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:
Congressional committees heard testimony regarding the Trump Administration’s FY 2021 budget and the coronavirus. Read more about this congressional activity below.
I. Regulations, Notices, & Guidance
- On February 20, 2020, the Centers for Medicare & Medicaid Services (CMS) issued a proposed rule entitled, Comprehensive Care for Joint Replacement Model Three-Year Extension and Changes to Episode Definition and Pricing. This proposed rule would revise certain aspects of the Comprehensive Care for Joint Replacement (CJR) model including the episode of care definition, the target price calculation, the reconciliation process, the beneficiary notice requirements and the appeals process. In addition, for proposed performance years 6 through 8, it would eliminate the 50 percent cap on gainsharing payments, distribution payments, and downstream distribution payments for certain recipients. This proposed rule would also extend the additional flexibilities provided to hospitals related to certain Medicare program rules consistent with the revised episode of care definition. Additionally, the proposed rule would allow time to test the proposed changes by extending the length of the CJR model for an additional 3 years, through December 31, 2023, for certain participant hospitals. Finally, it solicits comment on how CMS might best conceptualize and design a future bundled payment model focused on lower extremity joint replacements (LEJR) procedures performed in the ambulatory surgical center (ASC) setting.
- On February 26, 2020, the Centers for Disease Control and Prevention (CDC) announced the opening of a docket to obtain comment on the DRAFT Infection Control in Healthcare Personnel: Epidemiology and Control of Selected Infections Transmitted Among Healthcare Personnel and Patients: Diphtheria, Group A Streptococcus, Meningococcal Disease, and Pertussis Sections (“Draft Guideline”). The Draft Guideline updates four sections of the Guideline for Infection control in the health care personnel, 1998 (“1998 Guideline’), Part E: Epidemiology and Control of Selected Infections Transmitted Among Health Care Personnel and Patients, and their corresponding recommendations in Part II of the 1998 Guideline: “4. Diphtheria;” “9. Meningococcal Disease;” “12. Pertussis;” and “18. Streptococcus, group A infection.” The updated recommendations in the Draft Guideline are intended for use by the leaders and staff of Occupational Health Services to facilitate the provision of occupational infection prevention and control services to healthcare personnel (HCP) for the management of exposed or infected HCP who may be contagious to others in the workplace.
- March 2-4, 2020: The Health Resources and Services Administration (HRSA) announced a public meeting entitled, National Advisory Committee on Rural Health and Human Services (NACRHHS). NACRHHS provides advice and recommendations to the Secretary of the Department of Health and Human Services (HHS) on policy, program development, and other matters of significance concerning both rural health and rural human services.
- 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, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, CBER.
- March 9, 2020: FDA and the Federal Trade Commission (FTC) announced a public workshop entitled, Workshop on a Competitive Marketplace for Biosimilars. The purpose of the public workshop is to discuss FDA and FTC's collaborative efforts to support appropriate adoption of biosimilars, discourage false or misleading communications about biosimilars, and deter anticompetitive behaviors in the biologic product marketplace.
- March 10, 2020: FDA announced a public meeting entitled, Patient-Focused Drug Development for Stimulant Use Disorder. The purpose of the meeting is to allow FDA to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use disorder.
II. Congressional Hearings
- On February 25, 2020, the Senate Appropriation Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Hearing to Review the Fiscal Year 2021 Funding Request and Budget Justification for the U.S. Department of Health and Human Services.
House of Representatives
- On February 26, 2020, the House Appropriations Subcommittee on Labor, Health and Human Services, Education, and Related Agencies held a hearing entitled, Department of Health and Human Services Budget Request for FY 2021.
- On February 26, 2020, the House Energy & Commerce Subcommittee on Health held a hearing entitled, The Fiscal Year 2021 HHS Budget and Oversight of the Coronavirus Outbreak.
- On February 27, 2020, the House Ways & Means Committee held a hearing entitled, Proposed Fiscal Year 2021 Budget with Health and Human Services Secretary Azar.
III. Reports, Studies, & Analyses
- On February 18, 2020, JAMA published a study entitled, Private Equity Acquisitions of Physician Medical Groups Across Specialties, 2013-2016. Examining U.S. physician group practice acquisitions by private equity firms using the Irving Levin Associates Health Care M&A data set, the authors of the study found that acquisition of physician practices by private equity firms accelerated between 2013 and 2016, with unknown implications for care delivery and patient outcomes. In this study, the authors describe the physician group practices acquired during this time span across specialties.
IV. Other Health Policy News
- On February 27-28, 2020, the Medicaid and CHIP Payment and Access Commission held their February meeting. The meeting agenda is accessible here.