2023-09400. Agency Information Collection Activities: Submission for OMB Review; Comment Request

AGENCY:

Centers for Medicare & Medicaid Services, Health and Human Services (HHS).

ACTION:

Notice.

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 (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 a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate 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 on the collection(s) of information must be received by the OMB desk officer by June 5, 2023.

ADDRESSES:

Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/​public/​do/​PRAMain. Find this particular information collection by selecting “Currently under 30-day Review—Open for Public Comments” or by using the search function.

To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, please access the CMS PRA website by copying and pasting the following web address into your web browser: https://www.cms.gov/​Regulations-and-Guidance/​Legislation/​PaperworkReductionActof1995/​PRA-Listing.

FOR FURTHER INFORMATION CONTACT:

William Parham at (410) 786–4669.

SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (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 (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-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 that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: Medicare Enrollment Application for Institutional Providers; Use: The primary function of the CMS–855A Medicare enrollment application is to gather information from a certified provider or certified supplier (hereafter occasionally and collectively referenced as “provider(s)”) that tells us who it is, whether it meets certain qualifications to be a health care provider, where it practices or renders services, the identity of its owners, and other information necessary to establish correct claims payments. This collection of information reinstatement request is associated in part with our December 28, 2020 (85 FR 84472) final rule (CMS–1734–F, RIN 0938–AU10). The collection of information changes stemming from this final rule were approved by OMB on September 28, 2021 (ICR Reference No.: 202103–0938–010).

Existing § 424.67 outlines a number of enrollment requirements for opioid treatment programs (OTPs). One requirement, addressed in § 424.67(b)(1)(i), is that OTPs must maintain and submit to CMS a list of all physicians, other eligible professionals, and pharmacists who are legally authorized to prescribe, order, or dispense controlled substances on the OTP's behalf; the list must include the person's first and last name and middle initial, social security number, National Provider Identifier, and license number (if applicable). This reinstatement request will add these data elements to the CMS–855A, which OTPs must complete if they wish to bill for OTP services via an institutional claim form (specifically, the 837I).

On November 23, 2022, CMS published in the Federal Register a final rule with comment period rule titled “Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Organ Acquisition; Rural Emergency Hospitals: Payment Policies, Conditions of Participation, Provider Enrollment, Physician Self-Referral; New Service Category for Hospital Outpatient Department Prior Authorization Process; Overall Hospital Quality Star Rating; COVID–19” (CMS–1772–FC) (87 FR 71748). This final rule with comment period outlined requirements that rural emergency hospitals (REHs)—a new Medicare provider type established pursuant to Section 125 of Division CC of the Consolidated Appropriations Act, 2021—must meet in order to bill Medicare for REH services; in accordance with new section 1861(kkk) of the Social Security Act, a facility is eligible to convert to an REH if it was a critical access hospital (CAH) or rural hospital with less than 50 beds as of December 27, 2020. CMS–1772–FC's REH requirements include those necessary to enroll as an REH. The most pertinent of these is that a CAH or rural hospital seeking REH enrollment submits a CMS–855A change of information application and need not submit a full, initial CMS–855A application. This reinstatement request will address the expected REH burden associated with completing these CMS–855A changes of information.

As part of this request, and as described in the supporting statement, we also seek approval for additional changes to the CMS–855A. These changes principally (though not exclusively) involve the collection of information related to the provider's ownership.

Form Number: CMS–855A (OMB control number: 0938–0685); Frequency: On occasion; Affected Public: Business or other for-profits, not-for-profit institutions; Number of Respondents: 1,340; Total Annual Responses: 5,881; Total Annual Hours: 72,147. (For policy questions regarding this collection contact Frank Whelan at 410–786–1302.)

2. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Advantage, Medicare Part D, and Medicare Fee-For-Service Consumer Assessment of Healthcare Providers and Systems (CAHPS) Survey; Use: CMS is required to collect and report information on the quality of health care services and prescription drug coverage available to persons enrolled in a Medicare health or prescription drug plan under provisions in the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). Specifically, the MMA under Sec. 1860D–4 (Information to Facilitate Enrollment) requires CMS to conduct consumer satisfaction surveys regarding Medicare prescription drug plans and Medicare Advantage plans and report this information to Medicare beneficiaries prior to the Medicare annual enrollment period. The Medicare CAHPS survey meets the requirement of collecting and publicly reporting consumer satisfaction information. The Balanced Budget Act of 1997 also requires the collection of information about fee-for-service plans.

The primary purpose of the Medicare CAHPS surveys is to provide information to Medicare beneficiaries to help them make more informed choices among health and prescription drug plans available to them. Survey results are reported by CMS in the Medicare & You Handbook published each fall and on the Medicare Plan Finder website. Beneficiaries can compare CAHPS scores for each health and drug plan as well as compare MA and FFS scores when making enrollment decisions. The Medicare CAHPS also provides data to help CMS and others monitor the quality and performance of Medicare health and prescription drug plans and identify areas to improve the quality of care and services provided to enrollees of these plans. CAHPS data are included in the Medicare Part C & D Star Ratings and used to calculate MA Quality Bonus Payments. Form Number: CMS–R–246 (OMB control number: 0938–0732); Frequency: Yearly; Affected Public: Individuals and Households; Number of Respondents: 794,500; Total Annual Responses: 794,500; Total Annual Hours: 192,265. (For policy questions regarding this collection contact Lauren Fuentes at 410–786–2290).

3. Type of Information Collection Request: New collection (Request for new OMB control number); Title of Information Collection: End-stage Renal Disease (ESRD) Quality Incentive Program (QIP): Study of Quality and Patient Experience; Use: The Centers for Medicare & Medicaid Services (CMS) oversees the quality of care provided by dialysis facilities by administering the Quality Incentive Program (QIP). As part of the evaluation of this program, CMS seeks to gain a deeper understanding of emerging trends observed across the dialysis landscape by conducting qualitative data collection and analysis. These primary qualitative data collection activities seek to answer the following research questions related to dialysis quality, access to care, health equity, and quality of life:

1. What aspects of patient dialysis care do patients report as a priority?

2. How, if at all, do dialysis facilities evaluate the quality of care they provide?

3. What strategies do providers and dialysis facilities use to improve access to care for underserved populations?

4. What do patients, providers, and stakeholder organizations believe contributes to high quality of life for patients with ESRD? Do perceptions vary by respondent type or respondent characteristics?

5. How do dialysis facilities measure patient satisfaction and quality of life?

6. How do dialysis providers and stakeholder organizations think quality of life for dialysis patients has changed over time? What was the impetus for that change?

We are requesting to collect information through in depth interviews with stakeholders of the CMS end-stage renal disease (ESRD) Quality Incentive Program (QIP). The interviews will collect data from individuals with ESRD, dialysis facility administrators, dialysis social workers, transplant center administrators, corporate representatives from dialysis organizations, and patient advocacy organizations.

This data collection seeks to answer several research questions specific to health outcomes for dialysis patients, as measured by the QIP, that are not available through current literature or secondary data collection. In preparation for this study, the evaluation team conducted a scan of peer-reviewed literature and document review of previous ESRD QIP monitoring and evaluation reports and policy documents describing CMS priorities. Based on the results from this scan, the study team identified persistent knowledge gaps and opportunities for primary data collection. Drawing on high-quality data, empirical rigor, and knowledge of nonprogrammatic factors, the evaluation will benefit CMS by providing data-driven findings and recommendations to improve patient care, reduce health disparities, and promote health equity.

This primary data collection will allow CMS to more comprehensively understand the data being compiled and analyzed quantitatively and will provide more context related to dialysis quality, quality of life of individuals with ESRD, access to dialysis care, and the patient experience, which are current CMS priorities. Form Number: CMS–10823 (OMB control number: 0938–NEW); Frequency: Once; Affected Public: Private Sector (Business or other for-profits, Not-for-Profit Institutions), Individuals and Households; Number of Respondents: 1,945; Total Annual Responses: 1,945; Total Annual Hours: 604. (For policy questions regarding this collection contact Christopher King at (410) 786–6972).

Dated: April 28, 2023.

William N. Parham, III,

Director, Paperwork Reduction Staff, Office of Strategic Operations and Regulatory Affairs.