COVID-19

Published on: May 3, 2021

First Charges Filed Under the COVID-19 Consumer Protection Act

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.

Published on: April 27, 2021

Are COVID-19 Liability Waivers by Patients Enforceable?

by Wachler & Associates, P.C.

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.

Published on: April 19, 2021

HHS OIG Issues COVID-19 Vaccine Compliance Reminder to Providers

by Wachler & Associates, P.C.

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

Published on: April 5, 2021

A Summary of Changes in E/M Telephone Billing During the COVID-19 Pandemic

by Wachler & Associates, P.C.

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.

Published on: March 29, 2021

First Provider Relief Fund Indictment Provides Window Into Enforcement Issues

by Wachler & Associates, P.C.

On February 10, 2021, the United States Department of Justice filed the first criminal charges relating to a alleged violation of the terms the Provider Relief Fund (PRF). The allegations contained in the indictment illustrate some of the pitfalls of the PRF and the importance of compliance with its terms. It may also provide insight into coming enforcement actions.

The alleged defendant was a resident of southeastern Michigan who owned and operated a home health agency in Indiana. The home health agency closed in January 2020 and filed a notice of voluntary termination with Medicare in March 2020. However, despite the filing of this notice, when the first wave of payments under the PRF were automatically deposited into providers’ accounts in April, the defendant’s home health agency received approximately $38,000. The defendant then allegedly submitted an attestation to the terms and conditions of the PRF payment and allegedly distributed the funds to family members in a series of checks, all just under $10,000. The indictment charged the defendant with one count of Theft of Public Money, Property, or Records.

This indictment touches several possible areas of enforcement or audits of PRF payments, including eligibility criteria, attestations, and use of the funds. The first wave of payments under the PRF consisted of $30 billion that was automatically deposited in providers’ accounts in amounts based on a provider’s 2019 Medicare billing. Providers did not make requests or applications for this funding. However, simply because a provider received money did not mean they were entitled to keep it, a provider also had to meet the eligibility criteria, such as the requirement that it provided services after January 31, 2020.

Published on: March 25, 2021

CMS Increases Medicare Payment to Providers Administering COVID-19 Vaccines

by Wachler & Associates, P.C.

On March 15, 2021, the Centers for Medicare & Medicaid Services (CMS) announced it will increase the amount Medicare pays providers for administering the COVID-19 vaccine. For vaccines administered on or after March 15, 2021, the new national average payment rate for physicians, pharmacies, hospitals, and other providers who administer the vaccine of $40 per single-dose vaccine and $80 per two-dose vaccine. The exact payment rates will be based on the type of provider offering the vaccine and will be adjusted based on the location of the provider. For vaccines administered prior to March 15, 2021, Medicare rates will remain $28.39 per single-dose vaccine and $45.33 for both doses of a two-dose vaccine.

These changes in Medicare payment rates are based on new information regarding the costs of vaccine administration for different types of providers and more resources needed to safely administer the vaccine. The goal of CMS is to increase the number of providers offering the vaccine and further emphasize that no beneficiary, whether a beneficiary with private insurance, Medicare, or Medicaid, should pay cost-sharing to receive the COVID-19 vaccine. The new payment rate is effective for COVID-19 vaccines given on or after March 15, 2021.

In order to receive COVID-19 vaccines at no cost from the federal government, providers cannot charge patients for administration of the vaccine. Providers that receive federally purchased vaccines during the public health emergency must contractually agree to administer COVID-19 vaccines to patients regardless of their ability to pay; Providers are therefore prohibited from charging a patient any amount for administration of the vaccine, including a copay, coinsurance, or deductible, including seeking reimbursement from patients, such as balance billing. CMS provides payment information for various programs, to ensure consistent coverage across payers, such as:

Published on: March 18, 2021

A Peak Inside the $1.9 Trillion COVID-19 Relief Bill

by Wachler & Associates, P.C.

On March 11, 2021, President Biden signed the $1.9 trillion American Rescue Plan, a legislative package to help fund vaccinations, provide immediate relief to families during the COVID-19 pandemic, increase COVID-19 testing and identify new and emerging strains of COVID-19. The final bill includes several sources of funding for COVID-19 response and other healthcare programs:

Development of a national vaccination program

The bill includes $20 billion for a nationwide vaccination program, in partnership with state and local authorities. The vaccination program will include the creation of community vaccination centers as well as mobile vaccination units. Under the plan, the Biden Administration will work with Congress to expand the Federal Medicaid Assistance Percentage (FMAP) to 100%, to ensure all Medicaid enrollees will be vaccinated.

Published on: March 12, 2021

COVID Testing Providers Face Hurdles for HRSA Reimbursement

by Wachler & Associates, P.C.

As part of the response to the COVID-19 pandemic, Congress provided funding for testing of patients without health insurance. To receive this reimbursement for testing, providers must attest that the patient is uninsured. However, it is not clear how providers must gather this information, exposing providers to risk of enforcement actions.

For claims for COVID-19 testing and testing-related items and services, a patient is considered uninsured if the patient does not have coverage through an individual, or employer-sponsored plan, a federal healthcare program, or the Federal Employees Health Benefits Program at the time the services were rendered. For claims for treatment for positive cases of COVID-19, a patient is considered uninsured if the patient did not have any health care coverage at the time the services were rendered. For claims for vaccine administration, this means that the patient did not have any health care coverage at the time the service was rendered.

The funding of testing for the uninsured is administered by the Health Resources & Services Administration (HRSA) under the COVID-19 Claims Reimbursement to Health Care Providers and Facilities for Testing, Treatment, and Vaccine Administration for the Uninsured Program. Congress has allocated $2 billion to this program through The Families First Coronavirus Response Act (FFCRA) and the Paycheck Protection Program and Health Care Enhancement Act (PPPHCEA), as well as a portion of the Provider Relief Fund.

Published on: March 3, 2021

OCR to Ease HIPAA Enforcement for Web-Based Scheduling of COVID-19 Vaccinations

by Wachler & Associates, P.C.

On February 12, 2021, the Office for Civil Rights (OCR) at the U.S Department of Health and Human Services (HHS) announced the details of its previously-announced discretion in the enforcement of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health (HITECH) Act related to privacy, security, and date breaches. OCR will not penalize covered health care providers or their business associates for non-compliance under HIPAA for the good faith use of online or web-based scheduling applications (WBSAs) for scheduling COVID-19 vaccination appointments during the COVID-19 pandemic.

During the COVID-19 public health emergency, HIPAA covered providers, such as large pharmacy chains, or business associates acting on behalf of the covered providers, may utilize WBSAs to schedule individual appointments for COVID-19 vaccinations. For the purposes of this exercise of discretion, a WBSA is an online or web-based application that only allows the intended parties to access the data and that provides individual appointment scheduling related to largescale COVID-19 vaccination. Technology that directly connects to electronic health records (EHR) systems used by covered providers is not included in this discretionary measure and does not constitute a WBSA. The HIPAA privacy rules allow business associates of a covered entity to use and disclose protected health information (PHI) for certain functions, only as dictated by a business associate contract or other agreement. However, during the COVID-19 pandemic, health care providers need to quickly schedule many appointments for COVID-19 vaccinations and often do this through WBSAs. Some of these online scheduling applications, and the way in which healthcare providers use them, may not comply with the HIPAA privacy rules. Furthermore, vendors of the WBSAs may not know providers are using these applications to create and send PHI, potentially making the WBSA vendors business associates under HIPAA.

OCR will exercise discretion in the enforcement of HIPAA privacy rules and will not penalize covered healthcare providers, their business associates, or WBSA vendors who are technically business associates, for noncompliance as it relates to the scheduling of individual COVID-19 vaccination appointments during the COVID-19 pandemic. This enforcement discretion applies to covered healthcare providers and their business associates, which are, in good faith, using WBSAs to schedule COVID-19 vaccination appointments, as well as WBSA vendors whose platform is being used to schedule COVID-19 vaccination appointments. Discretion does not apply to covered providers or business associates for activities unrelated to the scheduling of COVID-19 vaccinations or if the covered providers or business associates fail to act in good faith. Instances where a covered provider or business associate are not acting in good faith include: the use of a WBSA that allows the sale of personal information collected, the use of a WBSA for purposes other than scheduling COVID-19 vaccination appointments, the use of a WBSA without reasonable safeguards to protect the PHI, and the use of a WBSA to screen individuals for COVID-19 before an in-person visit.

Published on: February 24, 2021

Michigan Announces New Resources to Aid COVID-19 Vaccine Sign Up

by Wachler & Associates, P.C.

The Michigan Department of Health of Human Services (MDHHS) recently announced various support programs to help Michigan residents sign up for and gain access to the COVID-19 vaccine. Methods to obtain a COVID-19 vaccine in Michigan have been difficult for individuals 65 and older; many county local health departments are not offering the vaccine and will not provide vaccine information over the phone. These resources may be useful to providers when consulting with elderly patients.

Since individual physician providers cannot yet distribute the vaccine, the only other option for older qualifying individuals is to make an appointment with a local hospital system or pharmacy that is currently distributing the vaccine. However, these hospitals require patients to have an active online chart account with the hospital. In addition, hospital vaccine appointments are given to online chart account holders at random, and patients must continue to monitor their emails for appointment notifications. Many pharmacies, such as Right Aid and Meijer, are following a similar format for those 65 and older, and require patients to schedule appointments online or through the pharmacy’s smartphone application. These processes have caused difficulty for elderly individuals seeking the vaccine, who may have more trouble navigating online portals, emails, and smartphone applications.

Due to the varying degrees of technological access and understanding of Michigan residents 65 and older, MDHHS is working with community partners to make the COVID-19 vaccine appointment process smoother. Qualifying residents can visit Michigan.gov/COVIDvaccine for the most current COVID-19 vaccine information or call the COVID-19 Hotline at 888-535-6136 for assistance. MDHHS has also partnered with 2-1-1, a free, confidential website service that helps connect Michigan residents with COVID-19 information and community organizations across Michigan with thousands of different programs. 2-1-1 utilizes a comprehensive database of health and human services in Michigan with more than 7,000 agencies providing over 36,000 services across the state. MDHHS first began its partnership with 2-1-1 in June of 2020 to help individuals in Michigan find and register for COVID-19 testing, over the phone or internet, and expanded its partnership on February 12, 2021 to include directing individuals to local vaccination clinics.