Below is Alston & Bird’s Health Care 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.
I. Regulations, Notices, & Guidance
- On June 13, 2019, Department of Health and Human Services (HHS) issued a proposed rule entitled, Nondiscrimination in Health and Health Education Programs or Activities. HHS is attempting to ensure the civil rights of all individuals who access or seek to access health programs or activities of covered entities under Section 1557 of the Patient Protection and Affordable Care Act. HHS proposes to revise its Section 1557 regulation in order to better comply with the mandates of Congress, address legal concerns, relieve undue regulatory burdens, further substantive compliance, reduce confusion, and clarify the scope of Section 1557 in keeping with pre-existing civil rights statutes and regulations prohibiting discrimination on the basis of race, color, national origin, sex, age, and disability.
- On June 13, 2019, the Department of Treasury, Department of Labor (DOL), and HHS issued a final rule entitled, Health Reimbursement Arrangements and Other Account-Based Group Health Plans. This document sets forth final rules to expand opportunities for working men and women and their families to access affordable, quality healthcare through changes to rules under various provisions of the Public Health Service Act (PHS Act), the Employee Retirement Income Security Act (ERISA), and the Internal Revenue Code (Code) regarding health reimbursement arrangements (HRAs) and other account-based group health plans. Specifically, the final rules allow integrating HRAs and other account-based group health plans with individual health insurance coverage or Medicare, if certain conditions are satisfied (an individual coverage HRA). The final rules also set forth conditions under which certain HRAs and other account-based group health plans will be recognized as limited excepted benefits. Also, the Treasury Department and the Internal Revenue Service (IRS) are finalizing rules regarding premium tax credit (PTC) eligibility for individuals offered an individual coverage HRA. In addition, the DOL is finalizing a clarification to provide assurance that the individual health insurance coverage for which premiums are reimbursed by an individual coverage HRA or a qualified small employer health reimbursement arrangement (QSEHRA) does not become part of an ERISA plan, provided certain safe harbor conditions are satisfied. Finally, HHS is finalizing provisions to provide a special enrollment period (SEP) in the individual market for individuals who newly gain access to an individual coverage HRA or who are newly provided a QSEHRA. The goal of the final rules is to expand the flexibility and use of HRAs and other account-based group health plans to provide more Americans with additional options to obtain quality, affordable healthcare. The final rules affect employees and their family members; employers, employee organizations, and other plan sponsors; group health plans; health insurance issuers; and purchasers of individual health insurance coverage.
- On June 14, 2019, HHS issued a final rule entitled, Removing Outmoded Regulations Regarding the Health Education Assistance Loan (HEAL) Program. This action removes the outmoded HHS regulations for the HEAL Program. As of July 1, 2014, this program transferred from HHS to the Department of Education (ED). On November 15, 2017, ED published HEAL Program regulations within its own regulatory framework. With the publication of ED’s regulations, the HHS HEAL Program regulations are rendered obsolete.
- 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.
- June 26, 2019: The Food and Drug Administration (FDA) announced a meeting of the Pain Management Best Practices Inter-Agency Task Force (Task Force). The Task Force will discuss payment and coverage policies for chronic and acute pain, service delivery models, access to therapies and medical devices, and other issues.
- 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.
- On June 12, 2019, the Senate Judiciary Committee held a hearing entitled, Your Doctor/Pharmacist/Insurer Will See You Now: Competitive Implications of Vertical Consolidation in the Healthcare Industry. Witnesses present included: Professor Craig Garthwaite, Kellogg School Of Management, Northwest University; Professor Thomas Greaney, College of the Law, EC Hastings; Cory Capps, Partner, Bates White Economic Consulting; Dr. Fiona Scott Morton, Ph.D., Theodore Nierenberg Professor of Economics, Yale School of Management.
House of Representatives
- On June 12, 2019, the House Energy and Commerce Subcommittee on Health held a hearing entitled, No More Surprises: Protecting Patients from Surprise Medical Bills. Witnesses present included: Sonji Wilkes, Patient Advocate; Sherif Zaafran, Chair, Physicians for Fair Coverage; Rick Sherlock, President & CEO, Association of Air Medical Services; James Gelfand, Senior Vice President of Health Policy, The ERISA Industry Committee; Thomas Nickels, Executive Vice President, American Hospital Association; Jeannette Thornton, Senior Vice President of Product, Employer, and Commercial Policy, America’s Health Insurance Plans; Claire McAndrew, Director of Campaigns and Partnerships, Families USA; and Vidor Friedman, President, American College of Emergency Physicians.
- On June 12, 2019, the House Ways and Means Committee held a hearing entitled, Pathways to Universal Health Coverage. Witnesses included: Rebecca Wood, Patient Advocate; Tricia Neuman, Senior Vice President and Director of Medicare Policy at the Henry J. Kaiser Family Foundation; Donald Berwick, MD, President Emeritus and Senior Fellow at the Institute for Healthcare Improvement; Pam MacEwan, CEO for the Washington Health Benefit Exchange in the State of Washington; Chiquita Brooks-LaSure, Managing Director at Manatt Health; and Grace-Marie Turner, President of the Galen Institute.
- On June 12, 2019, the House Committee on Small Business held a hearing entitled, The Doctor is Out. Rising Student Loan Debt and the Decline of the Small Medical Practice. Witnesses present included: Sandra Norby, American Physical Therapy Association; Dr. Lauren Wiese, Orthodontic Resident, University of Maryland School of Dentistry; Dr. Tracey Henry, Assistant Professor of Medicine, Emory School of Medicine, American College of Physicians; and Jason Delisle, Resident Fellow, American Enterprise Institute.
III. Reports, Studies, & Analyses
- On June 11, 2019, the Kaiser Family Foundation issued a study entitled, Data Note: Americans’ Challenges with Health Care Costs. The report consisted of surveys intended to gauge the impact of health care costs on Americans. Among other things, the report found that approximately 34 percent of respondents said it was very difficult to afford routine health services because of high deductibles.
IV. Other Health Policy News
- On June 14, 2019, the Medicaid and CHIP Payment and Access Commission (MACPAC) released its June Report to Congress. The report makes recommendations to improve Medicaid policy affecting prescription drug and hospital payment, program integrity, and foster care services for children and youth. The report is available here.