COVID-19

Published on: September 1, 2021

HHS Expands Its Capability to Audit the Provider Relief Fund

Demonstrating its commitment to audit Provider Relief Fund (PRF) recipients, the Department of Health and Human Services (HHS) has hired several outside contractors to provide audit or program integrity services relating to the PRF. The PRF is a $175 billion fund created by Congress through the CARES Act and administered by HHS (and its sub-agency the Health Resources and Services Administration or HRSA) 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.

Publicly available contracts provide a glimpse into HHS’s actions regarding the PRF. Over the last year, HHS has contracted with KPMG to provide “program integrity support,” Kearney & Company to provide “PRF Audit support services,” and Creative Solutions Consulting to provide “audit and financial review services.” Combined, HHS has committed approximately $5.5 million to these contracts. Reports indicate HHS has hired PricewaterhouseCoopers and Grant Thornton, as well.

Although HHS’s retention of contractors is nothing new, these agreements signal to providers that HHS is not taking PRF reporting lightly. Providers who received and retained payments through the PRF are required to file reports justifying their use of the funds and documenting their compliance with the terms and conditions of the payments. 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. Thus, some providers will be required to report significant amounts of financial information in considerable detail.

Published on: August 24, 2021

Audits Growing More Burdensome on Pharmacies

by Wachler & Associates, P.C.

According to data from the Pharmacy Audit Assistance Service (PAAS) National, the Covid-19 Public Health Emergency (PHE) has negatively affected pharmacies navigating audits by Pharmacy Benefit Managers (PBM). PBMs are companies who are primarily responsible for developing and maintaining drug formularies, contracting with pharmacies, negotiating discounts and rebates with drug manufacturers, and processing and paying prescription drug claims. PBMs manage prescription drug benefits on behalf of health insurers, Medicare Part D drug plans, large employers, and other payers. PBMs routinely conduct audits on member pharmacies in order to monitor pharmacies’ performance and identify alleged improper payments made to the pharmacies. However, PBMs have been criticized for overstepping those audit functions by utilizing audits as a source of revenue for themselves at the expense of independent pharmacies and patients.

In response to the PHE, many state insurance agencies and PBMs themselves suspended in-person audits in 2020 and shifted to virtual audits. The virtual nature of a PBM audit means pharmacies are responsible for a greater workload because they must complete tasks that would normally be completed by a PBM during a field audit. For example, pharmacies must locate, organize, and deliver hundreds of pages of documents and records in compliance with PBMs’ standards, while managing the day-to-day pharmacy operations. Although virtual PBM audits allows benefit managers to review more pharmacy claims than during traditional in-person audits, it also allows them to potentially deny more claims than before.

According to PAAS National, even though the number of pharmacy audits in 2020 declined nearly 14% year over year, the overall number of prescriptions reviewed increased by 40%. PAAS data also shows that the average audit in 2020 cost pharmacies $23,978, which is 35% more than the annual average over the previous five years. This data further implies that pharmacies are shouldering more of the administrative burden of responding to audits in addition to the task of pursuing a subsequent appeal where the PBM denies claims during an audit.

Published on: August 3, 2021

First PRF Reporting Deadline Coming Soon

by Wachler & Associates, P.C.

The first reporting deadline for the Provider Relief Fund (PRF) is less than two months away, the first batch of reports are due September 30, 2021. The PRF is a $175 billion fund created by Congress through the CARES Act and administered by the Department of Health and Human Services (HHS) 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.

In June 2021, HHS released long-awaited updates on the reporting requirements for entities that received payments from the PRF. These reporting requirements divided the payment based on when the provider received the payment and then set deadlines for reporting based on when the provider received the payment. Providers who received payments between April 10, 2020 and June 30, 2020, the first to receive payments, are required to file their reports by September 30, 2021. This time period includes most of the payments made under the Phase 1 General Distribution, some of the payments made under the Phase 2 General Distribution, and some payments made under the Target Distributions. The reporting portal opened on July 1, 2021 and is currently available to these recipients.

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. Further, HHS continues to update the guidance surrounding PRF reporting. Providers should be aware of the potential complexity of PRF reporting as the deadlines begin to approach.

Published on: July 22, 2021

OIG Focuses Efforts on Telehealth Audits

by Wachler & Associates, P.C.

The opportunity for expanded use of telehealth services spurred by the COVID-19 pandemic provided many individuals with greater access to healthcare services and allowed providers to furnish patient care in safe environments. However, this expansion has led to potential abuse concerns, prompting the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to issue a statement announcing that OIG is conducting seven different audits, evaluations, and inspections of telehealth services under the Medicare and Medicaid programs.

Because OIG is investigating providers specific to telemedicine, these audits will review remote patient monitoring, virtual check-ins, and e-visits. An OIG report issued in April 2018 concluded that 31% of the sample claims reviewed did not meet the Medicare conditions for payment for telehealth services. That report was prior to the broad expansion of telemedicine from the COVID -19 pandemic. Providers who have billed for telehealth services during the public health emergency (PHE) should be prepared to undergo audits of those claims.

Current OIG telemedicine audit projects include:

Published on: June 15, 2021

HHS Reveals New PRF Reporting Requirements

by Wachler & Associates, P.C.

On June 11, 2021, the Department of Health and Human Services (HHS) released long-awaited updates on the reporting requirements for entities that received payments from the Provider Relief Fund (PRF). HHS also pushed back the deadline for some recipients of PRF payments to use the funds. The PRF is a $175 billion fund created by Congress through the CARES Act and administered by HHS to provide financial relief to healthcare providers during the COVID-19 pandemic. HHS has subdivided the PRF into various general and targeted distributions.

Initially, the PRF reporting portal had been scheduled to open on January 15, 2021, with the first reports initially being due on February 15, 2021. However, HHS has repeatedly pushed these dates back. For the last several months, provides have been able to register and log into the reporting portal, but have been unable to file reports. Moreover, PRF recipients had previously been told that all PRF payments must be used by June 30, 2021. As June 30, 2021 approached, and no new reporting guidance or timeline had been released, providers and industry groups began to call for HHS to push back the deadline by which PRF funds must be used.

The new reporting guidance pushed this date back for some, but not all, recipients. The deadline to use the funds, as well as the reporting deadline, is now dependent on when the recipient received the payment.

Published on: June 14, 2021

Medicare Creates Additional Payment for At-Home COVID-19 Vaccine Administration

by Wachler & Associates, P.C.

Effective June 8, 2021, Medicare will pay an additional $35 per dose for administering the COVID-19 vaccine in the home for certain Medicare patients that have difficulties leaving their homes or are hard-to-reach. This $35 dollar payment is in addition to the standard payment for vaccine administration, which varies based on location but is approximately $40 per dose. The additional payment also applies to each dose of a two-dose vaccine if both doses are administered in the home. To be eligible for the at-home additional payment, both the location and the beneficiaries must be certain criteria.

Private residences, temporary lodging, apartments, most units in an assisted living facility (ALF) or group home, and the homes of Medicare beneficiaries have been made provider-based to a hospital during the COVID-19 public health emergency generally qualify as location eligible for the at-home additional payment. However, hospitals, skilled nursing facilities (SNFs), some ALFs, and the communal spaces of apartment buildings or group homes do not qualify for the at-home additional payment.

In addition, to an eligible location, the Medicare beneficiaries must also meet certain criteria. Specifically:

Published on: June 9, 2021

New Bill to Make Telemedicine Waivers Permanent as GAO Urges Caution

by Wachler & Associates, P.C.

During the COVID-19 pandemic, many of the Medicare requirements surrounding telemedicine have been greatly relaxed or waived entirely. These temporary waivers, including allowing Medicare coverage of certain audio-only services, have been welcome changes for many providers and patients. With the end of the pandemic in sight, many are wondering if these changes will end or if some of the temporary waivers will become permanent.

The COVID-19 telemedicine waivers were authorized under Section 1135 of the Social Security Act, which allows the Secretary of Health and Human Services to temporarily waive or modify certain Medicare requirements for the duration of a declared public health emergency. The telemedicine waivers include: allowing telehealth services to be provided nationwide, rather than only in certain locations; allowing beneficiaries to receive, and providers to furnish, telehealth services from any setting, including beneficiaries’ and providers’ homes; allowing additional types of providers, such as physical and occupational therapists, to furnish telehealth services; temporarily adding over 146 new telehealth services; and allowing certain services to be furnished using audio-only technology such as telephones, instead of interactive systems involving video technology. As the authority to issue waivers is based on the declaration of a public health emergency, these waivers will end when the declared public health emergency ends.

Likely in response to calls from both providers and patients to make the telemedicine waivers permanent, Congress recently introduced H.R.3447, a bill to amend the Social Security Act to expand accessibility to certain telehealth services under the Medicare program. While the bill in the early stages of the legislative process and will likely be subject to much debate and many changes, it is an encouraging sign that at least some of the telemedicine waivers may become permanent.

Published on: June 7, 2021

Vaccine Incentives for Healthcare Employers

by Wachler & Associates, P.C.

On May 28, 2021, the Equal Employment Opportunity Commission (EEOC) released guidance indicating that employers could, under certain circumstances, offer incentives to employees to receive the COVID-19 vaccine and offer the vaccine to employees’ family members. The EEOC largely confined its analysis to the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA). However, employers who are also healthcare providers must also consider whether these benefits to employees or their family members implicate prohibitions on payment for referrals.

The Physician Self-Referral Law (also known as the Stark Law), the Anti-Kickback Statutes (AKS), and the Eliminating Kickbacks in Recovery Act (EKRA) all prohibit various forms of payment for referrals. The Stark Law prohibits “physicians” (generally including MDs, DOs, dentists, optometrists, and chiropractors) from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. The AKS is a criminal statute that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by federal health care programs. EKRA provides criminal penalties for paying, receiving, or soliciting any remuneration in return for referrals to recovery homes, clinical treatment facilities, or clinical laboratories. All three and can carry stiff penalties, sometimes criminal penalties.

Healthcare employers who provide incentives to receive the COVID-19 vaccine to employees with the ability to make referrals to the employer or that offer benefits to such employees’ family members should account for these statutes. Depending on how the incentive is structured, it may fit into the bona fide employment exception to the Stark Law or one of the other exceptions or safe harbors in these rules. It is also important to note that, due to federal funding, the vaccine itself it available free-of-charge, but that administration of the vaccine and the convenience thereof may still represent things of value, as well as the value of any incentives, in cash or otherwise.

Published on: May 13, 2021

Will HHS Amend the PRF Spending Deadline and Reporting Requirements?

by Wachler & Associates, P.C.

Two significant areas of the Provider Relief Fund (PRF) are ripe for updates by the US Department of Health and Human Services (HHS): the current June 30, 2021 deadline for recipients to spend PRF payments and the long-awaited reporting requirements. The PRF is a $175 billion fund created by Congress through the CARES Act and administered by HHS to provide financial relief to healthcare providers during the COVID-19 pandemic. HHS has subdivided the PRF into various general and targeted distributions.

Currently providers who received payments under the PRF generally have until June 30, 2021 to use the funds. The funds must be used in specific ways as specified by HHS and often require careful documentation and accounting. The June 30, 2021 deadline was initially set early in the pandemic, but HHS has released guidance as recently as March 2021 that reinforces the deadline and provides that HHS expects that providers with unused PRF fund after June 30 will return any unused funds to HHS. However, as the pandemic and the corresponding public health emergency declaration appear likely to extend beyond June 30, 2021, providers are likely to continue to have PRF-eligible expenses well after HHS’s deadline. It would therefore likely benefit many providers for HHS to extend the June 30, 2021 deadline. Indeed, the American Hospital Association (AHA) recently penned a letter to HHS requesting providers be allowed to use PRF fund until the end of the declared public health emergency.

Another reason to extend the June 30, 2021 deadline would be that HHS has yet to release when providers will be required to submit PRF reporting. The statutes that created the PRF and the terms and conditions of the payment to which recipients were required to attest both require recipients to file reports with HHS regarding use of the funds. While HHS has released some details on the form and content of reports and set up a reporting portal, HHS has repeatedly pushed back the release of detailed reporting requirements and the due date of reports. The first reports had initially been due on February 15, 2021, but HHS has pushed this date back. HHS has not released a new date when reports are due but has indicated that recipients will receive a notification when reporting must be completed. A concrete reporting timeline that aligns with an extension of the June 30, 2021 deadline to spend PRF funds would likely be welcomed by providers struggling to plan and budget, while also providing critical care during a public health emergency.

Published on: May 10, 2021

HHS Announces New Mechanism to Reimburse for COVID-19 Vaccine Administration

by Wachler & Associates, P.C.

The US Department of Health and Human Services (HHS) has announced a new program to pay healthcare providers for COVID-19 vaccine administration to underinsured patients, the COVID-19 Coverage Assistance Fund (CAF). CAF is administered by the Health Resources & Services Administration and functions as a claims reimbursement program. Where vaccine administration to uninsured patients is covered by HRSA’s Uninsured Program, CAF is intended to reimburse providers for vaccine administration to patients who have insurance, but whose health plan either denied or only partially paid the claim for vaccine administration. CAF reimburses for COVID-19 vaccine administration at the national Medicare rate.

To submit claims to CAF, providers must first enroll in the program and attest that they (1) have submitted a claim to the patient’s primary health insurance plan and there is a remaining balance from that health insurance plan that either does not include COVID-19 vaccination as a covered benefit or covers COVID-19 vaccine administration but with cost-sharing; (2) have verified that no other third party payer will reimburse them for COVID-19 vaccine administration fees for that patient encounter, or other patient charges related to that COVID-19 vaccination, including co-pays for vaccine administration, deductibles for vaccine administration, and co-insurance; (3) will accept defined program reimbursement as payment in full; (4) agree not to balance bill the patient; and (5) agree to program terms and conditions and may be subject to post-reimbursement audit review.

COVID-19 vaccine administrations occurring on or after December 14, 2020 are eligible for reimbursement by CAF. CAF will reimburse for COVID-19 vaccine administration at the national Medicare rate, which is as follows: