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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.

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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:

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Two nurse practitioners, with Medicare patients based in Montana, recently pled guilty to conspiracy to commit healthcare fraud. The two NPs were among 345 other healthcare professionals charged in a nationwide healthcare fraud and opioid action undertaken by the United States Department of Justice (DOJ) in September 2020.  This alleged fraudulent activity has resulted in charges for defendants in various healthcare professions, including, genetic testing laboratories, pharmacies, and durable medical equipment (DME) companies.

Since September 2020, DOJ has been investigating a largescale telefraud scheme which alleges that a marketing network brought in hundreds of thousands of unaware participants through the use of telemarketing calls, direct mail, television advertisements, and internet advertisements. The telemedicine executives charged in the action allegedly paid healthcare providers to request DME, medications, and laboratory and diagnostic testing that were medically unnecessary and either without any patient interaction or with only a short telephone conversation with patients the providers had never met or seen. Often, the test results, medications, or DME ordered were not provided to the beneficiaries, were not medically necessary or of use to the beneficiaries, or were the result of false diagnoses. The two individual NPs pled guilty to conspiracy to commit healthcare fraud through their involvement in a plan related to DME, specifically braces used in orthotics. The two NPs received illegal payments from telemedicine companies in exchange for signing orders for braces received by unlicensed telemarketers with no formal training. Medicare patients received the braces without having been seen by a healthcare provider. The orthotics ordered by the nurses for Medicare patients were not medically necessary, and Medicare will only pay for services that are medically necessary and reasonable and supplies used to diagnose and treat a patient’s condition.

Since 2016, the Department of Health and Human Services Office of Inspector General (HHS OIG) has recorded a significant increase in telefraud, healthcare fraud related to telemedicine. Prior to the COVID-19 Public Health Emergency (PHE), Medicare only reimbursed providers for telehealth services for routine appointments in specific circumstances. In addition, the telehealth visit was required to be a real-time, two-way interactive communication using video technology, with a patient and provider who had a previous established relationship. However, as a result of the COVID-19 pandemic, the Center for Medicare and Medicaid Services (CMS) expanded Medicare’s telehealth benefits and allows for the billing of evaluation and management (E/M) audio-only telemedicine visits for the duration of the COVID-19 PHE.

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A St. Louis, Missouri based chiropractor has become the first person charged under the new COVID-19 Consumer Protection Act, with the government alleging numerous civil violations and seeking civil monetary penalties. The allegations serve as a cautionary tale for healthcare providers marketing and selling goods and services relating to the COVID-19 pandemic.

The COVID-19 Consumer Protection Act was enacted in December 2020 and makes it unlawful, for the duration of the ongoing COVID-19 public health emergency, for any person, partnership, or corporation to engage in unfair or deceptive acts or practices in or affecting commerce that are associated with the treatment, cure, prevention, mitigation, or diagnosis of COVID-19. The Act is similar to Section 5(a) of the FTC Act, but adds increased penalties for violations relating to the COVID-19 pandemic. The Act authorizes injunctive relief and Civil Monetary Penalties of up to $42,792 per violation.

In this case, the first under the Act, the government alleged that the chiropractor and his company violated the Act by making claims about the efficacy of their products that were not supported by scientific literature. Specifically, that the chiropractor sold various vitamin supplements and claimed that they prevented or treated COVID-19. The government also alleged that the chiropractor claimed the vitamin supplements were more effective that the available COVID-19 vaccines. The government alleged that the chiropractor made these claims in numerous videos posted on various social media and other websites and misrepresented the results of studies concerning the efficacy of the vitamin supplements in treating or preventing COVID-19. According to the allegations, these claims constituted violations of the Act because, even though there are studies showing correlation between vitamin deficiencies and elevated risk from the virus, there are no randomized clinical trials that establish the vitamin supplements caused positive health outcomes in connection with COVID-19.

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In general, liability waivers can be a useful tool for businesses and individuals to avoid personal injury lawsuits and liability. Typically, liability waivers are associated with participating in a dangerous activity, such as skiing, boating, gym classes, or school activities. The individual participating in the activity signs the waiver, acknowledging that he or she accepts the risks associated with the activity and agrees to release the business or individual from liability related to these risks. However, in response to the COVID-19 pandemic, liability waivers by patients for COVID-19 related risks are becoming increasingly common. While these waivers are likely enforceable, providers should be aware of potential legal issues if patients are asked to sign COVID-19 liability waivers.

Each state evaluates the enforceability of liability waivers differently. For example, in some states, such as Louisiana, Virginia, and Montana, personal injury liability waivers are all invalid. However, in most states, including Michigan, these liability waivers are generally enforceable, subject to certain restrictions. In Michigan, parties may contract against liability for harm caused by ordinary negligence, but not gross negligence, or willful and wanton misconduct. Therefore, a party will not be protected from liability if it intentionally or recklessly engaged in the conduct that caused harm. Although not explicitly stated in laws or statutes in Michigan, other important factors for providers to consider in drafting these liability waivers include:

  • Clear language. The waiver should clearly state that the individual is releasing the business or provider from liability. The terms should also be easy for the parties to understand.
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On April 15, 2021, the Department of Health and Human Services Office of Inspector General (OIG) issued a statement reminding providers that the COVID-19 vaccine must be provided at no cost to the public. OIG issued this message as a result of complaints from patients about charges from providers for receiving the COVID-19 vaccine. All supply of the COVID-19 vaccine in the United States has been purchased by the United States Government and is only to be used by providers through the Centers for Disease Control and Prevention’s (CDC) COVID-19 Vaccination Program. Because the vaccine is being supplied by the federal government, any provider participating in the CDC COVID-19 Vaccination Program must comply with the terms of the program and offer the vaccine to recipients for free.

Providers participating in the CDC COVID-19 Vaccination program must sign a CDC COVID-19 Vaccination Program Provider Agreement. Providers are responsible for compliance with the requirements in the agreement. Compliance with the program requires that providers administer the vaccine at no cost to the patient. All organizations and providers enrolled in the program:

  • Must administer the COVID-19 vaccine with no out-of-pocket charges to the patient
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Appealing Medicare claim denials and overpayments is a common yet often misunderstood part of providing care to Medicare beneficiaries. Any healthcare provider should be familiar with the appeals process and some common issues that may arise. Although Medicare audits were temporarily suspended due to the COVID-19 pandemic, they have since resumed.

When a Medicare contractor denies a claim, whether as part of a pre-pay, post-pay, or other type of review or audit, the provider generally has a right to a lengthy appeal process. The process often begins before the denial of the claim itself. The provider may receive Additional Document Requests (ADRs) from the contractor demanding information or documentation on a claim or claims. These requests should be reviewed carefully, however they often contain boilerplate language and it may be difficult to determine which specific documentation the contractor is requesting.

Once a claim has been denied, the first level of appeal is Redetermination before the same contractor that made the initial denial. A provider must request Redetermination within 120 days of the claim denial, or the appeal may be forfeit. A shorter deadline applies to stop recoupment on overpayment demands stemming from the denials. The second level of appeal is Reconsideration before a Qualified Independent Contractor (QIC). The QIC is separate from the contractor that initially denied the claims. A provider often has the opportunity to submit additional documentation at Redetermination and Reconsideration. A provider may also retain an expert to review the contractor’s assertion or submit write-ups on the individual claims.

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On October 22, 2020, the Michigan Legislature enacted Enrolled House Bills 4459 and 4460. These rules were enacted to create limitations on out-of-network provider payments, require certain disclosures to patients related to costs of services, and to generally protect patients from balance medical billing. Balance billing occurs when a healthcare provider bills a patient for services for the amount the patient’s insurance company does not pay. The typical example of balance or surprise medical billing occurs when a patient goes to the emergency room at a hospital in the patient’s insurance network. The patient may receive care from multiple physicians and not know which is participating with the patient’s insurance, because hospitals often employ out-of-network physicians, or those that have no relationship with a patient’s health insurance. After the patient’s insurance pays its allowed amount for in-network and out-of-network services, the patient is then billed for the remaining out-of-network balance.

House Bill 4459 limits how much an out-of-network provider can collect in certain situations by implementing fee restrictions. The amount an out-of-network provider can collect from the patient is limited in certain circumstances, including:

  • Where the service is provided to an emergency patient, is covered by the emergency patient’s health benefit plan, and is provided by a nonparticipating provider at either a participating health facility or nonparticipating health facility.
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When an expensive treatment option is unavailable to a patient because of cost or lack of insurance coverage, some healthcare providers turn to a Patient Assistance Program or PAP to help their patients pay for treatment. The Department of Health and Human Services Office of the Inspector General (OIG) has long recognized that PAPs provide important safety net financial assistance to patients that cannot afford the costs of treatment.

However, OIG believes PAPs also present a risk of fraud, waste, and abuse. OIG’s primary concerns are that donor contributions to the PAP and the PAP’s grants to patients both implicate the Anti-Kickback Statute because they could induce or influence the PAP to send business to the donor or influence the patient to choose certain items. Similarly, OIG has expressed concern that a PAP’s grants to patients implicate the Beneficiary Inducement Statute because it could influence the patient’s selection of a particular provider.

Therefore, a PAP should be structured with certain safeguards in place to steer clear of fraud, waste, and abuse allegations. These safeguards may include structuring the PAP as an independent charitable organization that is not controlled by the donors. OIG has indicated that, in order to ensure such independence, a PAP should not exert direct or indirect influence over its donors, nor should donors have links to the charity that could directly or indirectly influence the operations of the charity or its grant programs. Safeguards may also include making the assistance available to all eligible patients on an equal basis and providing it on a first-come, first-served basis to the extent that funding is available; awarding assistance without regard to any donor’s interests and without regard to the patient’s choice of product, provider, practitioner, supplier, or insurance plan; and providing assistance based upon a reasonable, verifiable, and uniform measure of a patient’s financial need. A PAP and providers should also be cautious about advertising the existence of the PAP or the availability of assistance.

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In response to the COVID-19 pandemic, the Centers for Medicare & Medicaid Services (CMS) created separate payments for audio-only telephone evaluation and management (E/M) services. E/M billing codes apply to medical services related to evaluating and managing a patient, such as, hospital visits, preventive services, and office visits. Coding for E/M services can be complicated because many variables are involved in selecting the proper code. For example, the type and complexity of history, examination, and decision making, as well as time spent with the patient are often factors to be considered. Audio-only telephone E/M services were not previously covered by Medicare under the physician fee schedule (PFS). However, beginning with the March 2020 Interim Final Rule with Comment (IFC), CMS found these types of visits to be clinically appropriate and began to cover certain audio-only codes. CMS further expanded the list of covered audio-only codes in the April 2020 IFC.

CMS soon found that audio-only health services became far more popular than CMS expected, and many beneficiaries were not using video technology to communicate from their homes. Since the new E/M codes were established, providers were seeing beneficiaries for more complex evaluation and management services using audio-only technology, when they would normally utilize telehealth video or in-person visits to evaluate the patient. According to CMS, the intensity and complexity of providing an audio-only visit to a beneficiary during the unique circumstances of the COVID-19 PHE was not properly valued as established in the March 2020 IFC. This was especially true when considering these audio-only services were often being used as a complete substitute for office/outpatient Medicare video telehealth visits. Therefore, CMS established new RVUs based on E/M codes in existence prior to the PHE and the time requirements necessary for telephone service-related codes. Because these audio-only visits were being used in replacement of office/outpatient E/M visits, they should be considered telehealth services and added to the Medicare telehealth service list while the PHE is ongoing.

In the CY 2021 PFS proposed rule, CMS elected not to continue covering the audio-only codes when the PHE ends. This is because, outside the circumstances of the COVID-19 PHE, telehealth services generally must be provided using interactive, two-way audio and video technology. Commenters on the proposed rule broadly supported maintaining payment for audio-only provided services. Commenters stated that many beneficiaries may not have access to two-way audio and video technology and that continuing to pay for these E/M services will help vulnerable populations and those with less access to quality healthcare. However, CMS declined to finalize payment of these E/M codes beyond the PHE. The Social Security Act requires telehealth services to be furnished using a telecommunications system. CMS maintains that there is a longstanding policy of interpreting “telecommunications system” to include technology that allows the telehealth visit to be analogous to an in-person visit. Outside the COVID-19 PHE, CMS continues to believe that the longstanding interpretation of telecommunications system excludes the use of audio-only technology for Medicare telehealth services. The PHE declaration must be renewed in 90-day increments and is currently slated to end April 20, 2021. However, HHS and the Biden administration have signaled that they are likely to repeatedly renew the PHE through at least the end of 2021, thereby allowing Medicare telehealth waivers to continue until the end of the year.

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