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CMS Offers New Stark Waivers and More Flexibility to Health Care Providers Due to COVID-19

Client Alert

On March 30, 2020, the Centers for Medicare & Medicaid Services (CMS) issued several temporary regulatory waivers to further enable the American healthcare system to respond to the COVID-19 pandemic with more efficiency and flexibility. The official publication can be found here: Physicians and Other Clinicians: CMS Flexibilities to Fight COVID-19.

The following measures will take effect immediately and will continue through the end of the public health emergency declaration:

  • “Stark Law” waivers. CMS is implementing waivers permitting certain referrals and the submission of related claims that would otherwise violate the Stark Law. A comprehensive list of these waivers can be found here
  • Hospitals or other health care providers may pay above or below fair market value for equipment rental or physician services. Examples:
    • A physician practice may rent or sell needed equipment to hospitals at a price that is below what the practice could charge another party.
    • A hospital may provide space on hospital grounds at no charge to a physician who is willing to treat patients who seek care at the hospital but are not appropriate for emergency department or inpatient care.
    • Health care providers can support each other financially to ensure continuity of health care operations. For example, a physician owner of a hospital may make a personal loan to the hospital without charging interest at a fair market rate so that the hospital can make payroll or pay its vendors.
    • Hospitals may provide certain benefits to their medical staff while the physicians are at the hospital and engaging in activities that benefit the hospital and its patients. These benefits may include multiple meals, laundry service, or childcare services. 
  • Certain items and services solely related to COVID-19 may be provided even though such provision may exceed the annual non-monetary compensation cap. Examples:
    • A home health agency may provide continuing medical education to physicians in the community on the latest care protocols for homebound patients with COVID-19.
    • A hospital may provide isolation shelter or meals to the family of a physician who was exposed to the novel coronavirus while working in the hospital’s emergency department.
    • Physician-owned hospitals can temporarily increase the number of their licensed beds, operating rooms, and procedure rooms, even though such expansion would otherwise be prohibited under the Stark Law. For example, a physician-owned hospital may temporarily convert observation beds to inpatient beds to accommodate an increased number of patients during the COVID-19 pandemic. 
  • Group practices can furnish medically necessary MRIs, CT scans or clinical laboratory services from locations like mobile vans in parking lots that the group practice rents on a part-time basis. 
  • Telehealth. Clinicians can now provide more services via telehealth, including home visits, emergency department visits, and therapy services to help mitigate the risk of spreading the virus while still caring for patients. A complete list of these services can be found here
    • Virtual check-ins. Clinicians may now provide virtual check-in services (HCPCS G2012, G2010) to both new and established patients. Previously, these services could only be provided to established patients. 
    • Telephone codes. CMS reimbursement is now available for telephone evaluation and management services (E/M services) provided by a physician (CPT 99441-99443) and telephone assessment and management services provided by a qualified non-physician health care professional (CPT 98966-98968). These services are currently only available for established patients. However, these services may be provided using audio-only devices. 
    • E-visits. Certain non-physician providers, including licensed clinical social workers, clinical psychologists, physical therapists, occupational therapists, and speech language pathologists, can provide e-visits (HCPCS G2061-G2063). These services are only available for established patients. Additionally, these e-visits must be initiated by the patient. 
    • Remote patient monitoring. Clinicians can now provide remote patient monitoring services to both new and established patients. Additionally, these services can be provided for both acute and chronic conditions and for patients with only one disease. 
    • Removal of frequency limitations on Medicare telehealth. Subsequent inpatient visits (CPT 99231-99233), subsequent skilled nursing facility visits (CPT 99307-99310), and critical care consult codes (CPT G0508-G0509) no longer have limitations on the number of times they can be provided by telehealth to Medicare beneficiaries. 
    • Waiver of copayments. Providers may waive copayments for these telehealth services for Original Medicare beneficiaries. 
  • Medicare physician supervision requirements. For services requiring direct supervision by a physician or other practitioner, the physician supervision can be provided virtually using real-time audio/visual technology. Additionally, a physician may now provide a general level of supervision, instead of direct supervision, for non-surgical extended duration therapeutic services provided in hospital outpatient departments and critical access hospitals. This relieves physicians of the requirement to be immediately available in the office suite. 
  • MIPS flexibilities. Two updates to the Merit-based Incentive Payment System (MIPS) in the Quality Payment Program have been made. 
    • Clinicians adversely affected by COVID-19 may submit an application to request reweighting of the MIPS performance categories for the 2019 performance year. 
    • A new Improvement Activity for the CY 2020 performance year has been added that, if selected, would provide high-weighted credit for clinicians within the MIPS Improvement Activities performance category. Clinicians will receive credit for this Improvement Activity by participating in a clinical trial utilizing a drug or biological product to treat a patient with COVID-19 and then reporting their findings to a clinical data repository or clinical data registry. 
  • Signature Requirements. Signature and proof of delivery requirements for Part B drugs and Durable Medical Equipment have been waived when a signature cannot be obtained because of the inability to collect signatures. Suppliers should document in the medical record the appropriate date of delivery and that a signature was not able to be obtained because of COVID-19.

BMD will continue to educate health care providers as additional waivers and further guidance on COVID-19 are issued. For questions, please contact Jeana M. Singleton at jmsingleton@bmdllc.com or 330-253-2001, or any member of the BMD Healthcare and Hospital Law group


The Ohio Chemical Dependency Professionals Board’s Latest Batch of Rules: What Providers Should Know

The Ohio Chemical Dependency Professionals Board has introduced new rules and amendments, covering various aspects such as CDCA certificate requirements, expanded services for LCDCs and CDCAs, remote supervision, and reciprocity application requirements. Notable changes include revised criteria for obtaining a CDCA certification, expanded services for LCDCs and CDCAs, and updated ethical obligations for licensees and certificate holders, including non-discrimination, confidentiality, and anti-sexual harassment measures.

Governor Mike DeWine and The Ohio State University Introduce the SOAR Study on Ohio Mental Illness

On January 19, Ohio Gov. Mike DeWine and The Ohio State University announced a new research initiative, the State of Ohio Adversity and Resilience (“SOAR”) study, which will investigate all factors influencing Ohio’s mental illness and addiction epidemic.

CHANGING TIDES: Summary and Effects of Burnett et. al. v. National Ass’n of Realtors, et. al.

In April 2019, a class-action Complaint was filed in federal court for the Western District Court for Missouri arguing that the traditional payment agreements employed by many across the United States amounted to conspiracy resulting in the artificial increase in brokerage commissions. Plaintiffs, a class-action group comprised of sellers, argued that they paid excessive brokerage commissions upon the sale of their home as a result of the customary payment structure where Sellers agree to pay the full commission on the sale of their property, with Seller’s agent notating the portion of commission they are willing to pay to a Buyer’s agent at closing on the MLS or other similar system.

The Ohio Board of Pharmacy’s Latest Batch of Rules: What Providers Should Know

The Ohio Board of Pharmacy released several new rules and proposed amendments to existing rules over the past month that will significantly impact pharmacy operations. Topics range from updates to the Terminal Distributor of Dangerous Drugs license to mobile clinics to mandatory rest breaks for pharmacists of outpatient pharmacies. A summary of the proposed changes is below, along with instructions for commenting on the rules. Your BMD healthcare attorney can help write comment letters and submit the comments on your behalf as well.

Employee or Independent Contractor? New Guidance Issued by the Department of Labor

On January 9, 2024, the U.S. Department of Labor (DOL) issued its long-awaited final rule — effective March 11, 2024 — revising its prior interpretation of worker classifications under the federal Fair Labor Standards Act (FLSA). The new final rule rescinds the standard previously established in 2021, in turn, shifting the analysis of whether a worker is an employee (versus an independent contractor) of a business from a more streamlined “economic reality” test to a more complex “totality of the circumstances” standard.