[Federal Register Volume 84, Number 123 (Wednesday, June 26, 2019)]
[Notices]
[Pages 30123-30125]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-13608]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-R-153, CMS-R-235, CMS-10439, CMS-10594, CMS-
10328 and CMS-460]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.

ACTION: Notice.

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SUMMARY: The Centers for Medicare & Medicaid Services (CMS) is 
announcing an opportunity for the public to comment on CMS' intention 
to collect information from the public. Under the Paperwork Reduction 
Act of 1995 (the PRA), federal agencies are required to publish notice 
in the Federal Register concerning each proposed collection of 
information (including each proposed extension or reinstatement of an 
existing collection of information) and to allow 60 days for public 
comment on the proposed action. Interested persons are invited to send 
comments regarding our burden estimates or any other aspect of this 
collection of information, including the necessity and utility of the 
proposed information collection for the proper performance of the 
agency's functions, the accuracy of the estimated burden, ways to 
enhance the quality, utility, and clarity of the information to be 
collected, and the use of automated collection techniques or other 
forms of information technology to minimize the information collection 
burden.

DATES: Comments must be received by August 26, 2019.

ADDRESSES: When commenting, please reference the document identifier or 
OMB control number. To be assured consideration, comments and 
recommendations must be submitted in any one of the following ways:
    1. Electronically. You may send your comments electronically to 
http://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) that are accepting comments.
    2. By regular mail. You may mail written comments to the following 
address: CMS, Office of Strategic Operations and Regulatory Affairs, 
Division of Regulations Development, Attention: Document Identifier/OMB 
Control Number _________, Room C4-26-05, 7500 Security Boulevard, 
Baltimore, Maryland 21244-1850.

[[Page 30124]]

    To obtain copies of a supporting statement and any related forms 
for the proposed collection(s) summarized in this notice, you may make 
your request using one of following:
    1. Access CMS' website address at https://www.cms.gov/Regulations-and-Guidance/Legislation/PaperworkReductionActof1995/PRA-Listing.html.
    2. Email your request, including your address, phone number, OMB 
number, and CMS document identifier, to [email protected].
    3. Call the Reports Clearance Office at (410) 786-1326.

FOR FURTHER INFORMATION CONTACT: William N. Parham at (410) 786-4669.

SUPPLEMENTARY INFORMATION: 

Contents

    This notice sets out a summary of the use and burden associated 
with the following information collections. More detailed information 
can be found in each collection's supporting statement and associated 
materials (see ADDRESSES).

CMS-R-153 Medicaid Drug Use Review (DUR) Program
CMS-R-235 Data Use Agreement (DUA) Form
CMS-10439 Data Collection to Support Eligibility Determinations and 
Enrollment for Employers in the Small Business Health Options Program
CMS-10594 Provider Network Coverage Data Collection
CMS-10328 Medicare Self-Referral Disclosure Protocol
CMS-460 Medicare Participation Agreement for Physicians and Suppliers

    Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. The term 
``collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA requires federal agencies 
to publish a 60-day notice in the Federal Register concerning each 
proposed collection of information, including each proposed extension 
or reinstatement of an existing collection of information, before 
submitting the collection to OMB for approval. To comply with this 
requirement, CMS is publishing this notice.

Information Collection

    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Medicaid Drug Use 
Review (DUR) Program; Use: States must provide for a review of drug 
therapy before each prescription is filled or delivered to a Medicaid 
patient. This review includes screening for potential drug therapy 
problems due to therapeutic duplication, drug-disease 
contraindications, drug-drug interactions, incorrect drug dosage or 
duration of drug treatment, drug-allergy interactions, and clinical 
abuse/misuse. Pharmacists must make a reasonable effort to obtain, 
record, and maintain Medicaid patient profiles. These profiles must 
reflect at least the patient's name, address, telephone number, date of 
birth/age, gender, history, e.g., allergies, drug reactions, list of 
medications, and pharmacist's comments relevant to the individual's 
drug therapy.
    The States must conduct RetroDUR which provides for the ongoing 
periodic examination of claims data and other records in order to 
identify patterns of fraud, abuse, inappropriate or medically 
unnecessary care. Patterns or trends of drug therapy problems are 
identified and reviewed to determine the need for intervention activity 
with pharmacists and/or physicians. States may conduct interventions 
via telephone, correspondence, or face-to-face contact.
    Annual reports are submitted to CMS for the purposes of monitoring 
compliance and evaluating the progress of States' DUR programs. The 
information submitted by States is reviewed and results are compiled by 
CMS in a format intended to provide information, comparisons, and 
trends related to States' experiences with DUR. States benefit from the 
information and may enhance their programs each year based on State 
reported innovative practices that are compiled by CMS from the DUR 
annual reports. Form Number: CMS-R-153 (OMB control number: 0938-0659); 
Frequency: Yearly, quarterly, and occasionally; Affected Public: State, 
Local, or Tribal Governments; Number of Respondents: 51; Total Annual 
Responses: 663; Total Annual Hours: 41,004. (For policy questions 
regarding this collection contact Mike Forman at 410-786-2666.)
    2. Type of Information Collection Request: Reinstatement with 
change of a currently approved collection; Title of Information 
Collection: Data Use Agreement (DUA) Form; Use: The Privacy Act of 1974 
allows for discretionary releases of data maintained in Privacy Act 
protected systems of records under Sec.  552a(b) (Conditions of 
Disclosure). The mandate to account for disclosures of data under the 
Privacy Act is found at Sec.  552a(c) (Accounting of Certain 
Disclosures). This section states that certain information must be 
maintained regarding disclosures made by each agency. This information 
is: Date, Nature, Purpose, and Name/Address of Recipient. Section 
552a(e) sets the overall Agency Requirements that each agency must meet 
in order to maintain records under the Privacy Act.
    The Data Use Agreement (DUA) form is needed as part of the review 
of each CMS data request to ensure compliance with the requirements of 
the Privacy Act for disclosures that contain PII. The DUA form also 
provides data requestors and custodians with a formal means to agree to 
the data protection and destruction statutory and regulatory 
requirements of CMS' PII data.
    When entities, such as academic, federal or state agency 
researchers or CMS contractors request CMS PII/PHI data, they enter 
into a Data Use Agreement (DUA) with CMS. The DUA stipulates that the 
recipient of CMS data must properly protect the data according to all 
applicable data security standards and also provide for its appropriate 
destruction at the completion of the project/study or the expiration 
date of the DUA. The DUA form enables the data recipient and CMS to 
document the request and approval for release of CMS data. Form Number: 
CMS-R-235 (OMB control number: 0938-0734); Frequency: Yearly; Affected 
Public: State, Local, or Tribal Governments; Number of Respondents: 
9,200; Total Annual Responses: 9,200; Total Annual Hours: 2,900. (For 
policy questions regarding this collection contact Kari A. Gaare at 
410-786-8612.)
    3. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Data Collection 
to Support Eligibility Determinations and Enrollment for Employers in 
the Small Business Health Options Program; Use: Section 1311(b)(1)(B) 
of the Affordable Care Act directs that the SHOP assist qualified small 
employers in facilitating the enrollment of their employees in QHPs 
offered in the small group market. Section 1311(c)(1)(F) of the 
Affordable Care Act directs HHS to establish criteria for certification 
of health plans as QHPs and plans to utilize a uniform enrollment form 
for qualified employers. Further, section 1311(c)(5)(B) directs HHS to 
develop a website that assists employers in determining if they are 
eligible to participate in SHOP. Form Number: CMS-10439 (OMB control 
number: 0938-1193); Frequency: Annually; Affected Public: Private 
Sector, Business or other for-profits, Not-for-profits

[[Page 30125]]

institutions; Number of Respondents: 6,000; Total Annual Responses: 
6,000; Total Annual Hours: 960. (For policy questions regarding this 
collection contact Michele Oshman at 410-786-4396.)
    4. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Provider Network Coverage Data Collection; Use: The Affordable Care Act 
(ACA) established competitive private health insurance markets called 
Marketplaces, or Exchanges, which gave millions of Americans and small 
businesses access to affordable, quality insurance options that meet 
certain requirements. These requirements include ensuring sufficient 
choice of providers and providing information to enrollees and 
prospective enrollees on the availability of in-network and out-of-
network providers. This information collection notice is for two of the 
standards from the HHS Notice of Benefit and Payment Parameters for 
2017 (CMS-9937-F) final rule: One applying in the FFE and one applying 
to all QHPs. Specifically, under 45 CFR 156.230(d) and 156.230(e), we 
require notification requirements for enrollees in cases where a 
provider leaves the network and for cases where an enrollee might be 
seen by an out of network ancillary provider in in-network setting. 
These standards will help inform consumers about his or her health plan 
coverage to better make cost effective choices. The Centers for 
Medicare and Medicaid Services (CMS) is updating an information 
collection request (ICR) in connection with these standards. The burden 
estimates for this ICR included in this package reflects the additional 
time and effort for QHP issuers to provide these notifications to 
enrollees. Form Number: CMS-10594 (OMB control number: 0938-1302); 
Frequency: Yearly; Affected Public: Private Sector (business or other 
for-profits, not-for-profit institutions); Number of Respondents: 470; 
Total Annual Responses: 356,260; Total Annual Hours: 194,250. (For 
policy questions regarding this collection contact Arunima Shukla at 
410-786-5017.)\
    5. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Medicare Self-Referral Disclosure Protocol; Use: Section 6409 of the 
ACA requires the Secretary to establish a voluntary self-disclosure 
process that allows providers of services and suppliers to self-
disclose actual or potential violations of section 1877 of the Act. In 
addition, section 6409(b) of the ACA gives the Secretary authority to 
reduce the amounts due and owing for the violations. To determine the 
nature and extent of the noncompliance and the appropriate amount by 
which an overpayment may be reduced, the Secretary must collect 
relevant information regarding the arrangements and financial 
relationships at issue from disclosing parties. The Secretary may also 
collect supporting documentation, such as contracts, leases, 
communications, invoices, or other documents bearing on the actual or 
potential violation(s). Most of the information and documentation 
required for submission to CMS in accordance with the SRDP is 
information that health care providers of services and suppliers keep 
as part of customary and usual business practices. Form Number: CMS-
10328 (OMB control number: 0938-1106); Frequency: Yearly; Affected 
Public: Private Sector (business or other for-profits, not-for-profit 
institutions); Number of Respondents: 470; Total Annual Responses: 
356,260; Total Annual Hours: 194,250. (For policy questions regarding 
this collection contact Matthew Edgar at 410-786-0698.)
    6. Type of Information Collection Request: Extension without change 
of a currently approved collection; Title of Information Collection: 
Medicare Participation Agreement for Physicians and Suppliers; Use: 
Section 1842(h) of the Social Security Act permits physicians and 
suppliers to voluntarily participate in Medicare Part B by agreeing to 
take assignment on all claims for services to Medicare beneficiaries. 
The law also requires that the Secretary provide specific benefits to 
the physicians, suppliers and other persons who choose to participate. 
The CMS-460 is the agreement by which the physician or supplier elects 
to participate in Medicare. By signing the agreement to participate in 
Medicare, the physician, supplier, or their authorized official agrees 
to accept the Medicare-determined payment for Medicare covered services 
as payment in full and to charge the Medicare Part B beneficiary no 
more than the applicable deductible or coinsurance for the covered 
services. For purposes of this explanation, the term ``supplier'' means 
certain other persons or entities, other than physicians, that may bill 
Medicare for Part B services (e.g., suppliers of diagnostic tests, 
suppliers of radiology services, durable medical suppliers (DME) 
suppliers, nurse practitioners, clinical social workers, physician 
assistants). Institutions that render Part B services in their 
outpatient department are not considered ``suppliers'' for purposes of 
this agreement. Form Number: CMS-460(OMB control number: 0938-0373); 
Frequency: Yearly; Affected Public: Private Sector (business or other 
for-profits); Number of Respondents: 29,000; Total Annual Responses: 
29,000; Total Annual Hours: 7,250. (For policy questions regarding this 
collection contact Mark Baldwin at 410-786-8139.)

    Dated: June 21, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office of Strategic Operations and 
Regulatory Affairs.
[FR Doc. 2019-13608 Filed 6-25-19; 8:45 am]
 BILLING CODE 4120-01-P