The Centers for Medicare & Medicaid Services (CMS), the Department of Health and Human Services (HHS), the Office for Civil Rights (OCR), the Office of the Inspector General (OIG), and other Federal and State agencies and regulatory boards across the nation are taking unprecedented steps to provide hospitals and other providers on the front lines battling the 2019 Novel Coronavirus (COVID-19) pandemic with maximum flexibility. Hospitals have been the main focus of funding and other efforts to provide regulatory relief, and private physician practices have struggled to sort through what opportunities may be available to them. Oncology practices face a unique problem. They must continue to treat cancer patients in the fight of their lives, during a time when the nation’s attention is fully focused on the pandemic. 

Many of the regulations that are being introduced to fight COVID-19 can benefit cancer care providers as they work to ensure their patients maintain access to much-needed treatments and can safely participate in critical clinical trials, address staffing shortages resulting from isolated or quarantined staff, offset decreased cash flow from patients that may not be able to come in for treatments, and manage strained supply chain and resource shortages during the crisis. This article will provide an overview of some of the recent regulatory shifts of which oncologists should be aware of during the pandemic. Some of these regulatory changes, particularly in the area of telehealth, have the potential to drive innovation in ways that are likely to result in profound and lasting change in cancer care delivery.

This post will be released in two parts, with today’s focus being on the reimbursement and funding opportunities. Part two will discuss Telehealth and other matters.

Coverage Concerns: Medicaid expansion, reopening of exchanges, and Waivers

Many oncology practices are concerned that patients in active treatment are losing their health care coverage as a result of the increasing unemployment rate, resulting in potentially detrimental delays in treatment. There are several attempts to address gaps in coverage that oncologists can work with their patients to consider. This includes, among other things, seeking Medicaid coverage in states that are using 1135 Waivers to expand coverage, taking advantage of health exchanges originally introduced under the Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (ACA), which have reopened in certain states to work with patients to understand COBRA coverage availability. Until broader guidance is available from the federal government, practices should understand what may be available in their respective markets and develop policies and talking points to respond to patient concerns.  

Grants and Other Financial Opportunities

For oncology practices that are impacted financially as a result of the COVID-19 pandemic, Congress has enacted three laws to authorize unprecedented levels of funding to support the health care industry: the Coronavirus Preparedness and Response Supplemental Appropriations Act 2020, the Families First Coronavirus Response Act, and the CARES Act. Much of the appropriated funding gives significant discretion to federal agencies to allocate and distribute the money, and many of the funds will be distributed in the coming days and weeks by various federal agencies. The funding opportunities, described in Foley’s earlier blog, include:

• $100 billion marked for distribution to reimburse—through grants or other mechanisms—eligible health care providers for health care related expenses or lost revenues that are attributable to coronavirus, including $250 million for grantees and sub-grantees of the Hospital Preparedness Program.
• The first $30 billion dollars were distributed to all providers who billed Medicare Part A or B in 2019 on April 10, 2020. Although deposited automatically, the funds have a few strings attached, and require a practice to submit an attestation within 30 days agreeing to certain terms and conditions and a report by July 10th (ten days after the end of the quarter) detailing how the funds were used. The funds may only be used “to prevent, prepare for, and respond to coronavirus, and shall reimburse the Recipient only for health care related expenses or lost revenues that are attributable to coronavirus.”
• Health Resource & Services Administration (HRSA) legislation include two appropriations for supplemental distributions to health centers (including Federally Qualified Health Centers (FQHCs) and Rural Health Clinics (RHCs) that have HRSA grants), one of $100 million that has already been distributed to health centers and a separate one for $1.32 billion that has not yet been distributed. 
• In addition, $180 million for health centers to carry out telehealth and rural health activities, $90 million for Ryan White grantees, and $125 million to re-authorize the Healthy Start Program for project areas with high (or increasing at a rate above national average) rates of infant mortality.

In anticipation of applying for these funds, businesses affected by the pandemic should begin identifying, documenting, and projecting expected additional costs and losses, and be prepared to submit a succinct statement justifying their need for the funds. In addition, providers should be aware that they may have a choice of programs from which they may seek reimbursement. 

Stark Law Waivers

CMS has issued nationwide blanket waivers under the Stark Law to encourage provider collaboration without fear of technical legal violations in responding to COVID-19. The Stark Law (1) prohibits a physician from making referrals for certain designated health services payable by Medicare to an entity with which he or she (or an immediate family member) has a financial relationship, unless all of the requirements of an applicable exception are satisfied; and (2) prohibits the entity from filing claims with Medicare (or billing another individual, entity, or third party payor) for designated health services furnished pursuant to a prohibited referral. A financial relationship is an ownership or investment interest in the entity or a compensation arrangement with the entity. 

Below are some of the circumstances cited by CMS that may be help cancer centers respond to the COVID-19 pandemic under the applicable waivers:

• A hospital may pay physicians above their previously-contracted rate for furnishing professional services for COVID-19 patients in particularly hazardous or challenging environments.
• A physician in a group practice whose principal medical practice is office-based may be able to order radiology services that are furnished by the group practice to a Medicare beneficiary who is isolated or observing social distancing in the beneficiary’s home. 
• A hospital may provide free telehealth equipment to a physician practice to facilitate telehealth visits for patients who are observing social distancing or in isolation or quarantine.•To accommodate patient surge, a hospital rents office space or equipment from an independent oncology practice at below fair market value or at no charge. 

The financial relationship covered under waivers must be solely related to COVID-19 purposes (including diagnosis or medically necessary treatment of COVID-19, securing the services of physicians and other providers to furnish medically necessary patient care services, ensuring and expanding the availability of health care providers to address patient and community needs during the pandemic, and shifting the diagnosis and care of patients to appropriate alternative settings). The Stark-Law waivers were retroactive to March 1, 2020 and may be used without notifying CMS. Providers utilizing the blanket waivers must develop and maintain records relating to the use of the blanket waivers, and make their records available to HHS upon request.