On April 3, 2020, OIG issued a process for inquiries to be submitted to OIG about the application of administrative enforcement authorities against certain arrangements directly connected to the 2019 novel coronavirus (COVID-19). OIG particularly asked for inquiries related to the Federal anti-kickback statute and civil monetary penalties prohibition on beneficiary inducements, where enforcement discretion may allow the healthcare system to function during this pandemic. OIG responses, including its first two responses described below, will be publicly available through a frequently asked questions (FAQ) posting on the OIG COVID-19 portal.
This initiative continues OIG’s efforts to simplify provider compliance during the COVID-19 pandemic. Last month, OIG issued a letter outlining its general perspective on enforcement during the COVID-19 crisis and this new process is intended to clarify OIG’s position. Questions can be submitted to OIGComplianceSuggestions@oig.hhs.gov with sufficient facts to allow for an understanding of the key parties and terms of the arrangement. OIG will not review questions related to the Federal Stark Law (providers can ask the Centers for Medicare & Medicaid Services for a waiver here) or the False Claims Act, and any feedback provided is limited to arrangements in existence during the COVID-19 public health emergency.
Currently OIG’s FAQs consists of two responses to public inquiries:
- Providers assisting long-term care providers. The first question was whether health care providers and practitioners can provide services for free or at a reduced rate to long-term care providers that are facing staffing shortages due to COVID-19. OIG opined on two fact-specific scenarios that fit within the broader question. The first scenario involves a hospice vendor that is already providing services to patients at a skilled nursing facility providing additional free basic care services, within its scope of practice, to clients at the facility that are not the hospice’s patients in order to help mitigate staffing shortages. The second scenario involves a skilled nursing facility fulfilling patient care needs that are unmet due to staffing shortages, by using community dentists or podiatrists who are not working at full capacity and are willing to offer services for free or at a reduced rate. Typically providing services to such facilities could be seen as an inducement to refer care that is more specialized. In both cases, OIG opined that the fraud and abuse risk is low during the COVID-19 outbreak so long as the following four conditions are met. First, the services being offered are necessary to meet patient care needs that are a result of staffing shortages directly connected to the COVID-19 outbreak. Second, the services being offered are being provided for free or at a reduced cost only when necessary because of the COVID-19 outbreak. Third, the services being offered are limited to the period during the COVID-19 public health emergency declaration. Fourth, the services being offered are not contingent on referrals for any items or services that may be reimbursable in whole or in part by a Federal health care program, whether during or after the COVID-19 public health emergency declaration.
- Hospitals assisting independent physicians on medical staff. The second question was whether a hospital may provide free access to an existing web-based telehealth platform to independent physicians on the hospital’s medical staff. In this scenario, the hospital would receive no payment from either the independent physicians receiving access or any payor for services provided through the telehealth platform by the independent physicians. Likewise, the physicians would not receive any remuneration from the hospital beyond access to the telehealth platform, would be responsible for maintaining any required records for patients seen through the platform, and must independently bill and receive reimbursement for any professional services provided. OIG opined that such an arrangement would pose low risk of fraud and abuse so long as the following four conditions are met. First, the platform must only be provided for free in order to facilitate medically necessary services. Second, the platform must only be provided only when necessary because of the COVID-19 outbreak, and only during the period of the public health emergency. Third, access to the platform must not be contingent on the physicians’ past or anticipated volume or value of referrals to the hospital for items or services that may be reimbursable by a Federal health care program. Fourth, access must be offered to all physicians on the medical staff on an equal basis, even if not all accept the offer.
McGuireWoods will continue to monitor OIG’s release of further FAQs as additional providers utilize this inquiry mechanism. Providers may welcome the flexibility provided by OIG exercising enforcement discretion during the COVID-19 pandemic assuming that OIG’s FAQ responses continue to provide additional flexibility to providers during COVID-19. OIG will likely require such relationships to end at the end of the COVID-19 public health emergency declaration, and therefore, providers seeking to utilize these statements in care to their communities should plan to terminate the relationship at the end of the pandemic.
McGuireWoods has published additional thought leadership related to how companies across various industries can address crucial coronavirus-related business and legal issues, and the firm’s COVID-19 Response Team stands ready to help clients navigate urgent and evolving legal and business issues arising from the novel coronavirus pandemic.
For related commentary, please see the following posts:
Providers May Offer Incentives to Federal Beneficiaries for Receiving COVID-19 Vaccine (June 9, 2021)
OIG Removes Mandatory Cost-Sharing Obligations for COVID-19 Ambulance Transport Waiver (May 17, 2021)
Rural FQHC Can Provide Free Space for COVID-19 Vaccinations (April 13, 2021)
Per-Click Compensation for Philanthropic Entity’s COVID-19 Vaccine Site Low Risk of Fraud According to OIG (March 2, 2021)
OIG Responds to Free/Discounted Lodging and Free Antibody COVID-19 Test Inquiries (August 27, 2020)
OIG Responds to Physician Group COVID-19 Personal Protective Equipment Arrangement Inquiry (May 17, 2020)
OIG Updates Enforcement Responses to COVID-19 Arrangement Inquiries (May 13, 2020)