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 January 30, 2019, the Department of Health and Human Services (HHS) issued a proposed rule entitled, Administrative Simplification: Modification of the Requirements for the Use of Health Insurance Portability and Accountability Act of 19996 (HIPPA) National Council for Prescription Drug Programs (NCPDP) D.0 Standard. This proposed rule would adopt a modification to the requirements for the use of the Telecommunication Standard Implementation Guide, Version D, Release 0 (Version D.0), August 2007, National Council for Prescription Drug Programs by requiring covered entities to use the Quantity Prescribed (460-ET) field for retail pharmacy transactions for Schedule II drugs. The modification would enable covered entities to clearly distinguish whether a prescription is a “partial fill,” where less than the full amount prescribed is dispensed, or a refill, in the HIPAA retail pharmacy transactions. HHS believes this modification is important to ensure information is available to help prevent impermissible refills of Schedule II drugs, which would help to address the public health concerns associated with prescription drug abuse in the United States.
- On January 30, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a rule entitled, Medicare Program: Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Part B for CY 2019; Medicare Shared Savings Program Requirements; Quality Payment Program; Medicaid Promoting Interoperability Program; Quality Payment Program--Extreme and Uncontrollable Circumstance Policy for the 2019 MIPS Payment Year; provisions from the Medicare Shared Savings Program. This document corrects technical errors that appeared in this final rule, which was published in the Federal Register on November 23, 2018.
- On January 31, 2019, HHS issued a notice entitled, Annual Update of the HHS Poverty Guidelines. This notice provides an update of the HHS poverty guidelines to account for last calendar year’s increase in prices as measured by the Consumer Price Index.
- On January 31, 2019, the Food and Drug Administration (FDA) issued draft guidance entitled, Rare Diseases: Common Issues in Drug Development. This draft guidance assists sponsors of drug and biological products intended to treat or prevent rare diseases in conducting more efficient and successful development programs through discussions of selected issues commonly encountered in rare disease drug development. This draft guidance addresses the following important aspects of drug development: adequate description and understanding of the disease’s natural history, adequate understanding of the pathophysiology of the disease and the drug’s proposed mechanism of action, nonclinical pharmacotoxicology considerations to support the proposed clinical investigation or investigations, reliable endpoints and outcome assessment, standard of evidence to establish safety and effectiveness, drug manufacturing considerations during drug development, participation of patients, caretakers, and advocates in development programs, and interactions with the Agency. This guidance revises and replaces the draft guidance of the same name issued on August 17, 2015.
- On January 31, 2019, HHS issued a proposed rule entitled, Fraud and Abuse; Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees. In this proposed rule, HHS proposes to amend the safe harbor regulation concerning discounts, which are defined as certain conduct that is protected from liability under the Federal anti-kickback statute, section 1128B(b) of the Social Security Act (the Act). The amendment would revise the discount safe harbor to explicitly exclude from the definition of a discount eligible for safe harbor protection certain reductions in price or other remuneration from a manufacturer of prescription pharmaceutical products to plan sponsors under Medicare Part D, Medicaid managed care organizations as defined under section 1903(m) of the Act (Medicaid MCOs), or pharmacy benefit managers (PBMs) under contract with them. In addition, HHS is proposing two new safe harbors. The first would protect certain point-of-sale reductions in price on prescription pharmaceutical products, and the second would protect certain PBM service fees.
Event Notices
- February 20, 2019: The Health Information Technology Advisory Committee announced a public meeting. The Committee will develop recommendations for the National Coordinator on interoperability.
- February 27, 2019: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment National Advisory Council (NAC). The NAC will discuss recovery housing and expanding access to medication-assisted treatment.
- March 8, 2019: The FDA announced a public meeting of the Microbiology Devices Panel. The panel will discuss and make recommendations regarding new or alternative approaches to the clinical study design and evaluation of devices detecting Human Papillomavirus (HPV).
- April 10, 2019: The FDA announced a public meeting entitled, Prescription Drug User Fee Act of 2017; Electronic Submissions and Data Standards. The purpose of the meeting is to fulfill FDA’s commitment to seek stakeholder input related to data standards and the electronic submission systems’ past performance, future targets, emerging industry needs and technology initiatives.
II. Congressional Legislation & Committee Action
U.S. Senate
- On January 29, 2019, the Senate Committee on Health, Education, Labor, and Pensions held a hearing entitled, Access to Care: Health Centers and Providers in Underserved Communities. Witnesses included: Dennis Freeman, Ph.D., Chief Executive Officer, Cherokee Health Systems; Andrea Anderson, M.D., Director of Family Medicine, Unity Health Care; John Waits, M.D., Residency Director Cahaba Family Medicine Residency; Thomas Trompeter, President, HealthPoint.
- On January 29, 2019, the Senate Finance Committee held a hearing entitled, Drug Pricing in America: A Prescription for Change, Part I. Witnesses included: Kathy Sego, Mother of a Child with Insulin-Dependent Diabetes; Douglas Holtz-Eakin, Ph.D., President, American Action Forum; Mark Miller, Ph.D., Vice President of Health Care, Laura and John Arnold Foundation; and Peter Bach, M.D., Director, Memorial Sloan Kettering Center for Health Policy and Outcomes.
House of Representatives
- On January 29, 2019, the House Ways and Means Committee held a hearing entitled, Protecting Americans with Pre-existing Conditions. Witnesses included: Karen Pollitz, Senior Fellow at the Kaiser Foundation; Andrew Stolfi, Insurance Commissioner in the Oregon Division of Finance Regulation; Keysha Brooks-Coley, Vice President for Federal Advocacy & Strategic Alliances at the American Cancer Society; Andrew Blackshear, American Heart Association; Rob Robertson, Chief Administrator/ Secretary-Treasurer for the Nebraska Farm Bureau.
- On January 29, 2019, the House Committee on Oversight and Reform held a hearing entitled, Examining the Actions of Drug Companies in Raising Prescription Drug Prices. Witnesses included: Antoinette Worsham, Mother of Two Insulin-Dependent Daughters; Catherine Alicia Georges, Ed.D., RN, FAAN, National Volunteer President, AARP; Aaron Kesselheim, M.D., J.D., M.P.H., Associate Professor of Medicine, Program on Regulation, Therapeutics and Law, Harvard Medical School; Gerard Anderson, Ph. D., Professor of Health Policy and Management, Bloomberg School of Public Health, Johns Hopkins University; and Avik Roy, M.D., President, Foundation for Research and Equal Opportunity.
III. Reports, Studies, & Analyses
- On January 30, 2019, the Government Accountability Office (GAO) released a report entitled, Health Insurance Exchanges: Claims Cost and Federal and State Policies Drove Issuer Participation, Premiums, and Plan Design. The report examined claims costs and factors driving changes in exchange participation, premiums, and plan design. In general, the report found that claims costs varied significantly across issuers and those costs drove changes in participation, premiums, and plan design.
IV. Other Health Policy News
- On January 30, 2019, CMS released Part II of the 2020 Advanced Notice of Methodological Changes for Medicare Advantage Capitation Rates and Part D Payment Policies (2020 Advance Notice), and Draft Call Letter. The 2020 Advance Notice and Draft Call Letter are available here.