Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and analyses; and other health policy news.
I. Regulations, Notices, & Guidance
- On July 15, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications. FDA has identified certain submission types that FDA believes warrant an exemption (Type III drug master files (DMFs)) or a long-term waiver (certain positron emission tomography (PET) drug products and certain Type II DMFs supporting PET drugs or noncommercial submissions or applications) from the requirement to submit to the Agency in electronic common technical document (eCTD) format. In addition, this guidance outlines certain circumstances where FDA may determine that a short-term waiver from eCTD submission requirements could be granted. This guidance is a revision of the final guidance issued on January 29, 2019, and when finalized, will supersede that guidance.
- On July 16, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule entitled, Medicare and Medicaid Programs: Requirements for Long-Term Care Facilities: Regulatory Provisions to Promote Efficiency, and Transparency. This proposed rule would reform the Medicare and Medicaid long-term care requirements that the CMS has identified as unnecessary, obsolete, or excessively burdensome. This rule would increase the ability of health care professionals to apportion resources to improving resident care by eliminating or reducing requirements that impede quality care or that divert resources away from providing high quality care.
- On July 16, 2019, the CMS issued a rule entitled, Medicare and Medicaid Programs: Revision of Requirements for Long Term Care Facilities: Arbitration Agreements. This final rule amends the requirements that Long-Term Care (LTC) facilities must meet to participate in the Medicare and Medicaid programs. Specifically, CMS is repealing the prohibition on the use of pre-dispute, binding arbitration agreements. They are also strengthening the transparency of arbitration agreements and arbitration in LTC facilities. This final rule supports residents' rights to make informed choices about important aspects of their health care. The regulations are effective on September 16, 2019.
- On July 17, 2019, the FDA issued guidance entitled, Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues. This guidance describes the FDA’s current recommendations regarding the overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone (GnRH) analogues for treating advanced prostate cancer.
- On July 17, 2019, the Internal Revenue Service issued notice of guidance entitled, Additional Preventive Care Benefits Permitted to be Provided by a High Deductible Health Plan Under § 223. This notice expands the list of preventative care benefits permitted to be provided by a high deductible health plan (HDHP) under section 223(c)(2) of the Internal Revenue Code without a deductible, or with a deductible below the applicable minimum deductible (self-only or family) for an HDHP.
- August 1, 2019: HHS announced a public meeting entitled, Advisory Committee on Heritable Disorders in Newborns and Children. The purpose of this meeting is to solicit public comments on the condition nomination, evidence review, and decision-making processes. The Committee can accommodate oral comments made in person or via the telephone.
- August 6 and August 7, 2019: Department of Health and Human Services (HHS) announced a public meeting entitled, National Committee on Vital and Health Statistics. The goal of this expert roundtable meeting is to identify research questions to inform evaluation of the benefit and cost of transition from International Classification of Diseases-10 (ICD-10) to ICD-11 for mortality and morbidity. Specific meeting objectives include: developing a shared understanding of lessons from the ICD-10 planning process/transition and the differences between ICD-10 and ICD-11; reaching consensus on the research questions to be answered to inform evaluation of cost and benefit of transition from ICD-10 to ICD-11 for mortality and morbidity—and to identify impacts of not moving to ICD-11 for morbidity; and identifying key topics and messages to communicate to the industry to foster early stakeholder engagement and preparation for the transition to ICD-11.
House of Representatives
- On July 16, 2019, the House Energy and Commerce Committee Subcommittee on Oversight and Investigations held a hearing entitled, Oversight of Federal Efforts to Combat the Spread of Illicit Fentanyl. Witnesses present included: Kemp Chester, Assistant Director of the National Opioids and Synthetics Coordination Group, White House Office of National Drug Control Policy; Matthew Donahue, Regional Director North and Central Americas, Operation Division, Drug Enforcement Administration, U.S. Department of Justice; Thomas Overacker, Executive Director, Office of Field Operations, Customs and Border Protection, U.S. Department of Homeland Security; Gary Barksdale, Chief Postal Inspector, U.S. Postal Service; David A. Prince, Deputy Assistant Director, Transnational Organized Crime, Homeland Security Investigations, Immigration and Customs Enforcement, U.S. Department of Homeland Security; and Carol Cave, Director, Office of Enforcement and Import Operations, Office of Regulatory Affairs, Food and Drug Administration, U.S. Department of Health and Human Services.
- On July 17, 2019, the House Energy and Commerce Committee held a markup of 25 bills, eight of which were health bills. Legislation included: H.R. 2781, Educating Medical Professionals and Optimizing Workforce Efficiency and Readiness for Health Act (EMPOWER for Health Act) of 2019; H.R. 728, Title VIII Nursing Workforce Reauthorization Act of 2019; H.R. 1058, Autism CARES Act of 2019; H.R. 2507, Newborn Screening Saves Lives Reauthorization Act of 2019; H.R. 776, Emergency Medical Services for Children Program Reauthorization Act of 2019; H.R. 2035, Lifespan Respite Care Reauthorization Act of 2019; H.R. 2296, More Efficient Tools to Realize Information for Consumers Act (the METRIC Act); and H.R. 2328, Reauthorizing and Extending America’s Community Health Act (the REACH Act) (which now incorporates H.R. 3631 and H.R. 3630). All eight bills, as amended, were favorably forwarded to the House.
III. Reports, Studies, & Analyses
- On July 19, 2019, MedPAC released its annual data book, Health Care Spending and the Medicare Program. The MedPAC Data Book provides information on national health care and Medicare spending, as well as Medicare beneficiary demographics, duel-eligible beneficiaries, quality of care in the Medicare program, and Medicare beneficiary and other payer liability. It also examines provider settings—such as hospitals and post-acute care—and presents data on Medicare spending, beneficiaries’ access to care in the setting (measured by the number of beneficiaries using the service, number of providers, volume of services, length of stay, or through direct surveys), and the sector’s Medicare Profit margins, if applicable. In addition, it covers the Medicare Advantage program and prescription drug coverage for Medicare beneficiaries, including Part D.
IV. Other Health Policy News
- On July 18, 2019, the Department of Health and Human Services, through the Health Resources and Services Administration (HRSA), awarded approximately $20 million in Rural Residency Planning and Development Program (RRPD) grants. Recipients across 21 states will receive up to $750,000 over a three-year period to develop new rural residency programs while achieving accreditation through the Accreditation Council for Graduate Medical Education. More information about this action is available here.
- On July 17, 2019, the House voted the repeal the Affordable Care Act’s High-Cost Plan Tax (HCPT), also known as the “Cadillac Tax.” For more information about this decision and the tax, read about it here.