Below is Alston & Bird’s Healthcare 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 January 6, the Centers for Medicare & Medicaid Services released Part I of the 2021 Advance Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part C and Part D Payment Policies. Read more about this policy and other news below.
I. Regulations, Notices, & Guidance
- On January 3, 2020, the Food and Drug Administration (FDA) issued guidance entitled, Enforcement Priorities for Electronic Nicotine Delivery Systems and Other Deemed Products on the Market Without Premarket Authorization. The FDA views the dramatic increase in youth use of Electronic Nicotine Delivery Systems (ENDS) products as a problem that requires an urgent response. This guidance describes, among other things, how FDA intends to prioritize its enforcement resources with regard to the marketing of ENDS that do not have premarket authorization.
- On January 6, 2020, the Drug Enforcement Administration (DEA) issued a final rule entitled, Schedules of Controlled Substances: Placement of Solriamfetol in Schedule IV. This final rule adopts, without change, an interim final rule with request for comments published in the Federal Register on June 17, 2019, placing solriamfetol (2-amino-3-phenylpropyl carbamate), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the Controlled Substances Act (CSA). With the issuance of this final rule, the Drug Enforcement Administration maintains solriamfetol, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.
- On January 6, 2020, the Health Resources and Services Administration (HRSA) issued a notice entitled, Update to the Women’s Preventive Services Guidelines. This update adds one additional service - Screening for Anxiety – to the HRSA-supported Women’s Preventive Services Guidelines to the 11 preventive services that were last updated in 2017. The 11 services included in the 2017 update are: Breast Cancer Screening for Average Risk Women, Breastfeeding Services and Supplies, Screening for Cervical Cancer, Contraception, Screening for Gestational Diabetes Mellitus, Screening for Human Immunodeficiency Virus Infection, Screening for Interpersonal and Domestic Violence, Counseling for Sexually Transmitted Infections, Well-Woman Preventive Visits, Screening for Diabetes Mellitus after Pregnancy, and Screening for Urinary Incontinence.
- On January 10, 2020, FDA issued guidance entitled, Peripheral Percutaneous Transluminal Angioplasty and Specialty Catheters—Premarket Notification (510(k)) Submissions. The FDA is issuing this draft guidance document to provide recommendations for 510(k) submissions for peripheral percutaneous transluminal angioplasty (PTA) balloons and specialty catheters (e.g., infusion catheters, PTA balloon catheters for in-stent restenosis (ISR), scoring/cutting balloons). This draft guidance is not final nor is it in effect at this time.
- January 14, 2020: HRSA announced a public meeting entitled, National Advisory Council on the National Health Service Corps. Calendar Year 2020 meetings and agenda items may include, but are not limited to, the identification of National Health Service Corps (NHSC) priorities for future program issues and concerns; proposed policy changes by using the varying levels of expertise represented on the National Advisory Council on the NHSC to advise on specific program areas; updates from clinician workforce experts; and education and practice improvement in the training development of primary care clinicians.
- January 14, 2020: FDA announced a public meeting entitled, Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application 211802 for oxycodegol, a new molecular entity full mu-opioid receptor agonist, submitted by Nektar Therapeutics, for the management of chronic low back pain in adult patients with pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The committees will be asked to discuss the safety and efficacy data as well as the overall risk-benefit profile of the product.
- January 15, 2020: FDA announced a public meeting entitled, Joint Meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committees will discuss new drug application (NDA) 213426, for tramadol 44 milligrams (mg) and celecoxib 56 mg tablet, which contains a fixed-dose combination of an opioid and a non-steroid anti-inflammatory drug, submitted by Esteve Pharmaceuticals, S.A., for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate. They will also discuss NDA 209653, for an extendedrelease oral tablet formulation of oxycodone, submitted by Intellipharmaceutics Corp., with the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time.
- January 27, 2020: HHS announced a public meeting entitled, Advisory Council on Alzheimer’s Research, Care, and Services. During the meeting, an invited panel will present lessons from epidemiology on understanding current rates of dementia, future trends, and potential preventive strategies. The Advisory Council will hear about the Department of Defense’s Peer Reviewed Alzheimer’s Research Program as well as an update on the recommendations from the Alzheimer’s Disease-Related Dementias Research Summit. Federal workgroups will also provide updates on work completed in the last quarter.
- January 28, 2020: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting entitled, Meeting of the Substance Abuse and Mental Health Services Administration’s National Advisory Council. The meeting will include remarks and dialogue from the Assistant Secretary for Mental Health and Substance Use; updates from the SAMHSA Centers Directors, and a council discussion on clinical trends and emerging national issues with SAMHSA NAC members.
- January 30-31, 2020: HHS announced a public meeting entitled, Meeting of the Advisory Committee on Minority Health. The topics to be discussed during this meeting will include strategies to improve access to and success of clinical prevention services among racial and ethnic minority populations. The recommendations will be given to the Deputy Assistant Secretary for Minority Health to inform efforts related to the Department’s community-wide, chronic disease prevention strategies.
- March 4, 2020: FDA announced a public meeting entitled, Vaccines and Related Biological Products Advisory Committee. The committee will discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines for the 2020 to 2021 influenza season. Also, on March 4, 2020, under Topic II, the committee will meet in open session to hear an overview of the research programs in the Laboratory of Respiratory and Special Pathogens (LRSP), Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.
II. Congressional Hearings
House of Representatives
- On January 8, 2020, the House Committee on Energy and Commerce Subcommittee on Health held a hearing entitled, Legislation to Improve Americans’ Health Care Coverage and Outcomes. Witnesses present included: Dr. Lee Beers, President-Elect, American Academy of Pediatrics; Kenneth Mendez, President and CEO, Asthma and Allergy Foundation of America; Stephanie Zarecky, Ambassador Program and Public Relations Manager, SUDC Foundation; Dr. Matthew Cooper, Director, Kidney and Pancreas Transplantation, Medical Director, QAPI, Medstar Georgetown Transplant Institute, Professor of Surgery, Georgetown University School of Medicine; Kevin Koser, Patient Advocate, National Foundation for Ectodermal Dysplasias; and Fred Riccardi, President, Medicare Rights Center.
III. Reports, Studies, & Analyses
- On January 6, 2020, Kaiser Family Foundation (KFF) published an issue brief entitled, Individual Insurance Market Performance in Late 2019. In this analysis, the authors look at financial data through the third quarter of 2019 to examine how the individual insurance market has responded to the elimination of the individual mandate penalty and resulting changes. They used financial data reported by insurance companies to the National Association of Insurance Commissioners and compiled by Mark Farrah Associates to look at the average premiums, claims, medical loss ratios, and gross margins from third quarter 2011 through third quarter 2019 in the individual insurance market. These figures include coverage purchased through the Affordable Care Act’s (ACA’s) exchange marketplaces and ACA-compliant plans purchased directly from insurers outside the marketplaces (which are part of the same risk pool), as well as individual plans originally purchased before the ACA went into effect. These new data from the first nine months of 2019 suggest that insurers in the individual market remain profitable, and that the risk pool is not significantly sicker than it was while the individual mandate was still in effect.
- On January 8, 2020, KFF published a “Preventative Services Tracker.” The ACA requires new private health insurance plans to cover many recommended preventive services without any patient cost-sharing. As new recommendations are issued or updated, coverage must commence in the next plan year that begins on or after exactly one year from the recommendation’s issue date. This tracker presents up-to-date information on the adult preventive services nongrandfathered private plans must cover, by condition, including a summary of the recommendation, the target population, the effective date of coverage, and related federal coverage clarifications.
IV. Other Health Policy News
- On January 6, 2020, HHS and the Centers for Medicare & Medicaid Services (CMS) announced that Brad Smith will serve as Director of the Center for Medicare & Medicaid Innovation (CMMI) at CMS and Senior Advisor to Secretary Azar for Value-Based Transformation. Smith most recently served as the Chief Operating Officer of Anthem’s Diversified Business Group and was previously co-founder and CEO of Aspire Health, a healthcare company focused on providing home-based palliative care services to patients facing serious illnesses. Read more about his appointment to CMMI here.
- On January 6, 2020, CMS released Part I of the 2021 Advance Notice of Methodological Changes for Medicare Advantage (MA) Capitation Rates and Part C and Part D Payment Policies, which contains key information about proposed updates to the Part C CMS-Hierarchical Condition Categories (HCC) risk adjustment model and the use of encounter data. The call letter addressed to MA organizations and prescription drug plan sponsors can be found here.