SubscribeAfter almost a year of negotiations among congressional Democrats and the White House, the Inflation Reduction Act of 2022 (IRA) was signed into law by President Biden on August 16, 2022. It passed in the US Senate by a vote of 50–50, with the vice president breaking the tie, on August 7, 2022. The bill passed the US House of Representatives August 12, 2022, by a party-line vote of 220-207. This McDermott+Consulting article summarizes the key healthcare provisions of the IRA, including prescription drug reform, inflationary rebates, a cap on insulin costs, a Medicare Part D benefit redesign and a new pharmacy benefit manager rebate rule.
Digital Health
Navigating Data Privacy Questions Post-Dobbs
The US Supreme Court’s recent decision to overturn Roe v. Wade in Dobbs v. Jackson Women’s Health Organization has raised many questions about potential efforts by law enforcement agencies to obtain data from healthcare and other service providers to detect the performance of a possibly unlawful abortion. For example, data collected by period-tracking apps, patients’ self-reported symptoms, or diagnostic-testing results might be used to establish the timeframe in which an individual became pregnant, and then demonstrate that a pregnancy was terminated, as part of investigative or enforcement efforts against individuals or organizations allegedly involved in such termination.
On June 29, 2022, the office within the US Department of Health and Human Services (HHS) that is responsible for enforcing the Health Insurance Portability and Accountability Act (HIPAA), the Office for Civil Rights (OCR), issued guidance addressing how HIPAA limits disclosures by covered entities and business associates to law enforcement agencies in the absence of a court order or other legal mandate. The guidance provides helpful insight on how OCR may use HIPAA enforcement to discourage unauthorized disclosures of protected health information (PHI) to law enforcement officials in the wake of new state laws outlawing abortion. The guidance also implicitly confirms, however, that HIPAA does not provide a complete shield against law enforcement and litigation-driven requests for abortion-related information.
US House Passes Telehealth Extension Through 2024
The US House of Representatives approved a bipartisan bill that would extend Medicare telehealth flexibilities through the end of 2024; immediate US Senate action on the bill is unlikely, however.
On July 27, 2022, the US House of Representatives approved the Advancing Telehealth Beyond COVID-19 Act (H.R. 4040) by a wide bipartisan margin of 416–12. This bill would extend Medicare telehealth flexibilities through the end of 2024, including geographic and originating site flexibilities, expanded eligible practitioners, reimbursement for federally qualified health centers and rural health clinics, delay of the in-person telemental health requirement, continued use of audio-only telehealth and flexibility to use telehealth to satisfy Medicare face-to-face requirements.
Immediate US Senate action on H.R. 4040 is not likely, as the Senate is working on other priorities heading into the August recess. In addition, given the limited number of legislative days on the calendar before the midterm elections, additional action on telehealth extensions is more likely to occur during Congress’s lame-duck session at the end of the year. These same provisions were extended for 151 days beyond the end of the public health emergency (PHE) through the enactment of the Consolidated Appropriations Act of 2022, making it less urgent for Congress to act on an extension before the end of the year—although this bill has significantly increased chances of Congress doing so.
How Telehealth Adoption May Drive Increase in Value-Based Care
The COVID-19 pandemic has ushered in significant changes to the healthcare industry, specifically the transition from a fee-for-service model to a value-based care model, and digital health has proved to be a driver of value-based care models. In this Westlaw Today article, McDermott Partners Marshall E. Jackson, Jr. and Jeremy Earl suggest that increased use of telehealth during the pandemic may lead to an increase in the adoption of value-based care models that reward providers for efficiency and effectiveness.
Healthcare Enforcement in the Post-Pandemic Era
As the world emerges from the COVID-19 pandemic, healthcare fraud enforcement remains a top priority for the US Department of Justice (DOJ) and other government agencies with enforcement authority. In this Westlaw Today article, McDermott Partners Laura McLane, Tony Maida and Dana M. McSherry describe some of the areas that have assumed particularly high enforcement priority, including private equity, telehealth and pandemic relief funds.
The Overturning of Roe v. Wade
On June 24, 2022, the Supreme Court of the United States issued its decision in Dobbs v. Jackson Women’s Health Organization (Dobbs), overturning Roe v. Wade (Roe) and upending 50 years of precedent protecting a woman’s right to privacy in choosing to abort a pregnancy prior to the point of viability.
The effect of this decision on US companies cannot be understated. Any organization whose operations touch family planning services in any way (e.g., providers, those that facilitate operations, investors, payors, employers that provide family planning benefits and health plan service providers) should immediately examine their precise services, geographic footprint, corporate structure and organizational priorities.
To determine the best steps to take for you and your business, we invite you to join us for the second program in our new webinar series on Wednesday, June 29, at 2:00-3:00 pm EDT with McDermott Partners Stacey Callaghan, David Gacioch and Caroline Reignley and Associate Sarah Raaii, who will analyze and share the latest developments around the reversal of Roe and its likely impacts on US companies.
Biden Administration Foreshadows Impending Nursing Home Quality Reforms
On February 28, 2022, the White House issued a fact sheet outlining several efforts aimed to increase safety, accountability, oversight and transparency in the senior services industry (Fact Sheet). Although the Fact Sheet’s initiatives have not yet been implemented, President Biden reiterated his administration’s focus on nursing home reform during his March 1, 2022, State of the Union address. Accordingly, the efforts described in the Fact Sheet provide stakeholders with a peek into the regulatory crystal ball of the governmental efforts that may be forthcoming, either through new laws, regulatory action, policy changes, enforcement activities or subregulatory guidance.
Trump-Era Medicare Program Under Increased Scrutiny
A Trump administration-era Medicare program is under increased scrutiny from progressive Democrats. According to this Politico article, the program is a “direct contracting model” that allows private companies to participate in Medicare. Some Democrats, however, say the program is opening up a lane for Medicare privatization.
“There’s a dynamic with the left that [the Center for Medicare & Medicaid Innovation] [has] to deal with for sure,” said McDermott+Consulting’s Mara McDermott.
Trends and Priorities for the Human Capital Committee
COVID-19 has not only accelerated dramatic shifts within the healthcare industry, but it has also become a catalyst for change in workforce strategies. In this special report, McDermott Partner Michael Peregrine offers perspective about key trends and priorities for the human capital committee to consider as it plans for the upcoming year and beyond.
Digital Health 2021 Year in Review
The continuation of the COVID-19 public health emergency (PHE) and consumer demand for digitally delivered healthcare not only necessitated the shift from in-person to virtual care, but also continued to drive interest, adoption, investment and transactions in digital health in 2021. Digital health funding in 2021 far surpassed 2020’s totals, with no signs of slowing down in 2022, and the potential permanence of some regulatory flexibilities beyond the PHE are charting a course for continued digital health growth in 2022 and beyond.
