maximally consumer-friendly. 
For example, we encourage, but will not require in this final rule, 
that hospitals provide appropriate disclaimers in their price estimator 
tools, including acknowledging the limitation of the estimation and 
advising the user to consult, as applicable, with his or her health 
insurer to confirm individual payment responsibilities and remaining 
deductible balances. Similarly, we encourage, but do not require in 
this final rule, that hospital pricing tools include: (1) Notification 
of the availability of financial aid, payment plans, and assistance in 
enrolling for Medicaid or a state program, (2) an indicator for the 
quality of care in the healthcare setting, (3) and making the estimates 
available in languages other than English, such as Spanish and other 
languages that would meet the needs of the communities and populations 
the hospital serves.
    We note that although we decline to be more prescriptive at this 
time, we may in the future revisit our policy to deem hospital online 
price estimator tools as having met requirements if we determine such 
tools are not meeting our goals for making hospital charge information 
meaningful to consumers. We further note that a hospital that meets the 
requirements for offering an internet-based price estimator tool would 
still be required to make public all standard charges for all hospital 
items and services online in a comprehensive machine-readable format as 
discussed in section II.E of this final rule and finalized under 45 CFR 
180.50.
    Comment: A few commenters addressed monitoring and oversight of 
price transparency tools. For example, one commenter suggested that 
CMS, or another federal agency, establish standards and require certain 
disclosures for software application developers of consumer-facing 
platforms for hospital standard charge data. This commenter expressed 
concern about consumers losing faith in cost transparency tools as they 
begin interacting with them, stemming from consumer-facing platforms 
that are not presenting information accurately or not using information 
appropriately.
    Another commenter suggested that standards must be in place for CMS 
to monitor and evaluate the impacts of price transparency tools, to 
help ensure there are not unintended effects, and to identify best 
practices. The commenter suggested that this includes developing a 
better understanding of any potential misinterpretations of the data by 
patients, as well as the extent to which hospitals may misrepresent 
rates.
    Response: For purposes of implementing section 2718(e) of the PHS 
Act, we will monitor and enforce compliance with the requirements to 
make public standard charges (as described in section II.G. of this 
final rule). This will include ensuring that hospitals have made public 
their standard charges in both ways required under these rules. 
Specifically, we will monitor to ensure that hospitals have made public 
all their standard charges for all items and services they provide in a 
comprehensive online machine-readable file format and have either made 
public standard charges for shoppable services in a consumer-friendly 
format (according to the requirements at 45 CFR 180.60), or have 
voluntarily offered an online price estimator tool. Although comments 
suggesting that CMS impose monitoring or enforcement efforts on 
software application developers are beyond the scope of the standard 
charge disclosure requirements we proposed, and that we are finalizing 
at new 45 CFR part 180 as discussed in this final rule, we note that 
HHS has ongoing efforts to improve health information exchange 
including through the ONC \163\ and recently promulgated proposed 
interoperability rules designed to expand access to health information 
and improve the seamless exchange of data in healthcare.\164\
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    \163\ HealthIT.gov website, Laws, Regulation, and Policy, at 
https://www.healthit.gov/topic/laws-regulation-and-policy.
    \164\ CMS.gov website, Interoperability, at https://www.cms.gov/Center/Special-Topic/Interoperability-Center.html.
---------------------------------------------------------------------------

    Final Action: We are finalizing as proposed to specify in new 45 
CFR 180.60(c) that hospitals retain flexibility on how best to display 
to the public online their standard charges in a consumer-friendly 
manner, so long as the website is easily accessible to the public.
    Based on the comments received, we are not finalizing our proposal 
to require that hospitals provide a paper copy (for example, a brochure 
or booklet) of information on consumer-friendly shoppable services to 
consumers upon request within 72 hours of the request.
    We are finalizing a modification to our proposal at new 45 CFR 
180.60(a)(2) to specify that a hospital is deemed by CMS to meet the 
requirements of 45 CFR 180.60 if the hospital maintains an internet-
based price estimator tool which meets the following requirements:
     Provides estimates for as many of the 70 CMS-specified 
shoppable services that are provided by the hospital, and as many 
additional hospital-selected shoppable services as is necessary for a 
combined total of at least 300 shoppable services.
     Allows health care consumers to, at the time they use the 
tool, obtain an estimate of the amount they will be obligated to pay 
the hospital for the shoppable service.

[[Page 65580]]

     Is prominently displayed on the hospital's website and 
accessible to the public without charge and without having to register 
or establish a user account or password.
6. Location and Accessibility Requirements
    Additionally, we proposed that hospitals make the data elements 
proposed in section XVI.F.4. of the CY 2020 OPPS/ASC proposed rule (84 
FR 39589 through 39590) public online in such a way that the standard 
charges and associated data elements could be easily located and 
accessed by consumers.
    First, we proposed that a hospital would have discretion to select 
an appropriate internet location to post the standard charge 
information required under this section (that is, the payer-specific 
charges for shoppable services and associated data elements). We 
further proposed that the website location be publicly available, that 
the data be displayed prominently and clearly identify the hospital 
location with which the standard charge information is associated, and 
that the standard charge data be easily accessible, without barriers, 
and that the data could be digitally searched. For purposes of the 
proposed requirements: (1) ``displayed prominently'' meant that the 
value and purpose of the web page \165\ and its content \166\ is 
clearly communicated, there is no reliance on breadcrumbs \167\ to help 
with navigation, and the link to the standard charge information is 
visually distinguished on the web page; \168\ (2) ``easily accessible'' 
meant that standard charge data are presented in format that is 
searchable by service description, billing code, and payer, and that 
the standard charge data posted on the website can be accessed with the 
fewest number of clicks; \169\ and (3) ``without barriers'' meant the 
data can be accessed free of charge, users would not have to input 
information (such as their name, email address, or other PII) or 
register to access or use the standard charge data. We proposed to 
codify this requirement at proposed new 45 CFR 180.50(d).
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    \165\ https://webstandards.hhs.gov/guidelines/49.
    \166\ Nielsen J. (2003, November 9). The ten most violated 
homepage design guidelines. Alertbox. Available at: http://www.useit.com/alertbox/20031110.html.
    \167\ https://webstandards.hhs.gov/guidelines/78.
    \168\ https://webstandards.hhs.gov/guidelines/88.
    \169\ https://webstandards.hhs.gov/guidelines/181.
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    We encouraged hospitals to review the HHS Web Standards and 
Usability Guidelines (available at: https://webstandards.hhs.gov/), 
which are research-based and are intended to provide best practices 
over a broad range of web design and digital communications issues.
    We sought comment on these proposed location and accessibility 
requirements, including whether there were additional requirements that 
should be considered to ensure public access to payer-specific 
negotiated charges for shoppable services.
    Comment: Several commenters noted the importance of making the 
information easily accessible and consumer-friendly. Specifically, a 
few commenters noted that it is important for hospitals to make this 
information easy or intuitive for lay-people to find on the websites.
    Other commenters made recommendations for requirements related to 
accessibility of consumer-friendly hospital charge information such as:
     Display on the website home page and clear indicators such 
as ``Price Check'' or ``Cost Estimator'' in the text for the link, 
rather than terms like ``Tools and Resources.''
     Conform with American with Disabilities Act (ADA) 
accessibility standards.
     Make information available in multiple languages based on 
the hospital's population.
    One commenter noted that rural consumers have less access to 
broadband, making it more difficult for them to access this information 
online. One commenter recommended that public outreach efforts, content 
generation, and coordination with existing user channels are needed to 
educate and engage audiences.
    Response: We thank commenters for their suggestions and agree that 
hospitals should seek to make their standard charge information easy or 
intuitive for lay-people to find on their websites. We would expect 
hospitals to post information in a format accessible to people with 
disabilities or to otherwise ensure that individuals with disabilities 
can readily access hospital standard charge information, in accordance 
with applicable federal or state laws.\170\ We encourage hospitals to 
post this information in a language and manner that is consumer-
friendly for their specific markets and to use terms to refer to their 
standard charge information that are clear indicators. While we are not 
finalizing any specific requirements related to either of these two 
issues at this time, we will continue to consider these suggestions, 
and should the information prove to be difficult to find or access, we 
may revisit these in future rulemaking.
---------------------------------------------------------------------------

    \170\ The Americans with Disabilities Act, the Rehabilitation 
Act and the ACA (see 45 CFR 92.202) require auxiliary aids and 
services when needed to communicate effectively with people with 
disabilities. https://www.ada.gov/effective-comm.pdf.
---------------------------------------------------------------------------

    Regarding the concern related to rural consumers being able to 
access online hospital charge information, we note that in July 2019, 
the Federal Communications Commission authorized $524 million in 
funding over the next decade to expand broadband to unserved rural 
homes and businesses.\171\ We agree that the availability of hospital 
charge information as a result of these final rules should be widely 
publicized. We plan to engage in communicating and publicizing these 
final rules and encourage other interested stakeholders to engage in 
communications strategies to enhance public awareness of the 
availability of hospital standard charge information.
---------------------------------------------------------------------------

    \171\ FCC. FCC Authorizes $524 Million for Rural Broadband 
Expansion in 23 States. News Release, July 15, 2019. Available at: 
https://www.fcc.gov/document/fcc-authorizes-524-million-rural-broadband-expansion-23-states.
---------------------------------------------------------------------------

    Comment: One commenter agreed that CMS' proposed location, 
accessibility, and technical requirements would allow patients to 
easily access standard charge information for shoppable services. A few 
other commenters expressed that being able to access standard charge 
information should be like comparing prices for groceries. One 
commenter suggested that hospitals clearly link the consumer-friendly 
list of shoppable services with the comprehensive machine-readable file 
of all items and services. A few commenters suggested that there be a 
standardized CMS file and web page format for displaying standard 
charges for shoppable services, arguing this would more easily enable 
cost comparisons across different facilities.
    Response: We appreciate commenter's support for our location and 
accessibility requirements and are finalizing them as proposed. We 
agree with commenters who believe that comparing prices for healthcare 
services should be as transparent as comparison pricing in other 
industries. We will continue to consider whether and how best to link 
the comprehensive machine-readable file and the consumer-friendly 
display of shoppable services. We agree that an exemplar template (not 
one that we will presently require) would be beneficial to help 
standardize format for displaying charges for shoppable services in a 
consumer-friendly format, and we have included such examples in this 
final rule. However, as explained in II.F.5 of this final rule, we 
believe

[[Page 65581]]

hospitals should retain flexibility to determine a format that displays 
charges for their shoppable services in a consumer-friendly manner.
    Comment: A few commenters suggested that patients needed to be able 
to access standard charge information for shoppable services through a 
secure portal that is password protected, and that the secure portal be 
tied to their actual health plan coverage while minimizing the risk 
that other providers will demand higher rates from payers.
    Response: We thank the commenters for their recommendation. 
However, in the interest of keeping access to the consumer-friendly 
display of shoppable services barrier-free, we disagree with requiring 
hospitals to develop a secure portal. As part of the requirements for 
making standard charges public, hospitals would not post any PII to the 
internet and consumers would not be asked to provide any in order to 
view payer-specific negotiated charges.
    Final Action: We are finalizing with technical modification our 
requirements for location and accessibility of information on consumer-
friendly shoppable services. Specifically, we are finalizing with 
modification that a hospital must select an appropriate publicly 
available internet location for purposes of making public the standard 
charge information for shoppable services in a consumer-friendly 
format.
    We are also finalizing with technical modification that the 
information must be displayed in a prominent manner that identifies the 
hospital location with which the standard charge information is 
associated.
    Finally, we are finalizing with technical modification the 
shoppable services information must be easily accessible, without 
barriers, including, but not limited to, ensuring the information is: 
(i) Free of charge; (ii) accessible without having to register or 
establish a user account or password; (iii) accessible without having 
to submit PII; (iv) searchable by service description, billing code, 
and payer. We note that we would expect hospitals would post 
information in a format accessible to people with disabilities or to 
otherwise ensure that individuals with disabilities can readily access 
hospital standard charge information, in accordance with any applicable 
federal or state laws.
    These final provisions are specified in new 45 CFR 180.60(d).
7. Frequency of Updates
    The statute requires hospitals to establish, update, and make 
public their standard charges for each year. Therefore, we proposed to 
require hospitals to make public and update the standard charge 
information proposed in section XVI.F.2 (84 FR 39585 through 39586) at 
least once annually (proposed new 45 CFR 180.60(e)). We recognized that 
hospital charges may change more frequently and therefore we encouraged 
(but are not requiring) hospitals to update this file more often, as 
appropriate, so that the public may have access to the most up-to-date 
charge information. We also recognized that hospitals update their 
charges at different times during the year and may also have various 
State price transparency reporting requirements that require updates. 
For purposes of these requirements, we believe that updates that occur 
at least once in a 12-month period will satisfy our proposed 
requirement to update at least once annually and reduce reporting 
burden for hospitals. In other words, the hospital could make public 
and update its list of standard charges at any point in time during the 
year, so long as the update to the charge data occurs no more than 12 
months after posting.
    We also proposed to require hospitals to clearly indicate the date 
of the last update they have made to the standard charge data, with 
some discretion as to where the date of late update is indicated.
    Comment: A few commenters disagreed that annually updating the 
display of standard charges in the consumer-friendly format would be 
sufficient to keep consumers apprised of costs. Commenters recommended 
more frequent updates, citing frequent changes in commercial payer 
rates. One commenter recommended requiring hospitals to update this 
information in real time to avoid the possibility of misleading 
patients with calendar-related gaming around the disclosure of rate 
hikes or true prices.
    Response: We appreciate the commenters' concerns and we agree that 
timely updates are an important aspect of keeping information relevant 
to consumers and avoiding confusion, but we believe the plain language 
of section 2718(e) of the PHS Act currently limits the requirement to 
make standard charges public to once annually. We strongly support and 
encourage hospital efforts to make more frequent updates to the 
standard charge information they make public online.
    Final Action: We are finalizing as proposed a policy to require 
hospitals to make public and update the standard charge information at 
least once annually (proposed new 45 CFR 180.60(e)). We are also 
finalizing as proposed a requirement that the hospital clearly indicate 
the date that the information was most recently updated. Hospitals 
would have some discretion as to where the date of late update is 
indicated.

G. Monitoring and Enforcement of Requirements for Making Standard 
Charges Public

1. Background
    Section 2718(b)(3) of the PHS Act requires the Secretary to 
promulgate regulations to enforce the provisions of section 2718 of the 
PHS Act, and, in so doing, the Secretary may provide for appropriate 
penalties. As such, we proposed that we may impose penalties on 
hospitals that fail to make their standard charges public in accordance 
with the requirements we finalize under section 2718(e) of the PHS Act. 
In the FY 2019 IPPS/LTCH PPS proposed rule (83 FR 20549), we sought 
public comments on a variety of issues related to enforcement of the 
requirement that hospitals make public their standard charges and noted 
our intent to address enforcement and other actions to ensure 
compliance in future rulemaking.
    We specifically sought comments on the following:
     What is the most appropriate mechanism for CMS to enforce 
price transparency requirements?
     Should CMS require hospitals to attest to meeting 
requirements in the provider agreement or elsewhere?
     How should CMS assess hospital compliance?
     Should CMS publicize complaints regarding access to price 
information or review hospital compliance and post results? What is the 
most effective way for CMS to publicize information regarding hospitals 
that fail to comply?
     Should CMS impose CMPs on hospitals that fail to make 
standard charges publicly available as required by section 2718(e) of 
the PHS Act?
     Should CMS use a framework similar to the Federal civil 
penalties under 45 CFR 158.601 through 158.615, that apply to issuers 
that fail to report information and pay rebates related to medical loss 
ratios (MLRs), as required by sections 2718(a) and (b) of the PHS Act, 
or would a different framework be more appropriate?
    As described in the CY 2020 OPPS/ASC proposed rule (84 FR 39591), 
we received a number of comments in response to this RFI. Many 
commenters agreed that enforcing this requirement under section 2718(e) 
of the PHS Act would send an important signal that CMS values 
transparency and ensure that the public has access to hospital charge 
information. Some commenters

[[Page 65582]]

suggested that CMS model enforcement after various quality reporting 
programs, such as the Hospital Inpatient and Outpatient Quality 
Reporting Programs or the LTCH Quality Reporting Program. Some 
commenters recommended publicizing noncompliant hospitals or providing 
a mechanism for the public to file complaints against noncompliant 
hospitals. Some commenters suggested that CMS propose to make the 
publication of standard charges a Medicare condition of participation 
or provider enrollment. However, one commenter indicated that revoking 
a provider agreement over lack of a website disclosure would be 
unnecessarily punitive. Other commenters warned that subjecting 
hospitals violating pricing transparency provisions to compliance 
actions could pose a challenge, particularly for smaller hospitals, and 
recommended limiting or deferring compliance actions to a later date. 
Some commenters agreed that imposing monetary penalties on noncompliant 
hospitals was appropriate, while other commenters believed that CMS 
does not have authority to enforce section 2718(e) of the PHS Act and, 
for that reason, should not adopt penalties for noncompliance.
    We stated in the CY 2020 OPPS/ASC proposed rule that we agree with 
commenters who noted that an enforcement regime signals the value we 
place on price transparency and assurance of public access to hospital 
standard charges. We interpret section 2718(b)(3) of the PHS Act as 
authorizing us to enforce the provisions of section 2718(e). Therefore, 
we proposed to adopt mechanisms to monitor and enforce our requirements 
for making standard charges public.
2. Monitoring Methods
    Section 2718(e) of the PHS Act requires hospitals to make public 
their list of standard charges and authorizes the Secretary to 
promulgate additional criteria that hospitals must satisfy in order to 
make such charges public. The statute does not prescribe monitoring 
procedures or the factors we should consider in imposing penalties on 
hospitals for noncompliance. Based on our experience with the Medicare 
program and healthcare marketplace plans, we believe it is important 
for the public to be informed, and, therefore, for CMS to ensure 
compliance with this statutory requirement. Therefore, we proposed to 
employ methods to monitor and assess hospital compliance with section 
2718(e) of the PHS Act, and specifically proposed new 45 CFR 180.40, 
180.50, and 180.60.
    In general, we proposed that CMS may use methods to monitor 
hospital compliance with the requirements under proposed 45 CFR part 
180. As explained in the CY 2020 OPPS/ASC proposed rule, we anticipate 
relying predominantly on complaints made to CMS by individuals or 
entities regarding a hospital's potential noncompliance. Therefore, we 
proposed that our monitoring methods may include, but are not limited 
to, the following, as appropriate:
     CMS' evaluation of complaints made by individuals or 
entities to CMS.
     CMS review of individuals' or entities' analysis of 
noncompliance.
    As we gain experience with monitoring compliance with the 
requirements for proposed 45 CFR part 180, we may consider self-
initiating audits of hospitals' websites as a monitoring method. 
Therefore, we proposed that our monitoring methods may include CMS 
audit of hospitals' websites.
    We proposed to set forth these monitoring methods in the 
regulations at proposed new 45 CFR 180.70.
    Comment: A few commenters suggested that the monitoring and 
enforcement requirements for making standard charges public should be 
well defined and robust. A few commenters agreed with CMS' proposal to 
rely mainly on complaints made to CMS by individuals or entities 
regarding a hospital's noncompliance, as well as CMS audits of 
hospitals' websites. One commenter stated that the proposed approach 
seems reasonable and that the monitoring methods and proposed actions 
to address noncompliance are appropriately varied and iterative.
    A commenter suggested that positive and effective enforcement is 
needed, such as encouraging community policing efforts that strive for 
prevention of a problem, and believes this approach could create a more 
transparent hospital reimbursement system for the public.
    A few commenters suggested that the burden of monitoring and 
enforcement may outweigh its benefits, and one commenter suggested that 
CMS withdraw altogether its proposed price transparency requirements, 
including the enforcement processes and CMPs for noncompliance, because 
of concerns about additional costs of compliance the proposed price 
transparency policies pose for financially fragile rural safety net 
providers, in particular Medicare Dependent Hospitals, Rural Referral 
Centers, and SCHs. One commenter stated that monitoring is a 
purposeless task.
    Response: We appreciate the support of commenters favoring the 
proposed approach to monitoring for compliance with the requirements 
for hospitals to make public standard charges. We disagree with the 
notion, expressed by one commenter, that monitoring hospitals for 
compliance with these price transparency disclosure requirements is a 
purposeless task and that its potential burden outweighs its potential 
benefits. We do, however, appreciate commenters' concerns about the 
potential additional burden that monitoring activities may pose for 
hospitals, though we do not believe the monitoring burden will impact 
hospitals unless they are not in compliance with the requirements.
    We decline to altogether forgo enforcement processes and CMPs for 
noncompliance as suggested by one commenter. We believe that 
enforcement of the policies is vital to ensuring that hospitals comply 
with the requirements to make public standard charges. Given the 
importance of ensuring that patients have access to data they need to 
make informed healthcare decisions, we believe monitoring hospitals' 
compliance with the requirements of new 45 CFR part 180 is critical. 
Therefore, we are finalizing our proposed monitoring methods. Further, 
we believe it is important to consistently apply the monitoring and 
enforcement provisions across all entities that meet the definition of 
``hospital'' that we are finalizing (as discussed in section II.B.2 of 
this final rule), regardless of factors such as hospital size, revenue, 
or location.
    In response to the commenter suggesting a community policing 
approach that strives for prevention of compliance problems, we note 
that the monitoring methods we are finalizing here include CMS' 
reliance on receipt of complaints made by individuals or entities to 
help inform CMS of potential issues so that CMS may initiate its own 
analyses, or CMS review of individuals' or entities' analysis of 
noncompliance. Further actions to address hospital noncompliance as 
described in section II.G.3 of this final rule include CMS' issuance of 
a written warning notice to a noncompliant hospital and CMS' requests 
for a CAP from a hospital in the event its noncompliance constitutes a 
material violation of one or more requirements. This approach 
contemplates that noncompliant hospitals will be offered opportunities 
to come into compliance with the requirements prior to the imposition 
of a CMP. Further, we note that these final policies do not preclude 
individuals or entities from raising their compliance concerns directly 
with hospitals, and for

[[Page 65583]]

hospitals to voluntarily address disclosure deficiencies.
    Comment: A few commenters addressed the scope of CMS' monitoring of 
hospital compliance to make public standard charges. A few commenters 
expressed support for meaningful oversight and enforcement by CMS to 
ensure the quality and accuracy of the standard charge information 
hospitals are required to disclose pursuant to this rule. One commenter 
recommended that CMS should have a system in place to ensure that rates 
are being updated regularly in accordance with the requirements.
    Response: We appreciate commenters' support for and interest in 
CMS' monitoring activities. In response to comments regarding the scope 
of CMS' proposed monitoring of hospitals with respect to compliance 
with these requirements to make public standard charges, we believe our 
authority is broad and includes, for example, our ability to monitor 
the accuracy of the information made public, and whether the 
information is made public in the form and manner and with the 
frequency specified in this final rule.
    According to the monitoring methods we are finalizing in this final 
rule, we anticipate relying on complaints made by individuals or 
entities, or individuals' or entities' analysis of noncompliance, as 
the basis for being notified about inaccuracies in the information made 
public by hospitals. To be clear, such notifications would not directly 
underlie an enforcement action. Rather, such notifications would merely 
trigger our independent analysis and conclusions, of which 
complainant's allegations or analyses may become a part, that would 
underlie any potential enforcement action. Pursuant to the monitoring 
methods we finalize here, we may also self-initiate the audit of a 
hospital's website. We anticipate that our review for inaccuracies in 
reported information would be for egregious and obvious instances of 
noncompliance, such as (in the extreme) all items and services made 
public by a hospital having the same value, or no value at all. Further 
we decline the commenters' suggestion to establish an additional, or 
different process, to monitor and take actions to address noncompliance 
in the form of inaccurate data. We anticipate consistently applying our 
monitoring and enforcement methods when addressing all types of 
possible violations. As we describe in section II.G.3 of this final 
rule, we may provide a written warning notice to a noncompliant 
hospital, request a CAP from a hospital if the noncompliance 
constitutes a material violation of one or more requirements, impose a 
CMP on the hospital if the hospital fails to respond to CMS' request to 
submit a CAP or comply with the requirements of a CAP, and publicize 
the notice of imposition of a CMP on a CMS website.
    Comment: A few commenters suggested, as an alternative approach, 
that hospitals should be required to report to CMS on their compliance 
with the requirements. For example, commenters' suggestions included 
that hospitals should be required to notify CMS of their adherence to 
price transparency requirements at regular intervals, or that hospitals 
should be required to submit a form to CMS to prove adherence with the 
requirements. A few commenters suggested that CMS require hospitals to 
attest that they are in compliance with the rule. One commenter 
explained that requiring such an attestation would put hospitals at 
risk of implicating the federal False Claims Act and associated 
penalties if they were determined to be noncompliant.
    One commenter, seeming to misinterpret the President's Executive 
Order 13877 on ``Improving Price and Quality Transparency in American 
Healthcare to Put Patients First'' (June 24, 2019), suggested a 
requirement may exist for hospitals to establish a monitoring mechanism 
to ensure compliance with the price list posting requirement.
    Response: We read the final sentence of section 3(a) of Executive 
Order 13877 to indicate two separate requirements related to the 
regulation requiring hospitals to publicly post standard charge 
information; specifically, that the regulation should: (1) Require 
hospitals to regularly update the posted information, and (2) establish 
a monitoring mechanism for the Secretary to ensure compliance with the 
posting requirement, as needed. We believe that (2) means that HHS 
should establish a monitoring mechanism to ensure hospitals' compliance 
with the posting requirements.
    At this time, we decline to adopt commenters' suggestions that we 
require hospitals to report or attest to CMS their compliance with 
these requirements, but as we gain experience with monitoring hospital 
compliance with the policies we finalize here, we may revisit these 
issues in future rulemaking.
    Comment: A few commenters stated that it is critical for CMS to 
implement a process for individuals to report noncompliance. One 
commenter expressed concern over the potential lack of guidance on how 
individuals or entities would report to CMS a hospital's noncompliance 
with the price transparency requirements. In comments on this topic, 
commenters suggested a variety of methods for how a complaint should be 
reported to CMS and subsequent actions CMS should take in processing 
the complaint.
    Response: We have established an email address, 
[email protected], through which individuals 
and entities may report to CMS concerns about hospital compliance with 
requirements to make public standard charges, including complaints 
about and analysis of noncompliance.
    Comment: Several commenters encouraged CMS to develop robust 
auditing procedures rather than relying solely on patients to know how 
to and take steps to report violations.
    Response: To clarify, we proposed that monitoring methods include, 
but are not limited to, CMS' evaluation of complaints made by 
individuals or entities, CMS review of individuals' or entities' 
analysis of noncompliance, and CMS audit of hospitals' websites. We 
agree with the commenters that CMS audit of hospitals may be an 
important method for monitoring hospitals compliance with the 
requirements of new 45 CFR part 180.
    Comment: Several commenters suggested that CMS work closely with 
hospitals to ensure they are aware of and understand CMS' monitoring 
mechanisms. One commenter suggested that CMS ensure both inpatient and 
outpatient providers have sufficient education and training required 
for compliance with the proposals. Several commenters suggested that 
CMS use education and outreach methods that exist within Medicare FFS 
to promote hospital awareness of and promote compliance with the 
requirements to make public standard charges.
    Response: We thank commenters for their suggestions, and we will 
consider these suggestions for education and outreach about compliance 
as we gain experience monitoring hospital compliance with these 
requirements to make public standard charges. We note that the 
suggestions of a few commenters focused on methods for education and 
outreach in relation to the Medicare program, but that the price 
transparency requirements are not limited to Medicare enrolled 
hospitals.
    Final Action: After considering the comments received on our 
proposed approach to monitor hospital compliance with the requirements 
to make public standard charges, we are finalizing our proposal to 
evaluate whether a hospital has complied with the requirements under 
Sec. Sec.  180.40,

[[Page 65584]]

180.50, and 180.60. We are also finalizing as proposed that the 
monitoring methods for determining a hospital's compliance with the 
requirements for making public standard charges may include, but are 
not limited to, the following, as appropriate:
     CMS' evaluation of complaints made by individuals or 
entities to CMS.
     CMS review of individuals' or entities' analysis of 
noncompliance.
     CMS audit of hospitals' websites.
    We are finalizing our proposal to set forth these monitoring 
methods in the regulations at new 45 CFR 180.70.
3. Actions To Address Hospital Noncompliance With Requirements To Make 
Public Standard Charges
    We proposed that hospitals that CMS identifies as noncompliant 
would be notified of their deficiencies and given an opportunity to 
take corrective action to come into compliance. As discussed in section 
II.G.4. of this final rule, for hospitals determined by CMS to be 
noncompliant with section 2718(e) of the PHS Act that fail to respond 
to CMS' requests to submit a CAP or comply with the requirements of a 
CAP, we proposed that we may impose CMPs and publicize these penalties 
on a CMS website.
    Should we conclude, based upon the proposed monitoring activities 
previously described, that a hospital is noncompliant with section 
2718(e) of the PHS Act and the requirements of proposed 45 CFR part 
180, we proposed that CMS may take any of the following actions, which 
generally, but not necessarily, would occur in this order:
     We may provide a written warning notice to the hospital of 
the specific violation(s).
     We would request a CAP from the hospital if its 
noncompliance constitutes a material violation of one or more 
requirements.
     If the hospital fails to respond to CMS' request to submit 
a CAP or comply with the requirements of a CAP, CMS may impose a CMP on 
the hospital and publicize the penalty on a CMS website.
    As discussed in the CY 2020 OPPS/ASC proposed rule (84 FR 39592), 
prior to requesting a CAP, or in the case of violations that are deemed 
nonmaterial violations warranting a CAP, CMS anticipates warning, via 
written notice, a hospital of noncompliance with one or more of the 
requirements to make public standard charges (according to section 
2718(e) of the PHS Act and the requirements of proposed 45 CFR part 
180), and of the need for voluntary corrective action. We would then 
reevaluate the hospital's compliance with the statutory and proposed 
regulatory requirements. Should we determine the hospital remains 
noncompliant and that the noncompliance constitutes a material 
violation of one or more requirements, we anticipate requiring that the 
hospital submit a CAP, and there would be increasing consequences for 
failure to remedy noncompliance.
    We proposed that a material violation may include, but is not 
limited to, the following:
     A hospital's failure to make public its standard charges 
required by proposed new 45 CFR 180.40.
     A hospital's failure to make public its standard charges 
in the form and manner required under to proposed new 45 CFR 180.50 and 
180.60.
    We proposed that CMS may request that a hospital submit a CAP, 
specified in a notice of violation issued by CMS to a hospital. A 
hospital required to submit a CAP must do so, in the form and manner, 
and by the deadline, specified in the notice of violation issued by CMS 
to the hospital and must comply with the requirements of the CAP.
    We proposed that a hospital's CAP must specify elements including, 
but not limited to, the deficiency or deficiencies that caused 
noncompliance to occur, the corrective actions or processes the 
hospital will take to come into compliance with the requirements of 45 
CFR part 180, and the timeframe by which the hospital will complete the 
corrective action. We proposed that a CAP would be subject to CMS 
review and approval. We proposed that after CMS' review and approval of 
a hospital's CAP, CMS may monitor and evaluate the hospital's 
compliance with the corrective actions.
    We proposed that a hospital's failure to respond to CMS' request to 
submit a CAP includes failure to submit a CAP in the form, manner, or 
by the deadline, specified in a notice of violation issued by CMS to 
the hospital. We proposed that a hospital's failure to comply with the 
requirements of a CAP includes failure to correct violation(s) within 
the specified timeframes.
    We proposed to set forth in the regulations at proposed new 45 CFR 
180.70 the actions CMS may take to address a hospital's noncompliance 
with the requirements to make public standard charges, and to set forth 
in proposed new 45 CFR 180.80 the requirements for a CAP.
    Comment: A few commenters offered suggestions on the process for 
CMS and hospitals to address potential noncompliance. One commenter 
expressed concern over the potential lack of guidance regarding the 
process CMS will use to investigate a complaint about a hospital's 
noncompliance with the price transparency requirements and request 
corrective action by a hospital. Another commenter stated that any 
penalties for noncompliance should not be accrued until the hospital 
has adequate time to respond to complaints. The commenter suggested, at 
a minimum, a six-month time frame for responding to and resolving the 
issues brought forward via a complaint.
    Response: The regulations we are finalizing at new 45 CFR 180.70 
specify the actions CMS will take to address hospital noncompliance. We 
anticipate that the specifics of each compliance action may depend on 
the circumstances of the complaint, CMS' determination of 
noncompliance, and the severity of the violation(s).
    Comment: One commenter expressed support for a policy under which 
CMS would request a CAP before imposing a CMP.
    Response: We appreciate the support of the commenter favoring the 
proposed approach.
    Comment: A few commenters indicated it was unclear what would 
constitute the basis for a finding of a material violation for CMS to 
determine it is necessary to request a CAP. One of these commenters 
recommended that CMS further delineate its expectations and grounds 
under which a CMP is warranted to avoid a system of arbitrary and 
capricious actions by CMS to penalize hospitals.
    These commenters stated that it is unclear what would constitute a 
finding of noncompliance with a required public disclosure of standard 
charges or noncompliance with disclosure in the form and manner 
required by CMS. One commenter specifically asked whether a hospital 
would only be cited as noncompliant after repeated violations or 
egregious violations or whether technical issues with formatting and 
posting of pricing data, including computer server issues, constitute 
an actionable violation. Another commenter asked if a hospital would be 
found noncompliant if a hospital made a good faith effort to publish 
data as required by CMS, but found some requirements impossible to 
meet. This commenter asked whether a CMP would be imposed on a hospital 
for failing to achieve something impractical based merely on web-
surfing by federal employees absent consumer complaints.
    Response: We believe these comments reflect concerns that hospitals 
will have limited opportunity to take corrective action prior to the 
imposition of a CMP.

[[Page 65585]]

As described in the CY 2020 OPPS/ASC proposed rule (as discussed 
above), prior to requesting a CAP for a material violation, CMS may 
issue a written warning notice so that the hospital may take voluntary 
corrective action to become compliant. We could then reevaluate the 
hospital's compliance with the statutory and proposed regulatory 
requirements. Should we determine the hospital remains noncompliant and 
that the noncompliance constitutes a material violation of one or more 
requirements, we anticipate requiring that the hospital submit a CAP. 
We may impose a CMP on a hospital identified as noncompliant that fails 
to respond to CMS' request to submit a CAP or comply with the 
requirements of a CAP.
    We further considered the proposed requirements for a CAP. Upon 
closer review we believe our proposals to require a hospital to specify 
in its CAP (i) the deficiency or deficiencies that caused noncompliance 
to occur, and (ii) the corrective actions or processes the hospital 
will take to come into compliance with the requirements of this part, 
among other elements, could raise due process considerations. In 
particular, the phrasing of these proposed elements suggest that in 
developing a CAP, the hospital must concur with CMS' finding(s) of 
noncompliance. This would be potentially problematic for a hospital in 
the event it seeks to dispute CMS' findings of noncompliance. 
Therefore, we are finalizing with modification to specify instead that 
a hospital's CAP must include, among other elements, a description of 
the corrective actions the hospital will take to address the deficiency 
or deficiencies identified by CMS. We believe this provision provides 
hospitals greater flexibility to specify in their CAP considerations 
about CMS' findings of noncompliance, in addition to actions to address 
such findings. We anticipate working with hospitals on an individual 
basis during the corrective action process to address concerns with 
CMS' findings and concerns about meeting the requirements.
    Comment: Many commenters indicated that implementation by January 
1, 2020 would not provide enough time to comply with requirements and 
suggested that CMS consider finalizing an effective date beyond January 
1, 2020, or otherwise permit delay or postponement of implementation. 
Several commenters expressed concern with the complexity of the data 
extract needed to meet the CY 2020 OPPS/ASC proposed rule's 
requirements, as well as the availability of that data within existing 
online systems or the need to divert hospital personnel to create the 
files manually given a lack of contract management system.
    One commenter expressed that, for those hospitals unable to afford 
a vendor, the staff labor cost will be astronomical and the likelihood 
of completing this ``herculean'' task prior to January 1, 2020, will be 
very low. This commenter suggested a postponement of the posting of 
negotiated rates for small rural and critical access hospitals until 
affordable software is developed and made available to assist with this 
task.
    Another commenter explained that an effective date of January 1, 
2020 would not afford hospitals enough time to evaluate consulting 
services, contract management systems, or hire additional personnel to 
fulfill these requirements.
    Commenters suggested a variety of alternative effective dates. For 
example, one commenter suggested an effective date of April 2020 or 
later, a few commenters suggested requiring implementation by January 
1, 2021, and one commenter stated it would take a minimum of 2 years to 
become compliant.
    One commenter expressed concern that CMS proposed ``an invasive and 
highly punitive'' monitoring and enforcement regime, up to and 
including CAPs and CMPs, that would take effect January 1, 2020.
    Response: We agree with commenters that some hospitals may find it 
challenging to initially comply with the new requirements of 45 CFR 
part 180 in a short timeframe, and may need time beyond January 2020 to 
develop the capacity to meet the new requirements. We also recognize 
that hospitals vary in the extent to which they already make public 
standard charge information similar to the data we are requiring 
hospitals to make public with this final rule. For instance, some 
hospitals may already comply with similar requirements under state 
laws, or already voluntarily make such information public and would, 
therefore, be able to quickly comply with the new requirements.
    In light of these considerations, we are finalizing a modification 
to extend the effective date of policies under new 45 CFR part 180 to 
January 1, 2021. We believe this duration of delay balances the 
concerns between providing additional time for hospitals to implement 
the new requirements while still ensuring that hospitals' standard 
charges are made public quickly to provide consumers access to this 
important information. We decline to create a different effective date 
for a subset of hospitals, such as rural hospitals, to delay price 
transparency requirements as we believe the hospital price transparency 
requirements we finalize here are important to informing all consumers' 
healthcare decision-making.
    In the meantime, we note that existing CMS guidance requires that 
hospitals make public their gross charges for items and services as 
found in the chargemaster online in a machine-readable format. We note 
that this guidance remains in effect until the effective date of the 
regulations we are establishing with this final rule, which is January 
1, 2021.
    Comment: A few commenters suggested that CMS take a phased approach 
to enforcement of the requirements for hospitals to make public 
standard charges. A few commenters, concerned about the excessive 
burden imposed by CMS' proposed requirements and the time it may take 
hospitals to develop the capacity to become compliant, suggested a 
grace period prior to the imposition of a CMP for noncompliance. A few 
commenters suggested that CMS phase-in the proposed monitoring and 
enforcement actions over several years. One commenter recommended that 
CMS' enforcement actions should begin by publicizing the names of 
hospitals determined to be noncompliant (referred to by the commenter 
as ``name and shame'') prior to giving these hospitals a chance to take 
corrective action, and then progress to requesting a CAP after several 
years. According to this commenter, if the implementation of CAPs does 
not induce full compliance after a few years then CMPs might be 
prudent.
    Response: We believe the monitoring methods we are finalizing as 
described in Section II.G.2 of this final rule and the actions to 
address hospital noncompliance described in this section are necessary 
to ensure compliance. We believe the proposed monitoring methods and 
enforcement actions give CMS the flexibility to employ a number of 
methods to be notified of, and investigate, hospital noncompliance, and 
allow CMS to take enforcement actions that escalate through stages. We 
believe the proposed approaches to addressing noncompliance, in which 
CMS (in sequence) issues a written warning notice, requests a CAP if 
the hospital's noncompliance constitutes a material violation of one or 
more requirements, and imposes a CMP on the hospital and publicizes the 
penalty on a CMS website, allows multiple opportunities for hospitals 
to take

[[Page 65586]]

corrective action over a period of time so that they may avoid 
imposition of a CMP. We decline the commenters' suggestions that we 
further phase-in the enforcement actions over a number of years, or to 
establish an approach that routinely provides hospitals a number of 
years to remedy their noncompliance.
    We considered the commenter's suggestion to expand our authority to 
publicize hospitals determined to be noncompliant with the requirements 
to make public standard charges. We believe that publicizing a 
hospital's noncompliance, prior to imposing a CMP (for example), could 
be an effective tool to raise public awareness of incomplete hospital 
data (for example), and could encourage hospitals to promptly remedy 
their violation(s) to avoid being publicly identified as noncompliant. 
However, at this time, we are finalizing our proposal to publicize on a 
CMS website the notice of imposition of a CMP. We may revisit through 
future rulemaking the timing for and approach by which CMS publicizes 
its determination of a hospital's noncompliance with the requirements 
to make public standard charges.
    Final Action: After considering the comments received, we are 
finalizing as proposed to set forth in the regulations at new 45 CFR 
180.70, actions to address hospital noncompliance with the requirements 
to make public standard charges. We are finalizing that CMS may take 
any of the following actions, which generally, but not necessarily, 
will occur in the following order if CMS determines the hospital is 
noncompliant with section 2718(e) of the PHS Act and the requirements 
of 45 CFR part 180:
     Provide a written warning notice to the hospital of the 
specific violation(s).
     Request a CAP from the hospital if its noncompliance 
constitutes a material violation of one or more requirements.
     Impose a CMP on the hospital and publicize the penalty on 
a CMS website if the hospital fails to respond to CMS' request to 
submit a CAP or comply with the requirements of a CAP.
    We are finalizing with modifications to set forth in new 45 CFR 
180.80 the requirements for CAPs. Specifically, we are finalizing as 
proposed to specify in 45 CFR 180.80(a) that a hospital may be required 
to submit a CAP if CMS determines a hospital's noncompliance 
constitutes a material violation of one or more requirements, which may 
include, but is not limited to, the following:
     A hospital's failure to make public its standard charges 
required by new 45 CFR 180.40.
     A hospital's failure to make public its standard charges 
in the form and manner required under new 45 CFR 180.50 and 180.60.
    We are finalizing as proposed to specify in 45 CFR 180.80(b), CMS 
may request that a hospital submit a CAP, specified in a notice of 
violation issued by CMS to a hospital.
    We are finalizing our proposals, except as noted otherwise, to 
specify in 45 CFR 180.80(c) the following provisions related to CAPs:
     A hospital required to submit a CAP must do so, in the 
form and manner, and by the deadline, specified in the notice of 
violation issued by CMS to the hospital and must comply with the 
requirements of the CAP.
     We are finalizing modifications that a hospital's CAP must 
specify elements including, but not limited to the corrective actions 
or processes the hospital will take to address the deficiency or 
deficiencies identified by CMS, and the timeframe by which the hospital 
will complete the corrective action.
     A CAP is subject to CMS review and approval. After CMS' 
review and approval of a hospital's CAP, CMS may monitor and evaluate 
the hospital's compliance with the corrective actions.
    We are finalizing as proposed to specify in 45 CFR 180.80(d) 
provisions for identifying a hospital's noncompliance with CAP requests 
and requirements:
     A hospital's failure to respond to CMS' request to submit 
a CAP includes failure to submit a CAP in the form, manner, or by the 
deadline, specified in a notice of violation issued by CMS to the 
hospital.
     A hospital's failure to comply with the requirements of a 
CAP includes failure to correct violation(s) within the specified 
timeframes.
    We are finalizing a modification to extend the effective date of 
the final policies to January 1, 2021.
4. Civil Monetary Penalties
    We proposed that we may impose a CMP on a hospital that we identify 
as noncompliant with the requirements of proposed 45 CFR part 180, and 
that fails to respond to CMS' request to submit a CAP or comply with 
the requirements of a CAP as we describe earlier.
    We proposed that we may impose a CMP upon a hospital for a 
violation of each requirement of proposed 45 CFR part 180. The maximum 
daily dollar amount for a CMP to which a hospital may be subject would 
be $300. We proposed that even if a hospital is in violation of 
multiple discrete requirements of proposed 45 CFR part 180, the maximum 
total sum that a single hospital may be assessed per day is $300.
    Further, we proposed to adjust the CMP amount annually by applying 
the cost-of-living adjustment multiplier determined by the Office of 
Management and Budget (OMB) for adjusting applicable CMP amounts 
pursuant to the Federal Civil Penalties Inflation Adjustment Act 
Improvements Act of 2015. This multiplier, based on the Consumer Price 
Index for All Urban Consumers (CPI-U), not seasonally adjusted, is 
applied to the CMPs in 45 CFR 102.3. For instance, the cost-of-living 
adjustment multiplier for 2018, based on the CPI-U for the month of 
October 2017, not seasonally adjusted, was 1.02041 (83 FR 51369).
    As discussed in the CY 2020 OPPS/ASC proposed rule, given the 
importance of compliance with the price transparency policies, we 
believe this proposed CMP amount strikes a balance between penalties 
that are sufficiently harsh to incentivize compliance but not 
excessively punitive. We reviewed CMP amounts for other CMS programs 
that require reporting information and we believe our proposed $300 
maximum daily dollar amount for a CMP is commensurate with the level of 
severity of the potential violation, taking into consideration that 
nondisclosure of standard charges does not rise to the level of harm to 
the public as other violations (such as safety and quality issues) for 
which CMS imposes CMPs and, therefore, should remain at a relatively 
lower level.
    We considered applying lower and higher maximum dollar amounts for 
a CMP for noncompliance with the requirements of proposed 45 CFR part 
180. For example, we considered that CMS has imposed $100 per day 
penalty amounts with respect to other compliance matters, such as where 
health insurers fail to comply with premium revenue reporting and 
rebate requirements found at 45 CFR 158.606. The basis for the CMPs 
under 45 CFR 158.606 is the number of individuals affected. With 
respect to the disclosure requirements under proposed 45 CFR part 180, 
where the lack of information could affect an unknown number of 
consumers and in myriad ways (for example, not just individuals who 
paid more for items and services), we noted our belief that it would 
not be feasible to utilize a ``per person'' type basis. We also 
considered proposing higher maximum daily dollar amounts, such as $400 
per day, $500 per day or more.
    Further, we considered establishing a cumulative annual total limit 
for the

[[Page 65587]]

CMP to which a hospital is subject for noncompliance with proposed 45 
CFR part 180. For example, we considered applying a cumulative annual 
total limit of $100,000 per hospital for each calendar year. However, 
such an approach could, for example, prevent accrual of additional 
penalties on hospitals that remain noncompliant for multiple years.
    If CMS imposes a penalty in accordance with the requirements of 
proposed 45 CFR part 180, we proposed that CMS provide a written notice 
of imposition of a CMP to the hospital via certified mail or another 
form of traceable carrier. This notice may include, but would not be 
limited to, the following:
     The basis for the hospital's noncompliance, including, but 
not limited to, the following: CMS' determination as to which 
requirement(s) the hospital violated; and the hospital's failure to 
respond to CMS' request to submit a CAP or comply with the requirements 
of a CAP.
     CMS' determination as to the effective date for the 
violation(s). This date would be the latest date of the following:
    ++ The first day the hospital is required to meet the requirements 
of proposed 45 CFR part 180.
    ++ If a hospital previously met the requirements of this part but 
did not update the information annually as required, the date 12 months 
after the date of the last annual update specified in information 
posted by the hospital.
    ++ A date determined by CMS, such as one resulting from monitoring 
activities specified in proposed new 45 CFR 180.70, or development of a 
CAP as specified in proposed new 45 CFR 180.80.
     The amount of the penalty as of the date of the notice.
     A statement that a CMP may continue to be imposed for 
continuing violation(s).
     Payment instructions.
     Intent to publicize the hospital's noncompliance and CMS' 
determination to impose a CMP on the hospital for noncompliance with 
the requirements of proposed 45 CFR part 180 by posting the notice of 
imposition of a CMP on a CMS website.
     A statement of the hospital's right to a hearing (as 
described in section II.H. of this final rule).
     A statement that the hospital's failure to request a 
hearing within 30 calendar days of the issuance of the notice permits 
the imposition of the penalty, and any subsequent penalties pursuant to 
continuing violations, without right of appeal.
    Further, in the event that a hospital elects to appeal the penalty, 
and if the CMP is upheld only in part by a final and binding decision, 
we proposed that CMS would issue a modified notice of imposition of a 
CMP.
    We proposed that a hospital must pay a CMP in full within 60 
calendar days after the date of the notice of imposition of a CMP from 
CMS. In the event a hospital requests a hearing (as described in 
section II.H. of this final rule), we proposed that the hospital must 
pay the amount in full within 60 calendar days after the date of a 
final and binding decision to uphold, in whole or in part, the CMP. We 
also proposed that if the 60th calendar day is a weekend or a Federal 
holiday, then the timeframe is extended until the end of the next 
business day.
    We also proposed to publicize, by posting on a CMS website, our 
notice of imposition of a CMP on a hospital for noncompliance with 
these requirements, and any subsequently issued notice of imposition of 
a CMP for continuing violations. In the event that a hospital requests 
a hearing, we proposed that CMS would indicate in its posting that the 
CMP is under review. If the CMP amount is upheld, in whole, by a final 
and binding decision, we would maintain the posting of the notice of 
imposition of a CMP on a CMS website. If the CMP is upheld, in part, by 
a final and binding decision, we would issue a modified notice of 
imposition of a CMP, and would make this modified notice public on a 
CMS website. If the CMP is overturned in full by a final and binding 
decision, we would remove the notice of imposition of a CMP from a CMS 
website.
    In addition, we proposed that CMS may issue subsequent notice(s) of 
imposition of a CMP, as described in this section of the CY 2020 OPPS/
ASC proposed rule, that result from the same instance(s) of 
noncompliance.
    We proposed to set forth in proposed new 45 CFR 180.90 the proposed 
CMPs for hospitals determined by CMS to be noncompliant with 
requirements for making standard charges public.
    We sought comment on whether the proposed amount of a CMP, in 
combination with making public on a CMS website our notice of 
imposition of a CMP, were reasonable and sufficient to ensure 
hospitals' compliance with the proposed requirements to make public 
standard charges. We were interested in public comments on our proposed 
$300 maximum daily dollar amount for a CMP for noncompliance with 
section 2718(e) of the PHS Act and proposed 45 CFR part 180. In 
particular, we sought comment on whether we should impose stronger 
penalties for noncompliance, or whether we should further limit the 
maximum amount of penalty we would impose on a hospital for a calendar 
year and the methodology for creating such a limit (for instance 
through limiting the maximum daily penalty amount, by establishing a 
cumulative annual total limit on the penalty amount, or both). We 
sought comment on unintended consequences of the proposed penalties for 
noncompliance. We also sought commenters' suggestions on whether other 
penalties should be applied for noncompliance with section 2718(e) of 
the PHS Act.
    Comment: Several commenters stated that the imposition of CMPs for 
noncompliance with the requirements to make standard public charges 
exceeds CMS' authority under section 2718(e) of the PHS Act. These 
commenters challenged CMS' reliance on section 2718(b)(3) as the basis 
for enforcing the requirements that hospitals make their standard 
charges public, and specifically as the basis for imposing a CMP on a 
hospital for noncompliance with the requirements to make public 
standard charges. These commenters asserted that section 2718(b)(3) 
applies only to the MLR and rebate requirements imposed by the ACA on 
health insurance issuers offering group or individual health insurance 
coverage under section 2718 of the PHS Act. A few commenters explained 
that had Congress intended to require the Secretary to enforce the 
requirement for public availability of hospital standard charge 
information, it would have constructed the provisions of section 2718 
of the PHS Act differently. A few commenters presented a review of the 
legislative history of section 2718 of the PHS Act, suggesting that the 
phrasing of section 2718(b)(3), referring to its applicability to 
``this section,'' was a drafting error, and suggested that Congress 
intended to apply this provision only to MLR provisions within the 
section. A few commenters further asserted that absent an express 
mandate for the Secretary in section 2718(b)(3) of the PHS Act to 
enforce the requirements for hospitals to disclose their standard 
charges under a different provision of law (namely, section 2718(e)), 
the Secretary may neither imply an intent to do so nor reverse its 
previous rulemaking policy that limited the use of that enforcement 
authority to issuers that do not comply with MLR and rebate 
requirements imposed under section 2718(b). One commenter explained 
that interpreting section 2718(b)(3) of the PHS Act as CMS does leads 
to an absurd result.

[[Page 65588]]

    A few commenters explained that HHS has not previously suggested 
that it could take enforcement action with respect to section 2718(e) 
of the PHS Act, which the commenters suggest means the agency lacked 
such powers. Specifically, one commenter suggested that HHS implicitly 
recognized that its enforcement authority under section 2718(b)(3) of 
the PHS Act should be read as confined to enforcing the MLR 
requirements when it adopted subparts D through F of 45 CFR part 158, 
stating that these provisions implement enforcement authority in 
section 2718(b)(3) and provide for enforcement of the reporting 
obligations set forth in section 2718(a) and rebate requirements in 
section 2718(b). Another commenter expressed that CMS has not 
previously asserted its ability to assess CMPs under section 2718(b)(3) 
of the PHS Act on noncompliant hospitals, or previously claimed any 
enforcement authority related to section 2718(e) of the PHS Act.
    Response: We continue to believe section 2718(b)(3) of the PHS Act, 
based on its plain meaning, authorizes the Secretary to enforce the 
provisions of section 2718 of the PHS Act and to provide for 
appropriate penalties under section 2718 of the PHS Act, including 
section 2718(e) of the PHS Act. It is not absurd to say that Congress 
wanted to provide HHS authority more generally to enforce all of the 
requirements set out in section 2718. Further, HHS has not previously 
conceded that it lacked authority to issue such rules for enforcing, or 
penalties pursuant to, section 2718(e) of the PHS Act in promulgating 
regulations pursuant to sections 2718(a) and (b). In fact, as we 
explained in earlier rulemaking, we have been considering developing 
regulations, through notice and comment rulemaking, to establish 
enforcement mechanisms to address hospital noncompliance with section 
2718(e) (83 FR 20548 through 20550; 83 FR 41686 through 41688).
    Therefore, consistent with our proposal, we continue to believe we 
have the legal basis to impose penalties on hospitals that fail to make 
their standard charges public in accordance with the requirements we 
finalize under section 2718(e) of the PHS Act. Accordingly, as 
described in this section and elsewhere in this final rule, we are 
finalizing our proposals to enforce the requirements under new 45 CFR 
part 180, and to potentially impose CMPs for noncompliance with the 
requirements of new 45 CFR part 180.
    Comment: A few commenters supported CMS' efforts to take 
enforcement actions and a few commenters supported the proposal to 
impose financially significant CMPs on large hospitals for 
noncompliance with the requirements to make public standard charges. A 
few commenters suggested that CMS forgo imposition of CMPs altogether 
while others suggested that CMS limit use of CMPs (particularly to 
avoid excessive financial penalties) or not impose CMPs on certain 
types of providers, such as IRFs or rural hospitals.
    Several commenters explained that the proposed CMPs were overly 
punitive, and suggested CMS forgo imposing CMPs. One commenter 
explained that CMPs are typically reserved for fraud and abuse, and 
opposed imposition of CMPs for price transparency requirement 
noncompliance, which is more likely to be based in technical 
difficulties or IT system limitations. A few commenters cited concerns 
about imposing CMPs on noncompliant hospitals in light of the 
complexity of making public standard charge data and the short 
timeframe by which hospitals would have to come into compliance. One 
commenter explained that it is not necessary to impose CMPs for 
noncompliance with price transparency requirements given that hospitals 
have undertaken numerous initiatives to enhance price transparency in 
recent years, and that they are making significant progress in this 
complex area.
    Response: We appreciate commenters supporting the importance of 
enforcement actions and the imposition of CMPs on hospitals as a method 
for ensuring compliance with the requirements to make public standard 
charges. We decline the commenters' suggestions that we not finalize 
the proposed use of CMPs as an enforcement mechanism. Given the 
importance of the requirements for hospitals to make public standard 
charges, we believe CMPs serve as an appropriate enforcement action to 
address noncompliance. As we explained in Section II.G.2. of this final 
rule, we believe it is important that we apply a consistent approach to 
imposing CMPs on noncompliant hospitals across all entities, regardless 
of factors such as hospital size, revenue or location. Therefore, we 
decline to adopt the commenters' suggestions that we apply alternative 
policies to a subset of hospitals, such as rural safety net providers. 
Further, we disagree with the commenter's suggestion that we forgo 
establishing the authority to impose CMPs for noncompliance in light of 
the demonstrated commitment to price transparency by some, but not all, 
institutions.
    We respond to comments on the amount of CMPs elsewhere in this 
section of this final rule. Under the actions to address hospital 
noncompliance which we are finalizing in this final rule, we anticipate 
that hospitals would have the opportunity to take corrective action 
prior to the imposition of a penalty. As we have described elsewhere in 
Section II.G of this final rule, prior to imposing a CMP on a hospital, 
we anticipate issuing a written warning notice and requesting a CAP 
from the hospital as initial steps to promote compliance. We may impose 
a CMP on a noncompliant hospital if it fails to respond to CMS' request 
to submit a CAP or comply with the requirements of a CAP. By complying 
with the requirements, a hospital can avoid financial penalties. We 
also note that hospitals determined to be noncompliant, and subject to 
a CMP, can avoid accruing larger amounts of CMPs by coming into 
compliance with the requirements.
    Comment: Comments on the amount of the CMP were mostly polarized, 
with some suggesting lower amounts and other suggesting higher amounts 
than the proposed $300 maximum daily dollar amount for a CMP. A 
recurring concern in comments was that the CMP amount could be overly 
burdensome and potentially detrimental to the continued operation of a 
small hospital with low margins, particularly CAHs, while posing an 
inadequate incentive for hospitals (particularly larger hospitals) to 
comply because the CMP amount does not pose a real financial burden. As 
one commenter explained, a large hospital could decide that $300 per 
day ($109,500 per year) is worth paying in order to not disclose 
information that could lead to payers with higher rates wanting to pay 
them less in light of discovering other payers have more favorable 
negotiated rates. A few commenters suggested that the proposed CMP 
amount is trivial for certain hospitals, compared, for instance, to the 
salaries of hospital executives, or the hospital's total revenue. One 
commenter expressed concern that stakeholders will view the 
noncompliance penalty as a new business expense rather than an 
incentive to comply with the transparency requirements. Another 
commenter explained that the proposed CMP amount is too low to compel 
hospitals to comply if they are adamantly opposed to making public this 
information.
    Another commenter noted that under the PAMA and 42 CFR 414.504(e), 
applicable laboratories that do not report applicable information as

[[Page 65589]]

required may be subject to a CMP in an amount of up to $10,000 per day 
for each failure to report or each misrepresentation or omission in 
reporting. The commenter suggested that compliance with these data 
reporting requirements was below expectations; therefore, the commenter 
suggested that it would be unlikely that the proposed $300 maximum 
daily dollar amount for a CMP would be sufficient to encourage prompt 
reporting of pricing data by hospitals.
    One commenter suggested that CMS increase the CMP amount, 
recommending the penalties be consistent with information blocking 
penalties (according to section 4004 of the 21st Century Cures Act), 
which can be up to $1 million per violation (which we note is 
applicable to health IT developers, health information networks, and 
health information exchanges),\172\ explaining that failure to disclose 
price information would be information blocking.
---------------------------------------------------------------------------

    \172\ Refer to HealthIT.gov, Information Blocking, available at 
https://www.healthit.gov/topic/information-blocking.
---------------------------------------------------------------------------

    A few commenters suggested alternative approaches, such as using 
factors that allow for scaling of the CMP amount. In particular, a few 
of these commenters suggested scaling penalties to ensure rural 
hospitals are not unduly burdened. For example, one commenter suggested 
that CMPs should be adjusted based on bed size and rural or urban 
designation. Another commenter suggested that CMS consider scaling the 
penalty based on the number of patients treated at the facility within 
a given year. If this information is not available due to lack of data 
on patients who self-pay or are insured by non-government payers, the 
commenter suggested that CMS scale the CMP amount according to the 
number of Medicare beneficiaries served in a given year. The commenter 
explained this approach could allow CMS to not overly penalize smaller 
hospitals while also providing a sufficient incentive for hospitals to 
comply.
    Response: We appreciate the comments received on the proposed $300 
maximum daily dollar amount for a CMP. Given that commenters tended to 
be divided between those in favor of lower and higher amounts, we 
believe the proposed amount strikes an appropriate balance between 
these concerns, and we are therefore finalizing this amount as 
proposed.
    The $300 maximum daily dollar amount for a CMP for noncompliance 
with 45 CFR part 180 is lower than CMPs imposed under certain other 
authorities administered by HHS agencies, where an entity's 
noncompliance poses immediate jeopardy, results in actual harm, or 
both. We believe the relatively lower amount for a CMP, for a 
hospital's noncompliance with requirements to make public standard 
charges, is reasonable since failure to make this information available 
is less serious than noncompliance that poses or results in harm to a 
patient.
    At this time, and given the nature of potential noncompliance with 
the requirements we are finalizing for hospitals to make public 
standard charges, we decline to impose penalties higher than the 
proposed amount. We decline to impose the higher penalties that are 
applicable to health IT developers, health information networks, and 
health information exchanges for information blocking under the 21st 
Century Cures Act, for interfering with, preventing, or materially 
discouraging access, exchange, or use of electronic health information. 
We also decline to impose a potentially higher CMP amount, such as is 
applicable to laboratories under PAMA, for noncompliance with reporting 
information which could affect payment rate setting by CMS.
    We also note that the $300 maximum daily dollar amount, when 
accrued over a year, is higher than our estimate of the cost per 
hospital to comply with the requirements to make public standard 
charges in the initial period of implementation (as described in 
Section V of this final rule). We considered commenters' concerns that 
a relatively lower CMP amount may be insufficient to encourage 
compliance if the cost of making public standard charges, or the value 
to the hospital of not disclosing standard charge data, is higher than 
the total annual amount of the CMP. For this reason, we believe it is 
important to maintain a sufficiently sizeable CMP sum and therefore 
decline commenters' suggestions to finalize a maximum daily dollar 
amount for a CMP that is less than $300.
    We appreciate the commenters' concerns that some hospitals may 
prefer to forgo meeting the requirements of 45 CFR part 180 (for 
example, to not expend resources on reporting or to protect pricing 
information they consider sensitive), and, instead, face compliance 
actions including a $300 maximum daily dollar amount for a CMP. We 
decline at this time to increase the amount of the CMP based on this 
concern alone, but as we gain experience with implementing the policy 
we intend to monitor for such occurrences, and may revisit the need to 
adjust the amount of the CMP in future rulemaking.
    We would need to further evaluate the feasibility of implementing a 
sliding scale CMP approach across institutions that meet the definition 
of hospital according to new 45 CFR 180.20 (as discussed in section 
II.B of this final rule). We believe it would be especially challenging 
to find a reliable source of data that provides for a scalable factor 
across all institutions that meet the definition of hospital. 
Therefore, we decline the commenters' suggestions to scale the CMP 
amount based on such factors as hospital bed size, location or patient 
volume. However, we anticipate that we will continue to consider this 
issue, and may revisit use of a CMP scaling methodology in future 
rulemaking. At this time, we are finalizing as proposed a policy that 
allows for a standardized daily maximum CMP amount.
    Comment: One commenter supported the alternative we described in 
the CY 2020 OPPS/ASC proposed rule, which was to apply a cumulative 
annual total limit (or cap) on the penalty amount, though the commenter 
did not specify what this limit should be and suggested only that it be 
a reasonable amount.
    Response: We believe we have struck an appropriate balance in 
determining the $300 maximum daily dollar amount for a CMP, and we 
therefore decline at this time to finalize applying a cumulative annual 
total limit on the CMP amount. We appreciate the commenter's support 
for this alternative approach.
    Comment: One commenter disagreed with the proposal that CMS 
publicize the notice of imposition of a CMP on a CMS website, 
explaining that this amounted to public shaming which the commenter 
believes has no benefit and seems petty.
    Response: We continue to believe it is appropriate to publish the 
notice of imposition of a CMP on a CMS website to identify hospitals 
determined to be noncompliant with the requirements to make public 
standard charges. We believe this information will help inform the 
public of noncompliant hospitals and is an opportunity to demonstrate 
the outcome of CMS' monitoring and enforcement activities for these 
important requirements.
    Final Action: After considering the comments received, we are 
finalizing as proposed policies for imposing a CMP on a hospital that 
we identify as noncompliant with the requirements of 45 CFR part 180, 
and that fails to respond to CMS' request to submit a CAP or comply 
with the requirements of a CAP.

[[Page 65590]]

    We are finalizing as proposed that CMS may impose a CMP upon a 
hospital for a violation of each requirement of 45 CFR part 180. 
Further, we are finalizing our proposal that the maximum daily dollar 
amount for a CMP to which a hospital may be subject is $300, even if 
the hospital is in violation of multiple discrete requirements of 45 
CFR part 180. The amount of the CMP will be adjusted annually using the 
multiplier determined by OMB for annually adjusting CMP amounts under 
45 CFR part 102.
    We are finalizing as proposed that CMS provides a written notice of 
imposition of a CMP to the hospital via certified mail or another form 
of traceable carrier. We are also finalizing as proposed the elements 
of this notice to the hospital, as previously described in this section 
of this final rule, will include but not be limited to the following:
     The basis for the hospital's noncompliance, including, but 
not limited to, the following: CMS' determination as to which 
requirement(s) the hospital has violated; and the hospital's failure to 
respond to CMS' request to submit a CAP or comply with the requirements 
of a CAP.
     CMS' determination as to the effective date for the 
violation(s).
     The amount of the penalty as of the date of the notice.
     A statement that a CMP may continue to be imposed for 
continuing violation(s).
     Payment instructions.
     Intent to publicize the hospital's noncompliance and CMS' 
determination to impose a CMP on the hospital for noncompliance with 
the requirements of 45 CFR part 180 by posting the notice of imposition 
of a CMP on a CMS website.
     A statement of the hospital's right to a hearing according 
to subpart D of 45 CFR part 180 (as discussed in section II.H of this 
final rule).
     A statement that the hospital's failure to request a 
hearing within 30 calendar days of the issuance of the notice permits 
the imposition of the penalty, and any subsequent penalties pursuant to 
continuing violations, without right of appeal.
    We are finalizing our proposal that CMS may issue subsequent 
notice(s) of imposition of a CMP, according to the aforementioned 
requirements (in short, where investigation reveals there is continuing 
justification), that result from the same instance(s) of noncompliance.
    We are finalizing with a clarifying modification that, in the event 
that a hospital elects to appeal the penalty, and if the CMP is upheld, 
in part, by a final and binding decision, CMS will issue a modified 
notice of imposition of a CMP, to conform to the adjudicated finding.
    We are also finalizing our proposals on timing of payment of a CMP. 
Specifically, a hospital must pay the CMP in full within 60 calendar 
days after the date of the notice of imposition of a CMP from CMS. In 
the event a hospital requests a hearing, pursuant to subpart D of 45 
CFR part 180, the hospital must pay the amount in full within 60 
calendar days after the date of a final and binding decision to uphold, 
in whole or in part, the CMP. If the 60th calendar day is a weekend or 
a Federal holiday, then the timeframe is extended until the end of the 
next business day.
    We are finalizing as proposed that CMS will post the notice of 
imposition of a CMP on a CMS website, including the initial notice of 
imposition of a CMP, and subsequent notice(s) of imposition of a CMP 
that result from the same instance(s) of noncompliance. Further, in the 
event that a hospital elects to request a hearing, pursuant to subpart 
D of 45 CFR part 180, CMS will indicate in its posting that the CMP is 
under review. We are finalizing the following policies regarding the 
posting of the notice of imposition of a CMP, pursuant to a final and 
binding decision from the hearing process specified in subpart D of 45 
CFR part 180:
     We are finalizing as proposed, CMS will maintain the 
posting of the notice of imposition of a CMP on a CMS website if the 
CMP is upheld, in whole.
     We are finalizing with a clarifying modification, CMS will 
issue a modified notice of imposition of a CMP, to conform to the 
adjudicated finding, if the CMP is upheld, in part. CMS will make this 
modified notice public on a CMS website.
     We are finalizing as proposed, CMS will remove the notice 
of imposition of a CMP from a CMS website if the CMP is overturned in 
full.
    We are finalizing our proposal to specify these policies on CMPs in 
new 45 CFR 180.90.

H. Appeals Process

    Under section 2718(b)(3) of the PHS Act, we proposed to impose 
penalties on hospitals that fail to make their standard charges public 
in accordance with the requirements we finalize under section 2718(e). 
As we described in the CY 2020 OPPS/ASC proposed rule (84 FR 39593 
through 39594), we believe it is important to establish a fair 
administrative process by which a hospital may appeal CMS' decisions to 
impose penalties under section 2718(b)(3) regarding the hospital's 
noncompliance with the requirements of section 2718(e) of the PHS Act 
and the requirements of proposed 45 CFR part 180. Through various 
Medicare programs, we have gained experience with administrative 
hearings and other processes to review CMS' determinations.
    We proposed to align the procedures for the appeals process with 
the procedures established under section 2718(b)(3) of the PHS Act for 
an issuer to appeal a CMP imposed by HHS for its failure to report 
information and pay rebates related to MLRs, as required by sections 
2718(a) and (b) of the PHS Act, and according to 45 CFR parts 158 and 
150. Therefore, we proposed that a hospital upon which CMS has imposed 
a penalty under proposed 45 CFR part 180 may appeal that penalty in 
accordance with 45 CFR part 150, subpart D, except as we have otherwise 
proposed.
    Generally, under this proposed approach, a hospital upon which CMS 
has imposed a penalty may request a hearing before an Administrative 
Law Judge (ALJ) of that penalty. The Administrator of CMS, at his or 
her discretion, may review in whole or in part the ALJ's decision. A 
hospital against which a final order imposing a CMP is entered may 
obtain judicial review.
    For purposes of applying the appeals procedures at 45 CFR part 150 
to appeals of CMPs under proposed 45 CFR part 180, we proposed the 
following exceptions to the provisions of 45 CFR part 150:
     Civil money penalty means a civil monetary penalty 
according to proposed new 45 CFR 180.90.
     Respondent means a hospital that received a notice of 
imposition of a CMP according to proposed new 45 CFR 180.90(b).
     References to a notice of assessment or proposed 
assessment, or notice of proposed determination of CMPs, are considered 
to be references to the notice of imposition of a CMP specified in 
proposed new 45 CFR 180.90(b).
     Under 45 CFR 150.417(b), in deciding whether the amount of 
a civil money penalty is reasonable, the ALJ may only consider evidence 
of record relating to the following:
    ++ The hospital's posting(s) of its standard charges, if available.
    ++ Material the hospital timely previously submitted to CMS 
(including with respect to corrective actions and CAPs).
    ++ Material CMS used to monitor and assess the hospital's 
compliance

[[Page 65591]]

according to proposed new 45 CFR 180.70(a)(2).
     The ALJ's consideration of evidence of acts other than 
those at issue in the instant case under 45 CFR 150.445(g) does not 
apply.
    We proposed to set forth in proposed new 45 CFR 180.100 the 
proposed procedures for a hospital to appeal the CMP imposed by CMS for 
its noncompliance with the requirements of proposed 45 CFR part 180.
    We also proposed to set forth in proposed new 45 CFR 180.110 the 
consequences for failure of a hospital to request a hearing. If a 
hospital does not request a hearing within 30 calendar days of the 
issuance of the notice of imposition of a CMP described in proposed new 
45 CFR 180.90(b), we proposed that CMS may impose the CMP indicated in 
such notice and may impose additional penalties pursuant to continuing 
violations according to proposed new 45 CFR 180.90(f) without right of 
appeal. We proposed that if the 30th calendar day is a weekend or a 
Federal holiday, then the timeframe is extended until the end of the 
next business day. We also proposed that the hospital has no right to 
appeal a penalty with respect to which it has not requested a hearing 
in accordance with 45 CFR 150.405, unless the hospital can show good 
cause, as determined at 45 CFR 150.405(b), for failing to timely 
exercise its right to a hearing.
    Alternatively, we considered and sought public comment on following 
a process for appealing CMPs similar to the approach specified in 42 
CFR part 498, subparts D through F. We explained that there are 
differences between the appeals procedures at 42 CFR part 498 compared 
to 45 CFR part 150. Under the regulations at 42 CFR part 498, for 
example, either party dissatisfied with a hearing decision by the ALJ 
may request Departmental Appeals Board review of the ALJ's decision.
    Final Action: We received no comments on our proposed process for a 
hospital upon which CMS has imposed a penalty under proposed 45 CFR 
part 180 to appeal that penalty in accordance with 45 CFR part 150, 
subpart D, except as we otherwise proposed. We are finalizing as 
proposed to specify in new 45 CFR 180.100 the procedures for a hospital 
to appeal the CMP imposed by CMS for its noncompliance with the 
requirements of 45 CFR part 180 to an ALJ, and for the Administrator of 
CMS, at his or her discretion, to review in whole or in part the ALJ's 
decision. Specifically, we are finalizing our proposal that a hospital 
upon which CMS has imposed a penalty under 45 CFR part 180 may appeal 
that penalty in accordance with 45 CFR part 150, subpart D, with the 
exceptions (for the propose of applying the provisions of part 150 to 
CMPs under part 180) as described in this section of this final rule.
    We are also finalizing as proposed to set forth in new 45 CFR 
180.110 the consequences for failure of a hospital to request a 
hearing. If a hospital does not request a hearing within 30 calendar 
days of the issuance of the notice of imposition of a CMP described in 
new 45 CFR 180.90(b), CMS may impose the CMP indicated in such notice 
and may impose additional penalties pursuant to continuing violations 
according to new 45 CFR 180.90(f) without right of appeal. If the 30th 
calendar day is a weekend or a Federal holiday, then the timeframe is 
extended until the end of the next business day. The hospital has no 
right to appeal a penalty with respect to which it has not requested a 
hearing in accordance with 45 CFR 150.405, unless the hospital can show 
good cause, as determined at 45 CFR 150.405(b), for failing to timely 
exercise its right to a hearing.

III. Comments Received in Response To Request for Information: Quality 
Measurement Relating To Price Transparency for Improving Beneficiary 
Access to Provider and Supplier Charge Information

    In the CY 2020 OPPS/ASC proposed rule (84 FR 39594 through 39595), 
we included a RFI related to (1) access to quality information for 
third parties and healthcare entities to use when developing price 
transparency tools and when communicating charges for healthcare 
services, and (2) improving incentives and assessing the ability of 
healthcare providers and suppliers to communicate and share charge 
information with patients. We received approximately 63 timely pieces 
of correspondence on this RFI. We appreciate the input provided by 
commenters.

IV. Collection of Information Requirements

A. Response to Comments

    Under the Paperwork Reduction Act of 1995 (PRA), we are required to 
provide 60-day notice in the Federal Register and solicit public 
comment before a collection of information requirement is submitted to 
the OMB for review and approval.
    We solicited comments in the CY 2020 OPPS/ASC notice of proposed 
rulemaking that published in the August 9, 2019 Federal Register (84 FR 
39398). For the purpose of transparency, we are republishing the 
discussion of the information collection requirements (ICR) along with 
a reconciliation of the public comments we received.

B. ICR for Hospital Price Transparency

    In this final rule, we seek to promote price transparency in 
hospital standard charges to implement section 2718(e) of the PHS Act. 
We believe that in doing so, healthcare costs will decrease, and 
consumers can be empowered to make more informed decisions about their 
healthcare. We believe these finalized requirements will represent an 
important step towards putting consumers at the center of their 
healthcare and ensuring they have access to needed information.
    In the CY 2020 OPPS/ASC proposed rule, we noted that hospitals in 
the United States maintain chargemasters, a list of their gross charges 
for all individual items and services as part of their standard billing 
and business practices.\173\ Additionally, we stated that most 
hospitals maintain electronic data on charges they negotiate with third 
party payers for hospital items and services as well as service 
packages. As such, we indicated we believed that the burden for making 
this information publicly available would be minimal and estimated only 
a small burden for each hospital to extract, review, and conform the 
posting of gross charges and third party payer-specific negotiated 
charges for all hospital items and services in the comprehensive 
machine-readable format. In addition, we estimated some burden 
associated with hospitals making public their payer-specific negotiated 
charges for a set of at least 300 (70 CMS-specified and at least 230 
hospital-selected) shoppable services in a consumer-friendly manner, 
with flexibility for hospitals to determine the most consumer-friendly 
format. We proposed a policy that hospitals would display the charge 
for the primary shoppable service along with charges for any ancillary 
services the hospital customarily provides in conjunction with the 
primary shoppable service.
---------------------------------------------------------------------------

    \173\ Batty M. and Ippolito B. Mystery of The Chargemaster: 
Examining The Role Of Hospital List Prices in What Patients Actually 
Pay. Health Affairs. April 2017; 36(4): 689-696. Available at: 
https://www.healthaffairs.org/doi/10.1377/hlthaff.2016.0986.
---------------------------------------------------------------------------

    We estimated the proposed requirements would apply to 6,002 
hospitals operating within the United States under the proposed 
definition of ``hospital.'' To estimate this number, we subtracted 208 
federally-owned or operated hospitals from the total

[[Page 65592]]

number of U.S. hospitals, 6,210 hospitals \174\ (6,210 total 
hospitals--208 federally-owned or operated hospitals).
---------------------------------------------------------------------------

    \174\ American Hospital Association. Fast Facts on U.S. 
Hospitals, 2019. Available at: https://www.aha.org/statistics/fast-facts-us-hospitals.
---------------------------------------------------------------------------

    We concluded that the annual burden per hospital should be 
calculated with all activities performed by four professions combined. 
The four professions included a lawyer, a general operations manager, a 
business operations specialist, and a network and computer system 
administrator. We estimated an annual burden assessment to be 12 hours 
(2 hours + 8 hours + 2 hours) per hospital with a cost of $1,017.24 
($257.80 + $592.00 + $167.44) per hospital. We also estimated a total 
national burden of 72,024 hours (12 hours x 6,002 hospitals) and total 
cost of $6,105,474 ($1,017.24 x 6,002 hospitals).
    Comment: Several commenters were concerned that CMS did not take 
into account the number of hours needed for specific technical 
activities or consultation with necessary professionals. For example, a 
few commenters were concerned that CMS underestimated the cost and time 
involved in consulting legal and compliance experts on implementation 
of the rule, suggesting that such investment would be necessary to 
ensure the hospital had satisfactorily met requirements. A few 
commenters suggested that CMS take into account the time, resources and 
input of clinical staff necessary for each hospital to identify and 
compile each shoppable service or service package and corresponding 
ancillary services to reach a total of 300 shoppable services. One 
commenter suggested that the burden estimate take into account the time 
hospitals need to develop policies and business practices to comply 
with the requirements of the rule. Several commenters were concerned 
that the burden estimate did not reflect the need to hire multiple 
additional full time equivalents (FTEs) to staff multiple departments 
to comply with the rule to keep up with new charges, technology, 
monitoring and reporting, and contract negotiations.
    A few commenters cited a need for increasing consumer-facing 
clinical staffing as a result of making public hospital standard charge 
information. Specifically, one commenter expressed concern that the 
increased complexity of information available to consumers would result 
in an increased volume of calls from an average of 25 patients per day 
to 200 patients per day to its hospital customer service center. As a 
result, the commenter stated that the hospital customer service center 
would need to add 8-10 additional FTEs, resulting in $500,000 to $1 
million in additional costs per year.
    Response: We thank commenters for their input and suggestions on 
the types of professions, and the time and resources needed to comply 
with these requirements. Our estimate takes into account the time 
needed to review and comply with these requirements. We acknowledge 
that some hospitals may require longer time or greater resources than 
others to identify and compile their standard charges in a manner 
consistent with our final rules. For example, some hospitals may have 
many third-payer contracts while others may have relatively few. 
Similarly, some hospitals may have already compiled and present their 
services to the public in a manner that is consumer-friendly as a 
result of state requirements or voluntarily actions. We also believe 
that the greatest impact will be in the first year related to 
organizing the display of information in the form and manner required 
under this final rule after which the hospital would simply have to 
update the numbers annually. In order to minimize the burden related to 
the consumer-friendly display of hospital charges for shoppable 
services, we are finalizing as modifications to new 45 CFR 180.60 that 
a hospital offering an internet-based price estimator tool, that meets 
the requirements we set forth in section II.F.5. of the final rule, is 
an acceptable alternative method for meeting our requirements to make 
public its standard charges for selected shoppable services in a 
consumer-friendly manner. We believe that hospitals that have already 
been offering price estimator tools will incur less costs to comply 
with the requirements of the final rule given this accommodation.
    Even so, we appreciate the suggestion from commenters that we 
consider time and input from clinical staff. We agree that clinical 
input would be helpful to ensure the display of shoppable services is 
presented the way patients experience their care and to translate 
billing code descriptions into plain language. As a result, we are 
adding in the wage of Registered Nurses as a proxy for clinical staff 
and accounting for 30 hours of clinical assistance per hospital. We 
believe this time would be important in the initial stages of 
implementation in order to determine what ancillary services are 
customarily provided with the provision of the primary shoppable 
service. We do not believe such clinical expertise would be required 
for annual updates to the disclosed information in subsequent years. 
Additionally, in response to commenters who indicate more time should 
be allocated for lawyers and general operations managers, we are 
increasing the number of hours for those professions to 10 hours per 
hospital. Since the time allocated for lawyers was for reviewing the 
final rules, we believe these hours should be included in the initial 
implementation year estimate only. We are also significantly increasing 
the number of hours needed in the initial implementation year for 
business operations specialists to complete necessary processes and 
procedures to gather and compile required information and post it to 
the internet in the form and manner specified in the final rule.
    Finally, we can find no evidence to support the assertion that 
public disclosure of hospital standard charges increases the number of 
consumer calls to hospitals, necessitating hiring of additional staff 
for a hospital customer service center. To the contrary, price 
transparency research suggests that disclosure of provider charges can 
reduce administrative costs for a hospital and improve patient 
satisfaction.\175\ We therefore have not included this in our analysis.
---------------------------------------------------------------------------

    \175\ https://www.advisory.com/research/market-innovation-center/the-growth-channel/2018/12/price-transparency.
---------------------------------------------------------------------------

    Comment: Several hospitals asserted that CMS had underestimated the 
total administrative burden and cost of meeting the requirements of the 
rule and disagreed with the 12-hour estimate. Commenters stated several 
reasons for this concern including not accounting for the number of 
payers that could be present in a geographic region, the variety of 
negotiated payment methodologies between hospitals and payers, and the 
amount and scope of hospital resources required to gather the relevant 
data from contracts and accounting systems. Some commenters also 
indicated that the administrative burden and cost estimate should take 
into consideration the electronic availability and display of data on a 
user-friendly platform, and the cost to hospitals to regularly update 
their standard charge information for monitoring and reporting. 
Commenters cited the complexity of information to be provided and the 
burden of gathering the data from disparate accounting and billing 
systems. In particular, commenters indicated that some hospitals do not 
already have their standard charge data available in any electronic 
format, stating that they do not have contract management systems.

[[Page 65593]]

    Several commenters disagreed with the estimate based on their 
experiences with compliance with the requirements under the FY 2019 
IPPS/LTCH PPS final rule (83 FR 41144) and state-based price 
transparency requirements. For example, one commenter indicated that 
chargemaster posting took 30 minutes to complete while another 
commenter said they have already exceeded 12 hours just to comply with 
posting their chargemaster data alone, while another commenter stated 
their experience in making standard charges public under the FY 2019 
IPPS/LTCH PPS final rule task required 60 to 100 hours. Another 
commenter stated that their medical center spent 6 months of planning 
and exceeded 50 hours to meet the requirements for price transparency 
under the FY 2019 IPPS/LTCH PPS final rule. One commenter stated that 
one of their hospital members voluntarily produced a website that 
allows consumers to obtain estimates of their total out-of-pocket costs 
by plugging in information from their insurers. Their online tool 
covers 500 of their 6,000 chargemaster services items and the hospital 
estimates it took them 20 FTE hours to set up the basic framework and 
an ongoing two to four FTE hours per week to continue the build of all 
services and test for errors and putting real-time insurance 
information has taken an estimated 150 FTE hours to date. Similarly, 
another commenter, a professional organization of individuals involved 
in various aspects of healthcare financial management, writing on 
behalf of hospital finance and management professionals based on a 
survey of those individuals their members estimated that the average 
time required to comply is 150 hours per hospital, based on a survey of 
its members. One commenter stated that North Carolina implemented a 
similar process to the ``service package'' portion of CMS' proposal 
that included top 100 DRGs, top 20 outpatient surgeries, and top 20 
imaging procedures at the State level with the de-identified minimum, 
average and maximum ``accepted'' (collected) for closed accounts. The 
commenter estimated that this effort required 500 hours of staff time 
for the first reporting period. Several commenters provided estimates 
of their anticipated burden and additional required FTEs to comply with 
the proposed requirements for hospitals to make public standard charges 
ranging from $1,000 to over $450,000 per hospital, 12.5 hours to 4,600 
hours per hospital, and 3-10 employees per hospital.
    Response: We appreciate the input provided by commenters. As 
indicated in the CY 2020 OPPS/ASC proposed rule at 84 FR 39579 through 
39580, based on an internal analysis of plans in the regulated 
individual and small group insurance markets under the ACA, we 
determined that per rating area there is an average of 1 to 400 payers 
in the small group market (averaging nearly 40 products or lines of 
service in each rating area) and an average of 1 to 200 payers in the 
individual market (averaging nearly 20 products or lines of service in 
each rating area). We therefore acknowledge and have taken into account 
that hospitals may have many payer-specific negotiated charges to 
compile and make public. We are also aware that hospitals and payers 
utilize a variety of payment methodologies in their contracts, which is 
why we have focused on the base payer rates negotiated between the 
hospital and payer for the services hospitals provide (section II.D.3 
of this final rule). We are also aware that the standard charge 
information may be housed in disparate systems, for example, the gross 
charges can be found in a hospital chargemaster while the payer-
specific negotiated charges can be found in the hospitals' revenue 
cycle management system or in the rate tables associated with the in-
network contract.
    Some commenters provided implementation estimates based on a 
hospital system comprised of more than one hospital, and in such 
instances, we converted the estimate to a per-hospital basis for our 
analysis. Others (as in the North Carolina example above) appeared to 
misunderstand the requirements by referencing a need to calculate and 
determine paid amounts, in contrast to the policies we are finalizing 
in this rule. Most of the outlier estimates submitted by commenters 
were unaccompanied by any details regarding the assumptions that were 
made to develop the estimate. We also noted that some commenters 
provided burden estimates in reference to development of a consumer-
friendly price estimator tool, however, we are not requiring hospitals 
to develop or display standard charge data in a tool. Our final 
policies provide hospitals with flexibility to determine the most 
appropriate internet-based format for purposes of complying with making 
standard charges public in a consumer-friendly manner. Further, we 
believe there are a variety of low cost formats a hospital could choose 
as suggested in section II.F of this final rule. For example, making 
public standard charges in a spreadsheet posted to a hospital website 
would be one way to satisfy the requirements of this final rule. We 
note that in response to comments on this issue, we have finalized a 
policy that would reduce hospital reporting burden further, 
specifically, we are finalizing a policy to specify that a hospital 
offering an internet-based price estimator tool, that meets the 
criteria we set forth in new 45 CFR 180.60, would be regarded as having 
met the requirements to make public their standard charges for selected 
shoppable services in a consumer-friendly manner. We also believe due 
to their existing public displays of data, these hospitals already have 
a framework or business processes that they can leverage that would 
minimize additional burden.
    We also acknowledge that some hospitals may require more time and 
resources than others to gather the relevant data, prepare for its 
electronic availability, display it in a consumer-friendly format, and 
regularly update that information for monitoring and reporting. We 
believe this to be true because some hospitals are already compiling 
and reporting similar data to meet State price transparency 
requirements and some are already making public their charges online in 
consumer-friendly ways. The wide range of burden hours submitted by 
commenters appears to support and reflect the notion that hospitals 
nationwide are at different stages of readiness to offer consumers 
transparent price information or are at various levels of participation 
in posting of charge and price information. We also believe that 
different hospitals may face different constraints when estimating 
their burden and resources required.
    With these considerations in mind, we agree that the burden 
estimate should be revised to reflect an increased number of hours. 
Commenters included individuals, hospitals and health systems, hospital 
associations, and a health finance association. The commenters provided 
estimates based on both their unique experiences as well as experiences 
from a wide variety of health financial management experts and members. 
As noted, estimates submitted by commenters (when calculated on a per 
hospital basis) ranged from $1,000 to over $450,000 per hospital, 12.5 
hours to 4,600 hours per hospital, and 3-10 employees per hospital. 
Most estimates by commenters fell within a range of 60 to 250 hours per 
hospital and approximately $4,800 to $20,000 per hospital, which we 
conclude is reasonable given our assumption that hospitals are in 
various states of readiness. Specifically, we

[[Page 65594]]

determined that a total burden of 150 hours for the first year is 
reasonable for hospitals nationwide, based on estimates provided by an 
organization with broad expertise and membership related to healthcare 
financial management and a large health care system with multiple 
hospitals. We believe an estimate of 150 hours per hospital for the 
first year represents a broad industry view that takes into account the 
range of hospital readiness and ability to comply with these rules.
    Comment: Several commenters referenced the cost of ongoing 
compliance with the rule in subsequent years and recommended an 
annualized burden estimate that would be reduced from the initial year 
of implementation of the requirement to publicize standard charges. 
However, few commenters provided any specific recommendations as to the 
potential ongoing costs. One commenter, for example, indicated that 
they believed an estimate of ``several thousand dollars'' would be 
reasonable to purchase software that would automatically update the 
charges on an annual basis (thus suggesting that there would be no 
maintenance costs). Two commenters suggested that maintenance costs 
would be approximately 25 percent of implementation costs, however, 
these commenters specifically discussed the costs associated with 
pricing tool development, and not the burden associated with our final 
policies. Another commenter estimated their compliance would require 
$100,000 for the first year working with an outside vendor and close to 
$50,000 in the out years, however, this commenter assumed that the file 
would be updated as frequently as weekly. One commenter shared their 
experience complying with a North Carolina requirement to calculate and 
report amounts paid and indicated their maintenance burden was 
approximately 40 percent of their initial effort.
    Response: We agree with commenters that there may be a continued 
cost of compliance with the rule past the initial year for some 
hospitals and are therefore adding a burden assessment for maintenance 
costs. We further agree with commenters that the annualized burden 
should show a reduction compared to the initial year because hospitals 
will have made the necessary updates to their software and business 
operations during the first year, and become more acclimated to the 
rule. Specifically, we believe there will no longer be a need for 
hospitals to: (1) Consult with a clinical professional to make a 
selection of shoppable services or to determine associated ancillary 
services; or (2) consult with a lawyer to review the requirements of 
this final rule as these are actions that will only need to take place 
prior to the initial public display of data. We therefore estimate that 
after eliminating the burden hours for these professionals and reducing 
the applicable burden hours for business and general operations in 
subsequent years, the total annual national burden for maintenance 
costs in subsequent years would be 276,092 hours (46 hours x 6,002 
hospitals) and total cost of $21,672,502 ($3,610.88 x 6,002 hospitals). 
(See Table 6.)
    Comment: Several commenters suggested that CMS engage in further 
research or solicit additional input from stakeholders and focus 
groups. Commenters recommended CMS work with a focus group of several 
large health systems and industry consultants to conduct further 
studies to understand the actual time and effort for implementation of 
these requirements. A few commenters suggested that CMS should do more 
research to better inform the COI and burden estimates and suggested 
CMS seek in-depth input from hospitals on how their contracts are 
developed and how negotiated rates may be displayed to include such 
considerations as the full scope of current hospital reporting and 
unintended consequences.
    Response: We appreciate commenters' suggestions. However, we 
believe that we have sufficient input as a result of our many RFIs and 
listening sessions conducted over the course of the past 18 months, in 
addition to the helpful input we received from comments to our CY 2020 
OPPS/ASC proposed rule. We note that we are making some accommodations 
in our final policies to relieve hospital burden and to provide 
additional time for hospitals to come into compliance with these new 
rules. Additionally, we are increasing our estimated burden in 
accordance with the recommendations from commenters, and including 
ongoing maintenance costs.
    Final Estimate: In this final rule, we seek to promote price 
transparency in hospital standard charges so that consumers can be 
empowered to make more informed decisions about their healthcare. If 
finalized, we believe these proposed requirements would represent an 
important step towards putting consumers at the center of their 
healthcare and ensuring they have access to needed information. We are 
making modifications to several of our proposed policies that impact 
our burden estimate. Specifically, we are adding three additional types 
of standard charges that the hospital would have to make public: The 
de-identified minimum negotiated charge, the de-identified maximum 
negotiated charge and the discounted cash price. We continue to believe 
that since these data exist in hospital financial and accounting 
systems (although not always in electronic format), the burden for 
making this information publicly available would be relatively minimal 
for posting of gross charges, payer-specific negotiated charges, de-
identified minimum negotiated charge, de-identified maximum negotiated 
charge, and discounted cash prices for all hospital items and services 
online in a single machine-readable format as specified in the final 
rule. In addition, we continue to estimate some burden associated with 
hospitals making public their payer-specific negotiated charges, de-
identified minimum negotiated charge, de-identified maximum negotiated 
charge, and cash discounted price for a set of at least 300 (70 CMS-
specified and at least 230 hospital-selected) shoppable services in a 
consumer-friendly manner, with flexibility for hospitals to determine 
the most consumer-friendly format.
    Although we are increasing the number of the types of standard 
charges a hospital must make public, we have reduced burden by 
finalizing a policy to specify that a hospital offering an internet-
based price estimator tool, that meets the criteria we set forth in new 
45 CFR 180.60, would be deemed as having met the requirements to make 
public their standard charges for selected shoppable services in a 
consumer-friendly manner. Because many hospitals already offer such 
price estimator tools, we believe this policy will serve to minimize 
the burden while meeting our policy goals of ensuring hospital pricing 
information can be readily accessible in a consumer-friendly manner.
    We estimate that the final rule applies to 6,002 hospitals 
operating within the United States under the definition of ``hospital'' 
discussed in section II.B.1. of the final rule. To estimate this 
number, we subtract 208 federally-owned or operated hospitals from the 
total number of U.S. hospitals, 6,210 hospitals \176\ (6,210 total 
hospitals -208 federally-owned or operated hospitals).
---------------------------------------------------------------------------

    \176\ American Hospital Association. Fast Facts on U.S. 
Hospitals, 2019. Available at: https://www.aha.org/statistics/fast-facts-us-hospitals.
---------------------------------------------------------------------------

    We estimate the hourly cost for each labor category used in this 
analysis by referencing Bureau of Labor Statistics report on 
Occupational Employment

[[Page 65595]]

and Wages (May 2018 \177\) in Table 4. There are many professions 
involved in any business's processes. Therefore, we use the wages of 
General and Operations Managers as a proxy for management staff, the 
wages of Lawyers as a proxy for legal staff, the wages of Network and 
Computer Systems Administrators as a proxy for IT staff, the wage of 
Registered Nurses as a proxy for clinical staff, and the wage of 
Business Operations Specialists as a proxy for other business staff 
throughout this analysis. Obtaining data on overhead costs is 
challenging. Overhead costs vary greatly across industries and facility 
sizes. In addition, the precise cost elements assigned as ``indirect'' 
or ``overhead'' costs, as opposed to direct costs or employee wages, 
are subject to some interpretation at the facility level. Therefore, we 
calculate the cost of overhead at 100 percent of the mean hourly wage 
in line with the Hospital Inpatient Quality Reporting Program and the 
Hospital Outpatient Quality Reporting Program (81 FR 57260 and 82 FR 
59477, respectively).
---------------------------------------------------------------------------

    \177\ Bureau of Labor Statistics. National Occupational 
Employment and Wage Estimates, May 2018. Available at: https://www.bls.gov/oes/2018/may/oes_nat.htm.

                                    Table 4--Occupation Titles and Wage Rates
----------------------------------------------------------------------------------------------------------------
                                                                                                     Adjusted
                Occupation title                    Occupation      Mean hourly   Fringe benefit  hourly wage ($/
                                                       code         wage ($/hr)       ($/hr)            hr)
----------------------------------------------------------------------------------------------------------------
Lawyers.........................................         23-1011          $69.34          $69.34         $138.68
General and Operations Managers.................         11-1021           59.56           59.56          119.12
Business Operations Specialists.................         13-1199           37.00           37.00           74.00
Registered Nurses...............................         29-1141           36.30           36.30           72.60
Network and Computer Systems Administrators.....         15-1142           41.86           41.86           83.72
----------------------------------------------------------------------------------------------------------------

    In order to comply with regulatory updates finalized in the final 
rule in the initial year of implementation, hospitals would first need 
to review the rule. We estimate that this task would take a lawyer, on 
average, 5 hours (at $138.68 per hour, which is based on the Bureau of 
Labor Statistics (BLS) wage for Lawyers (23-1011) \178\) to perform 
their review, and a general operations manager, on average, 5 hours (at 
$119.12 per hour, which is based on the Bureau of Labor Statistics 
(BLS) wage for General and Operations Managers (11-1021) \179\) to 
review and determine compliance requirements. Therefore, for reviewing 
the rule, we estimate 10 burden hours per hospital, with a total of 
60,020 burden hours (10 hours x 6,002 hospitals). The cost is $1,289 
per hospital (5 hours x $138.68 + 5 hours x $119.12), with a total cost 
of $7,736,578 ($1,289.00 x 6,002 hospitals).
---------------------------------------------------------------------------

    \178\ Bureau of Labor Statistics. Occupational Employment and 
Wage Estimates, May 2018: 23-1011 Lawyers. Available at: https://www.bls.gov/oes/current/oes231011.htm.
    \179\ Bureau of Labor Statistics. Occupational Employment and 
Wage Estimates, May 2018: 11-1021 General and Operations Managers. 
Available at: https://www.bls.gov/oes/current/oes111021.htm.
---------------------------------------------------------------------------

    After reviewing the rule, hospitals would need to review their 
policies and business practices in the context of the defined terms and 
requirements for information collection then determine how to comply. 
We believe this will require minimal changes for affected hospitals 
because the standard charge information to be collected is already 
compiled and maintained as part of hospitals' contracting, accounting 
and billing systems. Some hospitals may have to consult directly with 
their payer contracts to review and compile payer-specific negotiated 
charges. We note that we are finalizing requirements for hospitals to 
make public five types of standard charges including their gross 
charges (as reflected in the chargemaster), their payer-specific 
negotiated charges, discounted cash prices, the de-identified minimum 
negotiated charge, and the de-identified maximum negotiated charge. All 
five types of standard charges for all items and services, as 
finalized, must be made public in a comprehensive machine-readable file 
online. Additionally, all but gross charges would have to be made 
public for a total of 300 shoppable services (70 CMS-specified and 230 
hospital-selected) in a consumer-friendly manner, including listing the 
charges for associated ancillary services provided by the hospital so 
that the hospital charge information is more accessible and easier to 
digest for consumers seeking to obtain pricing information for making 
decisions about their treatment.
    We estimate it would take a business operations specialist, on 
average, 80 hours (at $74 per hour, which is based on the Bureau of 
Labor Statistics (BLS) wage for Business Operations Specialists, All 
Other (13-1199) \180\) to complete necessary processes and procedures 
to gather and compile required information and post it to the internet 
in the form and manner specified by the final rule. For this task, we 
estimate 80 burden hours per hospital. The total burden hours are 
480,160 hours (80 hours x 6,002 hospitals). The cost is $5,920 per 
hospital (80 hours x $74), with a total cost of $35,531,840 ($5,920 x 
6,002 hospitals).
---------------------------------------------------------------------------

    \180\ Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2018: 13-1199 Business Operations Specialist, All Other. 
Available at: https://www.bls.gov/oes/current/oes131199.htm.
---------------------------------------------------------------------------

    We estimate that a network and computer system administrator would 
spend, on average, 30 hours (at $83.72 per hour, which is based on the 
Bureau of Labor Statistics (BLS) wage for Network and Computer Systems 
Administrators (15-1142) \181\) to meet requirements specified by this 
final rule. The total burden hours are 180,060 hours (30 hours x 6,002 
hospitals). The cost is $2,511.60 per hospital (30 hours x $83.72), 
with a total cost of $15,074,623 (180,060 hours x $83.72).
---------------------------------------------------------------------------

    \181\ Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2018: 15-1142 Network and Computer System Administrators. 
Available at: https://www.bls.gov/oes/current/oes151142.htm.
---------------------------------------------------------------------------

    In addition, in the initial year of implementation, we estimate it 
would take a registered nurse, on average, 30 hours (at $72.60 per 
hour, which is based on Bureau of Labor Statistics (BLS) wage for 
Registered Nurses (29-1141) \182\) to capture necessary clinical input 
to determine a representative services package for a given service. We 
estimate 30 burden hours per hospital. The total burden hours for this 
task are 180,060 hours (30 hours x 6,002 hospitals). The cost is $2,178 
per hospital (30 hours x $72.60), with a total cost of $13,072,356 
($2,178 x 6,002 hospitals).
---------------------------------------------------------------------------

    \182\ Bureau of Labor Statistics. Occupational Employment and 
Wages, May 2018: 29-1141 Registered Nurses. Available at: https://www.bls.gov/oes/2018/may/oes291141.htm.

---------------------------------------------------------------------------

[[Page 65596]]

    Therefore, we are finalizing the total burden estimate for the 
first year to be 150 hours (10 hours + 80 hours + 30 hours + 30 hours) 
per hospital with a cost of $11,898.60 ($1,289 + $5,920 + $2,178 + 
$2,511.60) per hospital. We also estimate a total national burden of 
900,300 hours (150 hours x 6,002 hospitals) and total cost of 
$71,415,397 ($11,898.60 x 6,002 hospitals). (See Table 5.)

                                        Table 5--Summary of Information of Collection Burdens for the First Year
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Burden per                       Total labor
               Regulation section(s)                OMB control No.     Number of        Number of         response       Total annual       cost of
                                                                       respondents       responses         (hours)       burden (hours)   reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   180........................................        0938-NEW            6,002            6,002              150          900,300      $71,415,397
--------------------------------------------------------------------------------------------------------------------------------------------------------

    We anticipate that these costs will decline in subsequent years 
after the first year of finalization of the rule as hospitals gain 
additional efficiencies or may utilize the business processes and 
system infrastructures or software that would be built or purchased 
during the first year. We expect that the cost associated with 
maintenance would be significantly less than the cost hospitals would 
incur in the first year and would remain relatively level for a few 
years. We further believe that the activities associated with 
maintenance would only require General and Operations Managers, 
Business Operations Specialists, and Network and Computer Systems 
Administrators professions listed in Table 4. Utilizing their 
corresponding Adjusted Hourly Wage rates from this table, we estimate 
that it would take a general operations manager, on average, 2 hours to 
review and determine updates in compliance with requirements. 
Therefore, we estimate 2 burden hours per hospital, with a total of 
12,004 burden hours (2 hours x 6,002 hospitals). The cost is $238.24 
per hospital (2 hours x $119.12), with a total cost of $1,429,916 
($238.24 x 6,002 hospitals).
    We also estimate it would take a business operations specialist, on 
average, 32 hours to gather and compile required information and post 
it to the internet in the form and manner specified by the final rule. 
For this task, we estimate 32 burden hours per hospital. The total 
burden hours are 192,064 hours (32 hours x 6,002 hospitals). Using 
Adjusted Hourly Wage rates from Table 4, the cost is $2,368 per 
hospital (32 hours x $74.00), with a total cost of $14,212,736 ($2,368 
x 6,002 hospitals).
    Lastly, we estimate that a network and computer system 
administrator would spend, on average, 12 hours to maintain 
requirements specified by this final rule. The total burden hours are 
72,024 hours (12 hours x 6,002 hospitals). The cost is $1,004.64 per 
hospital (12 hours x $83.72), with a total cost of $6,029,849 (72,024 
hours x $83.72).
    Therefore, we are finalizing the total annual burden estimate for 
subsequent years to be 46 hours (2 hours + 32 hours + 12 hours) per 
hospital with a cost of $3,610.88 ($238.24 + $2,368.00 + $1,004.64) per 
hospital. We also estimate a total annual national burden for 
subsequent years of 276,092 hours (46 hours x 6,002 hospitals) and 
total cost of $21,672,502 ($3,610.88 x 6,002 hospitals). (See Table 6.)

                                        Table 6--Summary of Information of Collection Burdens for Subsquent Years
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                          Burden per                       Total labor
               Regulation section(s)                OMB control No.     Number of        Number of         response       Total annual       cost of
                                                                       respondents       responses         (hours)       burden (hours)   reporting ($)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Sec.   180........................................        0938-NEW            6,002            6,002               46          276,092      $21,672,502
--------------------------------------------------------------------------------------------------------------------------------------------------------

V. Regulatory Impact Analysis

A. Statement of Need

    As healthcare costs continue to rise, healthcare affordability has 
become an area of intense focus. Healthcare spending is projected to 
consume almost 20 percent of the economy by 2027.\183\ We believe that 
one reason for this upward spending trajectory in spending is the lack 
of transparency in healthcare pricing. Additionally, numerous studies 
suggest that consumers want greater healthcare pricing transparency. 
For example, a study of HDHP enrollees found that respondents wanted 
additional healthcare price information so that they could make more 
informed decisions about where to seek care based on price.\184\ Health 
economists and other experts state that significant cost containment 
cannot occur without widespread and sustained transparency in provider 
prices. We believe there is a direct connection between transparency in 
hospital standard charge information and having more affordable 
healthcare and lower healthcare coverage costs. We believe healthcare 
markets could work more efficiently and provide consumers with higher-
value healthcare if we promote policies that encourage choice and 
competition. The intent of this rule is to promote price transparency 
in hospital standard charges to implement section 2718(e) of the PHS 
Act. We believe that in doing so, healthcare costs will decrease 
through increased competition and consumers will be empowered to make 
more informed decisions about their healthcare. We believe these 
finalized requirements will represent an important step towards putting 
consumers at the center of their healthcare and ensuring they have 
access to needed information.
---------------------------------------------------------------------------

    \183\ National Health Expenditure Fact Sheet, Centers for 
Medicare & Medicaid Services, April 26, 2019. Available at: https://www.cms.gov/research-statistics-data-and-systems/statistics-trends-and-reports/nationalhealthexpenddata/nhe-fact-sheet.html.
    \184\ Sinaiko AD, et al. Cost-Sharing Obligations, High-
Deductible Health Plan Growth, and Shopping for Health Care: 
Enrollees with Skin in the Game. JAMA Intern Med. March 2016; 
176(3), 395-397. Available at: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2482348.
---------------------------------------------------------------------------

    We further identified a need to impose CMPs to ensure compliance 
with the requirements of this final rule. The amount of the CMP is $300 
per day per hospital. We believe this amount to be sufficient to prompt 
hospitals to

[[Page 65597]]

timely and properly display standard charges in both machine-readable 
and consumer-friendly formats in accordance with the requirements of 
this final rule.

B. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 on Regulatory Planning and Review (September 30, 1993), 
Executive Order 13563 on Improving Regulation and Regulatory Review 
(January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the SSA, section 202 of the 
Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), 
Executive Order 13132 on Federalism (August 4, 1999), the Congressional 
Review Act (5 U.S.C. 804(2)), and Executive Order 13771 on Reducing 
Regulation and Controlling Regulatory Costs (January 30, 2017).
    Executive Orders 12866 and 13563 direct agencies to assess all 
costs and benefits of available regulatory alternatives and, if 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety effects, distributive impacts, and equity). Section 
3(f) of Executive Order 12866 defines a ``significant regulatory 
action'' as an action that is likely to result in a rule: (1) Having an 
annual effect on the economy of $100 million or more in any 1 year, or 
adversely and materially affecting a sector of the economy, 
productivity, competition, jobs, the environment, public health or 
safety, or state, local or tribal governments or communities (also 
referred to as ``economically significant''); (2) creating a serious 
inconsistency or otherwise interfering with an action taken or planned 
by another agency; (3) materially altering the budgetary impacts of 
entitlement grants, user fees, or loan programs or the rights and 
obligations of recipients thereof; or (4) raising novel legal or policy 
issues arising out of legal mandates, the President's priorities, or 
the principles set forth in the Executive Order.
    An RIA must be prepared for major rules with economically 
significant effects ($100 million or more in any 1 year). In aggregate, 
we estimate that this rule will cost approximately $71.4 million for 
hospitals to implement nationwide, in the initial year of 
implementation. In subsequent years, we anticipate minimal burden on 
hospitals for remaining compliant with the requirements to make public 
standard charges by annually updating the data they make public 
because, as explained in the CY 2020 OPPS/ASC proposed rule, we believe 
most of the effort will be in reviewing the rule for compliance, 
selecting the hospital `shoppable' services, determining the ancillary 
services and displaying the shoppable services in a consumer-friendly 
manner. After the first year, hospitals would only need to update the 
data at least once every 12 months. We estimate that these annual 
updates and general operations for complying with the final rule will 
cost hospitals $21,672,502 annually after the initial year.
    Almost all hospitals operating within the United States will be 
affected by the requirement to make standard charges public in both a 
machine-readable, and consumer-friendly manner. Although the level of 
disclosure of standard charge data required under this final rule is 
unprecedented, we do not expect the requirements of the final rule to 
disrupt normal business operations because hospitals already keep and 
maintain these data within their billing and accounting systems. 
However, OMB has determined that the actions are economically 
significant within the meaning of section 3(f) of the Executive Order. 
Therefore, OMB has reviewed this regulation, and the Department of 
Health and Human Services has provided the following assessment of its 
impact.

C. Anticipated Effects

    This final rule would affect each hospital (as defined at 45 CFR 
180.20) operating within the United States. We estimate that the final 
rule applies to 6,002 hospitals operating within the United States 
under the definition of ``hospital'' discussed in section II.B.1. of 
this final rule. To estimate this number, we subtracted 208 federally-
owned or operated hospitals from the total number of United States 
hospitals, 6,210 hospitals.\185\ In order to comply with regulatory 
updates finalized in the final rule in the initial year, hospitals 
would first need to review the rule. We estimate that this task would 
take a lawyer, on average, 5 hours to perform their review, and a 
general operations manager, on average, 5 hours to review and determine 
compliance requirements. We then estimate it would take a business 
operations specialist, on average, 80 hours to complete necessary 
processes and procedures to gather and compile required information and 
post it to the internet in the form and manner specified by the final 
rule. We also estimate that a network and computer system administrator 
would spend, on average, 30 hours to meet requirements specified by 
this final rule. Lastly, we estimate it would take a registered nurse, 
on average, 30 hours to capture necessary clinical input to determine a 
representative services package for a given service. Therefore, we are 
finalizing the total burden estimate to be 150 hours per hospital for 
the first year immediately following the finalization of this rule.
---------------------------------------------------------------------------

    \185\ American Hospital Association. Fast Facts on U.S. 
Hospitals, 2019. Available at: https://www.aha.org/statistics/fast-facts-us-hospitals.
---------------------------------------------------------------------------

    For the burden hours in subsequent years, we estimate that it would 
take a general operations manager, on average, 2 hours to review and 
determine updates in compliance requirements, a business operations 
specialist, on average, 32 hours to update necessary processes and 
procedures to gather and compile required information and post it to 
the internet in the form and manner specified by this final rule, and a 
network and computer system administrator would spend, on average, 12 
hours to maintain requirements specified by this final rule. Therefore, 
we are finalizing the total burden estimate for the subsequent years to 
be 46 hours per hospital.
    In order to estimate the cost associated with these activities, we 
use the hourly cost for each labor category used in this analysis by 
referencing Bureau of Labor Statistics report on Occupational 
Employment and Wages (May 2018 \186\). There are many professions 
involved in any business's processes. Therefore, we use the wage rate 
of a profession as a proxy for professional activities under such 
category. Also, we calculate the cost of overhead at 100 percent of the 
mean hourly wage in line with the Hospital Inpatient Quality Reporting 
Program and the Hospital Outpatient Quality Reporting Program (81 FR 
57260 and 82 FR 59477, respectively). As a result, we use adjusted 
hourly wage rate of $138.68 for lawyers, adjusted hourly wage rate of 
$119.12 for general and operational managers, adjusted hourly wage rate 
of $74 for business operations specialists, adjusted hourly wage rate 
of $83.72 for network and computer systems administrators and hourly 
wage rate of $72.60 for registered nurses. With these numbers, we 
estimate a cost of $11,898.60 per hospital with total cost of $71.4 
million for affected hospitals nationwide in the initial period for

[[Page 65598]]

implementing the requirements we are finalizing with this rule.
---------------------------------------------------------------------------

    \186\ Bureau of Labor Statistics. National Occupational 
Employment and Wage Estimates, May 2018. Available at: https://www.bls.gov/oes/2018/may/oes_nat.htm.
---------------------------------------------------------------------------

1. Effects on Private Sector
    As discussed in the CY 2020 OPPS/ASC proposed rule (84 FR 39631 
through 39632), we considered the estimated effects on the private 
sector, and welcomed public comments on the impact of the proposed 
requirements on the private sector. As discussed in the Collection of 
Information section of this final rule, we continue to believe the 
burden on hospitals would be minimal. We also indicated that we believe 
the requirements in the final rule would encourage hospitals to adhere 
to best practices and industry standards by developing more robust and 
more efficient revenue integrity processes while working to comply with 
these requirements. Additionally, we are finalizing policies that could 
reduce potential compliance burdens, for example, we are finalizing as 
a modification that a hospital offering an internet-based price 
estimator tool that meets applicable requirements, is regarded as 
having met requirements to make public its standard charges for 
selected shoppable services in a consumer-friendly manner. Some 
hospitals already offer such tools, so fewer hospitals would need to 
develop display of consumer-friendly pricing information from scratch. 
Moreover, such hospitals would spend fewer hours complying because they 
would only need to review their existing price estimator tool to 
evaluate whether it meets the criteria specified at 180.60(a)(2).
    Therefore, we considered these new variables in estimating burden 
and cost after the initial period of implementation, and determined 
their value would largely depend upon the hospitals' initial readiness 
and compliance status. We believe some variables serve to reduce the 
hours required for one or more activities associated with complying 
with the final rule after the first year. For example, to be compliant 
initially, the hospital must determine its shoppable services and 
ancillary services for display, must determine the most consumer-
friendly format and display site, and must collect payer-specific 
negotiated charge information from its contracts or existing revenue 
management cycle process. Such activities are necessary only in the 
initial period of implementation for hospitals that do not already 
adhere to industry standards and best practices; once those activities 
have been completed, a hospital would simply need to update the 
standard charge data on an annual basis going forward. In addition, 
these variables may correlate and drive more changes in factors that 
would affect cost estimating after the initial period of 
implementation. Due to these considerations, we provided an updated 
burden estimate that reduces the number of total annual hours in 
subsequent years and are finalizing with this rule.
    Comment: A few commenters stated that CMS has not demonstrated that 
the benefit of the policies outweigh the costs of implementing the 
rule.
    Response: We appreciate commenters' input. However, we disagree 
with this comment. This final rule seeks to further advance hospital 
price transparency efforts that initiated with the FY 2015 IPPS/LTCH 
PPS and FY 2019 IPPS/LTCH PPS rules seeking to implement section 
2718(e) of the PHS Act. At the time these prior rules were published, 
and as echoed in the comments we are responding to in this final rule, 
we heard from many stakeholders and public commenters that more 
guidelines and specificity around the form and manner in which 
hospitals make standard charges public would be helpful. Such 
commenters requested that CMS include requirements for more types of 
standard charges, as gross charges or the chargemaster alone are not 
sufficient for patients to estimate their financial obligations or to 
drive improvements in value-based care. This final rule goes a step 
farther by requiring hospitals to make public payer-specific negotiated 
charges, the de-identified minimum negotiated charge, the de-identified 
maximum negotiated charge, and discounted cash prices, in addition to 
gross charges for all items and services. Throughout section II of this 
final rule, we discuss the benefits of informing and empowering the 
public with hospital price information. These requirements would make 
public data that consumers could use to better understand the cost of 
care, and inform their healthcare decision-making, before receiving 
services. Further, technology vendors may innovate and create new 
products, including internet-based price estimator tools, or upgrade 
existing technologies to support hospitals in meeting these 
requirements and aiding consumers and healthcare providers in using 
data that is made public by hospitals. Other members of the public, 
such as employers, would be better informed to monitor insurer 
effectiveness and to help their employees shop for value.
    In section V of this final rule, we analyze effects of these 
requirements on both the private sector and consumers. In section IV of 
this final rule, we detail how we determined the estimated burden of 
the requirements we are finalizing, at 150 hours with a cost of 
$11,898.60 per hospital, and how we arrived at these figures. In the 
following sub-sections of the RIA, we categorize our analyses within 
the estimated effects on consumers, small entities, small rural 
hospitals, and alternatives considered. We provide analyses from these 
perspectives to demonstrate that these requirements would bring 
consumers and other stakeholders' insights into healthcare costs, as 
well as the reasonable burden estimate for hospitals that takes into 
account commenters' concerns. In summary, we believe the overall 
benefits to consumers and healthcare markets nationwide will exceed the 
burden. For the initial year of implementation, we are finalizing an 
estimate of 150 hours and cost $11,898.60 per hospital for the burden 
of the requirements we are finalizing in this final rule that takes 
into account input from public comments.
    Comment: We received some comments on the potential impacts of the 
proposed hospital price transparency requirements on CAHs, rural 
hospitals, and SCHs, including their suggestion that CMS exempt these 
entities from part or all requirements to make standard charges public.
    Response: We believe that the benefits to consumers, and to the 
general public as a whole, outweigh the operational challenges faced by 
these entities. Further, elsewhere in the RIA (see section V.C.5 of 
this final rule), we analyze effects on small rural hospitals.
    Comment: Many commenters cautioned that disclosure of payer-
specific negotiated charges would increase, not decrease, healthcare 
costs in certain markets due to anticompetitive behaviors or increases 
in prices as a result of hospital knowledge of better rates negotiated 
by neighboring hospitals.
    Response: We continue to believe, as supported by (for instance) 
academic research, economics research, or both, that the healthcare 
market could work more efficiently and provide consumers with high-
value healthcare through policies that encourage choice and 
competition. Research suggests that in a normal market, price 
transparency (more generally) will result in reduced rates, 
overall.\187\ There are models in the

[[Page 65599]]

States that have shown that release of the information has driven costs 
down not up.\188\ On aggregate, we believe the effects on competition, 
resulting from hospital price transparency, would drive down healthcare 
prices. We acknowledge, that knowledge by a hospital of other 
hospitals' payer-specific negotiated charges could also drive up rates; 
especially if a hospital discovers it is currently being paid less than 
other hospitals by a payer and, thereby, negotiates higher rates. On 
the other hand, payers may negotiate lower rates, if they discover 
hospitals have negotiated lower rates with competing payers.
---------------------------------------------------------------------------

    \187\ Christensen HB, et al. 2018. ``The Only Prescription Is 
Transparency: The Effect of Charge-Price-Transparency Regulation on 
Healthcare Prices.'' SSRN Scholarly Paper ID 2343367. Rochester, NY: 
Social Science Research Network. Available at: https://papers.ssrn.com/abstract=2343367.
    \188\ Brown ZY. Equilibrium Effects of Health Care Price 
Information. The Review of Economics and Statistics. Published 
October 2019; 101:4, 699-712. Available at: http://www-
personal.umich.edu/~zachb/zbrown_eqm_effects_price_transparency.pdf.
---------------------------------------------------------------------------

    Comment: Typically described in the context of commenters' concerns 
on specific proposals, and as described within section II of this final 
rule, commenters suggested a number of possible unanticipated 
consequences for the private sector of the proposed requirements for 
hospitals to make public standard charges, including the following:
     The disclosure of payer-specific negotiated charges is 
likely to result in anti-competitive behavior and anti-trust exposure.
     Under the proposed requirements for hospitals to make 
public standard charges including payer-specific negotiated charges, 
hospitals would be exposed to litigation risk, due to the belief that 
these contractual reimbursement rates are proprietary.
     The proposal would contradict the goals of CMS' Patients-
over Paperwork initiative.
     The requirement to disclose standard charges for all items 
and services as defined under the CY 2020 OPPS/ASC proposed rule would 
result in hospital closures.
     Complying with the requirements, as proposed, would be 
cost-prohibitive for CAHs, rural hospitals, and small hospitals, among 
others.
     The CY 2020 OPPS/ASC proposed rule's focus on standard 
charges would negatively impact hospitals' transition to value-based 
care.
    Response: We appreciate commenters' concerns, and we have addressed 
these concerns elsewhere in this final rule. We do not believe that 
these concerns affect our estimate of the impact of the requirements we 
are finalizing, and accordingly we decline to adjust our economic 
analyses based on these concerns alone.
    As we detailed in Section IV.B, we estimated the total burden to 
implement the requirements of this rule to be 150 hours at a cost of 
$11,898.60 per hospital. We noted that hospitals nationwide are at 
different stages of readiness to offer consumers transparent price 
information or are at various levels of participation in posting of 
charge and price information. We also believe that different hospitals 
may face different constraints when estimating their burden and 
resources required. We believe that some hospitals will already have a 
framework or business processes in place that they can leverage that 
would minimize additional burden. However, there will be other 
hospitals that will have additional burden, above our projected 150 
hours we estimated, to meet the requirements of this rule. Therefore, 
we are providing alternative estimates on a range of hours in this 
impact analysis. We note that most commenters stated that a reasonable 
estimate for burden based for implementing existing requirements to 
disclose standard charges is within the range of 60-250 hours, 
therefore we are providing cost estimates ranging from 60 hours to 250 
hours.
    For a low estimate, we now estimate it would take a take a lawyer 2 
hours (at $138.68 per hour); a general operations manager 2 hours (at 
$119.12 per hour); business operations specialist 32 hours (at $74 per 
hour), a network and computer system administrator 12 hours (at $83.72 
per hour); a registered nurse 12 hours (at $72.60 per hour). Therefore, 
we are providing a low estimate of the total burden for the first year 
to be 60 hours (2 hours + 2 hours + 32 hours + 12 hours + 12 hours) per 
hospital with a cost of $4,759.44 per hospital. Table 7 provides the 
total cost.
    For a high estimate, we now estimate it would take a take a lawyer 
8 hours (at $138.68 per hour); a general operations manager 8 hours (at 
$119.12 per hour); business operations specialist 134 hours (at $74 per 
hour), a network and computer system administrator 50 hours (at $83.72 
per hour); a registered nurse 50 hours (at $72.60 per hour). Therefore, 
we are providing a high estimate of the total burden for the first year 
to be 250 hours (8 hours + 8 hours + 134 hours + 50 hours + 50 hours) 
per hospital with a cost of $19,794.40 per hospital. Table 7 provides 
the total cost.

                      Table 7--Cost Range Estimates
------------------------------------------------------------------------
  Hours per hospitals      Cost per hospital           Total cost
------------------------------------------------------------------------
              60                4,759.44                28,566,159
             250               19,794.40               118,805,989
------------------------------------------------------------------------

2. Effects on Consumers
    As discussed in the CY 2020 OPPS/ASC proposed rule (84 FR 39632 
through 39633), we considered the estimated effects on the consumers, 
and welcomed public comments on the impact of the proposed requirements 
on consumers. As indicated in this final rule, we believe the 
requirements from this final rule will make public data necessary for 
healthcare consumers to better understand how the level of price 
dispersion in various healthcare markets and its impacts on healthcare 
spending and consumer out-of-pocket costs. The information may also 
benefit other consumers of these data, for example, employers, third 
party tool developers, clinicians at the point of care, or economics 
research to drive value-based policy development. We noted in the CY 
2020 OPPS/ASC proposed rule that the negotiated charges for various 
procedures vary widely within and across geographic regions in the 
United States.\189\ Some factors associated with the level of hospital 
price dispersion in a geographic area are the hospital's size, 
healthcare demand, labor costs, and technology, although it was the 
hospital's market power (level of competition) that was most positively 
associated with high price dispersion.190 191 One major 
barrier to fully understanding healthcare price variation (and 
understanding the impact of transparency of healthcare pricing in 
general) is the lack of availability of negotiated charges to 
researchers and the public.\192\ We continue to believe that 
requirements from this final rule will make hospital charge information 
available, which will generate a better understanding of (1) hospital 
price dispersion, and (2) the relationship between hospital price 
dispersion and healthcare spending. Additionally, we believe 
understanding this relationship through the disclosure of pricing data 
could lead to downward price pressure and reductions in overall 
spending system-wide.
---------------------------------------------------------------------------

    \189\ Kennedy K, et al. Health Care Cost Institute. Past the 
Price Index: Exploring Actual Prices Paid for Specific Services by 
Metro Area. Healthy Marketplace Index. April 30, 2019. Available at: 
https://www.healthcostinstitute.org/blog/entry/hmi-2019-service-prices.
    \190\ Cooper Z, et al. The Price Ain't Right? Hospital Prices 
and Health Spending on the Privately Insured. The Quarterly Journal 
of Economics. December 2015. Available at: https://pdfs.semanticscholar.org/cb9c/f90786cc39ddac6d88f3ba1074a7c2d5f0a5.pdf.
    \191\ Bai G and Anderson GF. Market Power: Price Variation Among 
Commercial Insurers For Hospital Services. Health Affairs. Oct 2018; 
37(10): 1615-1622. Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.2018.0567.
    \192\ Ibid.

---------------------------------------------------------------------------

[[Page 65600]]

    Consumers may feel more satisfied with their care when they are 
empowered to make decisions about their treatment. A recent survey 
\193\ indicated a strong desire for price transparency and openness. 
Eighty-eight percent of the population polled, demanded improved 
transparency with their total financial responsibility, including co-
pays and deductibles. Other studies such suggest that improving a 
patient's financial experience served as the biggest area to improve 
overall customer satisfaction.\194\ Literature regarding consumer 
engagement with existing price transparency interventions demonstrates 
that disclosing price information positively impacts consumers by 
allowing them to compare prices for common procedures and shift their 
demand towards lower-priced options. One study examined consumer use of 
an employer-sponsored, private price transparency tool and its impact 
on claims payments for three common medical services: Laboratory tests; 
advanced imaging services; and clinician office visits.\195\ That study 
found that those who used the tool had lower claims payments by 
approximately 14 percent for laboratory tests; 13 percent for advanced 
imaging services; and approximately one percent for office visits 
compared to those who did not use the tool. Those using the tool mainly 
searched for information on shoppable services and also tended to have 
more limited insurance coverage.
---------------------------------------------------------------------------

    \193\ See Gruessner V. Consumer Satisfaction Dips When Payers 
Lack Price Transparency. Private Payers News (October 3, 2016). 
Available at: https://healthpayerintelligence.com/news/consumer-satisfaction-dips-when-payers-lack-price-transparency.
    \194\ See for example, Government Accountability Office. 
September 2011. Health Care Price Transparency: Meaningful Price 
Information Is Difficult for Consumers to Obtain Prior to Receiving 
Care. Available at: https://www.gao.gov/assets/590/585400.pdf. 
Experian Health, Improve the healthcare financial journey. Patient 
Engagement (June 21, 2018). Available at: https://www.experian.com/blogs/healthcare/2018/06/healthcare-financial-journey/.
    \195\ Whaley C, et al. ``Association Between Availability of 
Health Service Prices and Payments for These Services.'' JAMA. 2014; 
312(16):1670-1676. Available at https://jamanetwork.com/journals/jama/fullarticle/1917438.
---------------------------------------------------------------------------

    Price transparency initiatives have more impact when they are 
combined with other cost control tools like reference-based pricing. 
For example, for a plan with reference-based pricing, price 
transparency tools were associated with a reduction of 32 percent in 
lab test prices over three years.\196\
---------------------------------------------------------------------------

    \196\ Robinson JC, Whaley BA, Brown TT. Association of Reference 
Pricing for Diagnostic Laboratory Testing With Changes in Patient 
(2016) JAMA Int Med. 2016; 176(9); 1353-1359. Available at: https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2536187.
---------------------------------------------------------------------------

    Employers have also been encouraging consumers to share in the 
savings realized from engaging in comparative shopping. The state of 
Kentucky's public employee benefit program's price transparency shared 
savings initiative has saved state taxpayers $13 million dollars since 
its inception in 2015, and almost $2 million in cash benefits have been 
shared with the state's public employees.\197\ Another study of a group 
of 35 self-funded employers who deployed a shared savings program in 
2017 demonstrated an overall 2.1 percent cost reduction of the cost of 
medical care and total savings of $23 million a year, with 23 percent 
of the employees receiving shared savings rewards.\198\
---------------------------------------------------------------------------

    \197\ Rhoads J. Right to Shop for Public Employees: How Health 
Care Incentives are Saving Money in Kentucky. Foundation for 
Government Accountability. March 8, 2019. Available at: https://thefga.org/wp-content/uploads/2019/03/RTS-Kentucky-HealthCareIncentivesSavingMoney-DRAFT8.pdf.
    \198\ Whaley CM, et al. Paying Patients To Switch: Impact Of A 
Rewards Program On Choice Of Providers, Prices, And Utilization. 
Health Affairs. March 2019. Available at: https://www.healthaffairs.org/doi/10.1377/hlthaff.2018.05068.
---------------------------------------------------------------------------

    Finally, studies indicate that the existence of comparative price 
shopping information has the effect of reducing healthcare costs for 
everyone, regardless of whether they engage in shopping behavior. A 
national study of state price transparency efforts found an overall 
reduction of hospital pricing by 5 percent and a state of New Hampshire 
effort reduced consumer costs by 5 percent.199 200
---------------------------------------------------------------------------

    \199\ Christensen HB, et al. 2018. ``The Only Prescription Is 
Transparency: The Effect of Charge-Price-Transparency Regulation on 
Healthcare Prices.'' SSRN Scholarly Paper ID 2343367. Rochester, NY: 
Social Science Research Network. Available at: https://papers.ssrn.com/abstract=2343367.
    \200\ Brown ZY. Equilibrium Effects of Health Care Price 
Information. The Review of Economics and Statistics. Published 
October 2019; 101:4, 699-712. Available at: http://www-
personal.umich.edu/~zachb/zbrown_eqm_effects_price_transparency.pdf.
---------------------------------------------------------------------------

    Comment: Typically described in the context of commenters' concerns 
on specific proposals, and as described within section II of this final 
rule, commenters suggested a number of possible unanticipated 
consequences for consumers of the proposed requirements for hospitals 
to make public standard charges, including the following:
     The volume of data required for the display of standard 
charges under the rule would confuse consumers and potentially cause 
them to seek out the cheapest care, rather than the most effective or 
best quality care.
     The burden of understanding costs of care would shift from 
hospitals and/or payers to consumers.
     The information on standard charges would still not be 
sufficient to inform consumers of their plan-specific, out-of-pocket 
costs. The concerns included that the required information would be 
insufficient for consumers to rely on, as well as concerns that too 
much information is being required, will be overwhelming and 
potentially confusing to consumers.
    Response: We appreciate commenters' concerns, and we have addressed 
these concerns elsewhere in this final rule. We believe the 
requirements we are finalizing for hospitals to make public standard 
charges will provide information to consumers that helps inform their 
healthcare decision-making, and therefore ultimately benefit consumers. 
Informed decision-making, in turn, may have other positive effects; for 
example, as research suggests, informed healthcare consumers, that have 
a price estimate before getting care are more likely to pay their bills 
in a timely manner.201 202
---------------------------------------------------------------------------

    \201\ Kutscher, B. ``Report: Consumers demand price 
transparency, but at what cost?'' Modern Healthcare. June 2015. 
Available at: https://www.modernhealthcare.com/article/20150623/NEWS/150629957/consumers-demand-price-transparency-but-at-what-cost.
    \202\ HFMA Executive Roundtable: Reimagining Patient Access. 
December 2015. Available at: https://api.hfma.org/Content.aspx?id=43731.
---------------------------------------------------------------------------

    We do not believe that these concerns about unintended consequences 
on consumers affect our estimate of the impact of the requirements we 
are finalizing, and accordingly we decline to adjust our economic 
analyses based on these concerns alone.
3. Effects on Small Entities
    The RFA requires agencies to analyze options for regulatory relief 
of small entities, if a rule has a significant impact on a substantial 
number of small entities. More than half of 6,002 hospitals are small 
entities, either by nonprofit status or by having revenues of less than 
$41.5 million in any 1 year.\203\ We analyzed these hospitals and found 
that the estimated burden from this final rule never exceeded 1 percent 
of reported revenue for any hospital in this category, including the

[[Page 65601]]

hospital with the lowest revenue.\204\ For the over 3,000 hospitals 
that meet the standards for small entities defined by the SBA, we 
estimate the burden from this final rule to be, on average, 0.007 
percent of hospital total annual revenue. It is reasonable to assume 
that the inclusion or exclusion of hospitals with nonprofit status 
would not drive the percentages to go over the threshold because even 
the historically lowest revenue hospitals indicate the burden would not 
exceed at most about 1 percent of total hospital revenue in the most 
extreme case. As its measure of significant economic impact on a 
substantial number of small entities, HHS uses a change in revenue of 
more than 3 to 5 percent. We do not believe that this threshold will be 
reached by the requirements in this final rule. As a result, the 
Secretary has determined that this final rule will not have a 
significant impact on a substantial number of small entities.
---------------------------------------------------------------------------

    \203\ U. S. Small Business Administration, Table of Small 
Business Size Standards, Matched to North American Industry 
Classification System Codes (size standards effective August 19, 
2019). Available at: https://www.sba.gov/sites/default/files/2019-08/SBA%20Table%20of%20Size%20Standards_Effective%20Aug%2019%2C%202019_Rev.pdf.
    \204\ CMS Office of the Actuary analysis of 2016 Medicare Cost 
Report data.
---------------------------------------------------------------------------

4. Effects on Small Rural Hospitals
    Section 1102(b) of the SSA requires us to prepare an RIA if a rule 
may have a significant impact on the operations of a substantial number 
of small rural hospitals. This analysis must conform to the provisions 
of section 604 of the RFA. For purposes of section 1102(b) of the SSA, 
we define a small rural hospital as a hospital that is located outside 
of a metropolitan statistical area and has fewer than 100 beds. We 
identified almost 1,900 hospitals as having rural status and fewer than 
100 beds. We note that commenters submitted various concerns related to 
burden for smaller or less resourced hospitals. We have responded to 
these concerns throughout this final rule. As noted previously, we are 
aware that hospitals are in varying stages of readiness for 
implementation of this final rule. While smaller or rural hospitals may 
not have the staff or automation that larger hospital systems may have 
(which may increase burden relative to a better resourced hospital or 
hospital system), they are likely to have far fewer contracts with 
payers and provide fewer items and services overall, which would reduce 
rural hospital burden compared to larger hospitals in regions with many 
payers. For this reason it is difficult to determine a unique impact on 
small rural hospitals. For these small, rural hospitals, we estimate 
the burden from this final rule to be, on average, 0.037 percent of 
hospital total annual revenue.\205\ Therefore, we conclude that this 
final rule will not have a significant impact on the operations of a 
substantial number of small rural hospitals.
---------------------------------------------------------------------------

    \205\ Hospital Cost Report PUF is used for calculating these 
statistics. The latest PUF file publicly available is a 2014 dataset 
as of July 15, 2018, available at this link: https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Cost-Report/HospitalCostPUF.html.
---------------------------------------------------------------------------

5. Unfunded Mandates
    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also 
requires that agencies assess anticipated costs and benefits before 
issuing any rule whose mandates require spending in any 1 year of $100 
million in 1995 dollars, updated annually for inflation. In 2019, that 
threshold is approximately $154 million. This final rule contains no 
such unfunded mandates.
6. Federalism Analysis
    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a proposed rule (and subsequent 
final rule) that imposes substantial direct requirement costs on state 
and local governments, preempts state law, or otherwise has Federalism 
implications. Since this regulation does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable.

D. Alternatives Considered

    The final rule promulgates rules for hospital compliance with 
section 2718(e) of the PHS Act and aims to make price information more 
readily available to the public. As described in the CY 2020 OPPS/ASC 
proposed rule (84 FR 39633), we considered a number of alternative 
approaches to maximize the value and accessibility of these data to the 
public generally and directly to consumers. For example, proposals to 
require release of hospital standard charge data in an API format. We 
also considered other types of ``standard charges'' that could be 
useful to consumers. For example, in addition to or instead of the 
requirement to disclose gross charges and payer-specific charges, we 
sought comment on whether we should consider a definition of `standard 
charge' to be a volume-driven negotiated charge, the minimum/median/
maximum negotiated charge, or all allowed charges. Such charges could 
be relevant to specific groups of individuals, particularly those with 
health insurance coverage. We also sought comment on a definition of 
`standard charge' that might be relevant to subgroups of individuals 
who are self-pay, specifically, types of standard charges representing 
the discounted cash price for a service package, or the median cash 
price.
    We finalized the definition of standard charges to include gross 
charge (as discussed in section II.D.2 of this final rule), and payer-
specific negotiated charge (as discussed in section II.D.3), as 
proposed. We finalized modifications to include within the definition 
of standard charges the discounted cash price (as described in section 
II.D.4.c of this final rule), as well as the de-identified minimum 
negotiated charge, and de-identified maximum negotiated charge (as 
discussed in section II.D.4.d of this final rule). Of the other 
alternatives considered, we determined that allowed amounts of plans 
that are not negotiated are already publicly disclosed (as discussed in 
section II.D.4.b of this final rule), and that the median negotiated 
charge would have limited usefulness for consumers (as discussed in 
section II.D.4.d of this final rule). We also decided not to require 
standardization in the release of hospital standard charges, such as by 
requiring data be presented in an API format, noting that the 
requirements we are finalizing in this final rule, for hospitals to 
make public their standard charges, are a good initial step.
    As a result of comments, we considered an alternative in which CMS 
would specify all 300 shoppable services and specify the corresponding 
ancillary services. We estimate that this could reduce burden for 
hospitals by removing the clinical input necessary to develop such 
service groupings which would result in a first year burden of $9,721 
per hospital, or $58.3 million for all hospitals.
    Finally, we also considered an alternative approach that would 
require hospitals to make public a comprehensive machine-readable file 
of all standard charges for all hospital items and services, but not 
require hospitals to display charges for shoppable services in a 
consumer-friendly manner. We estimate that this could reduce burden for 
hospitals by removing the clinical input necessary and decrease the 
number of hours for the other professions which would result in a first 
year burden of $4,860 per hospital, or $29.2 million for all hospitals.

E. Accounting Statement and Table

    In accordance with OMB Circular A-4, Table 8 depicts an accounting 
statement summarizing the assessment of the benefits and costs 
associated with this regulatory action.

[[Page 65602]]



                                 Table 8--Accounting Statement Estimated Impacts
                                                 [CYs 2020-2022]
----------------------------------------------------------------------------------------------------------------
                                                                                       Units
                                                      Primary    -----------------------------------------------
                    Category                         estimate                     Discount  rate      Period
                                                     (million)     Year dollars         (%)           covered
----------------------------------------------------------------------------------------------------------------
                                                    Benefits
----------------------------------------------------------------------------------------------------------------
Qualitative.....................................    The rule is anticipated to have the potential to reduce the
                                                   range of prices charged by hospitals such that a net savings
                                                    would result for payers and consumers from a corresponding
                                                    reduction in income to hospitals. Price transparency would
                                                   help to create a healthcare information ecosystem that allows
                                                    and encourages the healthcare market to tailor products and
                                                   services to compete for patients, thereby increasing quality,
                                                     decreasing costs, and helping them live better, healthier
                                                                              lives.
----------------------------------------------------------------------------------------------------------------
                                                      Costs
----------------------------------------------------------------------------------------------------------------
Annualized monetized $ millions/year............           $39.4            2019               7       2020-2022
                                                            38.7            2019               3       2020-2022
----------------------------------------------------------------------------------------------------------------

F. Regulatory Reform Analysis Under E.O. 13771

    Executive Order 13771, titled Reducing Regulation and Controlling 
Regulatory Costs, was issued on January 30, 2017 and requires that the 
costs associated with significant new regulations ``shall, to the 
extent permitted by law, be offset by the elimination of existing costs 
associated with at least two prior regulations.'' This final rule is 
considered an Executive Order 13771 regulatory action. We estimate the 
rule generates $23.0 million in annualized costs in 2016 dollars, 
discounted at 7 percent relative to year 2016 over a perpetual time 
horizon. Details on the estimated costs of this rule can be found in 
the preceding and subsequent analyses.

G. Conclusion

    The analysis in this section, together with the remainder of this 
preamble, provides an RIA. In accordance with the provisions of 
Executive Order 12866, this regulation was reviewed by OMB.

List of Subjects in 45 CFR Part 180

    Definitions, Hospitals, Reporting and recordkeeping requirements.


0
For reasons stated in the preamble of this document, the Department of 
Health and Human Services amends 45 CFR subtitle A by adding subchapter 
E to read as follows:

Subchapter E--Price Transparency

PART 180--HOSPITAL PRICE TRANSPARENCY

PARTS 181-199 [RESERVED]

PART 180--HOSPITAL PRICE TRANSPARENCY

Sec.

Subpart A--General Provisions

180.10 Basis and scope.
180.20 Definitions.
180.30 Applicability.

Subpart B--Public Disclosure Requirements

180.40 General requirements.
180.50 Requirements for making public hospital standard charges for 
all items and services.
180.60 Requirements for displaying shoppable services in a consumer-
friendly manner.

Subpart C--Monitoring and Penalties for Noncompliance

180.70 Monitoring and enforcement.
180.80 Corrective action plans.
180.90 Civil monetary penalties.

Subpart D--Appeals of Civil Monetary Penalties

180.100 Appeal of penalty.
180.110 Failure to request a hearing.

    Authority: 42 U.S.C. 300gg-18, 42 U.S.C. 1302.

Subpart A--General Provisions


Sec.  180.10  Basis and scope.

    This part implements section 2718(e) of the Public Health Service 
(PHS) Act, which requires each hospital operating within the United 
States, for each year, to establish, update, and make public a list of 
the hospital's standard charges for items and services provided by the 
hospital, including for diagnosis-related groups (DRGs) established 
under section 1886(d)(4) of the Social Security Act. This part also 
implements section 2718(b)(3) of the PHS Act, to the extent that 
section authorizes CMS to promulgate regulations for enforcing section 
2718(e). This part also implements section 1102(a) of the Social 
Security Act, which authorizes the Secretary to make and publish rules 
and regulations, not inconsistent with that Act, as may be necessary to 
the efficient administration of the functions for which the Secretary 
is charged under that Act.


Sec.  180.20  Definitions.

    The following definitions apply to this part, unless specified 
otherwise:
    Ancillary service means an item or service a hospital customarily 
provides as part of or in conjunction with a shoppable primary service.
    Chargemaster (Charge Description Master or CDM) means the list of 
all individual items and services maintained by a hospital for which 
the hospital has established a charge.
    De-identified maximum negotiated charge means the highest charge 
that a hospital has negotiated with all third party payers for an item 
or service.
    De-identified minimum negotiated charge means the lowest charge 
that a hospital has negotiated with all third party payers for an item 
or service.
    Discounted cash price means the charge that applies to an 
individual who pays cash (or cash equivalent) for a hospital item or 
service.
    Gross charge means the charge for an individual item or service 
that is

[[Page 65603]]

reflected on a hospital's chargemaster, absent any discounts.
    Hospital means an institution in any State in which State or 
applicable local law provides for the licensing of hospitals, that is 
licensed as a hospital pursuant to such law or is approved, by the 
agency of such State or locality responsible for licensing hospitals, 
as meeting the standards established for such licensing. For purposes 
of this definition, a State includes each of the several States, the 
District of Columbia, Puerto Rico, the Virgin Islands, Guam, American 
Samoa, and the Northern Mariana Islands.
    Items and services means all items and services, including 
individual items and services and service packages, that could be 
provided by a hospital to a patient in connection with an inpatient 
admission or an outpatient department visit for which the hospital has 
established a standard charge. Examples include, but are not limited 
to, the following:
    (1) Supplies and procedures.
    (2) Room and board.
    (3) Use of the facility and other items (generally described as 
facility fees).
    (4) Services of employed physicians and non-physician practitioners 
(generally reflected as professional charges).
    (5) Any other items or services for which a hospital has 
established a standard charge.
    Machine-readable format means a digital representation of data or 
information in a file that can be imported or read into a computer 
system for further processing. Examples of machine-readable formats 
include, but are not limited to, .XML, .JSON and .CSV formats.
    Payer-specific negotiated charge means the charge that a hospital 
has negotiated with a third party payer for an item or service.
    Service package means an aggregation of individual items and 
services into a single service with a single charge.
    Shoppable service means a service that can be scheduled by a 
healthcare consumer in advance.
    Standard charge means the regular rate established by the hospital 
for an item or service provided to a specific group of paying patients. 
This includes all of the following as defined under this section:
    (1) Gross charge.
    (2) Payer-specific negotiated charge.
    (3) De-identified minimum negotiated charge.
    (4) De-identified maximum negotiated charge.
    (5) Discounted cash price.
    Third party payer means an entity that is, by statute, contract, or 
agreement, legally responsible for payment of a claim for a healthcare 
item or service.


Sec.  180.30  Applicability.

    (a) General applicability. Except as provided in paragraph (b) of 
this section, the requirements of this part apply to hospitals as 
defined at Sec.  180.20.
    (b) Exception. Federally owned or operated hospitals are deemed by 
CMS to be in compliance with the requirements of this part including 
but not limited to:
    (1) Federally owned hospital facilities, including facilities 
operated by the U.S. Department of Veterans Affairs and Military 
Treatment Facilities operated by the U.S. Department of Defense.
    (2) Hospitals operated by an Indian Health Program as defined in 
section 4(12) of the Indian Health Care Improvement Act.
    (c) Online availability. Unless otherwise stated, hospital charge 
information must be made public electronically via the internet.

Subpart B--Public Disclosure Requirements


Sec.  180.40  General requirements.

    A hospital must make public the following:
    (a) A machine-readable file containing a list of all standard 
charges for all items and services as provided in Sec.  180.50.
    (b) A consumer-friendly list of standard charges for a limited set 
of shoppable services as provided in Sec.  180.60.


Sec.  180.50  Requirements for making public hospital standard charges 
for all items and services.

    (a) General rules. (1) A hospital must establish, update, and make 
public a list of all standard charges for all items and services online 
in the form and manner specified in this section.
    (2) Each hospital location operating under a single hospital 
license (or approval) that has a different set of standard charges than 
the other location(s) operating under the same hospital license (or 
approval) must separately make public the standard charges applicable 
to that location.
    (b) Required data elements. A hospital must include all of the 
following corresponding data elements in its list of standard charges, 
as applicable:
    (1) Description of each item or service provided by the hospital.
    (2) Gross charge that applies to each individual item or service 
when provided in, as applicable, the hospital inpatient setting and 
outpatient department setting.
    (3) Payer-specific negotiated charge that applies to each item or 
service when provided in, as applicable, the hospital inpatient setting 
and outpatient department setting. Each payer-specific negotiated 
charge must be clearly associated with the name of the third party 
payer and plan.
    (4) De-identified minimum negotiated charge that applies to each 
item or service when provided in, as applicable, the hospital inpatient 
setting and outpatient department setting.
    (5) De-identified maximum negotiated charge that applies to each 
item or service when provided in, as applicable, the hospital inpatient 
setting and outpatient department setting.
    (6) Discounted cash price that applies to each item or service when 
provided in, as applicable, the hospital inpatient setting and 
outpatient department setting.
    (7) Any code used by the hospital for purposes of accounting or 
billing for the item or service, including, but not limited to, the 
Current Procedural Terminology (CPT) code, the Healthcare Common 
Procedure Coding System (HCPCS) code, the Diagnosis Related Group 
(DRG), the National Drug Code (NDC), or other common payer identifier.
    (c) Format. The information described in paragraph (b) of this 
section must be published in a single digital file that is in a 
machine-readable format.
    (d) Location and accessibility. (1) A hospital must select a 
publicly available website for purposes of making public the standard 
charge information required under paragraph (b) of this section.
    (2) The standard charge information must be displayed in a 
prominent manner and clearly identified with the hospital location with 
which the standard charge information is associated.
    (3) The hospital must ensure that the standard charge information 
is easily accessible, without barriers, including but not limited to 
ensuring the information is accessible:
    (i) Free of charge;
    (ii) Without having to establish a user account or password; and
    (iii) Without having to submit personal identifying information 
(PII).
    (4) The digital file and standard charge information contained in 
that file must be digitally searchable.
    (5) The file must use the following naming convention specified by 
CMS, specifically: __standardcharges.[json[verbar]xml[verbar]csv].
    (e) Frequency of updates. The hospital must update the standard 
charge information described in paragraph (b)

[[Page 65604]]

of this section at least once annually. The hospital must clearly 
indicate the date that the standard charge data was most recently 
updated, either within the file itself or otherwise clearly associated 
with the file.


Sec.  180.60   Requirements for displaying shoppable services in a 
consumer-friendly manner.

    (a) General rules. (1) A hospital must make public the standard 
charges identified in paragraphs (b)(3) through (6) of this section, 
for as many of the 70 CMS-specified shoppable services that are 
provided by the hospital, and as many additional hospital-selected 
shoppable services as is necessary for a combined total of at least 300 
shoppable services.
    (i) In selecting a shoppable service for purposes of this section, 
a hospital must consider the rate at which it provides and bills for 
that shoppable service.
    (ii) If a hospital does not provide 300 shoppable services, the 
hospital must make public the information specified in paragraph (b) of 
this section for as many shoppable services as it provides.
    (2) A hospital is deemed by CMS to meet the requirements of this 
section if the hospital maintains an internet-based price estimator 
tool which meets the following requirements.
    (i) Provides estimates for as many of the 70 CMS-specified 
shoppable services that are provided by the hospital, and as many 
additional hospital-selected shoppable services as is necessary for a 
combined total of at least 300 shoppable services.
    (ii) Allows healthcare consumers to, at the time they use the tool, 
obtain an estimate of the amount they will be obligated to pay the 
hospital for the shoppable service.
    (iii) Is prominently displayed on the hospital's website and 
accessible to the public without charge and without having to register 
or establish a user account or password.
    (b) Required data elements. A hospital must include, as applicable, 
all of the following corresponding data elements when displaying its 
standard charges (identified in paragraphs (b)(3) through (6) of this 
section) for its list of shoppable services selected under paragraph 
(a)(1) of this section:
    (1) A plain-language description of each shoppable service.
    (2) An indicator when one or more of the CMS-specified shoppable 
services are not offered by the hospital.
    (3) The payer-specific negotiated charge that applies to each 
shoppable service (and to each ancillary service, as applicable). Each 
list of payer-specific negotiated charges must be clearly associated 
with the name of the third party payer and plan.
    (4) The discounted cash price that applies to each shoppable 
service (and corresponding ancillary services, as applicable). If the 
hospital does not offer a discounted cash price for one or more 
shoppable services (or corresponding ancillary services), the hospital 
must list its undiscounted gross charge for the shoppable service (and 
corresponding ancillary services, as applicable).
    (5) The de-identified minimum negotiated charge that applies to 
each shoppable service (and to each corresponding ancillary service, as 
applicable).
    (6) The de-identified maximum negotiated charge that applies to 
each shoppable service (and to each corresponding ancillary service, as 
applicable).
    (7) The location at which the shoppable service is provided, 
including whether the standard charges identified in paragraphs (b)(3) 
through (6) of this section for the shoppable service apply at that 
location to the provision of that shoppable service in the inpatient 
setting, the outpatient department setting, or both.
    (8) Any primary code used by the hospital for purposes of 
accounting or billing for the shoppable service, including, as 
applicable, the Current Procedural Terminology (CPT) code, the 
Healthcare Common Procedure Coding System (HCPCS) code, the Diagnosis 
Related Group (DRG), or other common service billing code.
    (c) Format. A hospital has discretion to choose a format for making 
public the information described in paragraph (b) of this section 
online.
    (d) Location and accessibility of online data. (1) A hospital must 
select an appropriate publicly available internet location for purposes 
of making public the information described in paragraph (b) of this 
section.
    (2) The information must be displayed in a prominent manner that 
identifies the hospital location with which the information is 
associated.
    (3) The shoppable services information must be easily accessible, 
without barriers, including but not limited to ensuring the information 
is:
    (i) Free of charge.
    (ii) Accessible without having to register or establish a user 
account or password.
    (iii) Accessible without having to submit personal identifying 
information (PII).
    (iv) Searchable by service description, billing code, and payer.
    (e) Frequency. The hospital must update the standard charge 
information described in paragraph (b) of this section at least once 
annually. The hospital must clearly indicate the date that the 
information was most recently updated.

Subpart C--Monitoring and Penalties for Noncompliance


Sec.  180.70   Monitoring and enforcement.

    (a) Monitoring. (1) CMS evaluates whether a hospital has complied 
with the requirements under Sec. Sec.  180.40, 180.50, and 180.60.
    (2) CMS may use methods to monitor and assess hospital compliance 
with the requirements under this part, including, but not limited to, 
the following, as appropriate:
    (i) CMS' evaluation of complaints made by individuals or entities 
to CMS.
    (ii) CMS review of individuals' or entities' analysis of 
noncompliance.
    (iii) CMS audit of hospitals' websites.
    (b) Actions to address hospital noncompliance. If CMS concludes 
that the hospital is noncompliant with one or more of the requirements 
of Sec.  180.40, Sec.  180.50, or Sec.  180.60, CMS may take any of the 
following actions, which generally, but not necessarily, will occur in 
the following order:
    (1) Provide a written warning notice to the hospital of the 
specific violation(s).
    (2) Request a corrective action plan from the hospital if its 
noncompliance constitutes a material violation of one or more 
requirements, according to Sec.  180.80.
    (3) Impose a civil monetary penalty on the hospital and publicize 
the penalty on a CMS website according to Sec.  180.90 if the hospital 
fails to respond to CMS' request to submit a corrective action plan or 
comply with the requirements of a corrective action plan.


Sec.  180.80   Corrective action plans.

    (a) Material violations requiring a corrective action plan. CMS 
determines if a hospital's noncompliance with the requirements of this 
part constitutes material violation(s) requiring a corrective action 
plan. A material violation may include, but is not limited to, the 
following:
    (1) A hospital's failure to make public its standard charges 
required by Sec.  180.40.
    (2) A hospital's failure to make public its standard charges in the 
form and manner required under Sec. Sec.  180.50 and 180.60.
    (b) Notice of violation. CMS may request that a hospital submit a 
corrective action plan, specified in a notice of violation issued by 
CMS to a hospital.

[[Page 65605]]

    (c) Compliance with corrective action plan requests and corrective 
actions. (1) A hospital required to submit a corrective action plan 
must do so, in the form and manner, and by the deadline, specified in 
the notice of violation issued by CMS to the hospital and must comply 
with the requirements of the corrective action plan.
    (2) A hospital's corrective action plan must specify elements 
including, but not limited to:
    (i) The corrective actions or processes the hospital will take to 
address the deficiency or deficiencies identified by CMS.
    (ii) The timeframe by which the hospital will complete the 
corrective action.
    (3) A corrective action plan is subject to CMS review and approval.
    (4) After CMS' review and approval of a hospital's corrective 
action plan, CMS may monitor and evaluate the hospital's compliance 
with the corrective actions.
    (d) Noncompliance with corrective action plan requests and 
requirements. (1) A hospital's failure to respond to CMS' request to 
submit a corrective action plan includes failure to submit a corrective 
action plan in the form, manner, or by the deadline, specified in a 
notice of violation issued by CMS to the hospital.
    (2) A hospital's failure to comply with the requirements of a 
corrective action plan includes failure to correct violation(s) within 
the specified timeframes.


Sec.  180.90   Civil monetary penalties.

    (a) Basis for imposing civil monetary penalties. CMS may impose a 
civil monetary penalty on a hospital identified as noncompliant 
according to Sec.  180.70, and that fails to respond to CMS' request to 
submit a corrective action plan or comply with the requirements of a 
corrective action plan as described in Sec.  180.80(d).
    (b) Notice of imposition of a civil monetary penalty. (1) If CMS 
imposes a penalty in accordance with this part, CMS provides a written 
notice of imposition of a civil monetary penalty to the hospital via 
certified mail or another form of traceable carrier.
    (2) This notice to the hospital may include, but is not limited to, 
the following:
    (i) The basis for the hospital's noncompliance, including, but not 
limited to, the following:
    (A) CMS' determination as to which requirement(s) the hospital has 
violated.
    (B) The hospital's failure to respond to CMS' request to submit a 
corrective action plan or comply with the requirements of a corrective 
action plan, as described in Sec.  180.80(d).
    (ii) CMS' determination as to the effective date for the 
violation(s). This date is the latest date of the following:
    (A) The first day the hospital is required to meet the requirements 
of this part.
    (B) If a hospital previously met the requirements of this part but 
did not update the information annually as required, the date 12 months 
after the date of the last annual update specified in information 
posted by the hospital.
    (C) A date determined by CMS, such as one resulting from monitoring 
activities specified in Sec.  180.70, or development of a corrective 
action plan as specified in Sec.  180.80.
    (iii) The amount of the penalty as of the date of the notice.
    (iv) A statement that a civil monetary penalty may continue to be 
imposed for continuing violation(s).
    (v) Payment instructions.
    (vi) Intent to publicize the hospital's noncompliance and CMS' 
determination to impose a civil monetary penalty on the hospital for 
noncompliance with the requirements of this part by posting the notice 
of imposition of a civil monetary penalty on a CMS website.
    (vii) A statement of the hospital's right to a hearing according to 
subpart D of this part.
    (viii) A statement that the hospital's failure to request a hearing 
within 30 calendar days of the issuance of the notice permits the 
imposition of the penalty, and any subsequent penalties pursuant to 
continuing violations, without right of appeal in accordance with Sec.  
180.110.
    (3) If the civil monetary penalty is upheld, in part, by a final 
and binding decision according to subpart D of this part, CMS will 
issue a modified notice of imposition of a civil monetary penalty, to 
conform to the adjudicated finding.
    (c) Amount of the civil monetary penalty. (1) CMS may impose a 
civil monetary penalty upon a hospital for a violation of each 
requirement of this part.
    (2) The maximum daily dollar amount for a civil monetary penalty to 
which a hospital may be subject is $300. Even if the hospital is in 
violation of multiple discrete requirements of this part, the maximum 
total sum that a single hospital may be assessed per day is $300.
    (3) The amount of the civil monetary penalty will be adjusted 
annually using the multiplier determined by OMB for annually adjusting 
civil monetary penalty amounts under part 102 of this title.
    (d) Timing of payment of civil monetary penalty. (1) A hospital 
must pay the civil monetary penalty in full within 60 calendar days 
after the date of the notice of imposition of a civil monetary penalty 
from CMS under paragraph (b) of this section.
    (2) In the event a hospital requests a hearing, pursuant to subpart 
D of this part, the hospital must pay the amount in full within 60 
calendar days after the date of a final and binding decision, according 
to subpart D of this part, to uphold, in whole or in part, the civil 
monetary penalty.
    (3) If the 60th calendar day described in paragraphs (d)(1) and (2) 
of this section is a weekend or a Federal holiday, then the timeframe 
is extended until the end of the next business day.
    (e) Posting of notice. (1) CMS will post the notice of imposition 
of a civil monetary penalty described in paragraphs (b) and (f) of this 
section on a CMS website.
    (2) In the event that a hospital elects to request a hearing, 
pursuant to subpart D of this part:
    (i) CMS will indicate in its posting, under paragraph (e)(1) of 
this section, that the civil monetary penalty is under review.
    (ii) If the civil monetary penalty is upheld, in whole, by a final 
and binding decision according to subpart D of this part, CMS will 
maintain the posting of the notice of imposition of a civil monetary 
penalty on a CMS website.
    (iii) If the civil monetary penalty is upheld, in part, by a final 
and binding decision according to subpart D of this part, CMS will 
issue a modified notice of imposition of a civil monetary penalty 
according to paragraph (b)(3) of this section, to conform to the 
adjudicated finding. CMS will make this modified notice public on a CMS 
website.
    (iv) If the civil monetary penalty is overturned in full by a final 
and binding decision according to subpart D of this part, CMS will 
remove the notice of imposition of a civil monetary penalty from a CMS 
website.
    (f) Continuing violations. CMS may issue subsequent notice(s) of 
imposition of a civil monetary penalty, according to paragraph (b) of 
this section, that result from the same instance(s) of noncompliance.

Subpart D--Appeals of Civil Monetary Penalties


Sec.  180.100   Appeal of penalty.

    (a) A hospital upon which CMS has imposed a penalty under this part 
may appeal that penalty in accordance with subpart D of part 150 of 
this title, except as specified in paragraph (b) of this section.

[[Page 65606]]

    (b) For purposes of applying subpart D of part 150 of this title to 
appeals of civil monetary penalties under this part:
    (1) Civil money penalty means a civil monetary penalty according to 
Sec.  180.90.
    (2) Respondent means a hospital that received a notice of 
imposition of a civil monetary penalty according to Sec.  180.90(b).
    (3) References to a notice of assessment or proposed assessment, or 
notice of proposed determination of civil monetary penalties, are 
considered to be references to the notice of imposition of a civil 
monetary penalty specified in Sec.  180.90(b).
    (4) Under Sec.  150.417(b) of this title, in deciding whether the 
amount of a civil money penalty is reasonable, the ALJ may only 
consider evidence of record relating to the following:
    (i) The hospital's posting(s) of its standard charges, if 
available.
    (ii) Material the hospital timely previously submitted to CMS 
(including with respect to corrective actions and corrective action 
plans).
    (iii) Material CMS used to monitor and assess the hospital's 
compliance according to Sec.  180.70(a)(2).
    (5) The ALJ's consideration of evidence of acts other than those at 
issue in the instant case under Sec.  150.445(g) of this title does not 
apply.


Sec.  180.110   Failure to request a hearing.

    (a) If a hospital does not request a hearing within 30 calendar 
days of the issuance of the notice of imposition of a civil monetary 
penalty described in Sec.  180.90(b), CMS may impose the civil monetary 
penalty indicated in such notice and may impose additional penalties 
pursuant to continuing violations according to Sec.  180.90(f) without 
right of appeal in accordance with this part.
    (1) If the 30th calendar day described in this paragraph (a) is a 
weekend or a Federal holiday, then the timeframe is extended until the 
end of the next business day.
    (2) [Reserved]
    (b) The hospital has no right to appeal a penalty with respect to 
which it has not requested a hearing in accordance with Sec.  150.405 
of this title, unless the hospital can show good cause, as determined 
at Sec.  150.405(b) of this title, for failing to timely exercise its 
right to a hearing.

PARTS 181-199--[RESERVED]

    Dated: November 5, 2019.
Seema Verma,
Administrator, Centers for Medicare & Medicaid Services.
    Dated: November 7, 2019.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2019-24931 Filed 11-15-19; 4:15 pm]
BILLING CODE 4120-01-P