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Telehealth Flexibility Updates: HIPAA, DEA, and CMS

Client Alert

The Covid-19 Public Health Emergency (PHE) officially ended on May 11, 2023.[1] But what does that mean for telehealth, a field that expanded exponentially during the PHE? Fortunately, many of the flexibilities will remain intact, at least temporarily. This client alert presents a brief overview of the timelines that providers need to follow, but for a more comprehensive review of telehealth flexibilities and when they will end, please see my presentation on the same topic here:  https://youtu.be/mIpFaKG7jio.[2]

HIPAA

On May 11, the Notice of Enforcement Discretion issued under HIPAA ended, which means providers must use HIPAA-compliant platforms and patient communication tools for all telehealth appointments. The Office of Civil Rights has released a statement allowing for a 90-day transition period for covered health care providers to come into compliance with the HIPAA rules. After that, providers should expect enforcement to resume.

Medicare

The Centers for Medicare and Medicaid Services (CMS) have extended many of the telehealth flexibilities offered during the pandemic but not all. For example, the waivers regarding telehealth and remote patient monitoring (RPM) cost sharing expired on May 11. [3]  CMS currently reimburses telehealth services at non-facilities at an equivalent rate to in-person rates, but this Medicare payment parity is scheduled to end on December 31, 2023.[4] Also, at the end of 2023, CMS will no longer allow virtual direct supervision.[5] Through the Consolidated Appropriations Act of 2023, many flexibilities were extended through December 31, 2024. [6] These include, among others:

  • FQHCs and RHCs can still serve as distant site providers for non-behavioral and mental telehealth services.
  • Medicare patients may receive telehealth services authorized by the Medicare 2023 physician fee schedule in their homes, and there will be no geographic restriction for the originating site for non-behavioral and mental telehealth services.
  • Certain non-behavioral and mental telehealth services can be delivered using audio-only communication platforms.
  • Providers can use telehealth for recertification of eligibility for hospice care.
  • The acute hospital care at-home program may continue to provide hospital services to patients in their homes using telehealth.

Physical therapists, occupational therapists, speech-language pathologists, or audiologists can still provide telehealth services.

There will be important permanent changes as well including:

  • FQHCs and RHCs can serve as distant site providers for behavioral and mental telehealth services.
  • Medicare beneficiaries can receive telehealth services for behavioral and mental health care in their homes.
  • No geographic restrictions for the originating site for behavioral and mental telehealth services, and services can be delivered using audio-only communication platforms.
  • Rural hospital emergency departments are accepted as originating sites.

DEA – Controlled Substances Prescribing

The DEA proposed new rules for permanent telemedicine flexibilities on Feb. 24, 2023.[1] These rules added flexibility to the Ryan Haight Act, while also trying to guard against any bad actors who are prescribing controlled substances improperly. The new rules would not impact telemedicine consultations that do not involve prescribing controlled substance or practitioners who have previously had an in-person exam. But they would prohibit a practitioner from being able to use telemedicine to prescribe more than a 30-day supply of Schedule III-V non-narcotic controlled medications or a 30-day supply of buprenorphine for the treatment of opioid use disorder without an in-person evaluation or referral from a medical practitioner that has conducted an in-person evaluation. The rules were exceptionally controversial and garnered over 38,000 comments. As a result, the DEA announced on May 10, 2023 that they would allow all COVID flexibilities to continue for another six months, until November 11, 2023. This buys the DEA enough time to rewrite the proposed rules and incorporate the many submitted comments. Therefore, until November 11, 2023 all providers may prescribe controlled substances through telehealth under the same rules that have been utilized throughout the pandemic.

Also notable are all of the telehealth safeguards and rules that individual states have instituted as a result of the COVID-19 pandemic. Ohio, for example, has instituted new laws and rules that govern telehealth for Medicaid patients as well as for all types of providers. The practice and regulation of telehealth will continue to evolve over the next several years, so it is important to understand all of the rules that apply to your practice. For questions, please reach out to attorney Ashley Watson at abwatson@bmdllc.com or any member of the BMD Healthcare Team.

[1]88 FR 12890; 88 FR 12875; DEA Announces Proposed Rules for Permanent Telemedicine Flexibilities, DEA (March 3, 2023, 12:32 PM), https://www.dea.gov/press-releases/2023/02/24/dea-announces-proposed-rules-permanent-telemedicine-flexibilities.

[1] Telehealth policy changes after the COVID-19 public health emergency, Telehealth.HHS.Gov (February 19, 2023, 1:45 PM), https://telehealth.hhs.gov/providers/policy-changes-during-the-covid-19-public-health-emergency/policy-changes-after-the-covid-19-public-health-emergency/.

[2] Please note the presentation was given prior to the DEA’s announcement on May 10, 2023 to extend controlled substance prescribing flexibilities.

[3] OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak, OIG (March 17, 2020); see also FAQs—OIG Policy Statement Regarding Physicians and Other Practitioners That Reduce or Waive Amounts Owed by Federal Health Care Program Beneficiaries for Telehealth Services During the 2019 Novel Coronavirus (COVID-19) Outbreak, OIG (March 24, 2020).

[4] CY 2023 Medicare Physician Fee Schedule (PFS).

[5] CY 2023 Medicare Physician Fee Schedule (PFS).

[6] Consolidated Appropriations Act of 2023, H. R. 2617.


New York, Kansas, Massachusetts, and Delaware Become the latest States to Adopt Full Practice Authority for Nurse Practitioners

While the COVID-19 pandemic certainly created many obstacles and hardships, it also created many opportunities to try doing things differently. This can be seen in the instant rise of remote work opportunities, telehealth visits, and virtual meetings. Many States took the challenges of the pandemic and turned them into an opportunity to adjust the regulations governing licensed professionals, including for advanced practice registered nurses (APRNs).

Explosive Growth in Pot of Gold Opportunity for Bank (and Other) Cannabis Lenders Driving Erosion of the Barriers

Our original article on bank lending to the cannabis industry anticipated that the convergence of interest between banks and the cannabis industry would draw more and larger banks to the industry. Banks were awash in liquidity with limited deployment options, while bankable cannabis businesses had rapidly growing needs for more and lower cost credit. Since then, the pot of gold opportunity for banks to lend into the cannabis industry has grown exponentially due to a combination of market constraints on equity causing a dramatic shift to debt and the ever-increasing capital needs of one of the country’s fastest growing industries. At the same time, hurdles to entry of new banks are being systematically cleared as the yellow brick road to the cannabis industry’s access to the financial markets is being paved, brick by brick, by the progressively increasing number and size of banks that are now entering the market.

2021 EEOC Charge Statistics: Retaliation & Impact of Remote Work

The U.S. Equal Employment Opportunity Commission (EEOC) released its detailed information on workplace discrimination charges it received in 2021. Unsurprisingly, for the second year in a row, the total number of charges decreased as COVID-19 either shut down workplaces or disconnected employees from each other. In 2021, the agency received a total of approximately 61,000 workplace discrimination charges - the fewest in 25 years by a wide margin. For reference, the agency received over 67,000 charges in 2020, and averaged almost 90,000 charges per year over the previous 10 years.

Ohio’s Managed Care Overhaul Delayed – New Implementation Timeline

At the direction of Governor Mike DeWine, the Ohio Department of Medicaid (ODM) launched the Medicaid Managed Care Procurement process in 2019. ODM’s stated vision for the procurement was to focus on people and not just the business of managed care. This is the first structural change to Ohio’s managed care system since the Centers for Medicare & Medicaid Services' (CMS) approval of Ohio’s Medicaid program in 2005. Initially, all of the new managed care programs were supposed to be implemented starting on July 1, 2022. However, ODM Director Maureen Corcoran recently confirmed that this date will be pushed back for several managed care-related programs.

Laboratory Specimen Collection Arrangements with Contract Hospitals - OIG Advisory Opinion 22-09

On April 28, 2022, the Department of Health and Human Services, Office of Inspector General (“OIG”) published an Advisory Opinion[1] in which it evaluated a proposed arrangement where a network of clinical laboratories (the “Requestor”) would compensate hospitals (each a “Contract Hospital”) for specimen collection, processing, and handling services (“Collection Services”) for laboratory tests furnished by the Requestor (the “Proposed Arrangement”). The OIG concluded that the Proposed Arrangement would generate prohibited remuneration under the federal Anti-Kickback Statute (“AKS”) if the requisite intent were present. This is due to both the possibility that the proposed per-patient-encounter fee would be used to induce or reward referrals to Requestor and the associated risk of improperly steering patients to Requestor.