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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.


President Trump Signs Executive Orders that Enable Access to Affordable Meds

On Friday, July 24, 2020, President Trump signed four Executive Orders concerning prescription drug pricing which collectively direct the Secretary of the Department of Health and Human Services (HHS) to take following actions: 1. Increase Patient Access to Insulin and Injectable Epinephrine 2. Facilitate the Importation of Certain Prescription Drugs 3. Remove the Anti-Kickback Safe Harbor Protection for Prescription Rebates 4. Implement the “Most Favored Nation” Order to Lower Medicare Part B Drug Cost

Guidance for Employers Receiving HHS Funding During COVID-19 on Civil Rights Protections

On July 20, 2020, HHS OCR issued guidance to help employers receiving federal financial assistance understand their requirements to comply with applicable federal civil rights laws and regulations that prohibit discrimination on the basis of race, color, and national origin in HHS-funded programs during COVID-19; specifically, Title VI of the Civil Rights Act of 1964 (“Title VI”). Title VI states that “[n]o person in the United States shall, on the ground of race, color, or national origin, be excluded from participation in, be denied the benefits of, or be subjected to discrimination under any program or activity receiving Federal financial assistance.”

Ohio Businesses Required to Post Exceptions to State-wide Mask Mandate at all Entrances

On July 22, 2020, in conjunction with the state-wide mask mandate instituted by Governor Mike DeWine, Lance D. Himes, Interim Director of the Ohio Department of Health, issued an order requiring Ohio businesses to post any permitted exceptions they provide to customers, patrons, visitors, contractors, vendors and similar individuals to use facial coverings at all business entrances.

ODM and OhioMHAS Continue to Expand Telehealth

On July 17, 2020, Governor DeWine signed Executive Order 2020-29D, which allowed the Ohio Department of Medicaid (“ODM”) to immediately rescind old provisions and file a new rule (5160-1-18) and the Ohio Department of Mental Health and Addiction Services (“OhioMHAS”) to amend their current rule (5122-29-31), both expanding telehealth and introducing even more flexibility into Ohio’s healthcare system.

Top Questions of Employers - Sexual Orientation and Gender Identity Law

One month ago, the United States Supreme Court, in Bostock v. Clayton County, determined that federal law (Title VII of the Civil Rights Act of 1964) protects employees on the basis of sexual orientation or gender identity. Our earlier post discussed the full decision. The purpose of this article is to share and address the Top Questions of Employers since that decision was rendered.