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- On April 23, 2019, the Food and Drug Administration (FDA) issued a draft guidance entitled, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C. The draft guidance, if finalized, would establish guidance for industry and FDA staff regarding timely initiation of voluntary recalls of FDA-regulated products. The draft guidance discusses what preparations firms in a distribution chain, including manufacturers and distributors, should consider making to establish recall initiation procedures; to ensure timely identification of, and response to, product problems that might lead to a recall; and to promptly issue recall communications and press releases or other public notices. It also discusses preparations that firms in a distribution chain should consider making to ensure timely responses to a recall communication. In addition, it discusses how FDA assists firms with carrying out their recall responsibilities to protect the public health from distributed products in violation of the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA.
- On April 23, 2019, the FDA issued guidance entitled, Compliance Policy for Combination Product Postmarketing Safety Reporting; Immediately in Effect Guidance for Industry. This guidance describes FDA’s compliance policy for combination product applicants and constituent part applicants and activities under FDA regulations that addresses combination product postmarketing safety reporting. FDA is updating this guidance by extending the period of time during which FDA does not intend to enforce certain combination product postmarketing safety reporting requirements.
- On April 23, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Proposed Policy Changes and Fiscal Year 2020 Rates; Proposed Quality Reporting Requirements for Specific Providers; Medicare and Medicaid Promoting Interoperability Programs Proposed Requirements for Eligible Hospitals and Critical Access Hospitals. CMS is proposing to revise the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems for FY 2020 and to implement certain recent legislation. CMS is proposing to make changes relating to Medicare graduate medical education (GME) for teaching hospitals and payments to critical access hospital (CAHs). In addition, CMS is proposing to provide the market basket update that would apply to the rate-of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis, subject to these limits for FY 2020. CMS is proposing to update the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) for FY 2020. In this proposed rule, CMS is including proposals to address wage index disparities between high and low wage index hospitals; to provide for an alternative IPPS new technology add-on payment pathway for certain transformative new devices; and to revise the calculation of the IPPS new technology add-on payment. In addition, CMS is requesting public comments on the substantial clinical improvement criterion used for evaluating applications for both the IPPS new technology add-on payment and the OPPS transitional pass-through payment for devices, and CMS discusses potential revisions that they are considering adopting as final policies related to the substantial clinical improvement criterion for applications received beginning in FY 2020 for IPPS (that is, for FY 2021 and later new technology add-on payments) and beginning in CY 2020 for the OPPS. CMS is proposing to establish new requirements or revise existing requirements for quality reporting by specific Medicare providers (acute care hospitals, PPS-exempt cancer hospitals, and LTCHs). CMS also is proposing to establish new requirements and revise existing requirements for eligible hospitals and critical access hospitals (CAHs) participating in the Medicare and Medicaid Promoting Interoperability Programs. Lastly, CMS is proposing to update policies for the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program.
- On April 26, 2019, the Department of Health and Human Services (HHS) issued a notice entitled, Notification of Enforcement Discretion Regarding HIPAA Civil Money Penalties. This notification is to inform the public that HHS is exercising its discretion in how it applies HHS regulations concerning the assessment of Civil Money Penalties (CMPs) under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as such provision was amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act. Current HHS regulations apply the same cumulative annual CMP limit across four categories of violations based on the level of culpability. As a matter of enforcement discretion, and pending further rulemaking, HHS will apply a different cumulative annual CMP limit for each of the four penalties tiers in the HITECH Act.
- April 29, 2019: The FDA announced a public meeting entitled, Perspectives on the Impact of Rare Diseases: Bridging the Commonalities. The meeting is intended to obtain patients’ and caregivers’ perspectives on impacts of rare diseases on daily life and to asses commonalities that may help the FDA and medical product developers further understand and advance the development of treatments for rare diseases.
- May 9 – 10, 2019: The FDA announced a meeting of the Pain Management Best Practices Inter-Agency Task Force. The Task Force will review clinical guidelines and identify gaps and/or inconsistencies for best practices for pain management.
- May 13, 2019: The FDA announced a public meeting entitled, The Future of Insulin Biosimilars: Increasing Access and Facilitating the Efficient Development of Biosimilar and Interchangeable Insulin Products. The hearing is set to discuss access to affordable insulin products and issues related to the development and approval of biosimilar and interchangeable insulin products.
- June 11, 2019: The FDA announced a public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The Committee will discuss clinical utility and safety concerns associated with the higher range of opioid analgesic dosing in the outpatient setting.
- There were no health-related hearings this week.
House of Representatives
- There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On April 23, 2019, IQVIA issued a report entitled, The Changing Landscape of Research and Development: Innovation, Drivers of Change, and Evolution of Clinical Trial Productivity. The report found that, in 2018, 59 new active substances (i.e., new drugs) were approved and launched in the United States of which 27 percent were new therapies to treat cancer and 20 percent were for the treatment of infectious diseases. The report concludes that research and development is increasingly geared toward specialty drugs.
IV. Other Health Policy News
- On April 22, 2019, the Centers for Medicare & Medicaid Innovation announced the CMS Primary Cares Initiative, which consists of five new voluntary payment models under two paths: (1) Primary Care First, intended for smaller practices; and (2) Direct Contracting, intended for larger entities. The models are intended to increase opportunities for primary care providers and other organizations to participate in alternative payment models and take on risk. CMS estimates that these models could include 25 percent of the Medicare beneficiary population and hopes to eventually expand these models to Medicaid and private insurers. Additional information on the Primary Care First models is available here and information on the Direct contracting models is available here.