How Medicare statutes are created
- A statute is a written law passed by a legislature on the state or federal level.
Statutes set forth general propositions of law that are applied to specific situations. A statute may forbid a certain act, direct a certain
act, make a declaration, or set forth governmental mechanisms to aid
society. https://legal-dictionary.thefreedictionary.com/statute
Congress creates the laws that govern Medicare. Only Congress can change these laws.
How Medicare regulations are created
- Regulations add guidance, management, control, or disposition to laws.
- The Center for Medicare and Medicaid Services (CMS) establishes the regulations for most of the telehealth laws/statutes that are passed by Congress.
The Cares Act
On March 27, 2020, Congress passed the Coronavirus Aid, Relief, and Economic Security (CARES) Act (H.R.748), in response to the COVID-19 public health emergency. It signaled strong support for the use of telehealth and virtual care and created flexibilities for previously created telehealth laws. Congress directed CMS to develop regulation/guidance for these flexibilities.
The 1135 Waiver
When the President declares a disaster or emergency under the Stafford Act or National Emergencies Act and the HHS Secretary declares a public health emergency under Section 319 of the Public Health Service Act, the Secretary is authorized to take certain actions in addition to his/her regular authorities. For example, under section 1135 of the Social Security Act, he/she may temporarily waive or modify certain Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) requirements to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act programs in the emergency area and time periods and that providers who provide such services in good faith can be reimbursed and exempted from sanctions (absent any determination of fraud or abuse)
Medicare Reimbursement for Telehealth
Medicare reimbursement statutes and regulations for telehealth can be placed into seven categories or buckets. Each ‘bucket’ describes the statutes or regulations before the PHE, the actions taken during the PHE, and the actions needed to make the each flexibility permanent following the PHE, the 155-day extension, or the Omnibus bill extension (December 31, 2024).
The buckets are:
- Provider/patient location
- Eligible providers and facilities
- Types of services
- Billing, payment, and coverage for telehealth services
- Behavioral health and substance use disorders
- HIPAA
- Stark Laws
Bucket #1 Provider/Patient Location
Providers at home
- Before the PHE: providers providing services from their homes were required to update their Medicare enrollment to include their home location. Their clinic group practices were required to provide updated information if the provider had assigned his/her benefits to the practice.
- During the PHE: No update is required.
- CMS could choose to make this guidance permanent under its regulatory authority.
- Post PHE: Unless CMS chooses to make the guidance permanent under its regulatory authority following the PHE, providing updated information will again be required. CMS guidance needed to determine the exact date.
Geographic and originating site requirements
- Before PHE: Providers were reimbursed for services delivered to patients that were presented in an originating site located in a CMS defined rural area. The type of originating site had to be approved by CMS. Patients could receive services in their homes only for end-stage renal disease, acute stroke treatment, and substance use disorders and co-occurring mental health disorders and if they were located in a CMS defined rural area.
- During the PHE: Providers may deliver telehealth services to patients in their homes and other locations, and in any area of the country. CMS encourages states to relax their licensing laws.
- Post PHE: Congress will need to pass legislation to expand pre-COVID law to include the expansions allowed during the PHE. If no law is passed the flexibility will end on December 24, 2024.
Bucket #2 Eligible Providers and Facilities
RHCs and FQHCs
Before the PHE: Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) could only serve as originating sites for the provision of telehealth services.
During the PHE: Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) may serve as distant sites for the provision of telehealth services under code G2025.
How the action occurred: The CARES Act
Post PHE: A statutory change will be required to make this change permanent. The flexibility will expire on December 31, 2024.
* Through Administrative Actions, CMS redefined a “mental health visit” for FQHCs & RHCs to include provision of these services via live video or audio-only, however, because it is a redefinition of “mental health visit”, it is not considered “telehealth” and therefore FQHCs/RHCs are not considered telehealth providers
Additional Practitioners
Before the PHE: CMS limited the types of providers that could bill Medicare for telehealth services to physicians, nurse practitioners, physician assistants, nurse midwives, clinical nurse specialists, certified registered nurse anesthetists, clinical psychologists and clinical social workers (with limitations), and registered dietitians or nutrition professionals.
During the PHE: All health care professionals who are eligible to bill Medicare for their professional services (including physical therapists, occupational therapists, speech language pathologists, and others) may deliver and bill for services provided via telehealth.
How the action occurred: CARES ACT/1135 waiver
Post PHE: Statutory change needed. (The list of eligible providers could be expanded by Congress, or the HHS Secretary could be given the authority to determine eligible providers.)
The provision in the Omnibus bill only extended the expansion to qualified physical therapists, speech-language therapists, and audiologists. All other provider eligibility included in the PHE flexibility would end 155 days after the end of the PHE.
Hospital Outpatient Billing for Telehealth
Before the PHE: Not allowed prior to the PHE
Until the end of the Omnibus extension: Hospitals, including critical access hospitals (CAHs), may bill the outpatient perspective payment system (OPPS) or otherwise applicable payment system for therapy, training and education services furnished remotely by hospital clinical staff to Medicare patients registered as hospital outpatients, including when the patient is at home.
How the action occurred: CMS 5531-IFC Waiver authority
Change needed to make permanent: Statutory change needed or lawmakers could grant the HHS Secretary the authority to determine which providers may deliver and bill for different telehealth services.
Unless otherwise specified in upcoming CMS guidance this flexibility would end 155 days following the end of the PHE.
Direct Supervision
Before the PHE: As of January 1, 2020 direct supervision of covered services be performed under the general in person supervision of a physician or a non-physician practitioner.
During the PHE: Direct supervision may be provided using real-time, interactive audio and video technology.
How the action occurred: CMS 1744-IFC Waiver
Post PHE: CMS chose not to make the change permanent in the 2023 Physician Fee Schedule. However, supervision using telehealth (real-time audio and video will be allowed through the end of 2023.
Bucket #3 Types of Services
Additional Telehealth Services
Before the PHE: CMS provided payment for nearly 100 telehealth services when furnished via telehealth under the 2020 Physician’s Fee Schedule.
During the PHE: The 2021 Physician’s Fee Schedule made some of the codes allowed during the PHE permanent and created a list of codes that were placed in a third category (Category 3). These services “included codes in the list that were added for the duration of the PHE for which there is likely to be clinical benefit when furnished via telehealth, but for which there is not yet sufficient evidence available to consider the services as permanent additions under Category 1 or Category 2 criteria. Category 3 services would remain on the Medicare eligible telehealth services list through the calendar year in which the PHE ends. To become permanent, they would need to meet the qualifications of Category 1 or 2. The same process was followed for the 2022 and 2023 fee schedule. To see the list of services included in 2022 and 2023 Physician’s Fee Schedules go to Physician Fee Schedule | CMS
Audio-Only Communication
Before the PHE: Providers were required to deliver services through two-way audio and video communication.
During the PHE: Providers may deliver certain Medicare telehealth services via audio-only communication.
How the action occurred: CMS used its authority to waive its requirement that telehealth services must be delivered using two-way audio and video technology.
Under the Omnibus Act audio-only telehealth services can continue to be provided until December 31,2024
Post PHE: Legislation is required to either codify in statute that telecommunications services can, in certain, instances, include audio-only communication, or lawmakers could grant the HHS Secretary the authority to allow certain services to be delivered via audio-only communication.
In 2022 CMS amended the definition of “interactive telecommunications system” to include the audio-only communications technology when used for telehealth services for the diagnosis, evaluation, or treatment of mental health disorders furnished to established patients in their homes under certain circumstances.
Virtual check-in and E-visits (not considered telehealth by CMS and referred to as Communication Technology Based Services – CTBS)
Before the PHE: Virtual check-ins and e-visits could only be provided to established patients.
Until the end of the PHE: Virtual check-ins and e-visits can be provided to both new and established patients.
CMS clarified in the 2021 PFS that clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists may also provide and bill for these services to established patients.
Post PHE: CMS will need to provide guidance for requirements
Remote Patient Monitoring Services (not considered telehealth by CMS)
Note: Remote Patient Monitoring Services more specifically refers to remote physiological monitoring services.
Before the PHE: Remote Patient Monitoring (RPM) could be used for established patients with chronic conditions only.
Until the end of the PHE: RPM can be used for both new and established patients and for acute as well as chronic conditions.
In the final 2021 Physician Fee Schedule CMS proposed significant changes to the RPM rule. The most significant are:
- An established patient-physician relationship will be required following the end of the PHE
- Consent can be obtained at the time the RPM services are furnished
- Acute as well as chronic conditions qualify for RPM services
A complete list of the changes can be found on the CMS website.
Remote therapeutic monitoring codes adopted in 2022 to be used for non-physiologic monitoring are similar to remote physiologic monitoring codes; however, the primary billers are meant to be psychiatrists, nurse practitioners, and physical therapists, and allows non-physiological data to be collected.
Post PHE: CMS needs to provide guidance.
Acute Hospital Care at Home Services
Before the PHE: CMS required hospital nursing services to be provided on premises 24 hours a day, 7 days a week, and that there be the immediate availability of a registered nurse for care of any patient.
During the PHE: On November 25, 2020, CMS issued Acute Hospital Care at Home (AHCaH) flexibilities under the Hospital Without Walls initiative that suspended the pre-PHE requirements. It included the waiver of telehealth requirements including the home as an originating site.
Under the Omnibus extension, these flexibilities will continue through December 31, 2024.
Bucket #4 Billing, Payment, and Coverage for Telehealth Services
Parity of Payment
Before the PHE: Telehealth services were billed using the payment amount established for telehealth in the Physician Fee Schedule which was less that the rate for the in-person fee-for-service rate.
During the PHE: Payment is the same as would have been received if it had been provided in-person.
CMS could use its regulatory authority to make payment parity for telehealth permanent following the PHE. There is no guarantee that payment parity will continue past December 2023.
Post PHE: The 2024 CMS Physician Fee Schedule will determine its decision on payment parity.
Frequency Limitations
Before the PHE: CMS imposed frequency limitations on subsequent telehealth visits (in-patient – once every three days; skilled nursing facility – once every thirty days; and critical care consults – once a day).
During the PHE: All of the frequency limitations are removed.
In the 2021 PFS CMS revised the frequency limitation in a skilled nursing facility to once every 14 days. Other frequency limitations could be changed by CMS under its rule making authority.
Post PHE: CMS guidance is required.
Part B Facility Fee
Before the PHE: Hospitals were not allowed to bill the originating fee when the Medicare patient was registered as a hospital outpatient, but located at home.
During the PHE: Hospitals are allowed to bill the originating site facility fee for telehealth services paid under the Medicare PFS and furnished by hospital providers to Medicare patients registered as hospital outpatients including when the patient is located at home.
Post PHE: To become permanent Congress would need to pass legislation removing the prohibition or authorize the HHS Secretary to waive it as appropriate.
CMS guidance is required.
Consent to Treat (RPM)
Before the PHE: The annual consent to treat with RPM services had to be obtained prior to the service being provided and annually thereafter.
During the PHE: The annual consent for treatment may be obtained at the same time that services are furnished.
This change was made permanent by CMS in the 2021 PFS.
Physical Examination
Before the PHE: CMS required a history and/or physical examination in order to bill an office or outpatient evaluation and management (E/M) visit delivered via telehealth.
During the PHE: Visits can be provided for any patient via telehealth and the office/outpatient E/M level selection for these services when furnished via telehealth can be based solely on the level of medical decision-making or time spent by the provider on the day of the visit.
CMS could use its rule-making authority to make the change permanent.
Post PHE: CMS will need to provide guidance.
Codes and Modifiers
Place of Service Codes (POS) for telehealth
- The POS 2 code is used when a telehealth service is provided anywhere but to the patient’s home.
- The POS 10 code is used when a telehealth service is provided to a patient’s home.
Telehealth Modifiers for CPT codes
- Modifier 95 indicates a synchronous telemedicine service rendered via real-time interactive audio and video telecommunications system.
- Modifier 93 indicates synchronous telemedicine service rendered via telephone or other real-time interactive audio-only telecommunications system.
During the PHE: FQHCs/RHCs should use the HCPCS code G2025 to show that the service was delivered via telehealth.
Until the end of the PHE the “CS” modifier should be used only when providing a COVID-19 related service.
Post PHE: CMS will need to make permanent changes to the fee for service rules.
Please note: Telehealth billing codes and procedures can be very complex. Please use the resources provided by CMS, the American Medical Association and the Center for Connected Health Policy.
Bucket #5 Behavioral Health and Substance Use Disorders
Use of audio-only (phone) to prescribe buprenorphine for opioid use disorder treatment
Before the PHE: The DEA did not allow the use of the phone to prescribe buprenorphine. Even though the Drug Addiction Treatment Act (2018) allowing this use, the DEA has not yet established guidance.
During the PHE: A practitioner may prescribe buprenorphine to a new or established patient via audio-only communication.
Post PHE: When the PHE ends, practitioners will be required to conduct an in-person evaluation of a patient prior to prescribing buprenorphine, any schedule III-V drug, until such time as the DEA issues its guidance for the Drug Addiction Act.
In-person exam requirement for use of telehealth services in the home
Before the PHE: Patients could receive services in their homes only for substance use disorders and co-occurring mental health disorders and only if located in a CMS defined rural area.
During the PHE: Patients could receive services in their homes regardless of where they were located. In December 2020, Congress created a requirement for an in-person visit within six months of the first telehealth service and subsequent in-person visits every 12 months thereafter. It was to go into effect at the end of the PHE. This requirement is now delayed until December 31, 2024.
Following the PHE: Congress will need to a) permanently change the location requirement; and b) reverse the in-person visit requirement passed in 2020.
Bucket #6 HIPAA
Before the PHE: The HHS Office of Civil Rights (OCR)investigated all reported HIPAA violations.
During the PHE: A Notification of Enforcement Discretion was issued by the OCR at the start of the PHE. It applies to all health care providers that are covered by HIPAA and provide telehealth services during the emergency. The Notice stated that covered health care providers will not be subject to penalties for violations of the HIPAA Privacy, Security, and Breach Notification Rules that occur in the good faith provision of telehealth during the COVID-19 nationwide public health emergency. This included the use of “non-public facing remote communications products” such as FaceTime, Facebook Messenger video chat, Google Hangouts video, Zoom or Skype. Public facing applications may not be used. FAQs on Telehealth and HIPAA during the COVID-19 nationwide public health emergency (hhs.gov)
Following the PHE: Immediately following the end of the PHE the enforcement discretion will end.
Bucket #7 Stark Law
Before the PHE: Stark law did not permit High Deductible Health Plans and Health Savings Accounts to pay for telehealth services prior to the plan members’ deductibles being met.
During the PHE: Coverage of telehealth services was allowed without plan members incurring costs even before plan members’ deductibles were met
Following the PHE: This Safe Harbor is extended through December 31, 2024.
Sources
The Center for Connected Health Policy – Federal Information
Center for Connected Health Policy MEDICARE TELEHEALTH/CONNECTED HEALTH WAIVERS POST-PHE
The Center for Medicare and Medicaid Services Telehealth Information
Center for Medicare and Medicaid Services Corona Virus Waivers and Flexibilities Fact Sheet