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Legal Risks Loom For Employers Protecting Abortion Access

US employers are taking steps to provide abortion access to workers despite threats from anti-abortion activists and conservative lawmakers. In this Law360 article, McDermott’s Sarah Raaii said that “we’re certainly continuing to monitor” threats against employers.

“And we’re now in the position — really an unprecedented position for employers — of having to potentially look at 50 different states’ very specifically written laws regarding reproductive health care,” Raaii said. “Some states require some type of coverage, some states prohibit it. So it’s become a lot more burdensome for employers.”

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Post-Election Committee Membership Tracker

This document serves as a tool to track key congressional positions, as well as potential and pending changes that are relevant to health policy on Capitol Hill. It covers US House of Representatives and US Senate leadership and membership of the healthcare committees of jurisdiction. This tracker will be updated after the election when Congress returns, to determine the answers to the speculation below.

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COVID and a Cloud of Dust

The COVID-19 pandemic forced lawmakers to respond with an array of legislation to help Americans, such as the No Surprises Act, the Families First Coronavirus Responses Act and the Coronavirus Aid, Relief and Economic Security Act. Now, however, pandemic-related litigation involving the Employee Retirement Income Security Act of 1974 (ERISA) is becoming more common. In this Best Lawyers article, McDermott Partner Ted Becker highlights the major types of pandemic-related litigation, including out-of-network provider litigation, the Racketeer Influenced and Corrupt Organizations Act (RICO) and antitrust claims, and COVID-19-related litigation against ERISA health plans.

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Medicare Drug Price Negotiation Program and Drug Pricing Reform: Eligible Drugs to Know and Understanding What’s Next

On August 16, 2022, President Biden signed into law the Inflation Reduction Act of 2022 (IRA), which contains prescription drug pricing reform provisions. The three main Medicare prescription drug pricing reform provisions included are as follows:

  • Drug Price Negotiations: Allows the federal government to negotiate for a select number of vaccines and/or drugs
  • Inflation-Based Rebates: Mandates that manufacturers pay a rebate to the federal government when the list prices of Part B or Part D drugs grow at a faster rate than the inflation rate
  • Part D Benefit Redesign: Implements an out-of-pocket maximum for beneficiaries at $2,000 and redistributes liability among manufacturers, health plans, patients and the federal government across phases of the Part D benefit starting in 2024.

Leveraging data from the Centers for Medicare and Medicaid Services’ (CMS’s) Medicare Drug Spending Dashboard and FDA databases, McDermott+Consulting has identified the potential list of drugs subject to negotiations.

This information is particularly valuable for pharmaceutical companies, health plans, patients, pharmacies and other stakeholders as they evaluate and consider the implications of this legislation. In less than one year, on September 1, 2023, the Health and Humans Services (HHS) Secretary will publish the first list of selected drugs subject to drug price negotiations. Understanding the statutorily mandated negotiations framework, timeline and potential drugs that may be included is critical to support stakeholders’ efforts to obtain optimal outcomes.

This report describes the drug price negotiation program, an implementation timeline for drug price reforms from the IRA and information on which drugs are likely to be first subject to price negotiation.

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GAO Releases Report on Telehealth

On September 26, the US Government Accountability Office (GAO) released a report titled “Medicare Telehealth: Actions Needed to Strengthen Oversight and Help Providers Educate Patients on Privacy and Security Risks.” The 75-page report describes the utilization of Medicare telehealth services under current pandemic-related waivers, the Centers for Medicare & Medicaid Services (CMS) efforts to identify and monitor risks posed by the current waivers, and a change made by the US Department of Health and Human Services (HHS) Office for Civil Rights (OCR) to the enforcement of regulations governing patients’ protected health information during the COVID-19 public health emergency (PHE).

GAO made four recommendations—three directed to CMS and one directed to OCR—aimed at remedying the issues set forth in the report:

  • CMS should develop an additional billing modifier or clarify its guidance regarding billing of audio-only office visits to allow the agency to fully track these visits.
  • CMS should require providers to use available site of service codes to indicate when Medicare telehealth services are delivered to beneficiaries in their homes.
  • CMS should comprehensively assess the quality of Medicare services, including audio-only services, delivered using telehealth during the PHE.
  • OCR should provide additional education, outreach or other assistance to providers to help them explain the privacy and security risks to patients in plain language when using video telehealth platforms to provide telehealth services.

Among its utilization findings, the GAO report found that the use of telehealth services increased from about five million services pre-waiver (April to December 2019) to more than 53 million services post-waiver (April to December 2020) and that, post-waiver, 5% of providers delivered more than 40% of telehealth services, and 5% of beneficiaries accounted for almost 40% of telehealth utilization.

The report noted that CMS lacks complete data on the use of audio-only technology and telehealth visits furnished in patients’ homes, because there is no billing mechanism for providers to identify all instances of audio-only visits, and because providers are not required to use available codes to identify visits furnished in homes. The GAO report also noted that OCR did not advise providers about specific language to use or give direction on explaining risks to patients, with respect to OCR’s March 2020 policy that it would not impose penalties against providers for noncompliance with privacy and security requirements in connection with the good faith provision of telehealth during the PHE.

This GAO report comes on the heels of a recent report from the HHS Office of Inspector General that found little evidence of waste and fraud related to Medicare telehealth services during the first year of the pandemic. These reports are part of a broader push by Congress and the Biden administration to examine current telehealth flexibilities and determine how to extend them beyond the COVID-19 PHE.




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Monkeypox in the Workplace: Key Considerations for Employers

With much about the potential impact and scope of monkeypox still unknown, employers should consider taking proactive steps now, as may be appropriate for their workforce, to enhance and reinforce the safety protocols already in place from the COVID-19 pandemic. In this Employee Relations Law Journal article, McDermott’s Michelle S. Strowhiro, Lindsay Ditlow and Priya Singh offer three key considerations for employers with respect to monkeypox.

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Texas Judge Rules Against ACA Preventive Care Provisions

On September 7, 2022, a US district court judge for the Northern District of Texas issued a ruling that preventive care provisions in the Affordable Care Act (ACA) requiring private insurance plans to cover drugs that prevent HIV infection at no cost to patients violate religious rights.

The ACA requires that private insurers cover certain preventive health services, including STD screenings and HIV pre-exposure prophylaxis (PrEP) prevention drugs. In his ruling, the judge found that that the rights of the employers that brought suit have been violated under the Religious Freedom Restoration Act by the requirement that they sponsor health insurance that covers sexual health services such as PrEP drugs that help prevent the spread of HIV.

It is not yet clear whether enforcement will occur immediately and whether coverage requirements will be blocked for just those who brought suit, for everyone in Texas or nationwide. The US Department of Health and Human (HHS) is expected to appeal the ruling.




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Growing Antitrust Scrutiny of Healthcare Mergers: What Healthcare Executives Need to Know

How can healthcare executives navigate the growing antitrust scrutiny of healthcare mergers, and what are some of the key issues facing executives in the current regulatory environment? In this conversation with The Chartis Group, McDermott Partner Katharine O’Connor discusses the legal considerations for healthcare executives seeking to navigate mergers.

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How Employers, Insurers Are Coping with Abortion After Dobbs

The US Supreme Court’s ruling overturning Roe v. Wade has created more complexity to the country’s patchwork of abortion laws. In this Managed Healthcare Executive article, McDermott’s Sarah Raaii offers perspective about how insurers are navigating healthcare plans state-by-state.

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