Medicare beneficiaries reportedly are among the most vulnerable to the Covid-19 virus.
However, the federal fraud and abuse laws designed to protect Medicare beneficiaries actually can make it more difficult for them to get the care they need during this crisis by preventing well-intentioned providers, practitioners, and suppliers from waiving cost-sharing obligations that may impede beneficiaries’ access to care.
To alleviate some of the negative impact federal fraud and abuse laws may have on Medicare beneficiaries’ access to care during the Covid-19 outbreak, on March 17, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a policy statement notifying health-care providers that they will not be subject to administrative sanctions under the federal Anti-Kickback Statute or the Civil Monetary Penalty and exclusion laws for reducing or waiving cost-sharing amounts for telehealth services furnished to Medicare beneficiaries during the outbreak.
The OIG’s policy statement comes on the heels of the HHS’s recent exercise of the authority granted to it during national emergencies to expand coverage for telemedicine services and to waive potential penalties against health-care providers with respect to violations of certain HIPAA privacy protections associated with the “good faith provision” of telehealth services during the Covid-19 pandemic.
OIG’s Action Unprecedented
Cost-sharing waivers (other than those based on documented financial need) always have been a particular area of fraud and abuse enforcement priority because the OIG believes that they promote overutilization of health-care services and misstate the provider’s actual charge, resulting in a false claim. The OIG’s position has not changed since it first issued a fraud alert on the topic in 1991.
The OIG’s action is, accordingly, unprecedented: it has never before issued guidance granting providers prospective, across-the-board immunity from administrative sanctions in connection with cost-sharing waivers.
Notably, OIG’s policy statement applies to all telehealth services, not just telehealth services provided in connection with the diagnosis or treatment of Covid-19. The significance of the scope should not be understated: Medicare beneficiaries now will be able to receive medical care, such as routine office visits, prescription refills, preventative screenings, and mental health services, without having to travel to a doctor’s office or a health-care facility—and without necessarily having to pay a co-pay.
This is significant because it is just as important to keep non-Covid-19 patients out of the hospital emergency room as it is for patients who suspect they have Covid-19 to have access to the care they need.
However, the policy statement leaves certain questions unanswered—for example, it does not address services that a health-care provider may order or prescribe during a telehealth visit, such as laboratory or other diagnostic testing. The lack of definitive guidance could impact patients’ ability to access necessary follow-up care.
Other issues not addressed by the OIG include other types of provider forgiveness or assumption of costs on behalf of beneficiaries, such as premium payments to keep Medicare Supplemental policies in place. With the OIG’s coordinated care regulation still in proposed form, free or discounted access to care coordination apps and phone and computer hardware necessary to provide the telehealth services also remains unprotected. It would be helpful for the OIG to adopt on a temporary, emergency basis, the welcome latitude set forth in the proposed regulation.
Also unclear is what happens if a provider bills the patient for cost-sharing amounts associated with the telehealth service during the emergency, but the patient fails to pay the bill. Historically, a provider’s lack of serious collection efforts of outstanding cost-sharing obligations was a red flag of a de facto cost-sharing waiver for purposes of fraud and abuse liability. Will the OIG’s waiver apply to these types of “after-the-fact” waivers? What if the initial bill was issued during the emergency period but the collection effort (or lack thereof) occurs after the emergency is over?
Furthermore, given the uniqueness of the policy statement, the OIG is unlikely to extend its scope beyond telehealth, or to extend its length beyond the current crisis, without first assessing the impact these waivers may have on federal health-care programs.
Specifically, once the Covid-19 crisis has passed, the OIG likely will attempt to determine whether its prospective waiver of administrative sanctions resulted in overutilization of telehealth services or inappropriately increased costs to the federal health-care programs. Moreover, the OIG is clear that the policy statement applies only to cost-sharing waivers, and that care must be delivered in accordance with all coverage and payment guidelines. Thus, those providing telehealth for Medicare beneficiaries are likely to see scrutiny of their billing once the pandemic has passed.
Providers Should Maintain Good Records
Similarly, while we would anticipate that the DOJ will respect the OIG’s guidance to providers, false claims act authority will be exercised in retrospect, after the emergency is long past, and it is not clear now the burden of proof needed in the future to qualify for the waiver and avoid false claims liability. Therefore, providers should maintain contemporaneous records of when cost-sharing was waived and note the rationale for the waiver (i.e., Covid-19 emergency declaration waiver) in anticipation of future disputes with the government in this area.
Lastly, providers should also keep in mind that while the OIG’s pronouncement applies to “federal health care program beneficiaries,” which includes Medicaid recipients, many states may have their own Medicaid cost-sharing obligations, which may not necessarily be correspondingly waived.
If the national emergency continues for some time, the OIG and the Centers for Medicare & Medicaid Services may want to consider easing regulatory burdens to providing health care via other means. Parties looking to enter into relationships with providers for the provision of vital health care services related specifically to Covid-19 (e.g., extending ER services, support in testing venues, funding vaccine research, etc.) should not be subject to enforcement uncertainty under the fraud and abuse laws during this time.
It is imperative that regulators continue to think of broad and innovative ways that are responsive to provider needs in this crisis and alleviate the regulatory burden and barriers to innovation both with regards to providing patient care and developing responses to Covid-19.
This column does not necessarily reflect the opinion of The Bureau of National Affairs, Inc. or its owners.
Anjali N.C. Downs is a member of the firm in the Health Care and Life Sciences practice, in the Washington, D.C., office of Epstein Becker Green. Her practice focuses on fraud and abuse and federal and state regulatory compliance within the health care industry.
Melissa L. Jampol is a member of the firm in the Health Care & Life Sciences and Litigation & Business Disputes practices of Epstein Becker Green. A former federal and state prosecutor, Jampol represents health care organizations—including health care systems, physician group practices, pharmacies, clinical laboratories, and other health care providers—and their officers and directors, in a variety of enforcement matters at both the state and federal levels.
Jennifer E. Michael is a member of the firm in the Health Care and Life Sciences practice of Epstein Becker Green. She focuses her practice on federal and state fraud issues, including anti-kickback, self-referral, false claims, and regulatory compliance. Before joining Epstein Becker Green, Michael served as chief of the Industry Guidance Branch at the U.S. Department of Health & Human Services, Office of Counsel to the Inspector General.
Anjana D. Patel is a member of the firm in the Health Care and Life Sciences practice, in the Newark and New York offices of Epstein Becker Green. Her practice focuses on health care transactions and regulatory compliance counseling.
Carrie Valiant is a member of the firm in the Health Care and Life Sciences practice of Epstein Becker Green and co-chairs the firm’s health care fraud group. Valiant has more than 30 years of experience concentrating in health care fraud and abuse and government health care program payment matters.