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Healthcare Law Blog

Extension of Waivers, Including Telehealth, and Proposed OPIOID Treatment Rules

January 10, 2023

For more information about this blog post, please contact Khaled J. KleleRyan M. MageeRyan L. O’Neill, Connor Breza, William R. Meiselas or Labinot Alexander Berlajolli.

Takeaways From the 2023 Omnibus Appropriations Bill

The federal government’s 2023 Omnibus Appropriations Bill was signed by President Biden shortly before the New Year, appropriating a massive $1.7 trillion to fund government programs and initiatives for the coming year. Relevant to healthcare, the bill contains several provisions which will have varying effects on healthcare providers and entities through 2024.

Overall, the bill offers a mixed bag of assistance and drawbacks in 2023 and 2024. For providers, the bill extends both Medicare’s relaxed telehealth policies and the incentive for alternative payment models through 2024. The telehealth extension gives providers greater security in rendering telehealth services by decoupling the deadline for the relaxed telehealth standards from the end date of the federal COVID-19 Public Health Emergency (“PHE”) to the end of 2024. Similarly, although the extension of the alternative payment model incentives will benefit providers, the bill reduced the incentive from 5% to 3.5%. Similarly, the funding package extended the home waivers for acute hospital care to the end of 2024 as opposed to the end of the PHE.

The bill does alleviate the initially proposed reduction to the Medicare Physician Fee Schedule (“PFS”). The initial reduction was 4.5%, but the bill modifies the reduction to 2%. However, the bill sets up a further 3.25% PFS rate reduction for 2024.

A breakdown of the entire 2023 Omnibus Appropriations Bill may be accessed here. An HHS-specific fact sheet regarding the impact of the 2023 Omnibus Appropriations Bill may be accessed here.

HHS Extends COVID Emergency Powers to Other Viruses

The United States Department of Health and Human Services ("HHS") has issued a guidance letter to state governors clarifying that states and healthcare organizations may use regulatory flexibilities permitted under the COVID-19 public health emergency to address capacity challenges stemming from the present severe respiratory virus season.

Such flexibilities include a blanket waiver that allows hospitals to screen patients off-site, render telehealth services, provide care in temporary expansion sites, and easily transfer patients between facilities. Moreover, HHS has outlined further supportive actions it is undertaking to assist healthcare providers amid the “tripledemic,” including additional public health funding, monitoring the supply chain for drug and device shortages, and quickly responding to requests for federal medical assistance.

HHS Proposes Permanent Relaxation of Rules for Take-home Opioid Addiction Treatment

HHS has issued a proposed rule (87 FR 77330) seeking to codify regulatory relaxations regarding the prescription of take-home drugs in treating opioid addiction that were implemented during the COVID-19 pandemic. If implemented, HHS estimates that nearly 2,000 opioid treatment programs will be affected by the resulting rule changes.

The proposed rule would maintain certain “regulatory flexibilities” for programs treating opioid addiction. Such flexibilities would likely make permanent the pandemic rule modifications implemented by the Substance Abuse and Mental Health Services Administration (SAMHSA), including relaxed patient eligibility requirements for take-home drugs, including methadone, and waiver of the requirement that doctors prescribe buprenorphine instead of methadone for take-home opioid addiction treatment.

The proposed rule also seeks to remove barriers to accessing treatment drugs by waiving the requirement that a treatment program only admit people with at least one year of an opioid addiction. Additional proposed changes include updating definitions “to expand access to evidence-based practices such as split dosing, telehealth and harm reduction activities,” updating “outdated terms such as ‘detoxification’” to “remove stigmatizing language,” and expanding the definition of a “qualified practitioner” to include “a provider who is appropriately licensed by the state to prescribe (including dispense) covered medications and who possesses a waiver” to do so. Additionally, SAMHSA is proposing to eliminate the requirement that practitioners who have a waiver to prescribe buprenorphine for up to 275 patients provide reports to SAMHSA on an annual basis.

The public comment period for this proposed rule is currently open through February 14, 2023.

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Ryan Lee O'Neill

Ryan Lee O'Neill
Partner

Labinot Alexander Berlajolli

Labinot Alexander Berlajolli
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