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DEA and Telehealth

NAHC

At 4:15 p.m. [ET last Friday], the U.S. Department of Health and Human Services (HHS) jointly with the Drug Enforcement Administration (DEA) issued a rule, titled 'Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications'. This Third Temporary Rule extends the telemedicine flexibilities for prescribing controlled medications, originally set to expire on December 31, 2024, through December 31, 2025. These flexibilities have been in effect since March 2020.

The rule provides the following in pertinent part:

With the deadline of December 31, 2024, granted by the Second Temporary Rule quickly approaching, DEA, jointly with HHS, is now issuing a third temporary extension (Third Temporary Rule) to ensure a smooth transition for patients and practitioners that have come to rely on the availability of telemedicine for controlled medication prescriptions. This additional time will allow DEA (and also HHS, for rules that must be issued jointly) to promulgate proposed and final regulations that are consistent with public health and safety, and that also effectively mitigate the risk of possible diversion. Furthermore, this Third Temporary Rule will allow adequate time for providers to come into compliance with any new standards or safeguards eventually adopted in a final set of regulations.  

This Third Temporary Rule, like the First and Second Temporary Rules, covers the portions of the March 2023 NPRMs related to extensions of the telemedicine flexibilities in place during the COVID-19 PHE, and it extends, through December 31, 2025, the telemedicine flexibilities that have been in place since March 2020 for prescribing controlled medications via the practice of telemedicine.

The DEA and HHS anticipate releasing a final set of regulations in the future, but no specific timeframe has been provided. In implementing this extension, the DEA and HHS considered stakeholder feedback from E.O. 12866 meetings-of which the Alliance took part- along with the impending expiration of existing flexibilities and input from Telemedicine Listening Sessions and Tribal Consultations. 

 

Judge Overturns DoL OT Rule

[Last] Friday, November 15, 2024, U.S. District Judge Sean Jordan for the Eastern District of Texas issued a ruling overturning the Department of Labor’s Overtime Rule. The DOL rule was previously under injunction only in Texas and began to be enforced in July, was rescinded in its entirety nationwide and no longer applies anywhere in the country. Though the federal government would usually appeal a ruling such as this, the timing of the Presidential Transition, coupled with the likelihood that President Trump’s administration would cease to defend the rule in court, raises questions about what strategy DOL will take moving forward.

We anticipate that DOL will issue guidance and updates on the implications of today’s ruling shortly.

The DOL Rule is here: https://www.federalregister.gov/documents/2024/04/26/2024-08038/defining-and-delimiting-the-exemptions-for-executive-administrative-professional-outside-sales-and.

The ruling from Judge Jordan is here: https://nahc.org/wp-content/uploads/2024/11/Judge-Jordan-Ruling-Overturns-DoL-OT-Rule.pdf.

 

Trump Nominates RFK Jr. to Lead HHS

Healthcare Dive / By Sydney Halleman

President-elect Donald Trump has nominated vaccine skeptic and lawyer Robert F. Kennedy Jr. to lead the HHS in a controversial decision that’s expected to draw ire from some public health experts.

Trump announced the appointment on social media platform Truth Social.

“For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,” Trump wrote Thursday.

His role as secretary of the HHS would give him oversight over a budget of nearly $2 billion and agencies including the Food and Drug Administration and the CMS, which is responsible for administering federal healthcare programs like Medicare and Medicaid.

Kennedy has previously promised to overhaul the federal public health industry. “FDA’s war on public health is about to end,” Kennedy wrote in October in a post on X.

Most recently, Kennedy stated he wanted to eliminate fluoride in the country’s water supply, a decision that would upend one of the nation’s largest public health initiatives. Over social media, Kennedy has also criticized what he calls an epidemic of “chronic disease,” including autism, obesity and diabetes.

Originally a candidate for president, Kennedy endorsed Trump after dropping out of the race in August. On the campaign trail, Trump promised to let Kennedy “go wild” on healthcare.

If confirmed by the Senate, Kennedy would succeed the Biden administration’s Secretary Xavier Becerra.

 

New Congress Brings Churn in Health Policy Leadership

Roll Call / By Sandhya Raman

House Energy and Commerce, Senate Finance, to see dramatic shifts in health policy players
 
Congress’ most influential health panels will see dramatic changes next year, with several advocates on specific issues like mental health, Medicare and drug pricing retiring or losing their reelection bids. 

The biggest changes will be in store at the House Energy and Commerce Committee, whose wide-ranging jurisdiction includes health insurance, biomedical research, and drug 
and device safety.

Five of the 12 Democrats on the Health Subcommittee will not be returning: Ranking member Anna G. Eshoo of California and Reps. John Sarbanes of Maryland, Tony Cárdenas of California and Ann McLane Kuster of New Hampshire did not seek reelection this year. And Rep. Lisa Blunt Rochester of Delaware was elected to the Senate.

Eshoo was active in Democrats’ efforts to negotiate the price of some prescription drugs under Medicare and has pushed for increasing biomedical research and expanding access to health insurance. Cárdenas has been a proponent of the three-digit 988 suicide hotline and helped found the Bipartisan House 988 and Crisis Services Task Force.

Republicans will see at least four fewer familiar faces: Former Health Subcommittee Chair Michael C. Burgess of Texas and Larry Bucshon and Greg Pence of Indiana will retire at the end of this year. Full Committee Chair Cathy McMorris Rodgers, R-Wash., is also retiring. Iowa Rep. Mariannette Miller-Meeks’ race has not yet been called, though she currently holds a narrow lead.

Rodgers has led the committee on oversight of the Centers for Disease Control and Prevention, and she unveiled a framework to overhaul the National Institutes of Health with Labor-HHS-Education Appropriations Subcommittee Chair Robert B. Aderholt, R-Ala., earlier this year.

She’s been an advocate on disability rights issues and a co-chair of the Congressional Task Force on Down Syndrome…

Read Full Article

 

Act Now to Protect Hospice Patients

NAHC Report

GO HERE to tell Congress that CMS must fix the Hospice Special Focus Program

Soon, the Centers for Medicare & Medicaid Services (CMS) will implement the hospice Special Focus Program (SFP), which is based on flawed data that will misinform patients and families with inaccurate hospice performance rankings. The bipartisan Enhancing Hospice Oversight and Transparency Act [H.R. 10097] will delay the SFP and allow CMS time to fix the program, preventing great harm to patients and providers. Join the Alliance’s efforts by reaching out to your elected officials—it only takes 2 minutes of your time. Act now to protect patients from misinformation.

For more information about the hospice SFP and why it needs to be fixed before it is implemented, please see the Hospice SFP Resource Page on the Alliance website. There you will find an explanation of the SFP,  its many problems, a timeline of the program, research on its flaws, and member-only resources on how to talk about the SFP to various stakeholders.

 
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