On January 31, 2020, the Secretary of Health and Human Services, Alex M. Azar II (the “Secretary”), pursuant to this authority under section 319 of the Public Health Service Act, declared a public health emergency (“PHE”) as a result of the Coronavirus Disease 2019.  In the event of a PHE declaration, the Secretary may, pursuant to Section 1135 of the Social Security Act, temporarily waive or modify certain Medicare, Medicaid, State Children’s Health Insurance Program (“SCHIP”), and Health Insurance Portability and Accountability Act (“HIPAA”) requirements to ensure that sufficient health care items and services are available to meet the needs of these federal healthcare program beneficiaries, as well as to ensure that providers are reimbursed and exempted from sanctions for their inability to otherwise comply with certain aspects of these statutes.  The Centers for Medicare & Medicaid Services (“CMS”) issues these waivers or modifications based upon requests received from affected health care providers, hospitals and facilities.

On March 31, 2020, CMS issued an Interim Final Rule (85 Fed. Reg. 19,230), which set forth certain regulatory modifications designed to address the COVID-19 pandemic during the PHE (the “March 31st COVID-19 IFC”).  See NMRS’s blog post regarding the March 31st COVID-19 IFC.  On April 21, 2020, the Secretary extended his PHE declaration.  As a result, on April 30, 2020, CMS issued a second round of regulatory waivers and modifications in an Interim Final Rule titled “Medicare and Medicaid Programs, Basic Health Program, and Exchanges; Additional Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency and Delay of Certain Reporting Requirements for the Skilled Nursing Facility Quality Reporting Program” (the “Interim Final Rule”).  The regulations set forth in this Interim Final Rule are retroactive to March 1, 2020 and are effective through the duration of the PHE declaration.  

The purpose of the Interim Final Rule is to ensure that the states have the flexibilities they need to accommodate the growing demand for diagnostic testing and broad access to medical care, which CMS views as the “key precursors to ensuring a phased, safe and gradual reopening of America.”  The Interim Final Rule is extremely detailed, but some of the most significant modifications are highlighted below.

(1) COVID-19 Diagnostic Testing.  Pursuant to 42 C.F.R. § 410.32, diagnostic laboratory test (e.g., COVID-19 tests), are covered only when ordered by a physician or other practitioner treating the beneficiary.  If a patient presents at a community COVID-19 testing site without an order for the test from his or her physician or practitioner, the test would not be covered by Medicare.

• Interim Final Rule Modification. Medicare will no longer require a beneficiary to obtain an order from a treating physician or other practitioner to undergo COVID-19 tests and certain other laboratory tests required for a COVID-19 diagnosis.  Instead, COVID-19 tests may be covered when ordered by any healthcare professional authorized to do so under state law.  This modification will be expanded to cover additional diagnostic tests beyond COVID-19, pursuant to a list that will be issued by CMS at a later date.  Laboratories that conduct tests without such an order are required to notify patients of the results, as well as adhere to state and local public health reporting requirements.

(2) COVID-19 Serology Testing. FDA-approved, blood-based serology tests have been established that may identify whether a patient was previously infected with the virus that causes COVID-19, by identifying whether the patient has antibodies specific to the virus.  Patients who have these antibodies may have developed an immunity to COVID-19.  

• Interim Final Rule Modification. FDA-approved, COVID-19 serology tests fall under the Medicare benefit category of diagnostic laboratory tests and will be covered by Medicare, as they are reasonable and necessary pursuant to Section 1862(a)(1)(A) of the Act “for beneficiaries with known current or known prior COVID-19 infection or suspected current or suspected past COVID-19 infection.”  

(3) Expansion of Audio-Only Telehealth Services.  In the March 31st COVID-19 IFC, CMS established separate payment for audio-only telephone evaluation and management services, based on the notion that audio-only communication did not “fully replace a face-to-face visit.” 

• Interim Final Rule Modification. In light of feedback received from providers regarding the use of audio-only services, CMS acknowledged that “audio-only services are actually serving as a substitute for office/outpatient Medicare telehealth visits for beneficiaries not using video-enabled telecommunications technology contrary to the situation we anticipated when establishing payment for them in the March 31st COVID-19 IFC.”   Based on this, CMS adjusted the payment for certain audio-only E/M services and added such services to the list of permissible Medicare telehealth services. CMS will also be issuing a separate 1135(b) waiver for these services. 

(4) Reporting of COVID-19 Infections and Deaths. The conditions of participation for skilled nursing facilities, set forth in 42 CFR part 483, require that LTC facilities develop and maintain an infection control program, and requires such facilities to have written standards, policies and procedures for the program, including a system of surveillance designed to identify possible communicable diseases or infections.

• Interim Final Rule Modification. A new provision (42 C.F.R. § 483.80(g)(1)) was added to require facilities to electronically report information about COVID-19 in a standardized format specified by the Secretary, which must include information regarding suspected and confirmed COVID-19 infections and deaths among residents and staff; an inventory of personal protective equipment and hand hygiene supplies, ventilator capacity and supplies, resident beds, and a facility census; staffing shortages; access to COVID-19 testing; and other information as specified by the Secretary. 

Additional items to note include:

• The types of practitioners who may utilize telehealth services has been expanded to include physical therapists, occupational therapists, and speech-language pathologists.
• Hospitals may bill as the originating site for telehealth services furnished by hospital-based practitioners to Medicare patients registered as hospital outpatients, including when the patient is located at home. 
• CMS will add new services to its list of Medicare services that may be furnished via telehealth on a sub-regulatory basis rather than through the rulemaking process.
• Accountable Care Organizations whose participation is set to expire in 2020 will have the option to extend their participation for another year. 
• ACOs required to increase their financial risk over the course of their current agreement period have the option to maintain their current risk level for next year. 
• Certain partial hospitalization services delivered in temporary expansion locations, including patients’ homes, will be covered by Medicare (e.g., individual psychotherapy, patient education, group psychotherapy).
• Physical and occupational therapists may delegate maintenance therapy services to physical and occupational therapy assistants in outpatient settings. 
• The requirement for ambulatory surgical centers to periodically reappraise medical staff privileges is waived throughout the PHE.
• For Medicare and Medicaid, nurse practitioners, clinical nurse specialists, and physician assistants may order home health services, establish and periodically review a plan of care for home health patients, and certify and re-certify that the patient’s eligibility. 
• Freestanding inpatient rehabilitation facilities may accept patients from acute-care hospitals experiencing a surge. 
• Certain provider-based, off-campus hospital outpatient departments may be paid under the Outpatient Prospective Payment System instead of the Physician Fee Schedule. 

These are just a highlight of the temporary regulations implemented by the Interim Final Rule.  For information regarding the specific regulatory modifications set forth in the Interim Final Rule, and to see more information regarding some of the topics discussed in this post, visit CMS’s COVID-19 website.