Centers for Medicare and Medicaid Services – Federal Register Recent Federal Regulation Documents

In accordance with the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS) is providing notice of the re-establishment of a matching program between CMS and the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), ``Verification of Eligibility for Minimum Essential Coverage Under the Patient Protection and Affordable Care Act Through a Veterans Health Administration Plan.''

The Department of Health and Human Services (HHS or Department) is proposing to withdraw or repeal a final rule entitled ``Securing Updated and Necessary Statutory Evaluations Timely'' (SUNSET final rule) and published in the Federal Register of January 19, 2021. The SUNSET final rule was originally scheduled to take effect on March 22, 2021. However, after a lawsuit was filed on March 9, 2021, seeking to overturn the SUNSET final rule, HHS issued an administrative delay of effective date that extended the effective date of the SUNSET final rule until March 22, 2022. HHS is now proposing to withdraw or repeal the SUNSET final rule.

The Regulatory Flexibility Act (RFA) requires agencies to publish plans to conduct periodic reviews of certain of their regulations. Multiple Executive Orders also require agencies to submit plans for periodic reviews of certain regulations. To further comply with the RFA and Executive Orders, and to ensure the Department's regulations have appropriate impacts, the U.S. Department of Health and Human Services (HHS or the Department) issues this final rule amending its regulations to set expiration dates for the Department's regulations (subject to certain exceptions), unless the Department periodically assesses the regulations to determine if they are subject to the RFA, and if they are, performs a review that satisfies the criteria in the RFA.

This notice announces the national expansion of the Prior Authorization Model for Repetitive, Scheduled Non-Emergent Ambulance Transports to all states, but we are delaying the implementation of the expansion to all additional states due to the COVID-19 Public Health Emergency. The model will continue to operate in the states currently participating in the model under section 1115A of the Social Security Act (the Act), which includes Delaware, the District of Columbia, Maryland, New Jersey, North Carolina, Pennsylvania, South Carolina, Virginia, and West Virginia. CMS will continue to monitor the Public Health Emergency and will provide public notice before implementing the model in additional states.

In accordance with requirements of the Privacy Act of 1974, as amended, the Department of Health and Human Services (HHS) is updating an existing system of records maintained by the Centers for Medicare & Medicaid Services (CMS), system No. 09-70-0550, titled ``Medicare Retiree Drug Subsidy Program'' (RDSP), and renaming it ``Retiree Drug Subsidy (RDS), HHS/CMS/CM.'' This system collects and maintains information about individuals who are qualifying covered retirees so that accurate and timely subsidy payments may be made to plan sponsors who continue to offer actuarially equivalent prescription drug coverage to the qualifying covered retirees.

The Department of Health and Human Services (``the Department'') is committed to ensuring the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act. The Department proposes to revise its Section 1557 regulation in order to better comply with the mandates of Congress, address legal concerns, relieve billions of dollars in undue regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability.

This proposed notice acknowledges the receipt of an application from the Community Health Accreditation Partner (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs.

This notice announces an administrative hearing to be held on August 6, 2015, at the Department of Health and Human Services, Centers for Medicare and Medicaid Services, Division of Medicaid & Children's Health, Dallas Regional Office, 1301 Young Street, Room 714, Dallas, TX 75202, to reconsider CMS' decision to disapprove Texas' Medicaid SPA 14-25. Closing Date: Requests to participate in the hearing as a party must be received by the presiding officer by July 15, 2015.

In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new SOR, titled ``CMS Encounter Data System (EDS)'', System No. 09-70-0506. CMS intends to collect encounter data, or data on each item or service delivered to enrollees of Medicare Advantage (MA) plans offered by MA organizations as defined at Title 42, Code of Federal Regulation (CFR), Sec. 422.4. Pursuant to 42 CFR 422.310, each MA organization must submit encounter data to CMS that is used to determine the risk adjustment factors for payment, updating the risk adjustment model, calculating Medicare Disproportionate Share Hospital (DSH) percentages, Medicare coverage purposes, and quality review and improvement activities. Encounter data will be collected and maintained in the EDS. Under the authority granted in Section 1115 of the Social Security Act (the Act), CMS is authorized to conduct experimental, pilot or demonstration projects. CMS is conducting a demonstration project under the Financial Alignment Initiative to test a new capitated payment system and item/ service delivery model designed to lower costs and improve the quality of care for individuals eligible for both Medicare and Medicaid (dual eligibles). CMS and the participating State Medicaid agency jointly contract with health plans (known as Medicare-Medicaid Plans or ``MMPs''). MMPs are paid monthly on a capitated basis and are required to submit to CMS comprehensive encounter data on each item or service provided to each enrollee, including both Medicare and Medicaid items and services. The program and the SOR are more thoroughly described in the Supplemental Information section and System of Records Notice (SORN), below.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are correcting a notice that appeared in the Federal Register of October 11, 2011 (76 FR 62808). The document announced a pilot program for sponsors of innovative device technologies to participate in a program of parallel FDA-CMS review. The document was published with an incorrect Web page address and an incorrect email address. This document corrects those errors.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) (the Agencies) are soliciting nominations from sponsors of innovative device technologies to participate in a pilot program for concurrent review of certain FDA premarket review submissions and CMS national coverage determinations. The Agencies announced the intention to initiate a pilot program in the Federal Register of September 17, 2010. The Agencies are now providing notice of the procedures for voluntary participation in the pilot program, as well as the guiding principles the Agencies intend to follow.

This proposed notice with comment period acknowledges the receipt of an application from the Joint Commission for continued recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

The Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. This process will serve the public interest by reducing the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are establishing a docket to receive information and comment from the public on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies are also announcing their intent to create a pilot program for parallel review of medical devices. The pilot program will begin after both agencies have reviewed the public comments on this notice. A memorandum of understanding (MOU) concerning the exchange of data and information has been completed between the two agencies. See https://www.fda.gov/AboutFDA/ PartnershipsCollaborations/MemorandaofUnderstandingMOUs/Domes ticMOUs/ ucm217585.htm.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the establishment of a CMP that CMS plans to conduct with the Health Administration Center (HAC) of the Department of Veteran Affairs. We have provided background information about the proposed matching program in the ``Supplementary Information'' section below. The Privacy Act provides an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.

This proposed notice acknowledges the receipt of a deeming application from the Accreditation Commission for Health Care (ACHC) for recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. Section 1865(a)(3)(A) of the Social Security Act requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

This proposed notice acknowledges the receipt of a deeming application from the Community Health Accreditation Program (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization's complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice establishes a computer matching agreement between CMS and the Department of Defense (DoD). We have provided background information about the proposed matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act requires that CMS provide an opportunity for interested persons to comment on the proposed matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.