Alston & Bird Health Care Week in Review, October 25, 2019

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 October 22, CMS announced that the average premium for the second lowest cost silver plan on HealthCare.gov for a 27-year-old will drop by 4 percent for the 2020 coverage year. Read more about this below.

I. Regulations, Notices, & Guidance

• On October 22, 2019, the Drug Enforcement Administration (DEA) issued a proposed rule entitled, Management of Quotas for Controlled Substances and List I Chemicals. DEA proposes to revise existing regulations that manage the quotas for controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, held by DEA-registered manufacturers. This rule would define the types of quotas, update the method to abandon quota, clarify the current language to ensure that both manufacturers and distributors are required to obtain certification of a buyer’s quota, reduce overall inventories, formalize the existing practice of use-specific subcategories for individual manufacturing and procurement quotas, and modify existing deadlines to fix/issue quotas. The DEA is also amending certain regulations to implement updates to the Controlled Substances Act made by the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act.
• On October 24, 2019, the Department of Health and Human Services (HHS) issued a rule entitled, Mandatory Guidelines for Federal Workplace Drug Testing Programs—Oral/Fluid. This rule establishes scientific and technical guidelines for the inclusion of oral fluid specimens in the Mandatory Guidelines for Federal Workplace Drug Testing Programs.
• On October 24, 2019, the Food and Drug Administration (FDA) issued guidance entitled, Postmarketing Studies and Clinical Trials—Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act. This draft guidance describes the multiple factors that FDA considers, before requiring a postmarketing study or clinical trial for the purposes described in the Federal Food, Drug, and Cosmetic Act (FD&C Act), when determining the sufficiency of the reports under the FD&C Act and the active postmarket risk identification and analysis (ARIA) system available under the FD&C Act to meet these purposes. The draft guidance is also being revised to reflect certain provisions enacted under the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act as they relate to postmarketing studies and clinical trials.
• On October 24, 2019, FDA issued guidance entitled, Drug Products Labeled as Homeopathic. The revised draft guidance describes how FDA intends to prioritize enforcement and regulatory action with regard to drug products, including biological products, labeled as homeopathic and marketed in the United States without the required FDA approval that potentially pose higher risk to public health.
• On October 24, 2019, FDA issued a rule entitled, Medical Devices; Orthopedic Devices; Classification of Orthopedic Surgical Instrumentation Designed for Osteochondral Implants With Press-Fit Fixation. This rule classifies the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation’s classification.
• On October 25, 2019, HHS issued a rule entitled, Administrative Simplification: Rescinding the Adoption of the Standard Unique Health Plan Identifier and Other Entity Identifier. This final rule rescinds the adopted standard unique health plan identifier (HPID) and the implementation specifications and requirements for its use and the other entity identifier (OEID) and implementation specifications for its use. This final rule also removes the definitions for the “Controlling health plan" (CHP) and "Subhealth plan" (SHP).

Event Notices         

• October 31, 2019: FDA announced a public meeting entitled, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Global Meeting on E8(R1) Guideline on General Considerations for Clinical Trials. The purpose of the meeting is to provide information on the draft revised E8(R1) Guideline “General Considerations for Clinical Trials” (ICH E8 Guideline) following the closing of the FDA comment period and closing of the regional consultations conducted in other ICH regions. The ICH E8 Guideline is being revised to provide updated guidance that is both appropriate and flexible enough to address the increasing diversity of clinical trial designs and data sources being employed to support regulatory and other health policy decisions, while retaining the underlying principles of human subject protection and data quality.
• November 4, 2019: FDA announced a public meeting entitled, Health Canada and United States Food and Drug Administration Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. The purpose of the public meeting is to provide information and solicit public input on the current activities of the ICH, as well as the upcoming ICH Assembly Meeting and the Expert Working Group Meetings in Singapore scheduled for November 16 through November 20, 2019.
• November 5-6, 2019: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, Meeting of the National Advisory Council on Nurse Education and Practice. During meeting, NACNEP will welcome new members to the Council and discuss strategic priorities for nursing education and practice in preparation for the development of the Council’s 17th Report to Congress.
• November 12, 2019: FDA announced a public workshop entitled, Advancing the Development of Pediatric Therapeutics: Pediatric Clinical Trial Endpoints for Rare Diseases with a Focus on Pediatric Patient Perspectives. The purpose of this workshop is to discuss pediatric patient-specific engagement in the development of clinical trial endpoints for rare diseases. In this workshop, FDA will obtain the pediatric patient perspective on their disease/condition and what is most important to consider when designing rare disease trials. There will also be discussion regarding patients’ thoughts on clinical endpoints that are currently being used in clinical trials, potential areas of innovation, and how to create processes that might include pediatric patients and their caregivers as collaborators in endpoint development in early stages of medical product development (e.g., protocol design).
• November 13-14, 2019: FDA announced a public meeting entitled, Immunology Devices Panel of the Medical Devices Advisory Committee. The committee will discuss the topic of immunological responses to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam.
• November 6-7, 2019: The Centers for Disease Control and Prevention (CDC) announced a public meeting entitled, Clinical Laboratory Improvement Advisory Committee. The agenda will include agency updates from CDC, CMS, and FDA. Presentations and discussions will focus on a follow up on CLIAC recommendations; an update on the clinical laboratory workforce; improving integration of laboratory information systems with electronic health records; and future CLIAC topics. There will be an extended public comment session focusing on emerging technologies and the clinical laboratory. Agenda items are subject to change as priorities dictate.
• November 7, 2019: FDA announced a public meeting entitled, Promoting Effective Drug Development Programs: Opportunities and Priorities for the Food and Drug Administration's Office of New Drugs. The purpose of the meeting is to solicit specific, actionable policy suggestions that could be implemented in the near-term by the review staff of the Center for Drug Evaluation and Research's Office of New Drugs to promote effective drug development programs without compromising FDA regulatory standards for the assessment of safety and effectiveness.
• November 13, 2019: FDA announced a public meeting entitled, Endocrinologic and Metabolic Drugs Advisory Committee. The committee will discuss supplemental new drug application (sNDA) 204629/S-020 for empagliflozin oral tablet, sponsored by Boehringer Ingelheim Pharmaceuticals, Inc., for the following proposed indication: as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes mellitus.
• November 13-14, 2019: HHS announced a public meeting entitled, Meeting of the CDC/HRSA Advisory Committee on HIV, Viral Hepatitis and STD Prevention and Treatment. The purpose of the meeting is to discuss issues related to the President’s initiative on “Ending the HIV Epidemic: A Plan for America,” building community capacity, strategies for engaging people with HIV who are out of care, models of clinical care, workforce issues, pre-exposure prophylaxis services in community health centers, and pending committee reports.
• November 21, 2019: FDA announced a public meeting entitled, Pediatric Stakeholder Meeting. The purpose of the meeting is to solicit input from patient/parent groups, consumer groups, regulated industry, academia, and other interested parties to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatrics, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).
• November 22, 2019: FDA announced a public meeting entitled, Blood Products Advisory Committee. The committee will meet in open session to discuss scientific considerations for cold stored platelet products intended for transfusion, including product characterization, duration of storage and clinical indications for use. The committee will hear presentations on available characterization and functional studies of cold stored platelets, clinical studies, and the potential role of cold stored platelets in clinical care in military and civilian patient populations. The committee will also discuss the clinical studies needed to support the indications for use of cold stored platelet products stored beyond 3 days.
• December 5-6, 2019: The National Institute of Health (NIH) announced a public workshop entitled, National Center for Advancing Translational Sciences. This workshop is being held to discuss challenges around finding new uses for drugs that are already on the market but lack commercial and regulatory incentives for research and development.
• December 16-17, 2019: The Centers for Medicare and Medicaid Services (CMS) announced a town hall meeting entitled, Medicare Program; Town Hall Meeting on the FY 2021 Applications for New Medical Services and Technologies Add-On Payments. CMS is holding this meeting in accordance with section 1886(d)(5)(K)(viii) of the Social Security Act (the Act) to discuss Fiscal Year (FY) 2021 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system. Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2021 new medical services and technologies applications meet the substantial clinical improvement criterion.

II. Congressional Hearings

House of Representatives

• On October 22, 2019, the House Committee on Ways and Means held a markup of five health bills. Legislation included: H.R. 3, the Lower Drug Costs Now Act of 2019; H.R. 4665, the Medicare Vision Act of 2019; H.R. 4618, the Medicare Hearing Act of 2019; H.R. 4650, the Medicare Dental Act of 2019; and H.R. 3398, the Pathways to Health Careers Act of 2019. All five bills, as amended, were favorably forwarded to the House.
• On October 23, 2019, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing entitled, Sabotage: The Trump Administration's Attack on Health Care. The only witness was CMS Administrator Seema Verma.
• On October 23, 2019, the House Committee on Ways and Means held a markup of four tax and health bills. Legislation included: H.R. 4742, the Protecting American Lungs Act of 2019; H.R. 4716, the Inhaler Coverage and Access Now (I CAN) Act; H.R. 1922, the Restoring Access to Medication Act of 2019; and H.R. 3708, the Primary Care Enhancement Act of 2019.

Senate

• On October 24, 2019, the Senate Finance Committee held a hearing entitled, Treating Substance Misuse in America: Scams, Shortfalls, and Solutions. Witnesses present included: Jerome Adams, MD, MPH, Surgeon General, Office of the Secretary, HHS; Mary Denigan-Macauley, PhD, Director, Health Care, U.S. Government Accountability Office (GAO); Gary L. Cantrell, Deputy Inspector General for Investigations, Office of Inspector General (OIG), HHS; and Gary Mendell, Founder and CEO, Shatterproof.

III. Reports, Studies, & Analyses

• On October 22, the Bipartisan Policy Center published a report examining two different approaches to U.S. drug pricing: external reference pricing and internal reference pricing. External reference pricing uses the prices of drugs in other countries in order to potentially set or negotiate the price of drugs. It focuses largely on single-source brand-name drugs or biologics without therapeutic or generic competition. Internal reference pricing, which can ensure that therapeutically equivalent drugs are priced similarly, encourages the use of the least costly alternative therapy
• On October 24, the Kaiser Family Foundation (KFF) published an issue brief providing an overview of the Medicare Advantage plans that will be available for 2020, based on an analysis of data from CMS. KFF’s findings include: the number of plans, the variation in plan concentration across counties, number of firms, insurers entering and exiting the market, and extra benefits covered by the plans.
• On October 24, GAO published two reports on substance use disorder treatment. The first report, entitled Prevalence of Recovery Homes, and Selected States' Investigations and Oversight, examines state efforts to establish oversight of recovery homes. Although recovery homes can play an important role in the addiction treatment space, due to inconsistent oversight, it can be difficult to distinguish between legitimate and fraudulent facilities. Furthermore, GAO found there is incomplete data on the prevalence of recovery homes, so it is difficult to fully understand the extent of this fraud. The second report, entitled Opioid Use Disorder Services for Pregnant and Postpartum Women, and Children, details GAO’s evaluation of the various opioid addiction treatment services that Medicaid can cover for low-income pregnant and postpartum women.

IV. Other Health Policy News

• On October 22, CMS announced that the average premium for the second lowest cost silver plan on HealthCare.gov for a 27-year-old will drop by 4 percent for the 2020 coverage year. Additionally, 20 more issuers will participate in states that use the Federal Health Insurance Exchange platform in 2020 bringing the total to 175 issuers compared to 132 in 2018, delivering more choice and competition for consumers. Read more about the announcement here.
• On October 23, HHS announced $319 million in scholarship and loan repayment awards for clinicians and students through the National Health Service Corps (NHSC). With these providers entering NHSC service, there are now more than 13,000 medical, dental and behavioral health care clinicians providing quality care to more than 13.7 million Americans in rural, urban and tribal communities. There are also almost 1,480 students and medical residents preparing to serve in the Corps. Read more about this decision here.