Transition from Waivers and Flexibilities – Industry News, February 2023

Transition from Waivers and Flexibilities

The declaration of the public health emergency (PHE) in response to the COVID-19 pandemic brought an onslaught of waivers and flexibilities enacted by the Centers for Medicare and Medicaid (CMS) for beneficiaries to increase access to care, reduce exposure, and ease provider burden.

In December 2022, the Consolidated Appropriations Act (CAA) was signed into law. The CAA carved out funding for the extension of some of the major telehealth waivers initiated during the PHE. Approximately one month later in January 2023, it was announced the intent to end the national emergency and corresponding public health emergency on May 11, 2023.

CMS has provided updates on waivers and flexibilities granted during the PHE, some of which are summarized below. This is not a comprehensive summary, review of all released materials is recommended.

Medicare Telehealth

After the PHE ends on May 11, 2023, CMS will cease the modified process of adding services to the Medicare Telehealth Services List on a sub-regulatory basis and will resume consideration of changes to the List exclusively through notice and comment rulemaking.

Currently

PHE waivers allow for the use of audio-only equipment to furnish services described by the codes for audio-only telephone evaluation and management services, and behavioral health counseling and educational services.

  • Medicare payment for the telephone evaluation and management visits (CPT codes 99441-99443) is equivalent to the Medicare payment for office/outpatient visits with established patients.
  • Unless specified otherwise other services listed on the Medicare Telehealth Services List must be furnished using audio and video equipment permitting two-way, real-time interactive communication between the patient and distant site.
After the PHE
  • The availability of the telehealth services that can be furnished using audio-only technology will extend through December 31, 2024, per the CAA.
  • Payment equivalent to office/outpatient visits for telephone E/M visits, will be extended December 31, 2024, per the CAA.
  • In the CY 2022 Physician Fee Schedule Rule, CMS revised regulations to permit the use of audio-only equipment for telehealth services furnished to patients in their homes under certain circumstances for purposes of diagnosis, evaluation, or treatment of a mental health disorder (including substance use disorder).
Currently
  • Waivers expanded the types of health care professionals who can furnish distant site telehealth services to include all those who are eligible to bill Medicare for their professional services. As a result, practitioners such as physical therapists, occupational therapists, and speech language pathologists can use telehealth to provide many Medicare services.
After the PHE
  • After the PHE ends, this flexibility will extend through December 31, 2024, per the CAA.
Currently
  • Reporting Home Address: CMS allows practitioners to render telehealth services from their home without reporting their home address on their Medicare enrollment while continuing to bill from their currently enrolled location.
After the PHE
  • The waiver will continue through December 31, 2023.
Currently
  • During the PHE many services were added to the Medicare Telehealth Services list, including, but not limited to:
    • Emergency Department Visits, Levels 1-5 (CPT codes 99281-99285)
    • Initial Nursing Facility Visits, All Levels (Low, Moderate, and High Complexity) and Nursing Facility Discharge Day Management (CPT codes 99304-99306; CPT codes 99315- 99316; HCPCS code G9685)
    • Cardiac Care Services (CPT codes 93797-93798, CPT code 93750)
    • Critical Care Services (CPT codes 99291-99292)
    • Radiation Treatment Management Services (CPT code 77427)
    • Telephone E/M (CPT codes 99441-99443)
After the PHE
  • These services will remain on the Medicare Telehealth Services List and will be available through the end of CY 2023. CMS states they will address updates to the Medicare Telehealth Services List for CY 2024 and beyond through their established processes as part of the CY 2024 Physician Fee Schedule proposed and final rules.

Workforce

Currently
  • Medicare Physician Supervision Requirements:
    • CMS temporarily modified the regulatory definition of direct supervision, which requires the supervising physician or practitioner to be “immediately available” to furnish assistance and direction during the service, to include “virtual presence” of the supervising clinician through the use of realtime audio and video technology.
After the PHE
  • This flexibility is currently set to return to pre-PHE rules on December 31, 2023.
Currently
  • Medicare Nonphysician Practitioners: Nurse practitioners (NPs), clinical nurse specialists (CNSs), certified nurse-midwives (CNMs), and physician assistants (PAs) were granted permission to supervise diagnostic tests as authorized under state law and licensure. These practitioners continue the required statutory relationships with supervising or collaborating physicians.
After the PHE
  • In the CY 2021 PFS final rule, CMS made these flexibilities permanent and added certified registered nurse anesthetists (CRNAs) to the above list of nonphysician practitioners allowed to supervise diagnostic tests as authorized under state law and licensure.
Currently
  • Practitioner Locations: CMS has waived the Medicare requirement that a physician or non-physician practitioner must be licensed in the state in which they are practicing if the physician or practitioner 1) is enrolled as such in the Medicare program, 2) has a valid license to practice in the state reflected.
  • in their Medicare enrollment, 3) is furnishing services — whether in person or via telehealth — in a state in which the emergency is occurring in order to contribute to relief efforts in his or her professional capacity, and 4) is not affirmatively excluded from practice in the state or any other state that is part of the section 1135 emergency area. This waiver does not have the effect of waiving state or local licensure requirements or any requirement specified by the state or a local government as a condition for waiving its licensure requirements.
  • State Licensure: CMS allows licensed physicians and other practitioners to bill Medicare for services provided outside of their state of enrollment.
After the PHE
  • CMS originally implemented the waiver out of an abundance of caution; however, it turned out that regulations that existed before the PHE allowed for a deferral to state law.
  • CMS has determined that, when the PHE ends, CMS regulations will continue to allow for a total deferral to state law. Thus, there is no CMS-based requirement that a provider must be licensed in its state of enrollment.
Currently
  • Modification of 60-day limit for Substitute Billing Arrangements (Locum Tenens): CMS has modified the 60-day limit to allow a physician or physical therapist to use the same substitute (locum) for the entire time he or she is unavailable to provide services during the COVID-19 emergency, plus an additional period of no more than 60 continuous days after the public health emergency expires.
After the PHE
  • On the 61st day after the public health emergency ends (or earlier if desired), the regular physician or physical therapist must use a different substitute or return to work in his or her practice for at least one day in order to reset the 60-day clock. The modified timetable applies to both types of substitute billing arrangements under Medicare fee-for-service (i.e., reciprocal billing arrangements and fee-for-time compensation arrangements, formerly known as locum tenens).

Medicare Part B Drug Inflation Rebates

The Inflation Reduction Act of 2022 requires drug companies to pay Medicare a rebate when they raise their prices for certain Medicare Part B drugs faster than the rate of inflation.

For certain Part B drugs, including biological products, if beneficiary coinsurance increases faster than the rate of inflation, coinsurance will be based on the lower inflation-adjusted payment amount. The new inflation rebate applies to certain Medicare Part B single source drugs and biological products, including biosimilar biological products. If drug companies refuse to pay the required rebates, they will face a penalty equaling 125% of the rebate amount.

Starting April 1, 2023, when the payment amount for a Part B drug is higher than the inflation adjusted amount:

  • Coinsurance will be based on 20% of the inflation-adjusted payment amount for the quarter
  • The Medicare portion of the payment will be increased for the difference between the Medicare Part B payment amount and patient coinsurance
  • The patient must be charged the correct amount of coinsurance, which may vary quarterly

CMS will publish Medicare Part B payment amounts for all drugs and biologicals in the quarterly drug pricing files. CMS will also publish patient coinsurance percentages for all drugs and biologicals, including adjusted patient coinsurance percentages if the Medicare part B payment amount is higher than the inflation-adjusted amount.

Radiologists, Physician Groups Oppose Prior Authorization Policies

The American Society of Neuroradiology, Society of Interventional Radiology, American College of Cardiology, American Society of Nuclear Cardiology, American College of Radiation Oncology and the American Society for Radiation Oncology were among nearly 120 physician groups urging the Centers for Medicare and Medicaid Services (CMS) to amend prior authorization policies which they say are hindering patient care.

On February 13, 2023, the physician groups submitted a letter to CMS Administrator urging the agency to adopt the recently proposed actions to reform Medicare Advantage’s use of prior authorization. CMS announced the proposed Medicare Advantage changes on February 1 and is accepting comments through March 3, 2023.

Prior authorizations are utilized by insurance companies to determine if a product or service should be covered in an attempt to avoid unnecessary healthcare spending. Radiation oncology, cardiology and diagnostic radiology were cited in a JAMA Health Forum analysis as the top three specialties facing the heaviest burden from prior authorizations.

Following an April 2022 HHS Investigation, it was discovered Medicare Advantage plans improperly applied Medicare coverage rules to deny 13percent of prior authorization requests and 18 percent of payments.

“We urge CMS to finalize these important changes for [Medicare Advantage] and Part D plans and look forward to continuing to work with you to reduce the burden of [prior authorization] as it relates to all care in all health insurance markets,” the letter concluded.