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Doctor-Patient Relationships and Medical Marijuana: Where Are We Now?

Recently, President Joe Biden signed the Medical Marijuana and Cannabidiol Research Expansion Act, which provides a mechanism for industry and academia to access and research cannabis (including marijuana and other cannabis-derived products) without violating the Controlled Substances Act. This legislation creates a pathway for researchers to register with the US Department of Justice to legally conduct scientific research on such products subject to certain requirements. It also creates a system to allow drug manufacturers to legally produce products approved by the US Food and Drug Administration that contain cannabidiol or marijuana for commercial sale. The legislation also includes a doctor-patient relationship provision that permits state-licensed physicians to discuss the “currently known potential harms and benefits of marijuana and its derivatives, including cannabidiol, which may be derived from marijuana or other cannabis products such as hemp, as a treatment,” which may be of significant interest for healthcare providers.

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Proposed Universal Contraceptive Coverage in Response to Roe Reversal

The US Departments of Health and Human Services, Labor and Treasury (the Departments) recently issued a proposed rule to eliminate a moral exemption to the Affordable Care Act (ACA) contraceptive mandate and establish an “individual contraceptive arrangement” to permit individuals to obtain contraceptive services at no cost in instances in which their employer does not offer coverage based on its religious beliefs. This is the latest development in the Biden administration’s efforts to increase reproductive health access after Dobbs v. Jackson Women’s Health Organization. The Departments previously issued a reminder to health plans and insurers that the ACA requires contraceptive coverage at no additional cost to individuals.

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No Surprises Act and Three Takeaways on Surprise Billing

The No Surprises Act (NSA) provides federal protections against surprise billing with respect to emergency services, non-emergency items or services furnished by out-of-network providers at certain in-network healthcare facilities, and air ambulance services furnished by out-of-network providers of air ambulance services. The NSA also establishes that certain federal agencies publish information quarterly about the Federal IDR process. The first such report, Initial Report on the Independent Dispute Resolution (IDR) Process April 15 – September 30, 2022, offers insight into dispute volume, interaction of the Federal IDR process with the claims procedure rules and problems with botched claims.

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Drug Discount Review Boards Proposed by Biden Health Agency

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.

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Healthcare Predictions for 2023: Hard Choices and Working Smarter

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 this special report produced by Jarrad Inc.McDermott Partner Kerrin B. Slattery and other industry professionals provide insight into the themes that will shape the healthcare industry this year.

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Major Changes Proposed to Substance Use Disorder Confidentiality Law

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).

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Pandemic Response Accountability Committee Report Highlights Telehealth Program Integrity Concerns

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.

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EEOC Alleges Abortion Travel Benefits Violate ADA, Title VII; Abortion Rates Tick Up; Indiana Judge Rules Ban Violates Religious Freedom

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.

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Prescription Drug Data Reporting: What the “Good Faith Compliance” Extension Really Means for Self-Funded Group Health Plans

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).)

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