On March 31, 2020, the Centers for Medicare & Medicaid Services (“CMS”) released an interim final rule with comment period (the “Interim Rule”) regarding policy and regulatory revisions of the Medicare and Medicaid programs in response to the novel coronavirus (“COVID-19”) Public Health Emergency. The Interim Rule provides flexibilities for health care providers, including federally qualified health centers (“FQHCs”) and rural health centers (“RHCs”), to furnish technology-based services in order to support their patients during the COVID-19 emergency. These Medicare and Medicaid revisions and policy changes represent HHS’ latest response to expand access to health care during the COVID-19 emergency. Please note that some of the changes in the Interim Rule are permanent, and others are effective (as indicated below) only during the emergency period.
The Interim Rule impacts FQHCs by 1) allowing payment for “e-visits”; 2) eliminating the existing patient requirement for virtual communication services (including virtual check-ins, remote evaluation services, and e-visits); and 3) relaxing the home health shortage rules for FQHCs and RHCs when providing visiting nursing services.
As background, on January 31, 2020, the Secretary of HHS issued a declaration of a national public health emergency regarding COVID-19. On March 13, 2020, President Trump declared a national emergency under the National Emergencies Act relating to COVID-19. To prevent potential exposure to COVID-19, health care providers are now looking for ways to consult with patients virtually during the emergency – both to keep patients with routine primary care concerns out of the office, and to screen patients who are concerned they may be experiencing symptoms of the virus. However, health care providers found that some laws and regulations provided strict requirements and limitations that resulted in barriers to access health care.
Medicare Part B covers two broad categories of services furnished via technology: 1) telehealth services; and 2) a variety of non-face-to-face remote interactions that are not “telehealth” because they do not require real-time audio-video interaction. Services in this second category have been recognized sequentially by CMS in Part B rulemakings in recent years, rather than being listed in the statute. They include “virtual check-ins,” “remote evaluation services,” “online digital assessment services” (or “e-visits”), and telephonic evaluation and management services.
The “telehealth services” benefit, as described in Section 1834(m) of the Social Security Act, is comprised of two parts. A “distant site” provider furnishes “telehealth services” (a range of services, with codes updated annually by HHS), and receives payment according to the relevant payment methodology for the service. In addition, an “originating site facility fee” is available to the health care facility where a Medicare patient receiving telehealth services is located. The Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 authorized HHS, only during the COVID-19 emergency period as defined in Section 1135(g)(1)(B) of the Act, (1) to waive the originating site rules as well, and (2) to relax the requirements for the “telecommunications system” for telehealth services, as set forth in the federal regulations, to make clear that the use of telephones with audiovisual capabilities is permitted.
FQHCs and RHCs may bill Medicare for the originating site facility fee (as of Calendar Year (“CY”) 2020, $26.65), provided that the FQHC or RHC site is located in a remote area that meets the geographic requirements in the statute. However, until March 2020, FQHCs and RHCs were not authorized to bill Medicare for the distant site component of the telehealth service. In the Coronavirus Aid, Relief and Economic Security Act (“CARES Act”), Section 3704 (enacted on March 27, 2020), Congress amended Section 1834(m) of the Act to recognize FQHCs and RHCs as Medicare distant site telehealth providers for the duration of any HHS public health emergency relating to COVID-19, as defined in Section 1135(g)(1)(B) of the Act. For more information, please visit FTLF’s prior blog, Senate-Approved CARES Act Would Provide Temporary “Fix” for Federally Qualified Health Centers. CMS has yet to issue program guidance implementing the CARES Section 3704 distant site telehealth provision.
In the CY 2019 Physician Fee Schedule final rule, CMS established “virtual communication services,” for which FQHCs and RHCs, along with physicians and practitioners, are allowed to bill the Medicare program. These services are “not a substitute for a visit, but are instead brief discussions with the RHC or FQHC practitioner to determine if a visit is necessary.” As described further below, this category includes virtual check-ins and remote evaluation services.
In the CY 2019 Physician Fee Schedule Final Rule, CMS also recognized for the first time a new category of remote services dubbed by CMS “e-visits” (or “on-line digital assessment services” through a secure, online patient portal) under the Medicare program. E-visits allow practitioners to assess a patient’s condition remotely and provide a clinical decision that would typically be provided in the office. Also, this service must be initiated by the patient through a patient portal (which is a secure, online website). Until the issuance of the Interim Rule, as described below, CMS authorized only physicians and practitioners, not FQHCs, to bill Medicare for “e-visits.”
Finally, in the Interim Rule, CMS authorized physicians and practitioners to bill Medicare Part B for certain telephonic evaluation and management visits (CPT 99441-99443). FQHCs/RHCs have not been authorized to bill Medicare for these services.
Changes Announced in the Interim Rule
To remove barriers and increase access to health care during the COVID-19 emergency, CMS’s Interim Rule expands the technology-based services that Medicare will cover when furnished by FQHCs/RHCs, and also liberalizes the rules regarding in-home care covered under Medicare.
- Loosening Restrictions on “Virtual Communication Services” Billing
Under the rubric of “virtual communication services,” first recognized by Medicare in 2019, FQHCs and RHCs (as well as physicians and practitioners) may receive a separate payment for “virtual check-ins” and “remote evaluation” of patient-transmitted information. “Virtual check-ins” consist of brief (5 to 10 minutes) real-time consultations to determine whether an office visit is necessary, and remote evaluation of recorded video and/or images of patient-transmitted information in a non-face-to-face modality. “Remote evaluation services” (also involving a minimum of 5-10 minutes of practitioner time) allow practitioners to review pre-recorded “store and forward” technology and provide an interpretation of the condition, including a verbal follow-up, with the patient within 24 hours.
FQHCs and RHCs bill for virtual communication services on an FQHC/RHC claim, using G code G0071. Until this week’s rulemaking, the G0071 code reflected the national average non-facility rate for component services (HCPCS: G2012 (communication technology-based services) and G2010 (remote evaluation services)). Claims for virtual communication services are made on an FQHC claim, and can be included with another FQHC service or stand-alone. FQHCs should list costs associated with virtual communication services in the “other than RHC/FQHC services” portion of the Medicare cost report. For more details on these matters, please see CMS’ December 2018, Virtual Communication Services in Rural Health Clinics (RHCs) and Federally Qualified Health Centers (FQHCs) Frequently Asked Questions.
CMS places numerous limits on FQHCs’ and RHCs’ provision of virtual communication services. Prior to the Interim Rule, the chief limits were the following. First, the service must be initiated by the patient. In addition, the interaction that constitutes the virtual check-in or remote evaluation must not be related to a FQHC or RHC visit in the prior 7 days, and must not lead to a FQHC or RHC visit within the ensuing 24 hours (or next available appointment). The concept is that the virtual communication service stands in the place of an office visit. Third, the service must be conducted by an FQHC or RHC practitioner (not auxiliary personnel). Fourth, the patient must consent to the service (including providing consent to coinsurance being imposed for the service). Consent must be obtained by the FQHC/RHC practitioner or staff under direct supervision of the practitioner). Finally, the patient must be an “established” patient of the FQHC or RHC (meaning that the patient had been seen by an FQHC or RHC practitioner within the prior 12 months).
The Interim Rule relaxed these requirements in several regards for services rendered on or after March 1, 2020. Please note that these new measures are limited to the COVID-19 emergency period. First, CMS specified that patient consent may be given at the time virtual communication service is rendered; it need not be provided in advance of the service. Consent must, nonetheless, be obtained before the claim is submitted for payment. FQHCs/RHCs should still document the patient’s consent in the medical record. In addition, for the duration of the COVID-19 emergency, CMS is waiving the requirement that only established patients are eligible for virtual communication services. Rather, CMS authorized FQHCs and RHCs to bill Medicare Part B for services furnished through virtual communication to new patients as well as established patients during the emergency period.
- FQHCs May Bill Medicare for “E-Visits” as Part of “Virtual Communication Services” Bundle
The Interim Rule also expands the range of services Medicare Part B includes within the “virtual communication services” benefit furnished by FQHCs, to include “e-visits” that a FQHC or RHC practitioner may bill Medicare by incorporating three new online digital assessment codes into the “virtual communication services” bundle for FQHC/RHC purposes.
The Current Procedural Terminology (“CPT”) codes for “e-visits” (CPT 99421-99423) allow health care providers to have a more substantive consultation than the virtual communication service. The chief factor distinguishing the e-visit from virtual check-ins and remote evaluation services is that some level of clinical decision-making, that otherwise typically would have been conducted in the office, is contemplated as part of an e-visit. The “e-visit” CPT codes (99421-99423) are for the “online digital evaluation and management service, for an established patient for up to 7 days.” The codes vary depending on the cumulative time spent on the digital assessment during those 7 days: CPT code 99421 (5-10 minutes); CPT code 99422 (11-20 minutes); and CPT code 99423 (21 or more minutes).
The new rate for G0071, effective March 1, 2020 through the COVID-19 public health emergency, would be set as the average of the PFS national non-facility payment rate for these three CPT codes (99421-99423) in addition to the already established virtual communication HCPCS codes (G2012 and G2010). The final bundled rate for G0071 has not yet been established,
- Home Health Aide Shortage Area
Under Sections 1861(aa)(1)(C) and 1861(aa)(3) of the Social Security Act, an RHC or FQHC may provide part-time or intermittent nursing care and related medical supplies (other than drugs and biologicals) when the RHC or FQHC is located in an area with a shortage of home health aides (“HHAs”). In particular, FQHCs/RHCs can be paid for visiting nurse care where the patient is considered “confined to the home,” as that term is define for purposes of Medicare home health; the FQHC/RHC is located in a home health shortage area; the services are provided under a written plan of treatment; the nursing services are provided on a part-time or intermittent basis; and drugs and biological products are not provided.
The “home health agency shortage area” designation, while described in CMS guidance, has not been clearly explained, and CMS has rarely made such a designation.
The Interim Rule essentially waives the HHA shortage area requirements for the duration of the COVID-19 emergency period. CMS is amending the regulations, at 42 C.F.R. § 405.2416, to create an assumption, applicable only during the COVID-19 emergency, that any area that is included in the FQHC’s service area or any area typically serviced by the RHC meets the home health shortage area requirement.
For purposes of both the home health certification in Medicare and the standard for an individual to qualify for visiting nurse services furnished by an FQHC, CMS also clarifies in the Interim Rule the definition of the statutory term “confined to the home.” In general, patients are confined to the home if, among other requirements, leaving home would be clinically contraindicated by the patient’s condition. HHS noted: “As an example for the PHE for COVID-19 pandemic, this would apply for those patients: (1) where a physician has determined that it is medically contraindicated for a beneficiary to leave the home because he or she has a confirmed or suspected diagnosis of COVID-19; or (2) where a physician has determined that it is medically contraindicated for a beneficiary to leave the home because the patient has a condition that may make the patient more susceptible to contracting COVID-19.”
Note: No Medicare Payment for Telephone Evaluation and Management Services in FQHCs
Notably, CMS in the interim rule authorized physicians and practitioners to bill Medicare for telephonic evaluation and management (“E/M”) services (CPT 94411-99443) for the duration of the emergency period, but it did not authorize FQHCs/RHCs to bill for such services. These CPT codes are for “telephone evaluation and management service by a physician or other health care professional who may report evaluation and management services provided to an established patient, parent, or guardian not originating from a related E/M service provided in the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment.”
Comments on the Interim Rule are due by 5 P.M. on June 1, 2020. These regulations are applicable beginning on March 1, 2020.
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If you have any questions about this update or other matters, please contact Susannah Vance Gopalan (Partner), Brittney Hall (Law Clerk), or call (202) 466-8960.
 The Interim Rule is scheduled to be published in the Federal Register on April 6, 2020.
 Social Security Act § 1834(m)(4); 42 C.F.R. § 410.78(b)(4).
 83 Fed. Reg. 226, 59,683, 59,685 (Nov. 23, 2018).
 See also Medicare Benefit Policy Manual, Ch. 13, § 240 (Rev. 263, Dec. 12, 2019).
 Medicare PFS CY2020 Final Rule, 84 Fed. Reg. 221 62,568, 62,796 (Nov. 15, 2019).
 Medicare Benefit Policy Manual, Ch. 13, § 190 (Rev. 263, Dec. 12, 2019).
 Id. at § 190.3.
 Interim Final Rule, II.L at Section 2(b).
 Interim Final Rule, II.
 Interim Final Rule, II.S.