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 May 28, 2019, the Centers for Medicare & Medicaid Services (CMS) issued a notice entitled, Inpatient Rehabilitation Facility Prospective Payment System for Federal Fiscal Year 2020 and Updates to the Inpatient Rehabilitation Facility Quality Reporting Program; Correction. The document corrects technical errors in the proposed rule that appeared in the April 24, 2019, proposed rule.
- On May 29, 2019, CMS issued a final rule entitled, Medicare and Medicaid Programs; Programs of All-Inclusive Care for the Elderly (PACE). This final rule updates the requirements for the Programs of All-Inclusive Care for the Elderly (PACE) under the Medicare and Medicaid programs. The rule addresses application and waiver procedures, sanctions, enforcement actions and termination, administrative requirements, PACE services, participant rights, quality assessment and performance improvement, participant enrollment and disenrollment, payment, federal and state monitoring, data collection, record maintenance, and reporting. The changes will provide greater operational flexibility, remove redundancies and outdated information, and codify existing practice.
- On May 30, 2019, the Food and Drug Administration (FDA) issued a notice entitled, Fixed-Quantity Unit-of-Use Blister Packaging for Certain Immediate-Release Opioid Analgesics for Treatment of Acute Pain; Establishment of a Public Docket; Request for Comments. The FDA is announcing the establishment of a docket to solicit public comment on a potential modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) to require that certain solid, oral dosage forms of immediate-release opioid analgesics commonly prescribed for treatment of acute pain be made available in fixed-quantity unit-of-use blister packaging for outpatient dispensing. This could reduce the amount of unused opioid analgesics, thereby reducing opportunities for misuse, abuse, inappropriate access, and overdose, and possibly reducing the development of new opioid addiction.
Event Notices
- June 11, 2019: The FDA announced a public meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee. The Committee will discuss clinical utility and safety concerns associated with the higher range of opioid analgesic dosing in the outpatient setting.
- June 12, 2019: HHS announced a public meeting of the Pain Management Best Practices Inter-Agency Task Force. The purpose of the meeting is to discuss payment and coverage policies for chronic and acute pain, service delivery models, access to therapies and medical devices, and other issues.
- June 21, 2019: HHS announced a public meeting entitled, ReImagine HHS Accelerate Clinical Innovation Public Hearing. HHS is interested in how to decrease the overall time for new medical products (drug, medical device, biologic) to go from discovery to widespread patient access and use while maintaining public health standards.
- July 2, 2019: HHS announced a meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria. The meeting will include panel presentations and discussions surrounding emerging antifungals, and provider challenges and educational solutions to influence antibiotic stewardship.
II. Congressional Legislation & Committee Action
U.S. Senate
- There were no health-related hearings this week.
House of Representatives
- There were no health-related hearings this week.
III. Reports, Studies, & Analyses
- On May 30, 2019, the Biosimilars Forum issued a study entitled, Legislative Options to Save Patients & Taxpayers Billions. The study argues that biosimilar utilization would increase if Medicare Part B were to cover beneficiary out-of-pocket expenses. According to the study, this change could increase the biosimilar market share to 26-46 percent.
IV. Other Health Policy News
- On May 29, 2019, the Journal of the American Medical Association (JAMA) issued a research letter entitled, Specialty Drug Pricing and Out-of-Pocket Spending on Orally Administered Anticancer Drugs in Medicare Part D, 2010 to 2019. Despite reductions in cost-sharing obligations for Medicare Part D beneficiaries, the study finds that seniors spend more out-of-pocket on anticancer drugs today than in 2010.