Healthcare compliance in a post-pandemic world | Health Care Compliance Association (HCCA)

Care in the traditional setting

Nonphysician practitioner diagnostic testing. During the PHE, CMS used the flexibility at 42 C.F.R. § 410.32(b) to allow nurse practitioners, clinical nurse specialists, certified nurse–midwives, and physician assistants to supervise diagnostic tests as authorized under state law.^[6] Beginning at the end of the PHE, only physicians may supervise diagnostic X-ray tests, laboratory tests, and the other diagnostic tests contemplated by 42 C.F.R. § 410.32.

Locum Tenens 60-day limit. During the PHE, CMS modified the 60-day limit specified in section 1842(b)(6)(D)(iii) of the Social Security Act, allowing physicians or physical therapists to use the same substitute during the entire duration of their unavailability.^[7] Beginning 61 days after the end of the PHE, the regular physician or physical therapist must use a different substitute or return to their practice for at least one day to reset the 60-day limit. This modified schedule applies to both reciprocal billing arrangements and fee-for-time compensation arrangements.

Licensing and provider enrollment. During the PHE, CMS made several temporary changes to licensing requirements, including: expediting enrollment for new and pending applications; allowing practitioners to cancel their opt-out status; permitting practitioners to render telehealth services from home without reporting their home address; and allowing licensed practitioners to bill Medicare for services provided outside of their state of enrollment. Immediately following the conclusion of the PHE, CMS will return to normal processing times for applications, opt-out statuses will only be cancellable within regulations, practitioners must resume reporting their home address on the Medicare enrollment, and regulations will continue to allow a deferral to state law for licensing. Compliance officers are advised to review updated state licensure requirements, as many states have made once-temporary flexibilities permanent.^[8] For example, as of May 5, 2021, Arizona permanently allows healthcare providers licensed in another jurisdiction to practice telehealth with Arizona patients, assuming proper registration and compliance with other laws.

Supervision requirements. During the PHE, CMS modified the definition of direct supervision to allow for the “virtual presence” of the supervising clinician via synchronous audio and video technology to satisfy the “immediately available” requirement.^[9] This modification of the definition will revert at the end of 2023.

Services provided by residents. Throughout the PHE, CMS waived existing regulations applicable to teaching physicians to permit such physicians to use audio/video real-time communication to supervise residents.^[10] Following the PHE’s expiration, teaching hospitals will only receive Medicare payment for services where a teaching physician is physically present for a main portion of services that involves residents, and where the physician is immediately available to provide care for the entire procedure, when necessary and applicable. Physicians teaching at residency training programs outside of a metropolitan statistical area—a “core area containing a large population nucleus, together with adjacent communities that have a high degree of economic and social integration with that core”—would still be permitted to satisfy the physical presence requirement through audio/video real-time communications technology, except in certain high-risk, complex cases.^[11]

In addition, during the PHE, physicians in primary care centers could supervise residents via telehealth and bill for all evaluation and management (E/M) services when residents provided the service. The flexibility will terminate upon the PHE’s expiration, except for those teaching physicians at residency training sites outside of a metropolitan statistical area. The primary care exception will only allow a physician to bill for levels 1–3 E/M codes performed by a resident. To bill for levels 4–5, the physician must be physically present for the critical portion of the service performed by the resident.^[12]

Changes to occur in 2023

Remote patient monitoring (RPM). During the PHE, CMS waived the requirement for RPM services to be limited to “established patients.” After the PHE, however, RPM services will be limited to established patients, and a physician must conduct a new patient evaluation before ordering RPM for a new patient. RPM services may be provided to patients with acute or chronic conditions.

Additionally, during the PHE, Medicare allowed clinicians to bill for certain RPM services (described by Current Procedural Terminology (CPT) codes 99453 and 99454) after as few as two days of data collection if the patient was diagnosed with or suspected of having COVID-19. When the PHE ends, the waiver of CPT coding guidance also terminates, meaning that such RPM services must collect at least 16 days of data before clinicians may bill for these services.

Frequency limitations.Throughout the PHE, Medicare waived frequency limitations for certain telehealth services. Such frequency limitations will be reinstated following the end of the PHE. This change means that subsequent inpatient visits may only be furnished via telehealth once every three days, subsequent skilled nursing facility (SNF) visits may only be provided via telehealth once every 14 days, and critical care consult codes may only be furnished by telehealth to a Medicare beneficiary once per day.

Opioid treatment programs. During the PHE, periodic assessments furnished as part of an opioid treatment program (OTP) were permitted to be delivered by telephone when the beneficiary did not have access to synchronous, interactive audio–video technology.^[13] Immediately following the PHE, such flexibility will end, and all OTP patient counseling and therapy services must be delivered in person or via two-way interactive audio-video technology.

Prescription of controlled substances.Throughout the PHE, the Drug Enforcement Agency (DEA) relaxed its requirements for prescribing controlled substances by waiving the in-person exam rule of the Ryan Haight Act, allowing for telemedicine prescriptions for both established and new patients. When the PHE ends, the in-person exam requirement will again apply, and telemedicine prescriptions for certain controlled substances will no longer be allowed. This means patients who received prescriptions based solely on virtual visits during the PHE should be seen in person for a new prescription. On February 24, 2023, DEA issued two proposed rules that would introduce limitations to the prescribing of controlled substances through telehealth and allow for the use of telehealth prescribing under certain conditions.^[14] Compliance officers should stay apprised of these proposed rules and how they impact prescribing of controlled substance post-PHE if they are finalized.

Cost sharing. HHS Office of Inspector General announced that during the PHE, it would not penalize providers under the federal Anti-Kickback Statute for reducing or eliminating cost-sharing amounts for telehealth or RPM services.^[15] Once the PHE ends, physicians will no longer be able to routinely waive cost-sharing amounts for these services.

HIPAA. The HHS Office for Civil Rights announced that it would exercise its enforcement discretion not to impose penalties for HIPAA violations against covered entities in connection with their good faith provision of telehealth using communication technologies that were not HIPAA-compliant.^[16] This policy will end with the culmination of the PHE.

Changes to occur in 2024

The CAA extended certain telehealth flexibilities created during the PHE through December 31, 2024. For example, prior to the PHE, a telehealth visit had to take place via a synchronous, interactive audio–video system; the patient had to be in a specific location (i.e., hospital/clinic) and in a certain geographic area (i.e., outside of a metropolitan statistical area); and the patient could only receive specific identified services. The CAA extended all these flexibilities such that, through December 31, 2024, a patient can have a valid telehealth visit in their home—regardless of where they live—for an expanded list of services.

Flexibilities that were extended until the end of 2024 include:

• Reimbursement for particular audio-only evaluation and management services, as well as behavioral health counseling and educational services

• An expanded list of providers eligible to deliver telehealth services from a distant site

• An expanded list of services that may be delivered by telehealth^[17]

• Reimbursement for nonphysician practitioner remote evaluation of patient videos and images and other virtual services that are conducted via online patient portals (often referred to as “e-visits”) to both new and established patients

• Allowance for end-stage renal disease monthly visits to be furnished by telehealth

• Allowance for practitioners to perform visits to nursing home residents by telehealth

• Allowance for patient consent for virtual check-ins at the same time as the services are furnished for both new and established patients through the end of 2024

Conditions of payment flexibilities

The following essential flexibilities will end upon the PHE’s expiration, resulting in hospital reimbursement and payment changes.

Hospital originating site facility fee for professional services furnished via telehealth. Telehealth became a critical tool for hospitals to deliver care to patients during the COVID-19 pandemic. To facilitate hospitals’ use of telehealth during the PHE, CMS permitted practitioners to bill services provided through telehealth to patients in their homes as hospital outpatient services. CMS established this flexibility since the service would have been provided in an outpatient setting at the hospital but for the PHE. Under this flexibility, CMS paid for providers’ services under the PFS at the facility rate, which excludes payment for resources traditionally supplied in a hospital outpatient unit, such as supplies and clinical staff. Instead, the hospital may bill for these associated costs as an originating site facility fee under the Outpatient Prospective Payment System (OPPS). After the PHE expires, hospitals may no longer bill for telehealth services rendered while a patient is at home as if these services were performed in a hospital outpatient department.^[18]

The Calendar Year 2023 OPPS/Ambulatory Surgical Center Payment Systems final rule permits payment for behavioral health services furnished through telehealth by practitioners of hospital outpatient departments to patients at their homes.^[19] In general, providers are allowed to bill these services as covered outpatient department services payable under the OPPS.^[20] However, after December 31, 2024, CMS requires an in-person visit within six months before the start of telehealth services and every 12 months thereafter, with exceptions based on specific beneficiary circumstances.^[21]

Hospitals Without Walls. In late March 2020, CMS established Hospitals Without Walls, an initiative that expanded the delivery of patient care in nontraditional settings through virtual hospital services.^[22] This initiative allowed hospitals and critical access hospitals (CAHs) to set up “expansion sites” to provide care in other facilities, including in ambulatory surgical centers (ASCs), hotels, and dorms, among other community-based facilities.^[23] As part of this initiative, CMS permitted ASCs and independent, freestanding emergency departments to enroll in Medicare as hospitals, enabling these entities to provide hospital services outside the scope for which Medicare traditionally reimburses them. In November 2020, CMS expanded the Hospitals Without Walls initiative through another initiative—“Acute Hospital Care at Home”—which permitted hospitals to provide at-home care and services to patients with acute conditions traditionally treated in inpatient settings.^[24] These waivers will end with the expiration of the PHE.

Hospital-only clinical staff in-person services. During the PHE, CMS permitted health professionals to furnish certain outpatient services, including wound care, drug administration, and infusions, at a beneficiary’s home under the order and supervision of a physician or qualified nurse practitioner. Under this flexibility, CMS considered a beneficiary’s home a provider-based department (PBD). Accordingly, hospitals may bill such services as hospital outpatient services. Hospitals may receive payment for these services under the OPPS—which reimburses at a higher rate than PFS-equivalent services—so long as the “PBD is an on-campus or excepted off-campus PBD that relocated to the patient’s home, applied, and was approved for an extraordinary circumstances relocation exception.”^[25] These flexibilities will stop upon the PHE’s expiration, meaning that hospitals may no longer bill services provided at beneficiaries’ homes as outpatient hospital services under OPPS.^[26]

Distinct part units. CMS permitted hospitals to relocate inpatients to certain units to accommodate capacity issues amid the surge in hospitalizations during the pandemic. CMS allowed hospitals to house acute care inpatients in excluded distinct part units (i.e., inpatient psychiatric facilities and inpatient rehabilitation facilities) so long as the beds in the unit are appropriate for acute care inpatients. Under the Inpatient Prospective Payment System (IPPS), the hospital may then bill for care provided to these patients and note that the patient was housed in an excluded unit due to overcapacity. When the PHE expires, hospitals will no longer be able to bill under the IPPS for acute care patients in beds in excluded distinct part units.^[27]

In addition, CMS also permitted hospitals to transfer patients in inpatient psychiatric units and inpatient rehabilitation units to other appropriate acute care beds and units during the PHE. Hospitals may continue to bill for these services under the IPPS while noting in the medical record that the hospital relocated the patient in response to capacity issues or outstanding circumstances due to COVID-19. These waivers will expire when the PHE ends.^[28]

Finally, inpatient rehabilitation facilities (IRFs) were allowed to exclude certain patients from the freestanding hospital or distinct part units’ inpatient population count applicable to the thresholds for requirements to receive payment as an IRF. This flexibility applies to patients an IRF admits in response to the PHE, and the hospital must note this in the patient’s medical record upon billing. When the PHE ends, IRFs must include all patients in this population count.^[29]

SNF 3-day rule billing. During the PHE, CMS waived the requirement that a number of Medicare beneficiaries must have a medically necessary three-day inpatient hospital stay to qualify for SNF extended care services coverage under Medicare.^[30] This coverage extends a patient’s care after the patient is discharged from a hospital or swing bed.^[31] SNFs could apply for the waiver so that they could furnish Medicare Part A services and bill for such services without the three-day hospitalization prerequisite so long as they met certain conditions.^[32] Once the PHE ends, the three-day billing rule will apply, and stakeholders must meet the requirements at 42 C.F.R. § 409.30.

Stark Law blanket waivers

CMS waived particular requirements applicable to hospitals under the Stark Law.[^33] Specifically, these waivers apply to referrals or remuneration solely for COVID-19 purposes.^[34] These blanket waivers include:

• Fair market value. Hospitals were permitted to pay for the personal services of a physician valued above or below fair market value (FMV). Hospitals were also permitted to pay or charge below FMV for renting or purchasing equipment, items, or services. For example, to address workforce shortages, hospitals could provide a physician with space at no charge to treat hospital patients who are not eligible for emergency department or inpatient care.

• Financial support. Physician owners of a hospital were permitted to make interest-free, personal loans to their hospital to aid in critical operations, such as the administration of payroll to staff and payments to vendors.

• Hospital staff benefits. Hospitals were permitted to offer benefits to their physician staff, including daily meals, laundry services, and childcare services during the physician’s shift and when a physician was involved in activities that benefited the hospital and patients.

• COVID-19 items and services. Hospitals were allowed to offer items and services solely related to COVID-19 purposes beyond the annual nonmonetary compensation cap. For example, hospitals could provide isolation shelter to families of physicians exposed to COVID-19 while working in the emergency department.

• Licensed beds. Physician-owned hospitals were permitted to increase or convert the number of licensed beds, operating rooms, and procedure rooms to address the influx of patients during the PHE.

Once the PHE expires, these blanket waivers will end.^[35] Given the severity of Stark Law penalties and sanctions, hospital compliance officers should attempt to identify any transactions with physicians that will continue past the PHE’s expiration and ensure that they meet an applicable Stark exception.

Conditions of participation flexibilities

CMS also provided flexibilities for hospital conditions of participation to further relieve hospitals of administrative burdens related to staffing and hospital operations.^[36]

Medical staff requirements. CMS allowed physicians whose privileges expired to continue to practice at their hospitals during the PHE. New physicians were also allowed to practice at their hospitals before the governing body reviewed and approved their privileges. These flexibilities will end upon PHE’s expiration, and hospitals will need to ensure that all physicians are practicing according to 42 C.F.R. § 482.22(a)(1)-(4).

CAH personnel qualifications and licensure. CMS waived the federal minimum personnel qualifications for clinical nurse specialists, nurse practitioners, and physician assistants. CMS deferred to state law regarding staff licensure, certification, and registration requirements. Upon PHE’s expiration, hospitals must ensure that all affected practitioners comply with applicable federal requirements.^[37]

Hospital services. CMS temporarily lifted the requirements outlined in 42 C.F.R. § 482.12(c)(1)-(2) and (4), which previously required that physicians care for Medicare patients in the hospital. This waiver expires after the PHE, meaning physician assistants and nurse practitioners may no longer care for Medicare beneficiaries without physician supervision.

Discharge planning for hospitals and CAHs. CMS waived regulatory requirements for providing certain detailed information on discharge planning to allow hospitals and CAHs to attend to increased hospitalizations. Hospitals were required to ensure that patients were discharged to appropriate settings but did not need to assist patients in selecting a post-acute care provider that met patients’ needs. After the PHE, hospitals and CAHs will be required to assist patients using quality measures to choose an appropriate provider upon discharge. Hospitals will want to ensure that they are meeting the requirements outlined in 42 C.F.R. § 482.43(a), 482.61(e), and § 485.642(a)(8).

Life safety code requirements for hospitals and CAHs. CMS waived certain life safety code standards, specifically for the placement and storage of alcohol-based, hand-rub dispensers, the practice of fire drills, the use of temporary walls and barriers between patients, and the use of PBD as temporary expansion sites. For example, CMS permitted hospitals and CAHs to create new or relocate existing PBDs to expand patient capacity. These flexibilities will stop upon PHE’s expiration.