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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.


“I’m Out Of Here!” Now What?

We all know that the healthcare industry is experiencing a wave of integration. This trend has been evident for many years. Fewer physicians are willing to assume the legal, financial and other business risks associated with owning their own practices. More and more physicians, including anesthesiologists, are becoming employed by large physician groups, health systems and national providers. This shift necessarily involves not only entry into new employment arrangements but also the termination of existing relationships. And those terminations are often governed by written employment agreements, state and federal healthcare laws and employer benefit plans and other policies and procedures. Before pursuing their next opportunity, physicians should pause for a moment and first attend to the arrangement that they are leaving. Departing physicians need to understand their legal rights and obligations when leaving their current employment relationships in order to avoid unintended consequences and detrimental missteps along the way. Here are a few words of practical advice for physicians contemplating an exit from their current employment arrangements.

Investment Training for the Second and Third Generations

Consider this scenario. Mom and Dad started the business from the ground up. Over the decades it has expanded into a money-making machine. They are able to sell the business and it results in a multimillion-dollar payday for their labors. The excess money has allowed Mom and Dad to invest with various financial advising firms, several fund management groups, and directly with new startups and joint ventures. Their experience has made them savvy investors, with a detailed understanding of how much to invest, when, and where. They cannot justify formation of a full family office with dedicated investors to manage the funds, but Mom and Dad have set up a trust fund for the children to allow these investments to continue to grow over the years. Eventually, Mom and Dad pass. Their children enjoy the fruits of their labors, and, by the time the grandchildren are adults, Mom and Dad's savvy investments are gone.

Provider Relief Funds – Continued Confusion Regarding Reporting Requirements and Lost Revenues

In Fall 2020, HHS issued multiple rounds of guidance and FAQs regarding the reporting requirements for the Provider Relief Funds, the most recently published notice being November 2, 2020 and December 11, 2020. Specifically, the reporting portal for the use of the funds in 2020 was scheduled to open on January 15, 2021. Although there was much speculation as to whether this would occur. And, as of the date of this article, the portal was not opened.

Ohio S.B. 310 Loosens Practice Barrier for Advanced Practice Providers

S.B. 310, signed by Ohio Governor DeWine and effective from December 29, 2020 until May 1, 2021, provides flexibility regarding the regulatorily mandated supervision and collaboration agreements for physician assistants, certified nurse-midwives, clinical nurse specialists and certified nurse practitioners working in a hospital or other health care facility. Originally drafted as a bill to distribute federal COVID funding to local subdivisions, the healthcare related provisions were added to help relieve some of the stresses hospitals and other healthcare facilities are facing during the COVID-19 pandemic.

HHS Issues Opinion Regarding Illegal Attempts by Drug Manufacturers to Deny 340B Discounts under Contract Pharmacy Arrangements

The federal 340B discount drug program is a safety net for many federally qualified health centers, disproportionate share hospitals, and other covered entities. This program allows these providers to obtain discount pricing on drugs which in turn allows the providers to better serve their patient populations and provide their patients with access to vital health care services. Over the years, the 340B program has undergone intense scrutiny, particularly by drug manufacturers who are required by federal law to provide the discounted pricing.