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

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

HHS Announces an Additional $20 Billion In Provider Relief Grants

The U.S. Department of Health and Human Services (“HHS”) announced an additional $20 billion in new funding for providers on October 1, 2020. Eligible providers include those that have already received Provider Relief Fund payments as well as previously ineligible providers, such as those who began practicing in 2020, and an expanded group of behavioral health providers confronting the emergence of increased mental health and substance use issues exacerbated by the pandemic. The new Phase 3 General Distribution is designed to balance an equitable payment of 2% of annual revenue from patient care for all applicants plus an add-on payment to account for revenue losses and expenses attributable to COVID-19.

DOL Proposes New Rule Regarding Independent Contractor Status - But How Will the Election Affect Its Future?

On September 22, 2020, the U.S. Department of Labor announced a new proposed rule regarding employee and independent contractor status under the Fair Labor Standards Act. The full text of the proposed rule is available here. The rule's drafters intend to reduce uncertainty and enhance the precision and predictability of the long-standing "economic reality" test, which currently relies on a multifactor balancing test.

Major Change to Franklin County, Ohio Eviction Process: Landlord Testimony Required

Although there is currently a nationwide temporary halt on all residential evictions through December 31, 2020 in place, the eviction process in Franklin County – which processes the highest number of evictions in the State of Ohio at approximately 18,000 a year – recently changed significantly.

UPDATE: Governor Dewine Signs HB 606 Granting Short Window of Immunity from COVID-19 Personal Injury Lawsuits

The Ohio General Assembly, in Am. Sub. H.B. No. 606, is in the final stages of passing a law that will prohibit lawsuits seeking damages from COVID-19. This includes injury, death, or loss to person or property if the lawsuits are based, in whole or in part, on the exposure to, or the transmission or contraction of the coronavirus, unless the defendant in the lawsuit acted intentionally or recklessly. In circumstances where this immunity does not apply, H.B. 606 prohibits such claims being aggregated and brought as a class action.

Revised Department of Labor FFCRA Guidance, Effective September 16, 2020

In response to attacks on the legality of the Department of Labor’s (“DOL”) Final Rule regarding the Families First Coronavirus Act (“FFCRA” or the “Act”), which took effect in April 2020, the Department of Labor issued new guidance on Friday, September 11th to formally address ongoing questions and concerns related to the COVID-19 legislation.