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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


UPDATE - Vaccine Policy Considerations for Employers

If you read our post from November, you’re already an informed employer. This first post of 2021 is to share good news, give a few updates, and answer some other common questions. Q: What’s the Good News? First, the EEOC confirmed that employers may require employees receive the COVID-19 vaccine. Second, polling indicates that the number of Americans who said they will receive a vaccine has increased from around 63% to over 71%. The number of Americans who are strongly opposed to a vaccine is about 27%. Third, initial returns show that the efficacy rate for certain vaccines is as high as 95% for some at-risk recipients.

Changes to FFCRA Paid Leave: Congress’ Revisions to Employment COVID-19 Leave Benefits Signals the Light is at the End of the Tunnel

Late in the evening on December 27th, President Trump signed into law the government’s $900 billion COVID-19 relief package (the “Stimulus Bill”). Among other economic stimulus benefits, the Stimulus Bill contains the $600 stimulus checks that will be issued to eligible individuals as well as, relevantly, changes to the Families First Coronavirus Response Act (“FFCRA”). The FFCRA was implemented in April 2020 and provided benefits to individuals who missed work as a result of an actual or suspected COVID-19 illness or to care for a child when their school or childcare service was closed because of COVID-19. Importantly, the Stimulus Bill extends eligibility for employer payroll tax refunds for leave payments made to employees on or before March 31, 2021 under the FFCRA, signaling to the American people that Congress believes many of the employed public will be vaccinated by this time, the light at the end of the tunnel. However, the Stimulus Bill does contain a caveat that employers are no longer required to provide FFCRA leave benefits after December 31, 2020, but if they do, they will receive the payroll tax credits, up to the maximums provided in the FFCRA, for payments made prior to April 1, 2021. Below we provide a list of questions and answers we received to date following the passage of the Stimulus Bill. We expect the U.S. Department of Labor (“DOL”) to issue additional questions and answers as the Stimulus Bill is implemented, and we will update this Client Alert as these are received.

Healthcare Speaker Programs: New OIG Alert

In a rare Special Fraud Alert issued on November 16, 2020 (the “Alert”), the Office of Inspector General (“OIG”) urged companies who host speaker programs to reassess their programs in light of the “inherent risks” associated with these activities. The Alert reports that, in the last three years, drug and device companies have reported paying nearly $2 billion to health care professionals for speaker-related services.

Value-Based Care Advances – CMS Issues New Final Rules for Stark and Anti-Kickback Statutes

The Centers for Medicare & Medicaid Services (“CMS”) and the Department of Health and Human Services (“HHS”) Office of the Inspector General (“OIG”) issued two highly anticipated (and quite extensive) Final Rules to reform the Stark Law and Anti-Kickback Statute (“AKS”) regulations. The Final Rules generally take effect on January 19, 2021. The Final Rules include new safe harbors for the AKS and new exemptions to the Stark Law to allow for greater flexibility. According to the HHS, the goal of updating both laws is to make it easier for providers to engage in care coordination and value-based care programs without running afoul of the statutes. Please note that this client alert could not cover the full extent of the Final Rule changes so please contact your BMD Healthcare attorney with questions.

Mandatory Filings Under CFIUS New Rules

On September 15, 2020, the Committee on Foreign Investment in the United States (“CFIUS”) promulgated a final rule modifying its mandatory declaration requirements for certain foreign investment transactions involving “TID US businesses” (sensitive U.S. businesses dealing in critical technologies, critical infrastructure and sensitive personal data) dealing in “critical technologies” – i.e., U.S. businesses that produce, design, test, manufacture, fabricate, or develop one or more critical technologies. The new rule also makes amendments to the definition of the term “substantial interest” (used to determine whether a foreign government has a substantial interest in an entity). The final rule became effective on October 15, 2020.