Health Law Advisor

On Friday, November 15, 2024, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Third Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Third Temporary Extension”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2025. The Third Temporary Extension is scheduled for publication in the Federal Register on November 19, 2024.

This means the DEA will continue to allow DEA registered practitioners (“Practitioners”) to prescribe controlled substances via telemedicine without having previously conducted an in-person patient examination. Likewise, and of particular interest to telemedicine providers that practice in multiple states, Practitioners may continue prescribing via telemedicine to patients physically located in any state in which the Practitioners are licensed to practice medicine, without needing to have a separate DEA registration in each such state, subject to compliance with state prescribing requirements.

As the dust from the public health emergency (PHE) continues to settle and the PHE-era flexibilities expire, telehealth providers are bracing themselves for the changes soon to come.

These providers will inevitably face certain legal and regulatory complexities as federal and state lawmakers and regulators consider adopting further temporary or permanent policy changes impacting telehealth. Federal-level changes—particularly the Drug Enforcement Administration’s (DEA’s) remote prescribing rulemaking—may further compound these complexities and trigger a wave of changes in laws, regulations, and policies at the state and board levels.

Telehealth providers should continue to monitor these developments, capitalize on current and upcoming telehealth opportunities, and make investments in compliance infrastructures to operate in accordance with applicable federal and state laws, regulations, and policies.

Since 2016, Epstein Becker Green has researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders seeking to provide telehealth-focused services. 

We are pleased to once again release our latest update to our Telemental Health Laws app, an extensive compilation of laws, policies, and other state guidance for practitioners supporting the mental/behavioral health practice disciplines.

Late last year, the case Shannon MacDonald, MD, et al v. Otto Sabando was filed in the U.S. District Court for the District of New Jersey. The plaintiffs claimed that New Jersey’s licensure restrictions on the use of telehealth were unconstitutional as they infringe on basic civil rights everyone has and therefore should be struck down. However, the defendants argued that the licensure of physicians is within the jurisdiction of states to decide and regulate such that New Jersey’s licensure laws do not violate the U.S. Constitution. EBG discussed the initial arguments in this ...

Use of telehealth services has surged since the COVID-19 pandemic; however, this increase in use does not come without limitations. Telehealth providers are subject to regulations, which differ by state, that govern various aspects of providing services via telemedicine, including what types of health care providers can provide telehealth services, what services can be provided via telehealth, and where providers must be located in order to provide telehealth services to a patient. A requirement consistent across most states is that providers engaging in telehealth services ...

Interest in and acceptance of telehealth services continues to grow. In 2023, a key focus by the states has been addressing questions about how to modify existing regulatory infrastructures sustaining the provision of telehealth services to support the continued use of these services in a post-public health emergency world.

However, modifications to telehealth services also increases the potential for fraudulent behavior and enforcement activity. Providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on ...

On Friday, October 6, 2023, the Drug Enforcement Administration (“DEA”) and Department of Health and Human Services (“HHS”) filed a Second Temporary Extension of the COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications (“Second Temporary Rule”), extending the full set of telemedicine flexibilities adopted during the COVID-19 public health emergency (“PHE”) through December 31, 2024. The Second Temporary Rule is scheduled for publication in the Federal Register today (October 10, 2023) and scheduled to take effect on November ...

On August 4, 2023, the Drug Enforcement Administration (“DEA”) announced plans to host two public listening sessions, scheduled to take place on September 12 and 13, 2023 at DEA’s headquarters in Arlington, VA, to collect additional input regarding the practice of telemedicine and specifically the remote prescribing of controlled substances without conducting an in-person evaluation of patients before prescribing.

The listening sessions will be open to the public, and those who anticipate attending must register through DEA’s Diversion Control website. The registration process opens today (August 7, 2023). DEA also plans to make the listening sessions available via livestream and copies of transcripts from the sessions also will be made available at a later date on the DEA Diversion Control Program website.

On February 24, 2023, the Drug Enforcement Agency (“DEA”) announced proposed permanent rules around prescribing controlled substances via telemedicine that expand the circumstances under which practitioners can prescribe controlled substances without first conducting an in-person medical evaluation of the patient outside of the COVID-19 public health emergency (“PHE”). The proposed rules are more restrictive than the DEA emergency waivers under which providers conducted telemedicine prescribing for the last three years, but are less restrictive in comparison to the pre-PHE regulations applicable to telemedicine prescribing of controlled substances under the federal Controlled Substances Act (“CSA”).

Both the proposed rules related to telemedicine prescribing of Schedule III-V non-narcotic controlled substances, and the separate proposed rules related to telemedicine prescribing of buprenorphine, were published in the Federal Register on March 1, 2023. The public has been given until March 31, 2023 to review and provide comments regarding the proposed rules, which the DEA will consider before promulgating final regulations.

In the era of abortion regulation and the wind-down of the COVID-19 public health emergency (“PHE”), new legislation in states such as Utah may be a sign of what is to come for online and telehealth prescribing. On February 14, 2023, the Utah Senate passed a bill that would repeal the State’s “Online Prescribing, Dispensing, and Facilitation Licensing Act” (“Online Prescribing Act”). Utah H.B. 152. The bill currently awaits Governor Spencer Cox’s signature and would take effect sixty (60) days after its signing.[1] Originally enacted in 2010, the Online Prescribing Act has allowed health care providers to register with the State to prescribe and dispense certain FDA-approved drugs via online pharmacies and utilization of telehealth visits. Utah Code § 58-83-306. While providers have been required under the Online Prescribing Act to obtain a comprehensive patient history and assessment prior to issuing a prescription, at present, this may be done via telehealth. Utah Code § 58-83-305. Once signed into law, the effect of H.B. 152 would be to make asynchronous telehealth-only prescribing unlawful in the state, with Utah’s law on the scope of telehealth practice amended to prohibit “diagnos[ing] a patient, provid[ing] treatment, or prescribe[ing] a prescription drug based solely on . . . an online questionnaire; []an email message; or []a patient-generated medical history. Utah H.B. 152, amending Utah Code § 26-60-103.

Interest in and acceptance of telehealth services continues to grow. Recent events, like the COVID-19 pandemic and the U.S. Supreme Court’s ruling in Dobbs v. Jackson Women's Health Organization, have put more pressure than ever on federal and state legislators to promote access to telehealth services.

However, the greater use of telehealth services also increases the potential for fraudulent behavior and enforcement activity. Providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on telehealth opportunities while staying compliant with applicable laws.

Since 2016, Epstein Becker Green has researched, compiled, and analyzed state-specific content relating to the regulatory requirements for professional mental/behavioral health practitioners and stakeholders seeking to provide telehealth-focused services. We are pleased to release our latest compilation of state telehealth laws, regulations, and policies within the mental/behavioral health practice disciplines.

Interest in, and acceptance of, telehealth services continues to grow. Federal and state legislators are under pressure to codify the flexibilities granted in response to the COVID-19 pandemic that increased access to telehealth services. Meanwhile, increased use of telehealth has put a much greater focus on the potential for fraudulent behavior and increased enforcement activity as a result. Telehealth providers should continue to monitor developments in federal and state laws, regulations, and policies to capitalize on telehealth opportunities while at the same time ...

On April 29, 2021, the Federal Communications Commission (FCC) will begin accepting applications for the second round of its COVID-19 Telehealth Program (the “Program”). However, the application filing window will only be open for a very short seven day period and will close on May 6, 2021. To give all applicants an equal opportunity to have their applications reviewed, the FCC announced that all applications filed during this period will be reviewed once the application filing window has closed.

Initially, in March 2020, Congress appropriated $200 million for the first round of the COVID-19 Telehealth Program funding under the CARES Act. An additional $249.95 million was provided to the FCC in December 2020, under the Consolidated Appropriations Act (CAA), to helping address inequities in access to health care service. The COVID-19 Telehealth Program was designed to help health care providers purchase telecommunications equipment, broadband connectivity, and other devices necessary for providing telehealth services to rural, low-income and underserved populations.

The Program is limited to nonprofit and public health care providers (47 U.S.C. § 254(h)(7)(B)) that fall within the following categories:

1. Post-secondary educational institutions offering health care instruction, teaching hospitals, and medical schools;
2. Community health centers or health centers providing health care to migrants;
3. Local health departments or agencies;
4. Community mental health centers;
5. Not-for-profit hospitals;
6. Rural health clinics;
7. Skilled nursing facilities; or
8. Consortia of health care providers consisting of one or more entities falling into one of the first seven categories.

We hope that everyone is staying safe during the COVID-19 crisis. State health departments are, of course, doing what they can to facilitate management of transmission of COVID-19 by healthcare providers. Some recent actions by the New York Department of Health (“DOH”) to allow or promote telephonic and telehealth services include:

Telephonic Evaluation - Beginning with dates of service of March 13, Medicaid will reimburse telephonic evaluation and management services for established patients where face-to-face visits may not be recommended and it is medically ...

While the world continues to respond to the growing COVID-19 pandemic, the United States Congress recently passed legislation that provides for more than $8 billion in emergency funding to combat COVID-19. Part of this supplemental funding package, signed into law on March 6, 2020, includes the Telehealth Services During Certain Emergency Periods Act of 2020 (the “Act”),[1] which authorizes the Administration to loosen restrictions on telehealth in order to expand access to COVID-19 related telehealth services for Medicare beneficiaries—many of whom are especially vulnerable to this virus and in the event of future emergencies. On March 17, 2020, the Administration announced the implementation of this waiver with a retroactive effective date of March 6, 2020.

Our colleagues Amy F. Lerman, Francesca R. Ozinal, and team have released the 2019 update to Epstein Becker Green’s Telemental Health Laws survey.

Available as a complimentary app for iPhone, iPad, and Android devices, the survey covers state telehealth laws, regulations, and policies within mental health.

For more about the survey findings, visit “Epstein Becker Green Finds Telehealth Services Are Increasingly Accessible to Mental Health Professionals Despite Legislative Barriers.”

Also see the "Telemental Health Laws: Overview" for more about the ...

The Centers for Medicare & Medicaid Services (“CMS”) has published a final rule that will expand access to telehealth services for Medicare Advantage (“MA”) plan enrollees.[1] CMS Administrator Seema Verma characterized the agency’s latest policymaking efforts as “a historic step in bringing innovative technology to Medicare beneficiaries” and a way for the agency to provide “greater flexibility to Medicare Advantage plans, [so] beneficiaries can receive more benefits, at lower costs and better quality.”[2]

Traditionally, MA plans have been limited to ...

On February 9, 2018, President Trump signed into law the Bipartisan Budget Act of 2018 (“BBA”). Among the most notable changes that will occur with the enactment of the BBA is the inclusion of certain provisions taken from the Creating High-Quality Results and Outcomes Necessary to Improve Chronic (“CHRONIC”) Care Act of 2017 bill (S.870) which the Senate passed in September 2017. Among other things, the CHRONIC Care provisions will have the effect of redefining new criteria for special-needs plans (“SNPs”), in particular the special-needs Medicare Advantage ...

Updates to OIG FY 2017 Work Plan

The United States Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) recently updated its FY 2017 Work Plan. Traditionally, OIG’s annual Work Plan has given health care providers a preview of OIG’s enforcement priorities. With the OIG now making updates to its Work Plan on a monthly basis, providers stand to gain even more insight into how the focus of OIG is constantly shifting in order to assist in the identification of significant compliance risk areas.

In this most recent set of updates to the FY 2017 ...

On Monday, the World Health Organization ("WHO") declared the rise in birth defects linked to the Zika virus outbreak a public health emergency, marking only the fourth time that the WHO has made such a declaration. This announcement by the WHO underscores the seriousness of the Zika virus outbreak and, hopefully, will pave way for a coordinated and well-funded global response to this serious public health problem that may include intensified mosquito control efforts, expedited creation of a more rigorous diagnostic test to detect the virus, and development of a preventive ...

As we have explored a number of times on this blog, telemedicine has gone mainstream.  The more recent development is that employers seem to be paying more attention now. The numbers speak for themselves. A recent Towers Watson study focusing on employers with at least 1,000 employees concluded that U.S. employers could save up to $6 billion per year if their employees routinely engaged in remote consults for appropriate medical problems instead of visiting emergency rooms, urgent care centers, and physicians’ offices.

Attitudes towards telemedicine more generally in the United ...

Providers, take note: the Chronic Care Management (CCM) CPT Code 99490 is now payable by the Centers for Medicare & Medicaid Services (CMS). Effective January 1, 2015, the Medicare program began making payments under the Physician Fee Schedule (PFS) for certain non-face-to-face management and care coordination services provided to beneficiaries covered under the traditional Medicare fee-for-service program. CCM services include, but are not limited to, development and maintenance of a plan of care, communication with other treating health care professionals, and ...

The 2014 outbreak of the Ebola Virus Disease ("Ebola") is the largest in history and continues to affect multiple countries in West Africa. Although reports of new Ebola cases in the U.S. – potential or confirmed – have slowed down in recent weeks, the Centers for Disease Control and Prevention ("CDC") and its various domestic and international partners continue their efforts to prevent further transmission of Ebola in the U.S. as well as abroad. Earlier this week, in fact, the CDC released two new pieces of guidance regarding treatment of Ebola that will be of particular interest ...

Earlier this week, the American Telemedicine Association reported an important clarification regarding the Centers for Medicare & Medicaid Services’ (“CMS’s”) plans for expanding reimbursement for telehealth services provided to Medicare beneficiaries.  The October 31, 2014 final rule with comment period regarding payments to physicians generated much excitement in the telehealth community, particularly because it opens a door, albeit only slightly, to possible Medicare coverage for remote patient monitoring services.

However, the ATA has clarified with CMS ...

On October 29, 2014, the Office of Medicare Hearings and Appeals ("OMHA") hosted its second Medicare Appellant Forum ("Forum") to address the status of the Medicare appeals backlog and related processing delays of Administrative Law Judge ("ALJ") appeals, which are the third level of the Medicare appeals process that is available to suppliers, providers, and Medicare beneficiaries to challenge denied claims. Last week's Forum was a follow-up to OMHA's February 2014 Appellant Forum, which offered few assurances to stakeholders at the time that any effective remedies to the ...

Who knew?!  Buried among more than 1,000 pages of a new final rule with comment period on payments to physicians, released on October 31, 2014, the Centers for Medicare & Medicaid Services (“CMS”) finally has given telehealth providers a glimpse of its plans to expand reimbursement for telehealth services provided to Medicare beneficiaries. 

The final rule includes a provision that would cover remote chronic care management using a new current procedural terminology (“CPT”) code, 99490 (with a monthly unadjusted, non-facility fee of $42.60).  This new CPT code can be ...

In response to the ongoing threat of the Ebola Virus Disease ("EVD" or "Ebola") and the increased risk of individuals traveling from the affected countries to the United States, The Joint Commission recently launched an Ebola Preparedness Resources portal on its website.  The portal contains information addressing various safety actions for health care providers to consider, such as ensuring that all staff and clinicians who may come in contact with Ebola patients are educated and trained on Ebola guidance, re-evaluating infection control plans to ensure proper guidelines ...

Expansion of the DMEPOS Competitive Bidding Program; Legislative Inquiry Related to Fraud and Abuse Enforcement Actions; and Automated Pre-Enrollment Provider Screening

by George B. Breen, Amy F. Lerman, Emily E. Bajcsi, Deepa B. Selvam

In order to be prepared for upcoming changes and to respond to new initiatives, providers and suppliers participating in Medicare must be aware of recent Congressional activity that would hold the federal government accountable for its intended enforcement efforts designed to curb health care fraud, waste, and abuse, as well as an effort by the ...

by George B. Breen, Carrie Valiant, Emily E. Bajcsi, Anjali N.C. Downs, and Amy F. Lerman

On February 2, 2011, the Centers for Medicare and Medicaid Services ("CMS") published new rules ("Final Rule") authorized by the Affordable Care Act ("ACA") creating a vigorous screening process for new and existing Medicare, Medicaid and the Children's Health Insurance Program ("CHIP") providers and suppliers; giving CMS authority to temporarily stop enrollment of new providers and suppliers; expanding the ability of CMS and States to temporarily suspend payments to providers and ...

On Tuesday, President Obama announced Kansas Governor Kathleen Sebelius as his nominee for Secretary of Health and Human Services. She is known for her bipartisan approach to politics and her efforts as a governor in the health care arena. If confirmed, Governor Sebelius has a once in a lifetime opportunity to execute health care reform – a President enjoying positive public opinion, a national sense of urgency, and resources to get the job done.

The President also announced his choice for Director of the White House Office of Health Reform, Nancy-Ann DeParle, a former ...

Thursday's White House Forum on Health Reform brought together people who have a stake in our health care system with people who have the ability to change it. Prior to his inauguration, President Obama called on Americans to hold community discussions about health care. More than 9,000 Americans signed up to host discussions in all 50 states and more than 30,000 Americans attended these discussions. These community groups submitted reports to the White House that detailed their concerns about the health care system and their suggestions for reform. At the Forum, several of these ...

Many people ask, “can we afford to pay for health care reform?” However, the more pressing question is whether we can afford not to reform our health care system. The collapse of our financial markets and the general deterioration of the economy make fundamental health reform an urgent priority. Investing in our health care system will pay off by helping to keep Americans healthy and economically stable.

On February 10, 2009, Senate Budget Committee Chairman Kent Conrad (D-N.D.) said that health care reform plans cannot add substantial costs to the system, one which already ...