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Recent Medicare Coverage rule changes have lowered the bar for Medicare Fraud. Among them are Telehealth fraud and Covid Diagnostic Testing Fraud.
The CARES Act § 3703 removed the Medicare restriction that only established patients of a physician can receive telehealth services. Not limited to COVID-19 related services, these telehealth offerings became available to patients without regard to diagnosis, making claims for services permissible in lieu of in-person office visits, mental health counseling, and preventive health screenings.
The CARES Act §§ 3705 and 3706 also waived the requirements for certain face-to-face visits between (1) home dialysis patients and physicians and nurse practitioners and (2) hospice patients and physicians and nurse practitioners.
In addition, the CARES Act § 3707 broadened telehealth services to home health patients, including for remote patient monitoring. Section 3708 loosened the conditions of payment by allowing physician assistants, nurse practitioners, and other professionals, under physician supervision, to order home health services for beneficiaries.
While telehealth services are now broadly covered, a sound policy decision, Telehealth Fraud still occurs where the service level is either not provided or is not medically necessary (e.g., the provider submitted level four established patient visit, yet only furnished or the patient only needed a level two visit). Further, the patient file should reflect notations in support, using the current Evaluation and Management Services documentation guidelines (e.g., time or key components).
Covid Diagnostic Testing Fraud
Medicare covers inpatient hospital stays, skilled nursing facility stays, some home health visits, and hospice care under Part A. Outpatient services, including physician visits, emergency ambulance transportation, and emergency room visits, are covered under Part B. When inpatient hospitalization is required for treatment of COVID-19, such treatment will be covered for Medicare beneficiaries, including beneficiaries in traditional Medicare and those in Medicare Advantage plans.
Medicare Part B (Medical Insurance) has covered testing for COVID-19 since February 2020. .Under the FDA’s March 16, 2020 Guidance under CMS coverage regulations, tests and devices commercially developed prior to the FDA granting an EUA, have still been covered. Coverage became triggered after the manufacturer’s validation of the test’s efficacy; this could occur while the applicant manufacturer was preparing its EUA request, as long as the manufacturer provided instructions for use of the test and posted data about the test’s performance characteristics on its website. CMS also provides coverage of serology tests to identify antibodies to SARS-CoV-2 when the test has been validated, notification is adequately provided to the FDA, and appropriate warning statements are included with the tests. The warnings, for example, should note that the test has not been reviewed by the FDA and that results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
False Claims Act Part B violations for Covid diagnostic testing fraud arises where the manufacturer has submitted false data to the FDA, or failed to substantively comply with the FDA’s March 2020 Guidance.