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.
Week in Review Highlight of the Week:
On Thursday, HHS issued over $35 million in awards as part of the agency’s efforts to increase access to high quality care in rural communities. Read more about these awards and other news below.
I. Regulations, Notices & Guidance
- On August 17, 2020, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Department of Health and Human Services Good Guidance Practices. HHS proposes to issue regulations governing the agency’s release and maintenance of guidance documents. These regulations would help to ensure that the public receives appropriate notice of new guidance and that HHS guidance does not impose obligations on regulated parties that are not already reflected in duly enacted statutes or regulations lawfully promulgated under them.
- On August 17, 2020, the Food and Drug Administration (FDA) issued a final rule entitled, Medical Devices; Petition for an Administrative Stay of Action: Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior. The FDA is providing notice of a stay of the effectiveness of provisions for devices in use on specific individuals who have or would need to obtain a physician-directed transition plan as of the date of publication on March 6, 2020, of the final regulation banning electrical stimulation devices (ESDs) for self-injurious or aggressive behavior. FDA is publishing this notification in response to petitions for an administrative stay of action in accordance with regulatory requirements.
- On August 18, 2020, FDA issued guidance entitled, Compliance Policy for the Quantity of Bioavailability and Bioequivalence Samples Retained Under 21 CFR 320.38(c). This guidance describes FDA's policy concerning the conditions under which the Agency generally does not intend to take regulatory action against an applicant or a contract research organization (CRO) that retains less than the quantity of reserve samples (that is, samples of the test article and reference standard that were used in bioavailability (BA) or bioequivalence (BE) testing) required in our regulations. FDA developed this guidance in light of technological advances in FDA's ability to test retention samples and in response to communications from applicants and CROs requesting to retain a lower quantity of these reserve samples.
- On August 19, 2020, FDA issued guidance entitled, Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers. FDA is issuing this guidance to provide answers to frequently asked questions about regulatory and policy issues related to inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of HHS on January 31, 2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (42 U.S.C. 247d(a)(2)).
- On August 20, 2020, FDA issued a final rule entitled, Revocation of the Test for Mycoplasma. The FDA is issuing a final rule to remove the specified test for the presence of Mycoplasma for live virus vaccines and inactivated virus vaccines produced from in vitro living cell cultures. The rule is being finalized because the existing test for Mycoplasma is overly restrictive in that it identifies only one test method in detail to be used even though other methods also may be appropriate. More sensitive and specific methods exist and are currently being practiced, and removal of the specific method to test for Mycoplasma provides flexibility for accommodating new and evolving technology and capabilities without diminishing public health protections. This action is part of FDA’s implementation of Executive Orders under which FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve our public health mission and fulfill statutory obligations.
- August 26, 2020: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines.
- August 26-27, 2020: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Blood and Tissue Safety and Availability. The committee will discuss recommendations to improve the blood community’s response to future public health emergencies. In order to facilitate this discussion, key stakeholders from across the nation will present on their lessons learned during the latest pandemic. The committee will analyze strengths and weaknesses from the COVID-19 response on the blood community and blood supply.
- August 28, 2020: FDA announced a public meeting entitled, Meeting on the Center for Drug Evaluation and Research Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program—Summer 2020. The purpose of the public meeting is to ensure that as standard core sets of clinical outcome assessments (COAs) are developed as part of the FDA pilot grant program, the identified concepts, COAs, and endpoints reflect what is most important to patients and relevant to regulatory and potentially other stakeholder decision making.
- August 31, 2020: The Centers for Medicare & Medicaid Services (CMS) announced a public meeting entitled, Meeting of the Advisory Panel on Hospital Outpatient Payment. The purpose of the Panel is to advise the Secretary of the Department of Health and Human Services (HHS) and the CMS Administrator concerning the clinical integrity of the Ambulatory Payment Classification groups and their associated weights, and supervision of hospital outpatient therapeutic services. The advice provided by the Panel will be considered as CMS prepares the annual updates for the hospital outpatient prospective payment system.
- September 8-9, 2020: FDA announced a public meeting entitled, Meeting of the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. During the meeting, the committee will discuss the classification of several medical devices.
- September 14, 2020: HHS announced a public meeting entitled, Meeting of the National Committee on Vital and Health Statistics. The National Committee on Vital and Health Statistics (NCVHS), Subcommittee on Privacy, Confidentiality, and Security, will explore the privacy, confidentiality, and security considerations for data collection and use during a public health emergency, in light of the nationwide COVID-19 pandemic.
- September 15, 2020: FDA announced a public meeting entitled, Meeting of the Pediatric Advisory Committee. The committee will discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Pub. L. 107-109) and the Pediatric Research Equity Act of 2003 (Pub. L. 108-155).
- September 22, 2020: CDC announced a public meeting entitled, Meeting of the Advisory Committee on Immunization Practices (ACIP). The agenda will include discussions on COVID-19 vaccines.
- September 23-24, 2020: HHS announced a public meeting entitled, Meeting of the National Vaccine Advisory Committee (NVAC). During the September 2020 NVAC meeting, sessions will focus on future coronavirus vaccines, the upcoming flu season, immunization equity, and routine vaccination.
- October 2, 2020: FDA announced a public meeting entitled, Meeting of the Vaccines and Related Biological Products Advisory Committee. The committee will discuss and make recommendations on the selection of strains to be included in an influenza virus vaccine for the 2021 southern hemisphere influenza season.
- October 30, 2020: FDA announced a public workshop entitled, New Drugs Regulatory Program Modernization: Implementation of the Integrated Assessment of Marketing Applications and Integrated Review Documentation. The purpose of the public workshop is to seek public comments/feedback on the Integrated Review documentation generated by the new Integrated Assessment of marketing applications for new drug products developed as part of the New Drugs Regulatory Program Modernization.
II. Congressional Hearings
There were no Congressional events this week.
III. Reports, Studies & Analyses
- On August 17, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, Racial Disparities in COVID-19: Key Findings from Available Data and Analysis. Over the course of the COVID-19 pandemic, there has been a growing focus on its disproportionate impacts on people of color, particularly as availability of data to understand racial disparities has increased. This brief summarizes key findings from data and analyses examining COVID-19 related cases, deaths, hospitalizations, and testing by race and ethnicity as of early August 2020 to provide increased insight into these disparities.
- On August 20, 2020, KFF published an issue brief entitled, Cost-Sharing Waivers and Premium Relief by Private Plans in Response to COVID-19. This brief estimates the number of enrollees in individual and fully-insured group market plans that have waived cost-sharing—out-of-pocket costs including coinsurance, copayments, and deductibles—for COVID-19 treatment. The analysis also estimates the number of enrollees whose insurer is offering various forms of premium payment relief.
- On August 20, 2020, KFF published an issue brief entitled, Mail Delays Could Affect Mail-Order Prescriptions for Millions of Medicare Part D and Large Employer Plan Enrollees. Getting prescriptions through mail-order pharmacies can offer convenience and cost savings to patients. Many large group plan enrollees choose to fill prescriptions at reduced cost through the mail, while others are only able to fill scripts at a mail-order pharmacy. To understand who may be most affected by delays in the delivery of prescription drugs, this brief analyzes use of mail order in Medicare Part D and large group employer plans, and identifies the therapeutic classes and specific drugs with the highest volume of fills by mail-order pharmacies in each market.
IV. Other Health Policy News
- On August 17, 2020, CMS announced it will resume routine inspections of all Medicare and Medicaid certified providers and suppliers to improve the safety and quality of life of patients and residents. CMS had previously suspended certain routine inspections as part of its response to the COVID-19 pandemic to prioritize infection control and immediate jeopardy situations and to give health care providers and suppliers time needed to respond to the spread of COVID-19. More information about this announcement can be found here.
- On August 19, 2020, HHS issued a third amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to increase access to lifesaving childhood vaccines and decrease the risk of vaccine-preventable disease outbreaks as children across the United States return to daycare, preschool and school. The amendment authorizes State-licensed pharmacists (and pharmacy interns acting under their supervision to administer vaccines, if the pharmacy intern is licensed or registered by his or her State board of pharmacy) to order and administer vaccines to individuals ages three through 18 years, subject to several requirements. More information about this amendment can be found here.
- On August 19, 2020, CMS issued a Joint Informational Bulletin with the U.S. Department of Housing and Urban Development (HUD), the U.S. Department of Agriculture (USDA), and three other HHS agencies—the Administration for Community Living (ACL), the CDC, and HRSA. The Bulletin provides state Medicaid agencies, state and local housing agencies, state and local public health agencies, and other health and housing entities with information on existing federal resources available to help improve health and housing outcomes for older adults and those with disabilities in rural America. It also discusses a wide variety of federal resources that can be used to help reducephysical environmental barriers in the home, increase safety, minimize the risk of falls, and support a person’s ability and desire to remain in their own home. The informational bulletin can be found here.
- On August 20, 2020, HHS, through the Health Resources and Services Administration (HRSA), awarded over $35 million to more than 50 rural organizations across 33 states as part of a sustained federal effort to increase access to high quality care in rural communities. The awards reflect investments in key areas including telehealth, health workforce training, health research, technical assistance for vulnerable rural hospitals and HIV care and treatment. Additional information on these awards can be found here.