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 November 7, 2018, the Department of Health and Human Services (HHS) issued rules entitled, Moral Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act and Religious Exemptions and Accommodations for Coverage of Certain Preventive Services Under the Affordable Care Act. These rules finalize the interim final rules issued in the Federal Register on October 13, 2017 concerning moral and religious exemptions and accommodations regarding coverage of certain preventative services. These rules finalize expanded exemptions to protect moral and religious beliefs for certain entities and individuals whose health plans are subject to a mandate of contraceptive coverage through guidance issued pursuant to the Patient Protection and Affordable Care Act. These rules do not alter the discretion of the Health Resources and Services Administration, a component of the U.S. Department of Health and Human Services, to maintain the guidelines requiring contraceptive coverage where no recognized regulatory objection exists. These rules also leave in place an optional “accommodation” process for certain exempt entities that wish to use it voluntarily. These rules do not alter multiple other federal programs that provide free or subsidized contraceptives for women at risk of unintended pregnancy.
- On November 7, 2018, HHS issued a proposed rule entitled, Patient Protection and Affordable Care Act; Exchange Program Integrity. This proposed rule would revise standards relating to oversight of Exchanges established by states, periodic data matching frequency and authority, and the length of a consumer’s authorization for the Exchange to obtain updated tax information. This proposed rule would also propose new requirements for certain issuers related to the collection of a separate payment for the premium portion attributable to coverage for certain abortion services. Many of these proposed changes would help strengthen Exchange program integrity.
- On November 8, 2018, the Centers for Medicare & Medicaid Services (CMS) issued a rule entitled, Medicaid Program; Medicaid and Children’s Health Insurance Plan Managed Care. This proposed rule advances CMS’ efforts to streamline the Medicaid and Children’s Health Insurance Plan (CHIP) managed care regulatory framework and reflects a broader strategy to relieve regulatory burdens; support state flexibility and local leadership; and promote transparency, flexibility, and innovation in the delivery of care. These proposed revisions of the Medicaid and CHIP managed care regulations are intended to ensure that the regulatory framework is efficient and feasible for states to implement in a cost-effective manner and ensure that states can implement and operate Medicaid and CHIP managed care programs without undue administrative burdens.
- November 27, 2018: The Food and Drug Administration (FDA) announced a public meeting entitled, Identifying the Root Causes of Drug Shortages and Finding Enduring Solutions. The purpose of the hearing is to give stakeholders the opportunity to provide input on the underlying systemic causes of drug shortages and make recommendations for actions to prevent or mitigate drug shortages.
- December 5, 2018: The FDA announced a public hearing to discuss its efforts to eliminate youth electronic cigarette use as well as other tobacco use, with a focus on the potential role of drug therapies to support youth e-cigarette cessation and the issues impacting the development of such therapies.
- December 5-6, 2018: The Centers for Disease Control and Prevention (CDC) announced a meeting of the Board of Scientific Counselors, Office of Infectious Diseases (BSC OID). The BSC OID will hear updates from the infectious disease national centers and discuss recent outbreaks and affected populations.
- December 11, 2018: The FDA announced a public meeting entitled, Drug Development Tool Process under the 21st Century Cures Act and PDUFA VI. The meeting is intended to fulfill commitments made by FDA under the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI) and the 21st Century Cures Act (Cures Act) by soliciting comments on Drug Development Tool Qualification at FDA related to the qualification process under section 507 of the Federal Food, Drug, and Cosmetic Act (FD&C Act); discussing taxonomy for biomarkers and related concepts used in drug development; and planning activities to define a framework with appropriate standards and scientific approaches to support qualification for a specified context of use.
- There were no health-related hearings this week.
House of Representatives
- There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On November 7, 2018, the Urban Institute released a study entitled, How Have Workers Fared Under the ACA? The report found that from 2010 to 2016, occupations that experienced greater coverage under the ACA were not more likely to experience adverse labor market consequences. The authors found no association between changes in worker coverage rates within an occupation and changes in employment levels, the number of hours worked, or weekly earnings.
IV. Other Health Policy News
- On November 8, 2018, the Medicaid and CHIP Payment and Access Commission (MACPAC) sent a letter to HHS Secretary Azar regarding Arkansas’s work and community requirements. MACPAC’s letter is available here.