On January 30, 2023, the Biden Administration introduced its intent to finish the COVID-19 public well being emergency (PHE) on Could 11, 2023.
The PHE has been in place for over three years throughout which era many telehealth and different well being care associated flexibilities had been relied upon by each sufferers and clinicians. Whereas some telehealth waivers will survive the tip of the PHE, not each pandemic-era coverage will proceed. Digital well being firms counting on the PHE waivers ought to take steps now to convey operations into compliance with the post-PHE world earlier than the PHE ends in Could.
Listed below are seven key takeaways on how the tip of the PHE will have an effect on the digital well being trade:
1. Momentary Medicare Modifications by December 31, 2024
The Consolidated Appropriations Act (CAA) of 2023 prolonged the next telehealth flexibilities licensed in the course of the COVID-19 PHE by December 31, 2024:
- Well being care suppliers eligible to invoice Medicare can invoice for telehealth providers no matter the place the affected person or supplier is positioned (i.e., the affected person could be at dwelling).
- Audio-only telehealth visits will proceed to be reimbursable.
- The record of suppliers eligible to ship telehealth providers stays expanded to incorporate bodily therapists, occupational therapists, speech language pathologists, and audiologists.
- The acute hospital care at dwelling program can proceed to be utilized to supply hospital providers to sufferers of their properties, together with by telehealth.
- Telehealth can be utilized to conduct recertification of eligibility for hospice care.
- Sufferers with Excessive Deductible Well being Plans coupled with Well being Financial savings Accounts can make the most of first greenback protection for telehealth providers with out first having to fulfill their minimal deductible.
- Federally Certified Well being Facilities (FQHCs) and Rural Well being Clinics (RHCs) can present telehealth providers to Medicare beneficiaries (i.e., could be distant website suppliers), fairly than being restricted to being an originating website supplier for telehealth (i.e., the place the beneficiary is positioned).
The CAA additionally delayed the imposition of the pre-requisite in-person requirement for psychological well being providers furnished by telehealth till after December 31, 2024.
2. Medicare Fee Parity
In the course of the pandemic the Facilities for Medicare & Medicaid Companies (CMS) initiated increased reimbursement for telehealth providers at non-facilities, reminiscent of a affected person’s dwelling. In different phrases, Medicare has been paying for telehealth providers as in the event that they had been supplied in-person, which means the telehealth visits are being paid by Medicare on the similar price as common, in-person visits. These increased reimbursement charges are scheduled to finish this 12 months. After that, charges might return to decrease pre-pandemic ranges except lawmakers select to increase the coverage.
3. Telemedicine Managed Substances and Ryan Haight Act
In the course of the PHE, the Drug Enforcement Company (DEA) acted swiftly to waive the Ryan Haight Act’s in-person examination requirement for the prescribing of managed substances, thereby guaranteeing thousands and thousands of each established and new sufferers had been capable of obtain medically crucial prescriptions by way of telemedicine.
There have been efforts to amend the Ryan Haight Act and encourage the DEA to activate the telemedicine particular registration rule earlier than the PHE expires, together with pending federal laws. Nonetheless, to this point, the Ryan Haight Act has not been modified and the DEA has not activated the telemedicine particular registration rule.
Thus, when the PHE expires on Could 11, with out additional motion on the a part of the DEA, the in-person requirement is ready to revert, with none particular registration rule or different course of established to make sure continuity of care. Due to this fact, continued prescribing of managed substances for sufferers by no means seen in-person, and solely by digital means in the course of the PHE, might be prohibited and these sufferers would both should be seen in-person or have their care transitioned to a neighborhood supplier.
4. Finish of Telehealth & RPM Copayment Waivers
In the course of the PHE the U.S. Division of Well being and Human Companies (HHS) Workplace of Inspector Normal (OIG) issued a coverage assertion and FAQ notifying well being care suppliers that they won’t be topic to administrative sanctions beneath the federal Anti-Kickback Statute or the Civil Financial Penalty and exclusion legal guidelines for lowering or waiving cost-sharing quantities (like copayments and deductibles) for telehealth providers or distant affected person monitoring (RPM) providers furnished to Medicare beneficiaries in the course of the PHE.
The steerage paperwork expressly tie this waiver to the period of the PHE. Thus, except the OIG points further steerage or an extension, after Could 11, well being care suppliers providing telehealth or RPM providers to Medicare beneficiaries might now not cut back or wave any cost-sharing obligations that sufferers might owe for such providers. Digital well being firms with out cost and assortment mechanisms for these funds might want to act swiftly to operationalize new course of to make sure these quantities are charged and picked up.
5. RPM Companies Once more Restricted to “established sufferers”
In 2021, CMS reiterated that exterior of the PHE, RPM providers are restricted to “established sufferers.” Nonetheless, all through the PHE, CMS waived the “established affected person” requirement and allowed practitioners to invoice for RPM for brand new sufferers. When the PHE ends, CMS would require that RPM providers be furnished solely to established sufferers. CMS’ statements suggests after the PHE the doctor should first conduct a brand new affected person analysis and administration service earlier than rendering RPM to such affected person.
6. Digital Direct Supervision Scheduled to Finish This Yr
Among the many PHE waivers, CMS briefly modified the direct supervision guidelines to permit the supervising skilled to be distant and use real-time, interactive audio-video know-how. That change didn’t require the skilled’s real-time presence at, or reside statement of, the service by way of interactive audio-video know-how all through the efficiency of the process.
Within the 2023 doctor payment schedule, CMS declined to increase this short-term coverage past the tip of the calendar 12 months during which the PHE ends. Due to this fact, digital direct supervision will expire on the finish of this 12 months except CMS revises its coverage in future rulemaking.
7. Finish of HIPAA-related Enforcement Discretion
Throughout the PHE, the HHS Workplace for Civil Rights (OCR) exercised enforcement discretion permitting suppliers to make use of telehealth in good religion even when their platforms or software program didn’t comply with Well being Insurance coverage Portability and Accountability Act (HIPAA) guidelines. Nonetheless, this enforcement discretion solely stays in impact till the tip of the PHE.
Thus, after Could 11, the OCR will resume enforcement of penalties on suppliers for noncompliance with HIPAA guidelines for know-how use. Forward of the tip of the PHE, OCR has supplied clarification on how and the circumstances beneath which the HIPAA guidelines apply to telehealth.
To mitigate authorized threat, additional continuity of care, and keep away from problems with affected person abandonment, digital well being firms counting on the PHE waivers ought to take steps now to convey operations into full compliance with relevant necessities earlier than the PHE ends in Could. The Biden Administration has additionally introduced its intent to proceed to execute the method of a easy operational wind down of the flexibilities enabled by the PHE and the intent to supply continuous updates because the PHE involves a detailed. Thus, digital well being firms also needs to carefully monitor additional adjustments, or changes to expiring flexibilities which may be introduced within the coming months.
We are going to proceed to observe for regulatory and legislative adjustments in addition to casual steerage on how the tip of the PHE will impression digital well being firms and the well being care trade as complete.
Need to Be taught Extra?
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