General Publications June 22, 2018

Alston & Bird Healthcare Week in Review, June 22, 2018

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 June 19, 2018, the Department of Labor (DOL) issued a final rule entitled, Definition of “Employer” under Section 3(5) of ERISA - - Association Health Plans. This document contains a final regulation under Title I of the Employee Retirement Income Security Act (ERISA) that establishes additional criteria under ERISA section 3(5) for determining when employers may join together in a group or association of employers that will be treated as the “employer” sponsor of a single multiple-employer “employee welfare benefit plan” and “group health plan,” as those terms are defined in Title I of ERISA. By establishing a more flexible “commonality of interest” test for the employer members than the DOL had adopted in sub-regulatory interpretive rulings under ERISA section 3(5), and otherwise removing restrictions on the establishment and maintenance of Association Health Plans (AHPs) under ERISA, the regulation intends to facilitate the adoption and administration of AHPs and expand access to affordable health coverage, especially for employees of small employers and certain self-employed individuals. At the same time, the regulation continues to distinguish employment-based plans, the focal point of Title I of ERISA, from commercial insurance programs and other service provider arrangements. The final rule also sets out the criteria that would permit, solely for purposes of Title I of ERISA, certain working owners of an incorporated or unincorporated trade or business, including partners in a partnership, without any common law employees, to qualify as employers for purposes of participating in a bona fide group or association of employers sponsoring an AHP and also to be treated as employees with respect to a trade, business or partnership for purposes of being covered by the AHP. The regulation would affect AHPs, bona fide groups or associations of employers sponsoring such plans, participants and beneficiaries with health coverage under an AHP, health insurance issuers, and purchasers of health insurance not purchased through AHPs.
  • On June 20, 2018, the Centers for Medicare and Medicaid Services (CMS) issued a notice entitled, Medicare Program; Request for Information Regarding the Physician Self-Referral Law. The request for information seeks input from the public on how to address any undue regulatory impact and burden of the physician self-referral law.
  • On June 21, 2018, CMS issued a notice entitled, Medicare and Medicaid Programs; Application by the Compliance Team for Continued CMS Approval of its Rural Health Clinic Accreditation Program. This final notice announces CMS’ decision to approve “The Compliance Team” for continued recognition as a national accrediting organization for Rural Health Clinics that wish to participate in the Medicare or Medicaid programs.
  • On June 21, 2018, CMS issued a notice entitled, Medicare and Medicaid Programs: Application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. (AAAASF) for Continued Approval of its Ambulatory Surgical Center Accreditation Program. This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities, Inc. for continued recognition as a national accrediting organization for Ambulatory Surgical Centers that wish to participate in the Medicare or Medicaid programs.

Event Notices

  • June 25, 2018: The CMS announced the Annual Laboratory Public Meeting. The meeting will gather public input on the appropriate basis for establishing payment amounts for new or substantially revised Healthcare Common Procedure Coding System (HSPCS) codes being considered for Medicare payment under the clinical laboratory fee schedule for calendar year 2019.
  • June 25-26, 2018: The FDA announced a public symposium to discuss scientific topics related to the regulation of biologics and to highlight science conducted at the Center for Biologics Evaluation and Research. The symposium will include presentations by experts from academic institutions, government agencies, and research institutions.
  • June 26, 2018: The FDA announced a public 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 for, oxycodone extended-release capsules, submitted by Pain Therapeutics.
  • July 9, 2018: The FDA announced a public meeting on “Patient-Focused Drug Development for Chronic Pain.” The meeting will provide patients with an opportunity to present FDA their perspectives on the impacts of chronic pain, views on treatment approaches for chronic pain, and challenges or barriers to accessing treatments.
  • July 25, 2018: The CMS announced a public meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC). The meeting will focus on obtaining the MEDCAC’s appraisal and recommendations regarding the state of evidence for procedural volume requirements, especially pertaining to surgical aortic valve replacements, trans-catheter aortic valve replacements and percutaneous coronary interventions for hospitals.
  • August 1, 2018: The Substance Abuse and Mental Health Services Administration (SAMHSA) announced a public meeting of the Center for Substance Abuse Treatment (CSAT) National Advisory Council (NAC). The CSAT NAC will discuss substance use disorder spending estimates and the opioid epidemic.
  • August 20, 2018: The CMS announced the annual meeting of the Advisory Panel on Hospital Outpatient Payment (the Panel) for 2018. The purpose of the Panel is to advise the HHS Secretary on the clinical integrity of the Ambulatory Payment Classification groups and their associated weights as well as hospital outpatient therapeutic services supervision issues.

II. Congressional Legislation & Committee Action

U.S. Senate

  • On June 19, 2018, the Senate Health, Education, Labor and Pensions Committee held a hearing entitled, Effective Administration of the 340B Drug Pricing Program. Captain Krista Pedley, PharmD, Director at the Health Resources and Services Administration, was the only witness.
  • On June 19, 2018, the Senate Aging Committee held a hearing entitled, Changing the Trajectory of Alzheimer’s: Reducing Risk, Detecting Early Symptoms, and Improving Data. Witnesses included: Marcie Gay Harden, Academy Award-Winning Actress and Family Caregiver; Lisa McGuire, PhD, Alzheimer’s Disease and Healthy Aging Program, Centers for Disease Control and Prevention; the Honorable Teresa Osborne, Secretary, Pennsylvania Department of Aging; Gareth Howell, PhD, Associate Professor, Jackson Laboratory; Cheryll Woods-Flowers, Family Caregiver.
  • On June 20, 2018, the Senate Homeland Security & Governmental Affairs Committee held a hearing entitled, Medicaid Fraud and Overpayments: Problems and Solutions. Witnesses included the Honorable Eugene Dodaro, Comptroller General of the United States, Government Accountability Office; and Brian Ritchie, Assistance Inspector General for Audit Services, U.S. Department of Health and Human Services.

House of Representatives

  • On June 21, 2018, the House Ways and Means Committee held a markup entitled, Markup of Bills from the Subcommittees on Tax Policy, Health, Social Security, and Oversight. The health-related legislation included H.R. 4952, To direct the Secretary of Health and Human Services to conduct a study and submit a report on the effects of the inclusion of quality increases in the determination of blended benchmark amounts under part C of the Medicare program; H.R. 6138, Ambulatory Surgical Center Payment Transparency Act of 2018; and H.R. 6142, Reducing Drug Waste Act of 2018. The Committee advanced all health-related legislation by voice vote.

III. Reports, Studies, & Analyses

IV. Other Health Policy News

  • On June 19, 2018, Avalere announced that opioid supply levels are declining in most states. The study found that the amount of prescription opioids sold across the U.S. declined by 11 percent in 2017 compared to 2016.
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