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Thursday, August 18, 2022

Warner Pushes for Plan to Ensure Patient Access to Care Pending Expiration of COVID-19 Public Health Emergency - Senator Mark Warner

WASHINGTON – Today, U.S. Sen. Mark R. Warner (D-VA) sent a letter to the U.S. Department of Justice (DOJ) and U.S. Drug Enforcement Administration (DEA) asking the agencies to explain their plan to ensure continuity of care for patients being prescribed controlled substances via COVID-19 Public Health Emergency (PHE) telemedicine flexibilities. The current PHE declaration is set to expire on October 13, 2022 without intervention from the Biden Administration. Upon expiration current access to certain prescribed medications via telemedicine appointments will be stopped in order to remain in accordance with the Ryan Haight Online Pharmacy Consumer Protection Act of 2008.

During the COVID-19 Public Health Emergency, DEA has waived certain requirements of the Haight Act, including in-person or Special Registration requirements in order to prescribe controlled substances via telehealth.

“At the onset of the COVID-19 PHE, I was pleased to see the DEA act swiftly to ensure that patients could continue to access medically necessary controlled substances, including treatment for opioid use disorder, via telehealth by waiving the requirement that the patient have a prior in-person visit, regardless of their location, for the duration of the PHE,” wrote Sen. Warner.

He continued, “In the more than two years since that flexibility was put into place, patients have successfully continued and established treatment virtually, without reports of widespread harm. The pandemic has shown that telehealth is an appropriate modality for a great deal of health care services, and that health care providers and their patients should be at the center of modality decision-making.”

Sen. Warner posed a series of questions to ensure that there is a plan to continue to provide uninterrupted service:

  1. Does DEA plan to extend any current waivers or flexibilities regarding prescribing controlled substances over telehealth beyond the expiration of the PHE?
    1. If so, in what way(s)?
    2. If not, why not? Would additional authorities from Congress be needed?
  2. For patients who are under the care of a health care provider and are at risk of such care being interrupted or terminated upon PHE expiration, what flexibility or assistance will DEA provide such provider and patient to ensure appropriate continuity of care after the expiration?
  3. As opioid overdoses and deaths continue to impact our communities, is DEA considering continuing some of these telehealth flexibilities under the ongoing nationwide opioid crisis Public Health Emergency designation?
    1. If so, what are the agency’s plans?
    2. If not, why not?
  4. It is unacceptable that Americans have waited 14 years for the Special Registration rule; as telehealth will continue to expand, what is DEA’s plan to ensure appropriate access to legitimate health care services prior to the rule being finalized and implemented?

Earlier this year, Sen. Warner pushed the DEA to finalize a special registration for providers to prescribe controlled substances over telehealth, which has been required by Congress for nearly 14 years. Following this push, the DEA has drafted a rule, which is currently waiting for White House approval.

Sen. Warner has been a consistent leader for expanding telehealth accessibility. In May of this year, Sen. Warner led a bipartisan, bicameral group of lawmakers in legislation to expand telehealth services for patients undergoing dialysis. Sen. Warner was also an original co-sponsor of the 2016 Creating Opportunities Now for Necessary and Effective Care Technologies (CONNECT) for Health Act, reintroduced in 2021, and has been a longtime advocate for the expansion of telehealth in order to ease access to health care. 

Sen. Warner has consistently pushed for the permanent expansion of telehealth services, writing letters to congressional leadership in June 2020 and February 2022. Before the COVID-19 pandemic, Sen. Warner included a provision to expand telehealth services for substance abuse treatment in the Opioid Crisis Response Act of 2018. In 2003, then-Gov. Warner expanded Medicaid coverage for telemedicine statewide, including evaluation and management visits, a range of individual psychotherapies, the full range of consultations, and some clinical services, including in cardiology and obstetrics. Coverage was also expanded to include non-physician providers. Among other benefits, telehealth expansion allows individuals in medically underserved and remote areas of Virginia to access quality specialty care that isn’t always available nearby.

A copy of the letter is available here and below.

Dear Attorney General Garland, and Administrator Milgram:

As we await release of the proposed rule to create the Special Registration for Telemedicine, as directed by Congress first in 2008 in the Ryan Haight Online Pharmacy Consumer Protection Act and subsequently in the SUPPORT for Patients and Communities Act and appropriations legislation, I am writing today to request information about the Drug Enforcement Administration’s plan to ensure continued patient access to care upon expiration of the COVID-19 public health emergency (PHE).

At the onset of the COVID-19 PHE, I was pleased to see the DEA act swiftly to ensure that patients could continue to access medically necessary controlled substances, including treatment for opioid use disorder, via telehealth by waiving the requirement that the patient have a prior in-person visit, regardless of their location, for the duration of the PHE. In the more than two years since that flexibility was put into place, patients have successfully continued and established treatment virtually, without reports of widespread harm. The pandemic has shown that telehealth is an appropriate modality for a great deal of health care services, and that health care providers and their patients should be at the center of modality decision-making.

I am concerned for patients who are at risk of having their health care interrupted or terminated when DEA PHE flexibilities end. As you know, the goal of the Ryan Haight Act was not to stymie appropriate access to care, but to prevent illicit use and sale of controlled substances. To that end, it is critical that Congress understands what DEA’s plan is for the time between when the PHE expires and the Special Registration is implemented to ensure constituents receive the continued health care they need and deserve. Specifically, I would like to know:

(1)    Does DEA plan to extend any current waivers or flexibilities regarding prescribing controlled substances over telehealth beyond the expiration of the PHE?

  1. If so, in what way(s)?
  2. If not, why not? Would additional authorities from Congress be needed?

(2)    For patients who are under the care of a health care provider and are at risk of such care being interrupted or terminated upon PHE expiration, what flexibility or assistance will DEA provide such provider and patient to ensure appropriate continuity of care after the expiration?

(3)    As opioid overdoses and deaths continue to impact our communities, is DEA considering continuing some of these telehealth flexibilities under the ongoing nationwide opioid crisis Public Health Emergency designation?

  1. If so, what are the agency’s plans?
  2. If not, why not?

(4)    It is unacceptable that Americans have waited 14 years for the Special Registration rule; as telehealth will continue to expand, what is DEA’s plan to ensure appropriate access to legitimate health care services prior to the rule being finalized and implemented?

It is unacceptable that Americans have waited 14 years for the Special Registration rule; as telehealth will continue to expand, what is DEA’s plan to ensure appropriate access to legitimate health care services prior to the rule being finalized and implemented?

It is critical that the Department of Justice, the Drug Enforcement Administration, and Congress work together to ensure Americans receive the health care they need, both during the continuing COVID-19 pandemic and afterwards. I also urge you to expeditiously finalize the rulemaking for the Special Registration, as directed by Congress. Thank you in advance for your attention to this request and I look forward to hearing back from you.

Sincerely,

Mark R. Warner

cc: The Honorable Shalanda D. Young, Director, Office of Management and Budget

 

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Warner Pushes for Plan to Ensure Patient Access to Care Pending Expiration of COVID-19 Public Health Emergency - Senator Mark Warner
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