Wachler & Associates Health Law Blog

Published on: March 22, 2021

A Primer on the Stark Law, Anti-Kickback Statute, and EKRA

Imagine a physician wants to rent office space from another physician, but the two refer patients to each other. Or a clinical laboratory wants to contract with a marketer to promote their products. Three of the largest compliance concerns when structuring such an arrangement are the Stark Law, also known as the Physician Self-Referral Law, the Anti-Kickback Statute, often referred to as the AKS, and the Eliminating Kickbacks in Recovery Act, or EKRA. All three regulate referrals and can carry stiff penalties, sometimes criminal penalties. However, each also contains a series of exceptions or safe harbors into which some business structures may fit. Even simple arrangements between healthcare entities can involve complex analysis to comply with these statutes.

The Stark Law, 42 U.S.C. 1395nn, prohibits physicians 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. Financial relationships include both compensation and ownership or investment interests. Designated health services include clinical laboratory services, PT and OT, DME, some imaging services, and several other services. Some of the most common exceptions to the Stark law include the in-office ancillary exception, fair market value compensation, and bona fide employment relationships. CMS has also recently implemented exceptions related to value-based arrangements.

The AKS, 42 U.S.C. 1320a-7b(b), 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. Remuneration means far more than cash payments and includes anything of value. If the AKS applies, conduct may still be lawful if it falls into one of several “safe harbors.” Some of the most common safe harbors are the investment interest safe harbor, specific types of rental agreements for office space or equipment, and contracts for personal services that meet certain criteria. Like the Stark Law, CMS has also implemented safe harbors for certain value-based arrangements.

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 16, 2021

Extension of Public Comment Period for Proposed HIPAA Modifications

by Wachler & Associates, P.C.

On March 9, 2021 the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced a 45-day extension of the public comment period for the proposed modifications to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) privacy rule. The public comment period has been extended from March 22, 2021, to May 6, 2021 in order to give the public more time to fully consider the proposed changes.

OCR first announced the proposed rule making on December 10, 2020. The proposed changes to HIPAA are part of the larger transition to a value-based health care system in which providers are compensated based on patient health outcomes. The modifications propose to address standards that may impede the transition to a value-based health care system and other unnecessary burdens by increasing individuals’ rights to access their health information, enhancing information sharing for care coordination and case management, improving family and caregiver involvement for individuals experiencing health emergencies, reducing the administrative burden on HIPAA-covered providers, and facilitating the disclosure of certain health information during emergencies such as the opioid crisis and COVID-19 pandemic. Other major provisions include:

Defining the terms electronic health record (EHR) and personal health application

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: March 1, 2021

A Primer on Medicare Revocation

by Wachler & Associates, P.C.

A revocation of Medicare billing privileges can have devastating impacts on a healthcare provider. Not only does a revocation render the provider unable to bill the Medicare program for a period of time, but it can have wide-ranging impacts on a provider’s practical ability to operate or to practice in their chosen field.

Medicare billing privileges can be revoked for twenty-two enumerated reasons, including non-compliance with Medicare enrollment requirements, felony convictions, and failure to respond to requests for medical records. A recent expansion of CMS’s revocation authority also updated the ability to revoke a provider for an “abuse of billing privileges” to include a pattern or practice of submitting claims that do not meet Medicare requirements. In some cases, the Medicare Administrative Contractor (MAC) gathers the information and determines to revoke a provider. In other cases, the MAC forwards the information to the Centers for Medicare & Medicaid Services (CMS) and CMS makes the revocation determination. The revocation may be based on a prior interaction with the MAC or CMS, such as a prior audit of the provider. The provider may not necessarily be told during this interaction that it can lead to a revocation of billing privileges.

When CMS or a MAC revokes billing privileges, they will set a reenrollment bar, which dictates how long a provider must wait before it can reapply for Medicare billing privileges. CMS recently expanded its authority to set the reenrollment bar. In general, reenrollment bars may now be set between 1 and 10 years, depending on the circumstances, although certain provisions allow for longer bars. CMS may also decide to place a revoked provider on the CMS Preclusion List. The Preclusion List labels the provider a “bad actor” and cuts off their ability to bill Medicare Part C and Part D. A Medicare revocation or placement on the Preclusion List may also impact contracts outside the Medicare program. For example, commercial carriers may terminate participation agreements with a provider based on a Medicare revocation or placement on the Preclusion List.

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.

Published on: February 22, 2021

OIG Opines on Per-Vaccine Compensation for Administrative Services

by Wachler & Associates, P.C.

On February 17, 2021, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) updated its FAQ’s concerning the COVID-19 public health emergency. In the update, OIG gave guidance on its enforcement discretion regarding administrative services provided to COVID-19 vaccination sites on a per-vaccine basis. It should be noted that this guidance is not an advisory opinion, is not binding on OIG, and does not constitute a waiver of any statutory or regulatory requirement, though it may be helpful when structuring these arrangements.

OIG addressed the question of whether a non-provider philanthropic entity could contract to provide administrative services to a healthcare provider relating to the operation of COVID-19 vaccination sites and be compensated on a per-vaccine basis. The entity would provide administrative services including arranging for the physical vaccination sites, data systems, online and web-based scheduling, site development and training, and reporting to state agencies. The healthcare provider would provide clinical staff, oversee administration of the vaccine, and bill third-party payors, including federal healthcare programs.

After billing for the vaccine administration, the healthcare provider would retain a certain amount per hour for compensation and to cover staffing costs. The remainder of the compensation would flow to the entity providing the administrative services. OIG specified that there would be no other arrangements between the entity, the healthcare provider, any beneficiary, or other person capable of arranging for referrals for items or services payable by a federal healthcare program.

Published on: February 19, 2021

A Primer on Assignment of Payment

by Wachler & Associates, P.C.

Many Medicare practitioners, providers, and suppliers do not directly bill for the services they supply and similarly do not directly receive reimbursement. Billing and reimbursement may occur through an employment or independent contractor relationship, through a billing company, or through another arrangement. However, each of these arrangements must comply with the Medicare assignment of payment rules that dictate how and to whom the practitioner, provider, or supplier may assign their right to receive reimbursement from Medicare.

The general rule is that Medicare will pay assigned benefits only to the physician, practitioner, or supplier who furnished the service, and not to another person or entity. To reassign payment to another person or entity, an arrangement must meet one of several enumerated exceptions. The most common exceptions are:

Payment to Agent: Medicare may make payment, in the name of the provider, to an agent who furnishes billing or collection services. In general, the agent or billing company may not have a financial interest in the dollar amount billed or the actual collection of payment, and the agent must act under payment disposition instructions which the provider may modify or revoke at any time. Different provisions may apply if the agent merely prepares bills and does not receive payment for the provider or supplier.

Published on: February 15, 2021

2021 Special Enrollment Period for the Health Insurance Marketplace

by Wachler & Associates, P.C.

On January 28, 2021, The Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), and in accordance with an Executive Order issued by the Biden Administration, announced a Special Enrollment Period (SEP) for individuals and families to gain coverage on the Affordable Care Act (ACA) health insurance Marketplace. Due to the uncertainty caused by the COVID-19 pandemic, CMS determined that the public health emergency poses exceptional circumstances for consumers in obtaining health insurance. The SEP will be available to individuals in 36 states which participate in Marketplaces using the Healthcare.gov platform. CMS is encouraging states using their own Marketplace platform to offer a similar SEP. CMS’s goal is to guarantee quality, affordable coverage to more families during the COVID-19 pandemic.

The SEP will begin on February 15, 2021, and end on May 15, 2021. Marketplaces using Healthcare.gov will make operational a SEP for all eligible Marketplace users in the state. Eligible consumers who are submitting a new application, or current users who are modifying an existing application, may apply for coverage. Users will be able to access the SEP through various platforms, including Healthcare.gov, the Marketplace call center, or direct enrollment outlets. Consumers can obtain assistance with coverage from a network of more than 50,000 agents and brokers registered with the Marketplace and over 8,000 individuals trained in assisting with Marketplace coverage.

States with their own Marketplaces can, but are not mandated, to offer a similar enrollment period, although it is CMS’s recommendation that these states establish a SEP as well. Marketplace coverage is prospective; therefore, it will begin the first day of the month after an individual enrolls using Healthcare.gov. Current users must update their existing application to claim the SEP and to receive a determination on whether they are eligible. No additional application questions, documentation, verification requirements, or qualifying events such as job loss or the birth of a child, will be necessary for consumers to show they qualify for the SEP. Some consumers may already qualify for existing SEPs, Medicaid, or the Children’s Health Insurance Program (CHIP), and can find out if they are eligible using Healthcare.gov. Beginning February 15, 2021, consumers seeking to enroll using the SEP can find out if they qualify by using Healthcare.gov, and are no longer limited to calling the Marketplace call center. Eligible consumers will have 30 days after submitting an application to select a plan. Current enrollees will be able to switch to any plan available in their area without being restricted to the same coverage level as their current plan.