COVID-19

Published on: June 15, 2022

Study May Forecast More Audits of Labs that Perform COVID-19 Testing

A new study supports the growing perception that clinical laboratories will see an increase in audits from commercial insurance companies as the COVID-19 pandemic recedes. These audits will likely focus on a few particular areas of the COVID-19 testing services that clinical labs have developed and provided over the past two years.

The study reviewed lab revenue in Hawaii from May to December 2020 and is likely applicable to labs in other insurance markets. The study indicated strong growth in lab revenue from PCR tests and significant profit margins from PCR tests. Because federal law, namely the CARES Act, requires commercial insurers to cover COVID-19 testing without co-pays or other costs to the beneficiary, this increase in lab revenue will generally translate to higher costs for insurance companies. Further, when Congress passed the CARES Act, it did not provide funding to insurance companies for this coverage mandate. Many have long predicted that this would lead to increased costs for insurers, which would likely be passed on to members through higher premiums. Many insurance companies have pushed back against this coverage mandate since it was enacted.

Part of the pushback from commercial insurance companies has been to audit labs in an effort to deny claims for COVID-19 testing and to claw-back funds paid to labs for COVID-19 testing. These audits tend to focus on one or more of several issues: testing for a covered purpose, testing for travel, individualized clinical assessments, standing orders, posted cash prices, and collection codes. Some labs are particularly vulnerable to these audits because, during the pandemic, many labs rushed to invest and develop COVID-19 testing capability and capacity. Meanwhile, guidance regarding the CARES Act and the circumstances under which insurance companies are required to cover COVID-19 testing came out piecemeal and changed frequently as it developed. Due to these factors, labs may have high volumes of tests that represent a good-faith, best effort at complying with the CARES Act at the time the tests were performed, but may have compliance vulnerabilities as the law is currently understood.

Published on: May 4, 2022

What Clinical Labs Can Expect in Audits of COVID-19 Testing Claims

by Wachler & Associates, P.C.

The COVID-19 pandemic has brought seismic changes to the clinical lab industry. High demand for COVID-19 testing services, tremendous amounts of funding, and rapidly changing government regulations have created opportunity for clinical labs, but also new compliance and audit challenges. As the dust settles and government entities and commercial insurers review lab claims for COVID-19 testing over the past two years, these are some of the audit and compliance challenges labs may face.

Early in the pandemic, Congress required commercial insurers to cover certain claims for COVID-19 testing. However, Congress did not provide the insurers with funds to cover the cost of this mandate and some insurers have pushed back against lab claims for COVID-19 testing. Under the federal coverage mandate, insurers are generally required to cover tests that are for the diagnosis of COVID-19 where there is an “individual clinical assessment” by an authorized provider that testing is appropriate. Testing for travel, return to work/school, and general screening purposes is generally not required to be covered, although insurers may choose to cover it. Insurers that chose to cover only what they are legally required to cover may audit labs for providing testing for an uncovered purpose. Testing for travel is sometimes a contentious issue because, depending on the circumstances, it may constitute uncovered general screening, or, in the case of people who were exposed while travelling or who were unable to social distance per CDC guidelines while traveling, may constitute circumstances where testing would be covered.

Further, insurers may audit labs based on the requirement for an “individualized clinical assessment,” including whether the practitioner was authorized, whether the order for testing was within the scope of state law, whether the assessment was conducted by telemedicine or by a questionnaire, and what rules apply where a state does not or did not require an order for COVID-19 testing.

Published on: May 2, 2022

Providing Cross-State Telehealth Services

by Wachler & Associates, P.C.

As telemedicine becomes an increasingly popular method for connecting patients with healthcare providers, many providers are becoming interested in expanding the reach of their telehealth practices across state lines. Although technological advancements have helped providers communicate with patients remotely, state and federal regulations add additional considerations for practicing across multiple states.

Generally, healthcare providers will provide telehealth services to patients located within their own state. Most states allow for telehealth services and will allow state-licensed providers to provide telehealth services within the state in which they are licensed. State licensure requirements become more complex when an out-of-state provider wishes to provide telehealth services to a patient located in another state.

Telehealth services are generally considered to be performed at the patient’s physical location, which usually means that the provider must be licensed in the patient’s home state. Although the COVID-19 pandemic caused several states to temporarily waive some licensing requirements for cross-state telehealth services, many of those waivers has since expired.

Published on: April 21, 2022

Consolidated Appropriations Act Extends Post-PHE Telehealth Coverage

by Wachler & Associates, P.C.

On March 15, 2022, President Biden signed into law the Consolidated Appropriations Act, otherwise known as the “Omnibus Bill.” Included in the many provisions introduced by the Omnibus Bill is an extension of Medicare coverage of professional consultations, office visits, and office psychiatry services conducted via telemedicine for 151 days following the termination of the COVID-19 public health emergency (PHE).

As part of the government’s response to the COVID-19 pandemic in March 2020, administrative and legislative changes waived the traditional location and technology requirements necessary to qualify for Medicare coverage for the duration of the PHE. In addition to extending these waivers, the Omnibus Bill expands the types of practitioners eligible to provide telehealth services to patients. Prior to the PHE, Medicare covered telehealth services only if offered by physicians, physician assistants, nurse practitioners, clinical nurse specialists, nurse-midwives, clinical psychologists, clinical social workers, registered dieticians, or certified registered nurse anesthetics. The Omnibus Bill adds to the list of qualifying practitioners occupational therapists, physical therapists, speech-language pathologists, and audiologists. Other changes under the Bill include delaying in-person requirements for the provision of mental health services and extending coverage of telehealth services rendered by federally qualified health centers to provide telehealth services for the same 151-day post-PHE time period.

While these changes may be welcomed by many healthcare providers as supplying necessary resources for both telehealth patients and providers, it remains to be seen whether coverage flexibilities established during the PHE will become permanent moving forward. The Omnibus Bill requires the Medicare Payment Advisory Commission to provide Congress with a report by June 15, 2023 on the expansion of telehealth services as a result of the PHE. The Department of Health and Human Services (HHS) Office of Inspector General (OIG) is similarly required to provide Congress with a report by June 15, 2023 on program integrity risks associated with Medicare telehealth services. Additionally, HHS must post quarterly data, beginning on July 1, 2022, on Medicare claims for telemedicine services. Healthcare providers should be cognizant of these developments and take steps to ensure compliance is maintained as these and other legislative and regulatory changes unfold.

Published on: April 18, 2022

CMS Terminating Several COVID-19 Blanket Waivers

by Wachler & Associates, P.C.

On April 7, 2022, the Centers for Medicare and Medicaid Services (CMS) issued a memorandum stating that several COVID-19 blanket waivers for certain healthcare services will be ending soon. Specifically, CMS will terminate blanket waivers of regulatory requirements that apply to skilled nursing facilities (SNFs), inpatient hospices, intermediate care facilities for individuals with intellectual disabilities (ICF/IIDs), and end stage renal disease (ESRD) facilities.

CMS has expressed concern “about how residents’ health and safety has been impacted by the regulations that have been waived, and the length of time for which they have been waived.” Findings from onsite surveys conducted at the facilities previously mentioned “have revealed significant concerns with resident care that are unrelated to infection control (e.g., abuse, weight-loss, depression, pressure ulcers, etc.).” In response to these findings, CMS is removing certain operational flexibilities which do not directly relate to infectious disease control. The termination of these blanket waivers will not have any effect on other applicable blanket waivers, such as those for hospitals and critical access hospitals (CAHs).

Terminations of blanket waivers will occur in two groups and become effective either 30 days or 60 days from publication of the memorandum. CMS instructs all affected healthcare providers to “take immediate steps so that they may return to compliance with the reinstated requirements” within these timeframes. The specific blanket waivers ending under both timeframes are as follows:

Published on: April 8, 2022

HHS to Allow Late PRF Reporting

by Wachler & Associates, P.C.

Healthcare providers who missed a Provider Relief Fund (PRF) reporting deadline may get a second chance. In response to overwhelming industry outcry over its attempts to clawback PRF payments, the Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), which currently administers the PRF, will being accepting applications from providers who missed a reporting deadline to file a late report. Requests to file a late report must be filed between April 11 and April 22 and must include an “extenuating circumstance” justifying the request.

The PRF is a $178 billion fund created by Congress through the CARES Act and administered to provide financial relief to healthcare providers during the COVID-19 pandemic. HHS has subdivided the PRF into various general and targeted distributions. These distributions were paid to providers in several waves between April 2020 and the present. The first payments under the PRF, in April 2020, were unsolicited and were deposited directly into providers’ bank accounts without prior application or notification. While this infusion of cash was likely a welcome relief at the time, it came with strings attached. The two major requirements for a provider to keep the PRF payment were to only use the funds for specific COVID-related purposes and to file a report with HRSA justifying use of the funds.

The first of these reports were due on September 30, 2021, but that date was later extended into early December 2021. In March 2022, HRSA began sending letters to providers who had not filed reports indicating that they were now required to return the full amount of any PRF funds received within 30 days. After significant outcry from providers, representatives, and industry groups, HRSA has backtracked and will now accept requests to file late reports.

Published on: March 14, 2022

FDA Outlines Termination Plan for COVID-19 EUAs and Enforcement Policies for Medical Devices and PPE

by Wachler & Associates, P.C.

On February 22, 2022, the US Food and Drug Administration (FDA) hosted a webinar detailing its current transition plans for medical devices marketed pursuant to either Emergency Use Authorization (EUA) or Enforcement Policies during the COVID-19 public health emergency (PHE). The primary purposes of the webinar were to help prepare manufacturers and other stakeholders for the upcoming transition back to normal operations, provide examples illustrating the transition policies, and outline the 180-day transition period timeline. Providers that may be affected are encouraged to be proactive and take steps to understand FDA’s proposed plan and become prepared to handle the upcoming transition.

The FDA’s transition plans and policies are laid out in two recent draft guidance documents, Transition Plan for Medical Devices Issued EUAs During the COVID-10 PHE (EUA Transition Plan) and Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 PHE (Enforcement Policy Transition Plan), which are to be implemented with a focus on four key principles:

an orderly, transparent transition with consistent FDA-manufacturer interactions,

Published on: February 14, 2022

EKRA Continues to Cause Confusion for Clinical Labs

by Wachler & Associates, P.C.

The Eliminating Kickbacks in Recovery Act (“EKRA”) is an incredibly broad and incredibly vague criminal statute that continues to create compliance issues for clinical laboratories. Many arrangements between clinical laboratories and other entities that were previously compliant, or which are currently authorized under other federal statutes, may be unlawful under EKRA.

Congress enacted EKRA in 2018 and, throughout its drafting, it was intended to address patient brokering and kickback schemes in addiction treatment and recovery. For example, EKRA was targeted at individuals who received kickbacks for steering patients into sober living and recovery homes. However, shortly before EKRA was passed and with little consideration of the implications, the words “or laboratory” were inserted into the draft such that EKRA now likely applies to all referrals to clinical laboratories, regardless of payor and regardless of whether the testing relates to addiction treatment or recovery.

EKRA broadly prohibits paying, offering, receiving, or soliciting any remuneration in return for referrals to recovery homes, clinical treatment facilities, or laboratories. Further, EKRA is a criminal statute, the penalties for violation of which, up to 10 years in prison and fines up to $200,000, cannot be taken lightly. Like two other major federal healthcare fraud, waste, and abuse laws, the Anti-Kickback Statute and the Physician Self-Referral Law (commonly known as the Stark Law), EKRA contains a few exceptions. However, they are far fewer in number and often narrower than their counterparts in the older statutes.

Published on: February 7, 2022

HHS to Audit More Providers That Received COVID-19 Relief Funds

by Wachler & Associates, P.C.

The Department of Health and Human Services (HHS) recently announced additional audits of certain healthcare providers that received funding from the Provider Relief Fund (PRF). These audits will focus on whether hospitals that received PRF payments have complied with the surprise billing provisions of the PRF terms and conditions. HHS has long promised “significant enforcement” related to the PRF, a promise which is beginning to take effect.

The PRF was created by Congress through the CARES Act and was designed to provide financial relief to healthcare providers during the COVID-19 pandemic. Acceptance of a PRF payment is conditioned on, among other things, the provider agreeing to use the funds only for healthcare related expenses and lost revenue attributable to coronavirus, and to file reports demonstrating compliance with the conditions of the payment.

Providers who received and retained payments through the PRF are required to file reports justifying their use of the funds. Providers must report information on healthcare-related expenses attributable to coronavirus, lost revenue attributable to coronavirus, other pandemic assistance received, and administrative data. Providers who received more than $500,000 in aggregate payments are required to report some data elements in greater detail, including specific information regarding operations, personnel, supplies, equipment, facilities, and several other categories. Some providers will be required to report significant amounts of financial information in significant detail, which may require time to compile or calculate.

Published on: January 20, 2022

New Guidance on Insurance Coverage of OTC COVID-19 Tests

by Wachler & Associates, P.C.

On January 10, 2022, the Departments of Labor (DOL), Health and Human Services (HHS), and the Treasury (DOT) (collectively, the Departments) jointly issued FAQs regarding the implementation of required insurance coverage for at-home COVID-19 tests under the Families First Coronavirus Response Act (FFCRA). Pursuant to the new guidance, insurance plans and issuers must provide coverage over the counter (OTC) COVID-19 tests without cost-sharing requirements, prior authorization, individualized clinical assessment, or other medical management requirements with respect tests purchased on or after January 15, 2022 and during the public health emergency. This new requirement is in addition to the existing requirement that insurers cover COVID-19 testing where there is an individualized clinical assessment by an authorized provider.

With respect to OTC COVID-19 tests obtained without a healthcare provider’s involvement, plans and issuers must provide coverage for the cost of the test at no expense to the participant, beneficiary, or enrollee, unless the conditions of a safe harbor discussed below are met. While plans or issuers are encouraged to reimburse sellers of OTC tests directly, they are not required to do so. Some plans or issuers may require beneficiaries to provide upfront payment and then submit a claim for reimbursement after the fact.

If a plan or issuer provides direct coverage of OTC COVID-19 tests, it generally may not limit coverage to only tests provided through preferred pharmacies or other retailers. However, under a safe harbor, the Departments have indicated they will not take enforcement action related to OTC test coverage against a plan or issuer that provides coverage for such tests by arranging for direct coverage through both its primary pharmacy network and a direct-to-consumer shipping program, and otherwise limits reimbursement for OTC tests from non-preferred pharmacies or other retailers to no less than the actual price, or $12 per test, whichever is lower. Under this safe harbor, plans and issuer may not impose any prior authorization or other medical management requirements on beneficiaries and may not require any upfront out of pocket payments by beneficiaries. Additionally, under this safe harbor, the direct-to-consumer shipping program may be provided through one or more in-network provider(s) or another entity designated by the plan or issuer.