CMS Medicare

Medicare telehealth regulations are created by a statute –a written law passed by a legislature at the state or federal level. Statutes set forth general propositions of law that are applied to specific situations. Congress creates the laws that govern Medicare. Only Congress can change these laws. Regulations add guidance, management, control, or disposition.
How Medicare telehealth regulations are created
  • statute is a written law passed by a legislature on the state or federal levelStatutes set forth general propositions of law that are applied to specific situations.  
  • Congress creates the laws that govern Medicare.  Only Congress can change these laws.
  • 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.
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. 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 Regulations

Medicare regulations for telehealth fall into seven categories. Each category describes the statute or regulation before the PHE, the action taken during the PHE and how it occurred, the action that is being taken, or could be taken following the expiration of the PHE. Unless an action taken during the PHE is made permanent either by statute or regulation, the action will expire when the PHE expires.

Provider/patient location

Geographic and originating site requirements

Before the 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.   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 How the action occurred:  Cares Act/1135 waiver.  Change needed to make permanent:  Statutory – Congress will need to pass legislation to expand pre=COVID law to include the expansions allowed during the PHE.  Several bills that propose this change are currently before Congress.

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 During the PHE: Providers providing telehealth services do not need to update their Medicare enrollment to include their home location, not must their clinic/group practices do so if the provider has assigned his/her benefits. How the action occurred: 42 CFR 434.516 established this waiver.   Change needed to make permanent: CMS could choose to make this guidance permanent under its regulatory authority.

Licensing requirement

Before the PHE:  Licensure of providers was and still is the purview of the individual states.  The provider must be licensed in the patient’s state.  States could/can individually choose to license providers wishing to practice in their states or can participate in a licensure compact with other states that have joined the compact and provide reciprocity to the participating states.    Participating states must have the approval of their legislatures.  State requirements still apply.  During the PHE: CMS encouraged states to relax their licensing laws by temporarily waiving Medicare and Medicaid requirements to be licensed in the patient state if they are enrolled in Medicare, have a valid license in the state which relates to Medicare enrollment, in furnishing services in the state where there emergency is occurring, and not excluded from practicing in that state or any other state that is part of the emergency. State requirements will still apply. How the action occurred:  Cares Act/1135 waiver Change needed to make permanent: Statutory change will be required.            

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. How the action occurred: The CARES Act Change needed to make permanent: A statutory change would be required.  There are several bills currently in Congress that could make this change permanent.

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 Change needed to make permanent:  Statutory change needed.  

Hospital outpatient billing for telehealth

Before the PHE: Not allowed prior to the PHE During the PHE: 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.

Direct supervision

Before the PHE:  As of January 1, 2020, direct supervision of covered services must be performed under the general in person supervision of a physician or a non-physician practitioner. During the PHE: During the PHE direct supervision may be provided using real-time, interactive audio and video technology. How the action occurred: CMS 1744-IFC Waiver Change needed to make permanent: CMS could permanently retain this flexibility through rule-making

Types of Services

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. Change needed to make permanent: 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.

Hospice and home health face-to-face requirements

Before the PHE:  The Medicare home health benefit does not permit the inclusion of a telehealth service as a reimbursable service as a part of the plan of care. During the PHE:  The face-to-face visit for the purpose of recertification of Medicare hospice services can be performed via telehealth.   How the action occurred: CARES Act/1135 waiver Change needed to make permanent:  A statutory change would be needed to remove the mandate for a face-to-face encounter by a physician to certify a patient’s need for home health services.

Hospice and home health delivery of care

Before the PHE:  The Medicare home health benefit did not permit the inclusion of a telehealth service as a reimbursable service as a part of the plan of care.  During the PHE:  Professionals that provide home health and hospice services (including nurses and therapists) may do so via telehealth and bill accordingly. How the action occurred: CMS-1744-IFC Change needed to make permanent:  New statutory authority would be needed to allow the use of telehealth under the home health benefit.  

End-stage renal disease and home dialysis patients

Before the PHE: CMS required that home dialysis patients receiving services via telehealth must have a monthly face-to-face, non-telehealth encounter in the first initial three months of home dialysis and after the first initial three months, at least once every three consecutive months. ESRD clinicians must have one “hands on” visit/month for current required examination of vascular access site. During the PHE:  CMS has chosen to exercise enforcement discretion.  Clinicians will not have to meet the requirement for face-to-face visits for evaluations and assessments. How the action occurred: CMS-1744-IFC Change needed to make permanent: The National Coverage Determination or Local Coverage Determination of face-to-face visits for evaluations and assessments would need to be changed.

Skilled Nursing Facilities

Before the PHE:  Physicians and non-physician practitioners must perform visits in-person to residents of skilled nursing facilities.  Telehealth could only be used for patients covered by Medicare Advantage plans. During the PHE:  If appropriate, visits to residents of skilled nursing facilities may be done via telehealth. How the action occurred:  CARES Act/1135 waiver Change needed to make permanent:  CMS could choose to make this guidance permanent under its regulatory authority.

Additional telehealth services

Before the PHE:  CMS provided payment for nearly 100 telehealth services when furnished via telehealth.   During the PHE:  More than 140 additional telehealth services were added to the list of services that could be reimbursed by CMS and allowed additional services to be added on a sub regulatory basis to the list of Medicare telehealth services.  How the action occurred:  CMS-1744-IFC and CMS-5531-IFC Change needed to make permanent: CMS could use its regulatory authority to permanently retain the expanded list of approved telehealth services and could permanently retain the sub regulatory process for adding codes to the list of approved services. The 2021 Physician’s Fee Schedule (PFS) made some of these codes permanent, and others would undergo an assessment period.  The Center for Connected Health Policy provides an excellent analysis of the telehealth provisions in the 2021 PFS. 

Virtual check-Ins and E-visits (not considered telehealth by CMS; referred to as Communication Based Technology Services-CBTS)

Before the PHE: Virtual check-ins and e-visits could only be provided to established patients During the PHE: Virtual check-ins and e-visits can be provided to both new and established patients How the change occurred: CMS-144-IFC Change needed to make permanent:  CMS could use its regulatory authority to continue to allow virtual check-ins and e-visits to be used for new and established patients. CMS has also 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.

Remote Physiological Monitoring (RPM) services (not considered telehealth by CMS)

Before the PHE: RPM could be used for established patients with chronic conditions only. During the PHE: RPM can be used for both new and established patients and for acute as well as chronic conditions.   How the change occurred:  CMS-1744-IFC  Change needed to make permanent:  CMS could use its regulatory authority to permanently continue the changes. In the 2021 PFS CMS proposed significant changes to the RPM rule. A complete listing of the proposed changes can be found at this Center for Connected Health Policy webpage.

Billing payment and coverage for telehealth services

Parity of payment

Before the PHE:  Telehealth services were billed using the payment amount established in the PFS which differed from 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. Some rates for telephone visits have been increased. Change needed to make permanent:  CMS could use its regulatory authority to make the change permanent.

Frequency limitations 

Before the PHE: Medicare imposed frequency limitations on subsequent telehealth visits (in-patient – once every three days; skilled nursing facility – once every 30 days; and critical care consults – once a day. During the PHE: All the above frequency limitations are removed. How the change occurred: 1135 waiver/CMS-1744-IFC Change needed to make permanent: CMS can use its rulemaking authority to change frequency limitations, and CMS requested comments to their proposed 2021 PFE regarding making these changes permanent.

Part B facility fee 

Before the PHE:  Hospitals were not allowed to bill the originating site fee when the Medicare patient was registered as a hospital outpatient but located at home. During the PHE: Hospitals can 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.  How the change occurred:  CMS-5531-IFC Change needed make permanent:  A permanent change to the policy prohibiting payment of a facility fee if the originating site is the patient’s home, would require a statutory change to remove the prohibition or authorize the HHS Secretary to waive it as appropriate.

Physical examination

Before the PHE:  CMS required that a history and/or physical examination in order to bill an office or outpatient evaluation and management (E/M) visits 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. How the change occurred:  CMS-1744-IFC Change needed to make permanent:  CMS can use its rule-making authority to make the change permanent and has proposed such a change in its 2021 PFS.

Consent to treat

Before the PHE: The annual consent to treat with telehealth had to be obtained prior to the treatment. During the PHE: Annual consent for telehealth treatment may be obtained while services are furnished. How the change occurred:  CMS clarification in its FAQ on flexibilities to fight COVID-19 for physicians and other clinicians. Change needed to make permanent:  CMS could retain this approach to consent through its rule-making authority. 

Modifiers

During the PHE:  Providers are allowed to report POS code that would have been reported had the service been furnished in person so that providers can receive the appropriate facility or non-facility rate and use the modifier “95” to indicate the service took place through telehealth.  If providers wish to continue to use POS code 02, they may, and it pays the facility rate.  FQHCs/RHCs submit G2025.  How the change occurred:  CARES Act/1135 waiver. Change needed to make permanent:  CMS would need to make changes to the Fee-for-service rules. Please note:  Telehealth billing codes and procedures are not covered in this document.  If you need specific help with billing codes and procedures, please go to the Medicare Fee-For-Service (FFS) Response to the PHE on the Coronavirus (COVID-19) and/or CCHP Biliing Guide.

Out-of-pocket costs/co-pays

Before the PHE:  Telehealth providers were subject to sanctions from the Office of the Inspector General (OIG) if they waived or reduced any cost-sharing obligations that beneficiaries owed for telehealth services. During the PHE:  The physician or practitioner may reduce or waive the costs that the beneficiary may owe for telehealth services. How the change occurred:  The PHE allowed the OIG to use its waiver authority. Change needed to make permanent:  Changes would need to be made to the Federal anti-Kickback statues and the laws related to those statutes.

Prescribing controlled substances

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. The Drug Addiction Treatment Act allows this use, but the DEA has not yet established guidance. During the PHE: Opioid Treatment Programs (OTPs) “should feel free to dispense, and Drug Addiction Treatment Act (DATA)-waived practitioners prescribe, buprenorphine to new patients with OUD for maintenance treatment or detoxification treatment following an evaluation via telephone voice calls, without first performing an in-person or telemedicine evaluation.”   Change needed to make permanent: DEA would need to establish guidance for the DAT ACT.

HIPAA

HHS Office for Civil Rights (OCR) to suspend fines for violations during the PHE

Before the PHE: The OCR investigated  During the PHE: The OCR will “exercise enforcement discretion and waive penalties for HIPAA violations against health care providers that serve patients in good faith through everyday communications technologies, such as FaceTime or Skype, during the COVID-19 nationwide public health emergency.“  How the change occurred: Current OCR authority Change needed to make permanent: Statutory and regulatory changes would be needed.

Stark Laws

Stark Law and Anti-Kickback statute

Before the PHE: The Stark Law, otherwise known as the physician self-referral law, prohibits referrals by a physician to another provider if the physician or his immediate family has a financial relationship with the provider. The Anti-Kickback Statute bars the exchange of remuneration – which according to this law is anything of value – for referrals that are payable by a federal healthcare program like Medicare. During the PHE:  CMS is allowing certain waivers:  hospitals and other health care providers can pay above or below fair market value to rent equipment or receive services from physicians; health care providers can support each other financially to ensure continuity of health care operations. How the change occurred:  CARES Act/1135 waiver Change needed to make permanent:  The HHS Office of the Inspector General has issued a final rule which would make the changes permanent effective 60 days following its publication in the Federal Register. (Jan 2021).
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