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
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On July 25, 2018, the Department of Health and Human Services (HHS) issued a final rule entitled, Adoption of the Methodology for the HHS-operated Permanent Risk Adjustment Program under the Patient Protection and Affordable Care Act for the 2017 Benefit Year. The rule adopts the risk adjustment methodology that HHS previously established for the 2017 benefit year. In February 2018, a district court vacated the use of statewide average premium as a basis for the HHS-operated risk adjustment methodology for the 2014, 2015, 2016, 2017, and 2018 benefit years. Accordingly, HHS is issuing this final rule to allow changes to be collected and payments to be made for the 2017 benefit year.
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On July 25, 2018, the Center for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, Medicare Program: Proposed Changes to Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs; Requests for Information on Promoting Interoperability and Electronic Health Care Information, Price Transparency, and Leveraging Authority for the Competitive Acquisition Program for Part B Drugs and Biologicals for a Potential CMS Innovation Center Model. This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) and the Medicare ambulatory surgical center (ASC) payment system for CY 2019 to implement changes arising from CMS’ continuing experience with these systems. In this proposed rule, CMS describes the proposed changes to the amounts and factors used to determine the payment rates for Medicare services paid under the OPPS and those paid under the ASC payment system. In addition, this proposed rule would update and refine the requirements for the Hospital Outpatient Quality Reporting Program and the ASC Quality Reporting Program. The proposed rule also includes requests for information on promoting interoperability and electronic health care information exchange, improving beneficiary access to provider and supplier charge information, and leveraging the authority for the Competitive Acquisition Program for Part B drugs and biologicals for a potential CMS Innovation Center model. In addition, CMS is proposing to modify the Hospital Consumer Assessment of Healthcare Providers and Systems Survey measure under the Hospital Inpatient Quality Reporting Program by removing the Communication about Pain questions.
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On July 26, 2018, the Food and Drug Administration (FDA) issued guidance entitled, Clarification of Orphan Designation of Drugs and Biologics for Pediatric Subpopulations of Common Diseases. The FDA is making guidance available because it does not expect to grant any additional orphan-drug designation to drugs for pediatric subpopulations of common diseases (i.e., diseases or conditions with an overall prevalence of 200,000 or greater). This will help resolve an unintended loophole in the Pediatric Research Equity Act (PREA) orphan exemption process where a sponsor holding a pediatric-subpopulation designation can submit a marketing application for use of its drug in the non-orphan adult population of that disease, get a pediatric-subpopulation designation for the pediatric subset of the disease, and due to this designation, be exempt from conducting the pediatric studies normally required under PREA when seeking approval of the adult indication.
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On July 26, 2018, the FDA issued a notice entitled, Generic Drug User Fee Rates for Fiscal Year 2019. The Federal Food, Drug, and Cosmetic Act, as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes the FDA to assess and collect fees for abbreviated new drug applications, drug master files, generic drug active pharmaceutical ingredient facilities, finished dosage form facilities, contract manufacturing organization facilities, and generic drug applicant program user fees. In this document, FDA is announcing fiscal year 2019 rates for GDUFA II fees.
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On July 27, 2018, the FDA issued a notice entitled, Medical Device User Fee Rates for Fiscal Year 2019. The FDA is announcing the fee rates and payment procedures for medical device user fees for FY 2019. The Federal Food, Drug, and Cosmetic Act, as amended by the Medical Device User Fee Amendments of 2017 (MDUFA IV), authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration. This notice establishes the fee rates for FY 2019, which apply from October 1, 2018, through September 30, 2019.
Event Notices
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July 30, 2018: The Department of Health and Human Services (HHS) announced a public meeting of the Advisory Council on Alzheimer’s Research, Care, and Services (Advisory Council). The Advisory Council on Alzheimer’s Research, Care, and Services provides advice on how to prevent or reduce the burden of Alzheimer’s disease and related dementias on people with the disease and their caregivers. The Advisory Council will spend the majority of the July meeting considering recommendations made by each of the three subcommittees to present to the Secretary of HHS and Congress. Additional presentations in the afternoon will include a presentation on a recent study by RAND on the health care infrastructure, the CDC/Alzheimer’s Association’s joint Healthy Brain Initiative Roadmap, federal workgroup updates, and updates on work by the non-federal members.
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August 1, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The CSAT NAC will discuss substance use disorder spending estimates and the opioid epidemic.
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August 3, 2018: The FDA announced a meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The committees will discuss results from assessments of the transmucosal immediate-release fentanyl medicines’ risk evaluation and mitigation strategy.
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August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.
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August 21, 2018: The FDA announced a public work shop entitled, Development of Non-Traditional Therapies for Bacterial Infections. The purpose of the workshop is to discuss the general development considerations of non-traditional therapies, including pre-clinical development, early clinical studies, and phase 3 clinical trial designs to evaluate safety and efficacy.
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September 4, 2018: the FDA announced a public hearing on FDA’s approach to enhancing competition and innovation in the biological products marketplace, including facilitating greater availability of biosimilar and interchangeable products.
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September 12, 2018: The FDA announced a public hearing to solicit comments on FDA’s Predictive Toxicology Roadmap, which was issued by FDA on December 6, 2017. FDA is seeking comments on how to foster the development and evaluation of emerging toxicological methods and new technologies and incorporate these methods and technologies into regulatory review.
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September 12, 2018: The FDA announced a public meeting of the Pharmacy Compounding Advisory Committee (PCAC). The PCAC will receive information on balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements.
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September 28, 2018: the FDA announced a conference entitled, Scientific Conference: Opioid and Nicotine Use, Dependence, and Recovery – Influences of Sex and Gender. The purpose of the conference is to discuss the biological and sociological influences on misuse, abuse, and cessation of opioids and tobacco.
II. Congressional Legislation & Committee Action
U.S. Senate
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On July 25, 2018, the Senate Health, Education, Labor, and Pensions Committee held a markup of health-related legislation, including S. 2554 Patient Right to Know Drug Prices Act sponsored by Sen. Susan Collins (R-ME). S. 2554 was advanced by the Committee by a voice vote.
House of Representatives
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On July 24, 2018, the House Energy and Commerce Committee held a hearing entitled, Examining Advertising and Marketing Practices within the Substance Use Treatment Industry. Witnesses present included: Jason Brian, Redwood Recovery Solutions and TreatmentCalls.com; Michael Cartwright, American Addiction Centers; Mark Mishek, Hazelden Betty Ford Foundation; Robert Niznik, Addiction Recovery Now and Niznik Behavioral Health; Dr. Kenneth Stoller, Johns Hopkins Hospital Broadway Center for Addiction; and Marvin Ventrill, National Association of Addiction Treatment Providers.
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On July 26, 2018, the House Energy and Commerce Subcommittee on Health held a hearing entitled, MACRA and MIPS: An Update on the Merit-based Incentive Payment System. Witnesses present included: Dr. David Barbe, American Medical Association; Dr. Frank Opelka, American College of Surgeons; Dr. Parag Parekh, American Society of Cataract and Refractive Surgery; Dr. Ashok Rai, American Medical Group Association; Dr. Kurt Ransohoff, America’s Physicians Groups.
III. Reports, Studies, & Analyses
IV. Other Health Policy News
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On July 26, 2018, a group of Democratic attorneys general filed a lawsuit challenging the Trump Administration’s expansion of association health plans. The court filing is available here.
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