[Federal Register Volume 81, Number 95 (Tuesday, May 17, 2016)]
[Rules and Regulations]
[Pages 30487-30494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-11270]



[[Page 30487]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 411

[CMS-6054-F]
RIN 0938-AR90


Medicare Program; Obtaining Final Medicare Secondary Payer 
Conditional Payment Amounts via Web Portal

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

ACTION: Final rule.

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SUMMARY: This final rule specifies the process and timeline for 
expanding CMS' existing Medicare Secondary Payer (MSP) Web portal to 
conform to section 201 of the Medicare IVIG and Strengthening Medicare 
and Repaying Taxpayers Act of 2012 (the SMART Act). The final rule 
specifies a timeline for developing a multifactor authentication 
solution to securely permit authorized users other than the beneficiary 
to access CMS' MSP conditional payment amounts and claims detail 
information via the MSP Web portal. It also requires that we add 
functionality to the existing MSP Web portal that permits users to: 
Notify us that the specified case is approaching settlement; obtain 
time and date stamped final conditional payment summary statements and 
amounts before reaching settlement; and ensure that relatedness 
disputes and any other discrepancies are addressed within 11 business 
days of receipt of dispute documentation.

DATES: These regulations are effective June 16, 2016.

FOR FURTHER INFORMATION CONTACT:  Suzanne Mattes, (410) 786-2536.

SUPPLEMENTARY INFORMATION:

I. Background

    The Medicare IVIG and Strengthening Medicare and Repaying Taxpayers 
Act of 2012 (the SMART Act) was enacted on January 10, 2013. Section 
201 of the SMART Act amends section 1862(b)(2)(B) of the Social 
Security Act (the Act) and requires the establishment of an internet 
Web site (referred to as the ``Web portal'') through which 
beneficiaries, their attorneys or other representatives, and authorized 
applicable plans (as defined in section 1862(b)(8)(F) of the Act (42 
U.S.C. 1395y(b)(8)(F)) who have pending liability insurance (including 
self-insurance), no-fault insurance, or workers' compensation 
settlements, judgments, awards, or other payments, may access related 
CMS' MSP conditional payment amounts and claims detail information.
    The existing MSP Web portal currently permits authorized users 
(including beneficiaries, attorneys, or other representatives) and 
applicable plans to register through the Web portal in order to access 
MSP conditional payment amounts electronically and update certain case-
specific information online.
    Beneficiaries are able to log into the existing Web portal by 
logging into their MyMedicare.gov accounts. The Web portal provides 
detailed data on claims that Medicare paid conditionally that are 
related to the beneficiary's liability insurance (including self-
insurance), no-fault insurance, or workers' compensation settlement, 
judgment, award, or other payment (hereinafter, for ease of reference, 
referred to as ``settlement(s)''). This detailed claims data for each 
claim includes dates of service, provider information, total charges, 
conditional payment amounts, and diagnosis codes.
    Beneficiaries' attorneys or other representatives, as well as 
applicable plans, may register through the Web portal to access 
conditional payment information. In order to comply with federal 
privacy and security requirements, including the Federal Information 
Security Management Act (FISMA), we have implemented a multifactor 
authentication tool that will permit authorized individuals, other than 
the beneficiary, to securely access detailed conditional payment 
information through the Web portal.
    Once the beneficiary's attorney or other representative is 
designated as an authorized user, he or she may log into the Web portal 
to view the conditional payment amount and perform certain actions, 
which include addressing discrepancies by disputing claims and 
uploading settlement information. It is important to note that, in 
situations where there is a pending insurance or workers' compensation 
settlement, the beneficiary is designated as the ``identified debtor''. 
This means that only the beneficiary and his or her attorney or other 
representative have the authority to take action on the beneficiary's 
MSP recovery case. This includes disputing claims and requesting a 
final conditional payment amount through the Web portal. An applicable 
plan is only able to take these actions if it submits proper proof of 
representation. The applicable plan cannot take action on a 
beneficiary's case unless it has obtained proof of representation that 
authorizes it to act on behalf of the beneficiary.
    In keeping with the requirements of the SMART Act, we have added 
functionality to the existing Web portal that permits users to notify 
us when the specified case is approaching settlement, download or 
otherwise obtain time and date stamped final conditional payment 
summary statements and amounts before reaching settlement, and ensure 
that relatedness disputes and any other discrepancies are addressed 
within 11 business days of receipt of dispute documentation.

II. Provisions of the Interim Final Rule With Comment and Analysis of 
and Response to Public Comments

A. Introduction

    In the September 20, 2013 Federal Register (78 FR 57800), we 
published an interim final rule with comment period (IFC) that 
specified a timeline for developing a multifactor authentication 
solution to securely permit authorized users other than the beneficiary 
to access CMS' MSP conditional payment amounts and claims detail 
information via the MSP Web portal. It also required that we add 
functionality to the existing MSP Web portal that permits users to: 
Notify us that the specified case is approaching settlement; obtain 
time and date stamped final conditional payment summary statements and 
amounts before reaching settlement; and ensure that relatedness 
disputes and any other discrepancies are addressed within 11 business 
days of receipt of dispute documentation. We received 21 timely public 
comments. In this final rule, we provide a general overview of the 
public comments received by subject area, with a focus on the most 
common issues and suggestions raised.

B. Definitions

    In the September 2013 IFC (78 FR 57804), we defined ``Applicable 
plan'' as the following laws, plans, or other arrangements, including 
the fiduciary or administrator for such law, plan or arrangement:
     Liability insurance (including self-insurance).
     No fault insurance.
     Workers' compensation laws or plans.
    We also defined ``Medicare Secondary Payer conditional payment 
information'' as a term that means all of the following:
     Dates of service.
     Provider names.
     Diagnosis codes.
     Conditional payment amounts.
     Claims detail information.

[[Page 30488]]

    Comment: Many commenters requested that we define certain terms in 
the regulation.
    Response: We note we have defined ``applicable plan'' in Sec.  
411.39(a) of the regulation text.
    We note that we are removing the definition of ``Medicare Secondary 
Payer conditional payment information'' to avoid redundancy and 
confusion. The language of the rule, itself, specifies which pieces of 
conditional payment information will be available via Web portal, based 
upon the level of authorization the user has when he or she accesses 
the Web portal.

C. Accessing Conditional Payment Information Through the Medicare 
Secondary Payer Web Portal

    In the September 2013 IFC (78 FR 57801), we noted that we will 
continue to provide beneficiaries with access to details on claims 
related to their pending settlements through the Web portal. This will 
include dates of service, provider names, diagnosis codes, and 
conditional payment amounts. Beneficiaries and their attorneys or other 
representatives will continue to be able to dispute the relatedness of 
claims and submit a notice of settlement and other types of 
documentation through the Web portal. We have added functionality that 
will permit beneficiaries to download or otherwise electronically 
obtain time and date stamped payment summary statements, and exchange 
other information securely with Medicare's contractor via the Web 
portal.
    A beneficiary's attorney or other representative and the applicable 
plan will continue to be able to register to use the Web portal and 
access conditional payment amounts. To access more detailed information 
related to a beneficiary's pending settlement, users will register to 
use a multifactor authentication process, as defined in and required by 
the most recent version of the CMS Enterprise Information Security 
Group Risk Management Handbook, Volume III, Standard 3.1, CMS 
Authentication Standards, developed in accordance with FISMA and 
regulations promulgated by the National Institute of Standards and 
Technology (NIST). The most recent version of CMS' Risk Management 
Handbook can be found at http://www.cms.gov/Research-Statistics-Data-and-Systems/CMS-Information-Technology/InformationSecurity/Downloads/RMH_VIII_3-1_Authentication.pdf.
    With this tool, a beneficiary's authorized attorney or other 
representatives or an authorized applicable plan that has appropriately 
registered to access the Web portal, and has registered to use the 
multifactor authentication tool, has access to more detailed MSP 
conditional payment information for a specified MSP recovery case. This 
additional information includes dates of services, provider names, 
diagnosis codes, as well as the conditional payment amounts already 
available through the Web portal. If an authorized user does not 
register to use the multifactor authentication tool, he or she will 
continue to have access to the conditional payment amounts and he or 
she will continue to be able to perform certain functions, but details, 
including dates of service, provider names, diagnosis codes, will not 
be visible to that user.
    Comment: Many commenters stated that beneficiaries should not be 
required to set up separate accounts to access the Web portal because 
they can already access the information on the Web portal through their 
MyMedicare.gov accounts.
    Response: The provisions of the September 2013 IFC do not require 
that beneficiaries set up separate accounts. Beneficiaries who access 
the existing Web portal are instructed to login to their MyMedicare.gov 
accounts. Beneficiaries will continue to access information on the Web 
portal through their MyMedicare.gov accounts.
    Comment: Many commenters stated that ``pre-registration'' to use 
the Web portal negates its utility and pre-registration should not be 
required.
    Response: To clarify, registration is already required when 
accessing the existing Web portal for the first time. Once an 
authorized user has access to the portal, the user may, at any time, 
elect to register to use the multifactor authentication tool to access 
more detailed information. We note that authorized users will be able 
to view information on the Web portal, regardless of whether the 
beneficiary has accessed the portal or logged in through 
MyMedicare.gov.
    Comment: Many commenters stated that multifactor authentication is 
not needed because CMS already provides this information by mail and it 
will delay development of the Web portal solution.
    Response: We require written proof of representation or consent to 
release (depending on the nature of the relationship between the 
beneficiary and the individual or entity requesting the beneficiary's 
information) before we provide privacy protected information, by mail 
or by phone, to authorized representatives or other authorized 
individuals or entities. To provide information that is categorized as 
personally identifiable information via the internet, all government 
agencies, including CMS, are bound by statutory requirements imposed by 
the Federal Information Security Management Act (FISMA), as well as 
security regulations promulgated by the National Institute of Standards 
and Technology. For more information on security requirements, see 
section II.D. of this final rule.

D. Obtaining a Final Conditional Payment Amount

    In the September 2013 IFC (78 FR 57801), we noted that once the 
beneficiary, his or her attorney or other representative, or an 
applicable plan provides notice of pending liability insurance 
(including self-insurance), no-fault insurance, and workers' 
compensation settlements, judgments, awards, or other payments to the 
appropriate Medicare contractor, the Medicare contractor will compile 
and post claims that are related to the pending settlement for which 
Medicare has paid conditionally. Once a recovery case is established 
and posted on the Web portal, the beneficiary, or his or her attorney, 
other representative, or authorized applicable plan may access the 
recovery case through the Web portal, and notify CMS once--and only 
once--that a settlement is expected to occur in 120 days or less. 
Conditional payment information will be posted to the Web portal within 
65 days or less of receipt of the notice of the pending settlement.
    Section 1862(b)(2)(B)(vii)(V) of the Act permits us to extend our 
response timeframe by an additional 30 days if we determine that 
additional time is required to address related claims that Medicare has 
paid conditionally. We anticipate that such situations would include, 
but are not limited to, the following:
     A recovery case that requires CMS' contractor to review 
the systematic filtering of associated claims for a case and 
subsequently adjust those filters manually to ensure that claims are 
related to the pending settlement.
     CMS' systems failures that do not otherwise fall within 
the definition of exceptional circumstances.
    Section 1862(b)(2)(B)(vii)(V) of the Act also permits us to further 
extend our claims compilation response timeframe by the number of days 
required to address the issue(s) that result from ``exceptional 
circumstances'' pertaining to a failure in the claims and payment 
posting system. Per the statute, such situations must be defined in 
regulations in a manner such that ``not

[[Page 30489]]

more than 1 percent of the repayment obligations . . . would qualify as 
exceptional circumstances.'' Therefore, we are adding new regulations 
at 42 CFR 411.39 that define exceptional circumstances to include, but 
not be limited to: System failure(s) due to consequences of extreme 
adverse weather (loss of power, flooding, etc.); security breaches of 
facilities or network(s); terror threats; strikes and similar labor 
actions; civil unrest, uprising or riot; destruction of business 
property (as by fire, etc.); sabotage; workplace attack on personnel; 
and similar circumstances beyond the ordinary control of government or 
private sector officers or management.
    If the beneficiary, or his or her authorized attorney or other 
representative, believes that claims included in the most up-to-date 
conditional payment summary statement are unrelated to the pending 
liability insurance (including self-insurance), no-fault insurance, or 
workers' compensation settlement, he or she may address discrepancies 
through the dispute process available through the Web portal. The 
beneficiary, or his or her authorized attorney or other representative, 
may dispute the relatedness of an individual conditional payment once 
and only once. The beneficiary or his or her authorized attorney or 
other representative may be required to submit additional supporting 
documentation in a form and manner specified by the Secretary to 
support the assertion that the disputed conditional payment is 
unrelated to the settlement. If the Medicare contractor does not accept 
a dispute for a particular conditional payment, that conditional 
payment will remain part of the total conditional payment amount and 
may not be disputed through this process again.
    Once CMS has been notified that a pending settlement is 120 days or 
less from settlement, disputes submitted through the Web portal will be 
resolved within 11 business days of receipt of the dispute, including 
any required supporting documentation, as per section 
1862(b)(2)(B)(vii)(IV) of the Act.
    After disputes have been fully resolved, the beneficiary, or his or 
her attorney or other representative, may download or otherwise request 
a time and date stamped final conditional payment summary statement 
through the Web portal. This statement will constitute the final 
conditional payment amount if settlement is reached within 3 days of 
the date on the conditional payment summary statement. If the 
beneficiary or his or her attorney is approaching settlement and any 
disputes have not been fully resolved, he or she may not download or 
otherwise request a final conditional payment summary statement until 
the dispute has been resolved.
    It is important to note that, per section 1862(b)(2)(B)(vii)(IV) of 
the Act, this dispute process is not an appeals process, nor does it 
establish a right of appeal regarding that dispute. There will be no 
administrative or judicial review related to this dispute process. 
However, the beneficiary will maintain his or her appeal rights 
regarding CMS' MSP recovery determination, once CMS issues its final 
demand. Those appeal rights are explained in the final demand letter 
issued by CMS, and more information may be found in 42 CFR 405, subpart 
I.
    The beneficiary or his or her attorney or other representative may 
obtain the recovery demand letter by submitting settlement information 
specified by the Secretary through the Web portal in 30 days or less 
from date of settlement. The amount and type of settlement information 
required will be the same information that CMS typically collects to 
calculate its recovery demand amount. This information will include, 
but is not limited to: The date of settlement, the total settlement 
amount, the attorney fee amount or percentage, and additional costs 
borne by the beneficiary to obtain his or her settlement. This 
information must be provided within 30 days or less of the date of 
settlement. Otherwise, the final conditional payment amount obtained 
through the Web portal will expire and any additional conditional 
payments with dates of service through and including the date of 
settlement will be included in the recovery demand letter. Once 
settlement information is received, we will apply a pro rata reduction 
to the final conditional payment amount in accordance with 42 CFR 
411.37 and issue a MSP recovery demand letter. We expect to incorporate 
a method into the Web portal that will allow settlement information to 
be entered directly through the Web portal and/or uploaded directly 
through the Web portal.
    If the underlying liability insurance (including self-insurance), 
no-fault insurance, or workers' compensation claim derives from alleged 
exposure to a toxic substance or environmental hazard, ingestion of 
pharmaceutical drug or other product or substance, or implantation of a 
medical device, joint replacement or something similar, the beneficiary 
or his or her attorney or other representative must provide notice to 
the CMS contractor via the Web portal before beginning the process to 
obtain a final conditional payment summary statement and amount through 
the Web portal. Many of these types of recovery cases require 
additional manual filtering and review to ensure that the claims 
included in the payment summary statement are related to the pending 
settlement.
    An applicable plan may only obtain a final conditional payment 
amount related to a pending liability insurance (including self-
insurance), no-fault insurance, or workers' compensation settlement, in 
the form and manner described in 42 CFR 411.39(c), if the applicable 
plan has properly registered to use the Web portal and has obtained 
from the beneficiary, and submitted to the appropriate Medicare 
contractor, proper proof of representation. The applicable plan may 
obtain read only access if the applicable plan obtains from the 
beneficiary proper consent to release and submits it to the appropriate 
Medicare contractor.
    The final conditional payment amount obtained via the Web portal 
represents Medicare covered and otherwise reimbursable items and 
services that are related to the beneficiary's settlement and that are 
furnished prior to the time and date stamped on the final conditional 
payment summary statement. Systems and process changes to provide final 
conditional payment summary statements and amounts via the Web portal 
were implemented on January 1, 2016.
BILLING CODE 4120-01-P

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[GRAPHIC] [TIFF OMITTED] TR17MY16.336

BILLING CODE 4120-01-C

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    Comment: Many commenters requested clarity on what it means to 
dispute a claim ``once and only once.''
    Response: We have clarified the language in the final rule to 
reflect that a claim, meaning an individual conditional payment amount, 
or line item, on a payment summary statement, may be disputed once and 
only once. An individual or entity may submit disputes more than once, 
but never for the same conditional payment or line item.
    Comment: Many commenters requested clarity on what it means to 
provide initial notice and why notice about the impending settlement 
must be supplied separately.
    Response: In order for us to establish an MSP recovery case and 
initiate claims compilation in our system, we must know that there is a 
pending insurance or workers' compensation claim. This means that a 
beneficiary, his or her attorney or other representative, or the 
insurer or workers' compensation entity must call or write to us. This 
type of notice does not necessarily mean that the reported insurance or 
workers' compensation claim is 120 days (or less) from settlement. If 
the insurance or workers' compensation claim is, in fact, 120 days or 
less from settlement, that notice may be provided through the Web 
portal, once a recovery case has been posted on the Web portal.
    Comment: Many commenters requested clarification regarding whether 
Medicare continues to make conditional payments after the initial 
claims compilation is complete, how the claims refresh interacts with 
the dispute process, and whether the concept of the claims refresh is 
consistent with what the SMART Act requires.
    Response: Medicare pays conditionally up through and including the 
date of settlement. In this final rule, we have removed the claims 
refresh requirement.
    Comment: Many commenters requested that we remove the limitation 
that an anticipated settlement may be reported to CMS once and only 
once, via the Web portal, after we have completed the initial claims 
compilation.
    Response: We recognize that it can often be difficult to project 
exactly when a settlement will occur. However, the SMART Act imposed 
workload timeframes on CMS related to the processing of cases that 
expect to settle within 120 days. Where we fail to comply with such 
timeframes, the SMART Act requires us to relinquish certain rights 
related to recovery. As a result, we have developed the ''once and only 
once'' requirement to encourage conscious decision-making by identified 
debtors and to promote our ability to provide timely and responsive 
service.
    Comment: Many commenters requested clarification regarding the 
timeframe in which settlement information must be provided and 
specifically requested that CMS utilize a 90-day timeframe, rather than 
a 30-day timeframe. A few commenters requested that the 30-day 
timeframe remain optional because this timeframe is not in the SMART 
Act. They further asserted that there is no need for such a timeframe 
because many beneficiaries do not have attorneys, thereby negating the 
need to apply a pro rata reduction.
    Response: In this final rule, we clarify that settlement 
information must be submitted within no more than 30 days of reaching 
settlement in order for CMS to remain bound by any final conditional 
payment amount it provided through the Web portal.
    We recognize that the intent of the final conditional payment 
process is to expedite Medicare reimbursement and promote timely 
settlement. However, we are required to apply a pro rata reduction, in 
accordance with to 42 CFR 411.37, to account for attorney fees and 
costs borne by the beneficiary to obtain his or her settlement. In 
order to comply with this regulatory requirement and comport with the 
aforementioned intent of the final conditional payment process, we have 
imposed a requirement that settlement information must be submitted 
within no more than 30 days of reaching settlement.
    Comment: Many commenters expressed concern that being required to 
reach a settlement within 3 days of obtaining a final conditional 
payment amount is not a reasonable timeframe.
    Response: The SMART Act specifically established this 3-day 
timeframe. As a result, we maintain this requirement in this final 
rule. If settlement is not reached within 3 days of obtaining the final 
conditional payment amount, we are not bound by the final conditional 
payment amount. This means that, once settlement information is 
submitted, we will review any conditional payments it made for dates of 
service up through and including the date of settlement and issue our 
demand letter.
    Comment: Many commenters raised concerns regarding the IFC's 
reference to future medical obligations.
    Response: We recognize that the SMART Act did not specifically 
reference future medical care, but medical care related to the 
insurance or workers' compensation claim may continue to be provided 
after the date of settlement. As a result, we have retained the 
language referencing future medical items and services.

E. Discussion of Additional Comments by Public Comment Topic

1. Publication of an IFC Versus a Proposed Rule
    Comment: Many commenters requested that CMS retract the IFC and 
issue a proposed rule before finalizing a rule related to the MSP Web 
portal.
    Response: Section 201of the SMART Act imposed an obligation on the 
Secretary to promulgate final regulations not later than 9 months after 
the date of the enactment of this clause. In order to promulgate a 
final rule in such a short timeframe, we were required to forego the 
more traditional rulemaking process, which would have resulted in 
significant delay, and publish an IFC that simply reflected the 
addition of key process components that the SMART Act requires CMS to 
include in existing recovery program.
2. Timeframes of the IFC
    Comment: Many commenters questioned whether certain timeframes 
stipulated in the IFC comported with the requirements in the SMART Act.
    Response: We recognize that there is some confusion regarding the 
65-day Secretarial response timeframe and 120-day protected period. We 
have clarified the language in this final rule to establish that a 
final conditional payment amount may be requested at any time after a 
recovery case has been posted on the Web portal. Additionally, there is 
no requirement that 120 days must elapse before a final conditional 
payment amount may be requested.
    Comment: Many commenters raised concerns that beneficiaries will be 
unable to meet timeframes specified in the IFC because they do not have 
or use computers or because they do not access the Internet.
    Response: We understand these concerns, but pursuing a final 
conditional payment amount before settlement is not required. 
Information will be available on the Web portal, regardless of whether 
the Final conditional Payment process is used. Further, the existing 
process that CMS' contractor uses to provide conditional payment 
information and demand letters via mail will continue to be available.

III. Provisions of the Final Regulations

    After consideration of all of the comments received, we are 
finalizing the provisions included in the September 2013 IFC (78 FR 
57800) with the following modifications to Sec.  411.39:

[[Page 30492]]

     Paragraph (a), we are removing the definition of 
``Medicare Secondary Payer conditional payment information'' to avoid 
redundancy and confusion.
     Paragraph (b), we removed language related to Web portal 
functionality before January 1, 2016.
     Paragraph (c)(1)(iii), we removed the claims refresh 
requirement.
     Paragraphs (c)(1)(iv) and (v), we revised the language to 
clarify that a claim, meaning an individual conditional payment amount, 
or line item, on a payment summary statement, may be disputed once and 
only once. An individual or entity may submit disputes more than once, 
but never for the same conditional payment or line item.
     Paragraph (c)(1)(viii), we revised the language to clarify 
that settlement information must be submitted within no more than 30 
days of reaching settlement in order for CMS to remain bound by any 
final conditional payment amount it provided through the Web portal.
     Paragraph (c)(2), we revised the language to clarify that 
a final conditional payment amount may be requested at any time after a 
recovery case has been posted on the Web portal.

IV. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

V. Regulatory Impact Statement

    We have examined the impact 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 
(February 2, 2011), the Regulatory Flexibility Act (RFA) (September 19, 
1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, 
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) and the Congressional Review Act (5 U.S.C. 804(2)). 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). A regulatory impact analysis (RIA) 
must be prepared for major rules with economically significant effects 
($100 million or more in any 1 year). We have determined that the 
effect of this final rule on the economy and the Medicare program is 
not economically significant, since it imposes certain requirements on 
the Agency to merely improve its current mechanism for providing 
conditional payment information to beneficiaries, their attorneys or 
other representatives, and authorized applicable plans.
    The RFA requires agencies to analyze options for regulatory relief 
of small entities. For purposes of the RFA, small entities include 
small businesses, nonprofit organizations, and small governmental 
jurisdictions. Most hospitals and most other providers and suppliers 
are small entities, either by nonprofit status or by having revenues of 
less than $7.5 million to less than $38.5 million in any 1 year. 
Individuals and states are not included in the definition of a small 
entity. We have determined that this final rule will not have a 
significant economic impact on a substantial number of small entities 
because there is and will be no change in the administration of the MSP 
provisions. Therefore, we are not preparing an analysis for the RFA.
    In addition, section 1102(b) of the Act 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 for proposed rules of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area for Medicare payment regulations and has fewer than 
100 beds. We have determined that this final rule will not have a 
significant effect on the operations of a substantial number of small 
rural hospitals because there is and would be no change in the 
administration of the MSP provisions. Therefore, we are not preparing 
an analysis for section 1102(b) of the Act.
    Section 202 of the Unfunded Mandates Reform Act of 1995 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 2015, that 
threshold is approximately $146 million. This final rule has no 
consequential effect on state, local, or tribal governments or on the 
private sector because there is and will be no change in the 
administration of the MSP provisions.
    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 final rule does not impose any costs on state 
or local governments, the requirements of Executive Order 13132 are not 
applicable. In accordance with the provisions of Executive Order 12866, 
this final rule was not reviewed by the Office of Management and 
Budget.

List of Subjects in 42 CFR Part 411

    Kidney diseases, Medicare, Physician referral, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Centers for Medicare 
& Medicaid Services adopts as final, the interim rule amending 42 CFR 
part 411 which was published on September 20, 2013 (78 FR 57800) with 
the following changes:

PART 411--EXCLUSIONS FROM MEDICARE AND LIMITATIONS ON MEDICARE 
PAYMENT

0
1. The authority citation for part 411 continues to read as follows:

    Authority: Secs. 1102, 1860D-1 through 1860D-42, 1871, and 1877 
of the Social Security Act (42 U.S.C. 1302, 1395w-101 through 1395w-
152, 1395hh, and 1395nn).


0
2. Amend Sec.  411.39 by:
0
A. In paragraph (a) removing the definition of ``Medicare Secondary 
Payer conditional payment information''.
0
B. Revising paragraph (b)(1)(ii).
0
C. Removing paragraph (b)(2).
0
D. Redesignating paragraph (b)(3) as (b)(2).
0
E. Revising newly redesignated paragraph (b)(2).
0
F. Revising paragraph (c).
    The revisions read as follows:


Sec.  411.39  Automobile and liability insurance (including self-
insurance), no-fault insurance, and workers' compensation: Final 
conditional payment amounts via Web portal.

* * * * *
    (b) * * *
    (1) * * *
    (ii) The appropriate Medicare contractor has received initial 
notice of a pending liability insurance (including self-insurance), no-
fault insurance, or workers' compensation settlement, judgment, award, 
or other payment and has posted the recovery case on the Web portal.
    (2) Beneficiary's attorney or other representative or applicable 
plan's

[[Page 30493]]

access using the multifactor authentication process. A beneficiary's 
attorney or other representative or an applicable plan may do the 
following:
    (i) Access conditional payment information via the MSP Recovery 
Portal (Web portal).
    (ii) Dispute claims.
    (iii) Upload settlement information via the Web portal using 
multifactor authentication.
* * * * *
    (c) Obtaining a final conditional payment amount. (1) A 
beneficiary, or his or her attorney or other representative, or an 
authorized applicable plan, may obtain a final conditional payment 
amount related to a pending liability insurance (including self-
insurance), no-fault insurance, or workers' compensation settlement, 
judgment, award, or other payment using the following process:
    (i) The beneficiary, his or her attorney or other representative, 
or an applicable plan, provides initial notice of a pending liability 
insurance (including self-insurance), no-fault insurance, and workers' 
compensation settlement, judgment, award, or other payment to the 
appropriate Medicare contractor before accessing information via the 
Web portal.
    (ii) The Medicare contractor compiles claims for which Medicare has 
paid conditionally that are related to the pending settlement, 
judgment, award, or other payment within 65 days or less of receiving 
the initial notice of the pending settlement, judgment, award, or other 
payment and posts a recovery case on the Web portal.
    (iii) If the underlying liability insurance (including self-
insurance), no-fault insurance, or workers' compensation claim derives 
from one of the following, the beneficiary, or his or her attorney or 
other representative, must provide notice to CMS' contractor via the 
Web portal in order to obtain a final conditional payment summary 
statement and amount through the Web portal:
    (A) Alleged exposure to a toxic substance.
    (B) Environmental hazard.
    (C) Ingestion of pharmaceutical drug or other product or substance.
    (D) Implantation of a medical device, joint replacement, or 
something similar.
    (iv) Up to 120 days before the anticipated date of a settlement, 
judgment, award, or other payment, the beneficiary, or his or her 
attorney, other representative, or authorized applicable plan may 
notify CMS, once and only once, via the Web portal, that a settlement, 
judgment, award or other payment is expected to occur within 120 days 
or less from the date of notification.
    (A) CMS may extend its response timeframe by an additional 30 days 
when it determines that additional time is required to address claims 
that Medicare has paid conditionally that are related to the 
settlement, judgment, award, or other payment in situations including, 
but not limited to, the following:
    (1) A recovery case that requires manual filtering to ensure that 
associated claims are related to the pending settlement, judgment, 
award, or other payment.
    (2) Internal CMS systems failures not otherwise considered caused 
by exceptional circumstances.
    (B) In exceptional circumstances, CMS may further extend its 
response timeframe by the number of days required to address the issue 
that resulted from such exceptional circumstances. Exceptional 
circumstances include, but are not limited to the following:
    (1) Systems failure(s) due to consequences of extreme adverse 
weather (loss of power, flooding, etc.).
    (2) Security breaches of facilities or network(s).
    (3) Terror threats; strikes and similar labor actions.
    (4) Civil unrest, uprising, or riot.
    (5) Destruction of business property (as by fire, etc.).
    (6) Sabotage.
    (7) Workplace attack on personnel.
    (8) Similar circumstances beyond the ordinary control of 
government, private sector officers or management.
    (v) The beneficiary, or his or her attorney, or other 
representative may then address discrepancies by disputing individual 
conditional payments, once and only once, if he or she believes that 
the conditional payment included in the most up-to-date conditional 
payment summary statement is unrelated to the pending liability 
insurance (including self-insurance), no-fault insurance, or workers' 
compensation settlement, judgment, award, or other payment.
    (A) The dispute process is not an appeals process, nor does it 
establish a right of appeal regarding that dispute. There will be no 
administrative or judicial review related to this dispute process.
    (B) The beneficiary, or his or her attorney or other representative 
may be required to submit supporting documentation in the form and 
manner specified by the Secretary to support his or her dispute.
    (vi) Disputes submitted through the Web portal and after the 
beneficiary, or his or her attorney, other representative, or 
authorized applicable plan has notified CMS that he or she is 120 days 
or less from the anticipated date of a settlement, judgment, award, or 
other payment, are resolved within 11 business days of receipt of the 
dispute and any required supporting documentation.
    (vii) When any disputes have been fully resolved, the beneficiary, 
or his or her attorney or other representative, may download or 
otherwise request a time and date stamped conditional payment summary 
statement through the Web portal.
    (A) If the download or request is within 3 days of the date of 
settlement, judgment, award, or other payment, that conditional payment 
summary statement will constitute Medicare's final conditional payment 
amount.
    (B) If the beneficiary, or his or her attorney or other 
representative, is within 3 days of the date of settlement, judgment, 
award, or other payment and any claim disputes have not been fully 
resolved, he or she may not download or otherwise request a final 
conditional payment summary statement.
    (viii) Within 30 days or less of securing a settlement, judgment, 
award, or other payment, the beneficiary, or his or her attorney or 
other representative, must submit through the Web portal documentation 
specified by the Secretary, including, but not limited to the 
following:
    (A) The date of settlement, judgment, award, or other payment, 
including the total settlement amount, the attorney fee amount or 
percentage.
    (B) Additional costs borne by the beneficiary to obtain his or her 
settlement, judgment, award, or other payment.
    (1) If settlement information is not provided within 30 days or 
less of securing the settlement, the final conditional payment amount 
obtained through the Web portal is void.
    (2) [Reserved]
    (ix) Once settlement, judgment, award, or other payment information 
is received, CMS applies a pro rata reduction to the final conditional 
payment amount in accordance with Sec.  411.37 and issues a final MSP 
recovery demand letter.
    (2) An applicable plan may only obtain a final conditional payment 
amount related to a pending liability insurance (including self-
insurance), no-fault insurance, or workers' compensation settlement, 
judgment, award, or other payment in the form and manner described in 
Sec.  411.38(b) if the applicable plan has properly registered to use 
the Web portal and has obtained

[[Page 30494]]

from the beneficiary, and submitted to the appropriate CMS contractor, 
proper proof of representation. The applicable plan may obtain read 
only access if the applicable plan obtains from the beneficiary, and 
submits to the appropriate CMS contractor, proper consent to release.
* * * * *

    Dated: April 25, 2016.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
    Dated: April 29, 2016.
Sylvia M. Burwell,
Secretary, Department of Health and Human Services.
[FR Doc. 2016-11270 Filed 5-13-16; 11:15 am]
BILLING CODE 4120-01-P