The Federal Trade Commission’s newly proposed rules that would prohibit most noncompete clauses in employment represent a seismic shift for business. In this Barron’s article, McDermott Partner Michael Peregrine says corporate leadership should “take very seriously” the threat that federal antitrust policy presents to business operations and strategic development.
“This government activity has risen to a level that demands serious board and executive attention as a possible corporate enterprise risk,” Peregrine writes.
The Biden administration recently finalized an overhaul of an initiative known as the Medicare Shared Savings Program that seeks to pay health providers based on patient outcomes instead of the number of services they perform. In this Axios article, McDermott+Consulting’s Mara McDermott offers insight into providers’ Congressional push to extend a 5% pay increase for participants in advanced alternative payment models.
“If the bonus is not continued, it will soften or dampen the momentum toward alternative payment models, because it would create this mentality, or the view, that we’re not serious about that transformation,” McDermott said.
On November 15, the Senate approved a resolution to end the national emergency concerning COVID-19 declared by the president on March 13, 2020. The resolution was approved by a bipartisan vote of 62–36, with 13 Democrats joining all present Republicans in voting for the resolution.
While ending the national emergency is different than ending the public health emergency (PHE), which is declared by the US Department of Health and Human Services (HHS), the two are related, as the PHE must be tied to another declaration. Should the national emergency declaration end (as intended in this Senate resolution), most current waivers would terminate. There are notable exceptions, however, where other pieces of legislation have enacted additional flexibility (including telehealth waivers), and where policy changes in HHS rulemakings specified that policy changes are tied to the PHE. Should the national declaration end but the PHE stand, such policies would continue until the end of the PHE. Should both the national emergency declaration and the PHE end, all waiver authority would cease. Please see this +Insight for additional information.
The COVID-19 PHE, which is extended in 90-day increments, was most recently extended in mid-October, until mid-January 2023. The Biden administration has maintained a commitment to provide 60 days’ advance notice of any plans to end the PHE, and that 60-day mark recently passed with no indication that the PHE will end in mid-January. This indicates that the PHE is likely to be extended at least once more, through mid-April 2023.
Senate passage of this resolution will not have a tangible impact, as it is unlikely to be taken up by the Democratic-controlled House this year, and the president has threatened to veto it. However, the vote in the Senate demonstrates “pandemic fatigue” as well as significant bipartisan support for ending COVID-19 declarations, which suggests that the next presumed PHE extension through mid-April 2023 could be the last.
On October 11, 2022, the United States Department of Labor (DOL) issued its Notice of Proposed Rulemaking (NPRM) seeking to undo the Trump administration’s 2021 independent contractor regulations and revert to the six-factor economic realities test. While the test factors remain the same (for the most part), the DOL’s NPRM advances interpretations of the various factors that support employment status at every turn.
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.
After 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.
On August 4, 2022, the Biden administration declared monkeypox a public health emergency (PHE), a step that will allow the federal government to work with more agility to combat the spreading outbreak, including via expedited vaccine distribution and expanded testing.
The PHE declaration follows the recent appointment of federal officials to head up the monkeypox response team, including Robert Fenton of the Federal Emergency Management Agency as White House national monkeypox response coordinator, and Dr. Demetre Daskalakis of the US Centers for Disease Control and Prevention as White House national monkeypox response deputy coordinator.
The administration also began holding what will be a recurring weekly briefing with congressional staff on August 4. A press release from the US Department of Health and Human Services (HHS) on the PHE declaration can be found here.
On July 8, President Biden signed an executive order for abortion access. In this order, the US Department of Health and Human Services (HHS) pledged to take steps to ensure that all patients have access to the full rights and protections for emergency medical care afforded under the law. Currently, medical providers and hospitals are required by the Emergency Medical Treatment and Labor Act to provide stabilizing treatment for patients with emergency medical conditions. On July 11, the Biden administration reiterated, through new guidance from HHS, that medical providers must offer abortion services if the life of a mother is at risk and that procedures conducted under such circumstances would be protected regardless of state law. The state of Texas has already filed a lawsuit challenging the Biden administration on this new guidance on the grounds that it violates the rights of physicians who oppose providing abortions and violates a state’s right to invoke its own policies.
Additionally, the Office of Civil Rights released guidance for retail pharmacies on access to reproductive healthcare services. The guidance, directed toward the nation’s 60,000 retail pharmacies, directed that pharmacists must provide medications related to reproductive healthcare as directed and prescribed by providers. This includes abortion pills, birth control and other reproductive care treatments. The agency cited reports outlining instances in which women were denied certain medications because the drugs may be linked to abortion or the drugs have ingredients like those used for medication abortion, for example Methotrexate, which is sometimes used to treat certain types of cancer, psoriasis and rheumatoid arthritis, but can also be used off-label to end ectopic pregnancies.
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.
The federal government’s COVID-19 vaccine mandate has spurred an uptick in religious exemption requests. In this Politico article, McDermott Partner Michelle Strowhiro explains how some workers are copying and pasting exemption documents from anti-vaccine websites.
“The religious exemption is not a tough standard for a worker to submit,” Strowhiro said. “There can be a level of people making things up, unfortunately.”
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