Background: 1135 Waiver Authority
On March 13, 2020, the President of the United States issued a proclamation that the 2019 Novel Coronavirus (previously referred to as 2019-nCoV, now as COVID-19) outbreak in the United States constitutes a national emergency by the authorities vested in him by the Constitution and the laws of the United States, including sections 201 and 301 of the National Emergencies Act (50 U.S.C. 1601 et seq.), and consistent with section 1135 of the Social Security Act. On January 27, 2020, the Secretary of Health and Human Services, pursuant to the authority vested in him under section 319 of the Public Health Service Act, determined that a public health emergency exists and has existed since January 27, 2020, nationwide.
When the President of the United States declares a major disaster under the Stafford Act or an emergency under the National Emergencies Act and the U.S. Department of Health and Human Services (HHS) Secretary declares a Public Health Emergency (PHE) under Section 319 of the Public Health Service Act, the Secretary is authorized to take certain actions in addition to his or her regular authorities under section 1135 of the Social Security Act. For example, under section 1135 of the Social Security Act (the Act), he or she may waive or modify certain Medicare, Medicaid, Children’s Health Insurance Program (CHIP), and Health Insurance Portability and Accountability Act (HIPAA) requirements as necessary to ensure to the maximum extent feasible that, in an emergency area during an emergency period, sufficient health care items and services are available to meet the needs of individuals enrolled in Social Security Act programs and that providers of such services who are unable to comply with certain statutory requirements are reimbursed and exempted from sanctions for noncompliance other than fraud or abuse.
On March 13, 2020, pursuant to section 1135(b) of the Act (42 U.S.C. § 1320b-5), the Secretary of HHS waived or modified certain requirements of Titles XVIII, XIX, and XXI of the Act and regulations thereunder and the following requirements of Title XI of the Act, and regulations thereunder, insofar as they relate to Titles XVIII, XIX, and XXI of the Act, but in each case, only to the extent necessary, as determined by the Centers for Medicare & Medicaid Services (CMS), to ensure that sufficient health care items and services are available to meet the needs of individuals enrolled in the Medicare, Medicaid, and CHIP programs and to ensure that health care providers that furnish such items and services in good faith, but are unable to comply with one or more of these requirements as a result of the consequences of the COVID-19 pandemic, may be reimbursed for such items and services and exempted from sanctions for such noncompliance, absent any determination of fraud or abuse.1
Originating Site Expansion
联邦医疗保险
Under the Coronavirus Preparedness and Response Supplemental Appropriations Act, as signed into law by President Trump on March 6, 2020, and the Section 1135 wavier authority, CMS broadened access to Medicare telehealth. Effective March 6, 2020, health care providers permitted to furnish Medicare telehealth services during the public health emergency, including physicians and certain non-physician practitioners such as nurse practitioners, physician assistants, and certified nurse midwives, may now provide covered tele-health services to patients outside of rural areas, including treating patients in their homes. This is a shift from the pre-emergency requirements that conditioned coverage of telehealth services upon a beneficiary being located in a qualifying rural area and being located at a qualifying “originating site.”2
Medicaid
States have also begun relaxing practice standards for telehealth. For example, on March 23, 2020, the New York State (NYS) Department of Health issued updated guidance regarding use of telehealth by Medicaid providers, which expanded the ability of all Medicaid providers to provide telehealth services for the care of Medicaid members by expanding what constitutes acceptable originating site (site where the NYS Medicaid member is located at the time health care services are delivered by means of telehealth) and distant site (site where the telehealth provider is located while delivering health care services via telehealth) requirements.3 During the State of Emergency, originating sites can be anywhere the NYS Medicaid member is located, and a permissible distant site is any location, including a health care provider’s home, that is within the 50 United States or United States’ territories.
Medicare: Covered Services
联邦医疗保险
Under the Coronavirus Preparedness and Response Supplemental Appropriations Action 2020, legislation aimed at fighting the COVID-19 emergency, only limited waivers of Medicare telehealth coverage requirements were authorized. These waivers primarily related to the location of the Medicare beneficiaries receiving telehealth services. On March 27, Congress passed and the President signed the Coronavirus AID, Relief and Economic Security (CARES) Act, which grants the Secretary of HHS to waive “the requirements of Section 1834(m)”, which is the Section of the Act containing all statutory Medicare coverage requirements for telehealth. On March 30, 2020, CMS announced that Medicare will now pay for more than 80 additional services when furnished via telehealth. These include emergency department vis-its, initial nursing facility and discharge visits, and home visits, which must be provided by a clinician that is allowed to provide telehealth.4
The recently released list of Medicare-covered services may be found here. These services are described by Healthcare Common Procedure Coding System (HPCS) codes and paid under the Physician Fee Schedule. As suggested above, the enumerated services may be provided to patients by certain health care professionals and covered by Medicare regardless of the patients’ location. The steps CMS is taking make clear that CMS is working to reduce in-person clinical care and bolster the use of telehealth.
State Parity
The COVID-19 health crisis has caused some late adopters to require payment parity for telehealth services. For example, on March 15, 2020, in response to a state of emergency due to the outbreak of the 2019 novel Coronavirus (COVID-19), Massachusetts Governor Charlie Baker executed an order requiring the state’s Group Insurance Commission (GIC), all Commercial Health Insurers, Blue Cross and Blue Shield of Massachusetts, Inc., and Health Maintenance Organizations (Carriers) regulated by the Division of Insurance (Division) to allow all in-network providers to deliver clinically appropriate, medically necessary covered services to members via telehealth and mandating reimbursement for such services.5 Under the terms of the order, the GIC and all Carriers must ensure that rates of payment to in-network providers for services delivered via telehealth are not lower than the rates of payment established by the Carrier for services delivered via traditional (i.e., in-person) methods.6
Modalities
联邦医疗保险
On March 30, 2020, CMS announced that health care providers may now evaluate beneficiaries who have audio phones only, which stands in sharp contrast with the gold-standard Medicare requirement that all telehealth visits be conducted using real-time audio/video communication technology.7
Medicaid
States have also begun relaxing their requirements for technology when con-ducting telehealth. For example, in New York, Medicaid providers and health care organizations may bill Medicaid for audio-only services, such as through use of a telephone, if they cannot provide the services through synchronous audio-visual communication modalities normally required by Medicaid.8
Medicare: Waiver of Prior Relationship Requirement
HHS announced a policy of enforcement discretion for Medicare telehealth services furnished pursuant to the waiver under section 1135(b)(8) of the Act. To the extent the waiver requires that a patient have a prior established relationship with a particular practitioner, HHS will not conduct audits to ensure that such a prior relation-ship existed for claims submitted during this public health emergency.9
HIPAA Enforcement Discretion
In advance of the COVID-19 pandemic, telehealth providers were subject to enforcement for failing to comply with HIPAA, as amended by the Health Information Technology for Economic and Clinical Health (HITECH) Act, and its implementing regulations, which required health care providers to use HIPAA-compliant platforms when con-ducting telehealth. On March 17, 2020, HHS’ Office for Civil Rights (OCR), the department charged with enforcing certain regulations issued under HIPAA, published a Notification of Enforcement Discretion for telehealth remote communications during the COVID-19 nationwide public health emergency.10 The notice stated that OCR is exercising enforcement discretion to not impose penalties for noncompliance with the HIPAA rules in connection with the good faith provision of telehealth using such non-public facing audio or video communication products during the COVID-19 nationwide public health emergency.11 Specifically, OCR noted that covered health care providers may use popular applications that allow for video chats, including Apple FaceTime, Facebook Messenger video chat, Google Hangouts video, or Skype, to provide telehealth without risk that OCR might seek to impose a penalty for noncompliance with the HIPAA rules related to the good faith provision of telehealth during the COVID-19 nationwide public health emergency. OCR encouraged health care providers to notify patients that these third-party applications potentially introduce privacy risks, and health care providers should enable all available encryption and privacy modes when using such applications.12
Licensure Waivers and Exceptions
Medicare and Medicaid Licensure Waiver
In advance of the President’s declaration, barring an applicable exception, a health care provider had to be licensed in the state in which he or she was delivering care. This is true because most states define the practice of medicine based on where the patient is located and consequently require that a physician be licensed within the particular state in order to practice telemedicine on a patient in that state. Following the declarations issued by HHS and by President Trump, CMS activated blanket waivers that took effect retroactively to March 1, 2020. Specifically, CMS waived the requirement that health care professionals be licensed in the state in which they are providing services, provided that they have equivalent licensing in another state (and are not affirmatively barred from practice in that state or any state a part of which is included in the emergency area).13 The waiver applies to Medicare and Medicaid patients.14
Although the federal medical licensure waiver allows authorized health care providers to render services outside their states of Medicare enrollment, the waiver is limited in scope to conditions of participation and payment for federal health care programs such as Medicare, Medicaid, and CHIP. The 1135 waiver authority applies only to federal requirements and does not apply to state requirements for licensure or conditions of participation. These federal medical licensure waivers alone do not and cannot waive the requirement that health care providers have an active license in states where they are practicing, including via telehealth. Before practitioners may deliver care via telehealth in compliance with applicable state laws and regulations, practitioners must be licensed in the state in which they are practicing or subject to a waiver of state licensure requirements issued by the applicable state. Many states have enacted such waivers, but the nuances of each waiver vary from state to state.
State Licensure Exceptions
Governors across the United States have relaxed licensure requirements related to physicians licensed in another state treating residents within the governor’s state. For example, in Pennsylvania, Governor Wolf granted the Department of State’s request for a suspension to allow licensed health care providers in other states to provide services to Pennsylvanians via the use of telemedicine, without obtaining a Pennsylvania license, for the duration of the emergency.15 Out-of-state health care providers must be licensed and in good standing in their home state, territory, or country, and provide the Pennsylvania board from whom they would normally seek licensure with the following information prior to practicing telemedicine with Pennsylvanians:
- their full name, home or work mailing address, telephone number and email address; and
- their license type, license number or other identifying information that is unique to that practitioner’s license, and the state or other governmental body that issued the license.16
The information requested above must be submitted to the appropriate board resource account listed on the Bureau of Professional and Occupational Affairs’ Web site Health care professionals using telemedicine in Pennsylvania must remain informed on all federal and state laws, regulations, and guidance regarding telemedicine, including applicable obligations under HIPAA.
In Kentucky, on March 17, 2020, the Secretary of the Cabinet for Health and Family Services activated its operation of the emergency system for advanced registration of volunteer health practitioners and directed the Kentucky Board of Medical Licensure and the Kentucky Board of Nursing to accept and review licenses for volunteer health practitioners and con-firm that they have an active license in good standing to perform health services during the state of emergency regarding COVID-19.17 Medical and osteopathic physicians not already licensed to practice in the Commonwealth of Kentucky may register to practice within Kentucky during this state of emergency as follows:
- Complete and submit the Emergency System Application for Health Practitioner provided on the Board’s Web site; and
- No fee is required for this type of registration.18
In Florida, medical doctors, osteopathic physicians, physician assistants, nurse practitioners, clinical social workers, marriage and family therapists, mental health counselors, and psychologists holding valid, unrestricted licenses in states outside of Florida are explicitly permitted to provide health care services to individuals in Florida via telehealth for a period not to exceed 30 days unless extended by order of the State Surgeon General.19 Out-of-state health care providers must still abide by Florida’s telehealth practice standards requirements under section 456.47(4), Florida statutes, and all applicable practice standards laws and/or regulations, including complying with scope of practice requirements.
In Massachusetts, health care providers who are licensed in another state who present to the corresponding Massachusetts licensing authority verification that such license is in good standing in that other state where it was issued shall forthwith be issued a corresponding Massachusetts license that shall remain valid during the state of emergency.20 “Good standing” does not include a license that has been revoked, canceled, surrendered, suspended, or is subject to disciplinary restrictions.
Each state is taking its own approach to issue licensure waivers. Some states have made a full waiver of licensing requirements for out-of-state providers while others have introduced an expedited licensing process. Before a health care provider initiates health care services during the COVID-19 pandemic in a state where he or she is not licensed, it is important to ensure compliance with applicable requirements. Such information is typically available through the applicable state’s licensing boards such as the state’s Board of Medicine or the state’s Department of Health. The Federation of State Medical Boards is also tracking executive orders related to licensure.
管制药物处方
Prior to the COVID-19 national health emergency, in accordance with the Ryan Haight Online Pharmacy Consumer Protection Act of 2008, which amended the federal Controlled Substances Act, a health care provider could not issue a “valid prescription” for a controlled substance by means of the Internet (which, for all practical purposes, includes telemedicine technologies) without having first conducted at least one in-person medical evaluation, except in certain specified circumstances.21 On March 16, 2020, the Drug Enforcement Agency (DEA) published a COVID-19 Information Page on its Diversion Control Division Website, which included a section addressing telemedicine and sanctioned the ability to prescribe controlled substances via telemedicine without a prior in-person exam.
结论
Since COVID-19 became a national health emergency, the landscape for telehealth has shifted dramatically and will continue to shift as health care needs increase over time. Telehealth advocates have been push-ing for years for the kind of approach being taken to virtual care observed currently. Relaxing originating site requirements so that patients may be treated where they are located, increasing the services covered under government programs, requiring payment parity, expanding the acceptable modalities to include the technology most convenient for care, and foregoing the in-office visit requirement for the prescribing of controlled substances are all advances telehealth advocates have been championing for years. Following the COVID-19 crisis, some relaxed standards will prove temporary, e.g., HIPAA enforcement discretion, but the efficiencies gained amidst this crisis will likely counsel toward allow-ing this forced acceptance of telehealth with relaxed requirements to remain unchanged.
End Notes
1 See CMS, Section 1135 Flexibilities Requested in March 16, 2020 and March 19, 2020 Communications (Mar. 23, 2020), available at www.dhcs.ca.gov/Documents/COVID-19/CA-1135-Flexibilities-Approval-Letter-Rev-032320.pdf.
2 See CMS, Telehealth Services, available at www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/TelehealthSrvcsfctsht.pdf.
3 New York State Department of Health, Comprehensive Guidance Regarding Use of Telehealth including Telephonic Services During the COVID-19 State of Emergency, Medicaid Update March 23, 2020, Vol 36, Number 5 (Mar. 23, 2020) www.health.ny.gov/health_care/medicaid/program/update/2020/%20docs/2020-03-21_covid-19_telehealth.pdf.
4 CMS, Additional Background: Sweeping Regulatory Changes to Help U.S. Healthcare System Address COVID-19 Patient Surge (Mar. 30, 2020), available at www.cms.gov/newsroom/fact-sheets/additional-backgroundsweeping-regulatory-changes-help-us-healthcare-system-address-covid-19-patient.
5 Office of the Governor, Order Expanding Access To Telehealth Services And To Protect Health Care Providers (Mar. 15, 2020), www.mass.gov/doc/march-15-2020-telehealth-order/download.
6 Id.
7 Id.
8 New York State Department of Health, supra n.3.
9 Medicare Telehealth Frequently Asked Questions (FAQs) (March 17, 2020), available at www.quality-insights.org/ResourcesFolder/COVID-19-Telehealth-Waiver-FAQ-20200317-CMS.aspx.
10 Notification of Enforcement Discretion for Telehealth Remote Communications During the COVID-19 Nationwide Public Health Emergency (Mar. 17, 2020), available at www.hhs.gov/hipaa/for-professionals/special-topics/emergency-preparedness/notification-enforcement-discretion-telehealth/index.html.
11 Id.
12 同上。
13 Waiver or Modification of Requirements Under Section 1135 of the Social Security Act (Mar. 13, 2020), available at www.phe.gov/emergency/news/healthactions/section1135/Pages/covid19-13March20.aspx</a>; CMS, COVID-19 Emergency Declaration Health Care Providers Fact Sheet, available at www.cms.gov/files/document/covid19-emergency-declaration-health-care-providers-fact-sheet.pdf.
14 同上。
15 PA Media, Licensed Health Care Practitioners Can Provide Telemedicine Services to Pennsylvanians During Coronavirus Emergency, available at www.media.pa.gov/Pages/State-Details.aspx?newsid=375.
16 Id.
17 Kentucky Board of Medical Licensure, Instructions For Registration Of Health Practitioners In Response To Emergency, available at kbml.ky.gov/Documents/Registration%20for%20Health%20Practitioners%20%20in%20Response%20to%20Emergency.pdf.
18 Id.
19 State of Florida Department of Health, Emergency Order 20-002 (March 16, 2020), www.flhealthsource.gov/pdf/emergencyorder-20-002.pdf</a>; State of Florida Department of Health, Emergency Order 20-003 (Mar. 21, 2020), www.flgov.com/wp-content/uploads/covid19/DOH%20EO%2020-003%203.21.2020.pdf.
20 See Department of Public Health, Order Of The Commissioner Of Public Health Maximizing Health Care Provider Availability (Mar. 29, 2020), www.mass.gov/doc/order-maximizing-available-healthcare-providers/download.
21 See Drug Enforcement Administration, COVID-19 Information Page, www.deadiversion.usdoj.gov/coro-navirus.html
