Alston & Bird’s Week in Review provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and Congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On December 18, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a request for information (RFI) entitled, Medicare Program: Accrediting Organizations Conflict of Interest and Consulting Services; Request for Information. This RFI seeks public comment regarding the appropriateness of the practices of some Medicare-approved Accrediting Organizations (AOs) to provide fee-based consultative services for Medicare-participating providers and suppliers as part of their business model. CMS wish’s to determine whether AO practices of consulting with the same facilities which they accredit under their CMS approval could create actual or perceived conflicts of interest between the accreditation and consultative entities. CMS intends to consider information received in response to this RFI to assist in future rulemaking.
- On December 19, 2018, the Food and Drug Administration (FDA) issued a proposed rule entitled, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations. The FDA is extending the comment period for the proposed rule that appeared in the Federal Register of November 15, 2018. The FDA is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.
- On December 20, 2018, CMS issued a proposed rule entitled, Medicare and Medicaid Programs; Risk Adjustment Data Validation. This document extends the comment period for the Risk Adjustment Data Validation (RADV) provisions of the proposed rule titled “Medicare and Medicaid Programs; Policy and Technical Changes to the Medicare Advantage, Medicare Prescription Drug Benefit, Program of All-inclusive Care for the Elderly (PACE), Medicaid Fee-For-Service, and Medicaid Managed Care Programs for Years 2020 and 2021” that was published in the November 1, 2018 Federal Register. The comment period for the RADV provision of this proposed rule, which would end on December 31, 2018, is extended by 120 days until April 30, 2019. The comment period for all other provisions of the November 1, 2018 proposed rule ends on December 31, 2018.
- On December 21, 2018, CMS issued a final rule entitled, Medicare Shared Savings Program; Accountable Care Organizations Pathways to Success and Extreme and Uncontrollable Circumstances Policies for Performance Year 2017. Under the Medicare Shared Savings Program (Shared Savings Program), providers of services and suppliers that participate in an Accountable Care Organization (ACO) continue to receive traditional Medicare fee-for-service (FFS) payments under Parts A and B, but the ACO may be eligible to receive a shared savings payment if it meets specified quality and savings requirements. The policies included in this final rule provide a new direction for the Shared Savings Program by establishing pathways to success through redesigning the participation options available under the program to encourage ACOs to transition to two-sided models (in which they may share in savings and are accountable for repaying shared losses). These policies are designed to increase savings for the Trust Funds and mitigate losses, reduce gaming opportunities, and promote regulatory flexibility and free-market principles. This final rule also provides new tools to support coordination of care across settings and strengthen beneficiary engagement; and ensure rigorous benchmarking. In this final rule, CMS also responds to public comments received on the extreme and uncontrollable circumstances policies for the Shared Savings Program that were used to assess the quality and financial performance of ACOs that were subject to extreme and uncontrollable events, such as Hurricanes Harvey, Irma, and Maria, and the California wildfires, in performance year 2017, including the applicable quality data reporting period for performance year 2017.
Event Notices
- January 9, 2019: The Health Resources and Services Administration (HRSA) announced a public meeting of the Advisory Committee on Training in Primary Care Medicine and Dentistry. The meeting will cover the annual report describing the activities of the Committee and recommendations for training programs in oral health and dentistry.
- January 16, 2019: CMS announced a public meeting of the Advisory Panel on Outreach and Education (APOE). The meeting will allow the public to present oral presentations on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act.
- February 27, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment National Advisory Council (NAC). The NAC will discuss recovery housing and expanding access to medication-assisted treatment.
- April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission systems’ past performance, future targets, emerging industry needs and technology initiatives.
II. Congressional Legislation & Committee Action
U.S. Senate
- There were no health-related hearings this week.
House of Representatives
- There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On December 20, 2018, the Department of Health and Human Services (HHS) issued a document entitled, Naloxone: The Opioid Reversal Drug That Saves Lives. The document provides guidance for prescribing naloxone with opioid prescriptions. The document recommends clinicians co-prescribe naloxone and provide education about its use for patients who are at risk of overdose.
IV. Other Health Policy News
- On December 20, 2018, CMS issued a letter entitled, Advanced Notice of Methodological Changes for Calendar Year (CY) 2020 for the Medicare Advantage CMS-HCC Risk Adjustment Model. The letter outlined some of CMS’s proposed 2020 payment policies for Medicare Advantage (MA), including changes to MA’s financial risk among insurers and the use of encounter data. A second letter dealing with the remaining MA payment issues for 2020 is expected to be released in the coming weeks.