The Biden administration recently proposed revising the process behind an outlet for pharmaceutical companies to resolve price fights for those participating in the 340B drug discount program. According to this Bloomberg article, disputes between providers and pharmaceutical companies were in limbo as the industry waited for the Biden administration to replace an administrative dispute resolution (ADR) board. McDermott Partner Emily J. Cook said the proposed US Department of Health and Human Services rule ushers in “some significant changes” from the prior ADR process.
What is the primary force that will act on healthcare in 2023? What topics, trends and opportunities are hot this year? And how does the public feel about healthcare provider organizations today?
In a Notice of Proposed Rulemaking published December 2, 2022 (the Proposed Rule), the United States Department of Health and Human Services (HHS) proposed long-awaited changes to the regulations protecting the confidentiality of substance use disorder patient records under Part 2 of Title 42 of the Code of Federal Regulations (42 CFR Part 2, or Part 2). Specifically, the Proposed Rule would implement provisions of Section 3221 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), which required HHS to align Part 2 with certain provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and to make certain changes to the HIPAA Notice of Privacy Practices, the form given to patients and plan members that describes patient privacy rights, covered entity duties, and the covered entity’s uses and disclosures of protected health information (PHI).
On December 1, 2022, the Pandemic Response Accountability Committee (PRAC) Health Care Subgroup issued its report on fraud, waste and abuse risks that arose as a result of the dramatic increase in telehealth services provided during the COVID-19 pandemic. The PRAC was created under the CARES Act to oversee the historic spending that was part of the federal government’s response to the COVID-19 pandemic. The PRAC Health Care Subgroup comprises the offices of the inspector general (OIGs) for six federal agencies:
The US Department of Health and Human Services (HHS)
The US Department of Defense (DoD)
The Office of Personnel Management (OPM)
The US Department of Veterans Affairs (VA)
The US Department of Labor (DOL)
The US Department of Justice (DOJ).
Each OIG oversees an agency that administers a federal program connected to using or paying for telehealth services.
The report highlights the increased access to services that telehealth facilitated during the pandemic and notes key focus areas with respect to program integrity and preventing fraud and abuse. The report is a resource intended to be used by stakeholders across the healthcare industry, including congressional lawmakers, federal and state agencies, and healthcare organizations. The report aims to raise awareness of the importance of safeguarding expanded telehealth services against fraud, waste and abuse.
Lawyers are advising employers to beef up their health-related travel benefits to emphasize equal access for all employees as the Equal Employment Opportunity Commission begins to target employers that have expanded travel coverage for abortions.
EEOC’s charges come as new data indicate the rate of abortions accessed by Americans has ticked up, reversing a years-long decline, according to a new census from the Guttmacher Institute.
While litigation over state bans simmers in several states, abortion activists scored a win in Indiana after a judge ruled the state’s ban violates religious freedom protections enacted by statehouse Republicans. Abortion access has been temporarily restored in Indiana while litigation continues.
We recently reported on an FAQ issued December 23, 2022 (FAQ About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 56) by the US Departments of Labor, Health and Human Services and the Treasury (collectively, the Departments). The FAQ provides limited, albeit welcome, relief by extending the time for reporting information under the prescription drug data collection (RxDC) rules, which were enacted by Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021.
Under the statute, the first RxDC reports for the 2020 calendar (or reference) year, were due to be filed by December 27, 2021. However, in response to concerns expressed by stakeholders, enforcement was pushed back a full year to December 27, 2022, at which time the reports for both the 2020 and 2021 reference years were due. The RxDC reporting process required the submission of one or more “plan lists,” a series of eight data files (files D1 through D8) and an accompanying narrative response. (The contents of the plan lists, data files and narrative responses are comprehensively explained here (the Instructions).)
The IRS finalized regulations concerning information reporting of health insurance coverage for Code Sections 5000A, 6055 and 6056. The regulations provide an automatic deadline extension for filing ACA forms and an alternate method for providing ACA forms to certain individuals, among other changes.
Section 204 of Title II of Division BB of the Consolidated Appropriations Act, 2021 amended the Internal Revenue Code, the Employee Retirement Income Security Act of 1974 and the Public Health Service Act to add rules governing prescription drug data collection (RxDC). The rules require group health plans, including plans offered to Federal Employees Health Benefits carriers, and health insurance issuers to report certain information related to prescription drug and other healthcare expenditures to the US Departments of Labor, Health and Human Services and the Treasury (collectively, the Departments). Under the statute, the first RxDC reports were due to be filed by December 27, 2021. However, in response to concerns expressed by stakeholders, enforcement was pushed back a full year to December 27, 2022.
In an FAQ issued December 23, 2022 (FAQ About Affordable Care Act and Consolidated Appropriations Act, 2021 Implementation Part 56), the Departments provided relief to group health plans and health insurance issuers who are required to report information relating to prescription drug and healthcare spending.
On December 23, 2022, US Congress approved a year-end omnibus legislative package, Consolidated Appropriations Act, 2023 (CAA 2023), which consists of all 12 fiscal year 2023 appropriations bills and numerous other provisions, including health policy changes. The healthcare provisions in this omnibus package extend key Medicare telehealth flexibilities and the temporary telehealth safe harbor for High Deductible Health Plans (HDHP) first-dollar coverage.
The passing of the omnibus package presents a victory for industry advocates that have sought to extend the COVID-19 Medicare flexibilities and the HDHP safe harbor. The Medicare provisions will continue the flexibilities for providers and, coupled with the HDHP safe harbor, will enable beneficiaries to access expanded healthcare options through telehealth services. However, as the COVID-19 flexibilities and HDHP safe harbor are extended on a temporary basis through December 31, 2024, stakeholders will need to continue to engage with Congress on a more permanent solution.
Multiple Republican lawmakers are opposing a US Department of Health and Human Services (HHS) proposed rule that would expand the Affordable Care Act’s Section 1557 requirement preventing most health plans from discriminating on the basis of sex. According to this SHRM article, the rule applies to health insurers or plans that receive federal funds or that contract with the government. McDermott lawyers previously wrote about this proposed rule, noting that the definition of a covered entity is “similar in many ways to the 2016 Final Rule” but “does not explicitly include employee benefit group health plans as covered entities subject to Section 1557.”
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