Congress Grants Five Month Extension for Telehealth Flexibilities

On Tuesday, March 16, 2022, President Biden signed into law H.R. 2471, the Consolidated Appropriations Act, 2022 (“2022 CAA”). This new law includes several provisions that extend the Medicare telehealth waivers and flexibilities, implemented as a result of COVID-19 to facilitate access to care, for an additional 151 days after the end of the Public Health Emergency (“PHE”). This equates to about a five-month period.

The 2022 CAA extension captures most of the core PHE telehealth flexibilities authorized as part of Medicare’s pandemic response, including the following:

  • Geographic Restrictions and Originating Sites: During the extension, Medicare beneficiaries can continue to receive telehealth services from anywhere in the country, including their home. Medicare is permitting telehealth services to be provided to patients at any site within the United States, not just qualifying zip codes or locations (e.g. physician offices/facilities).
  • Eligible Practitioners: Occupational therapists, physical therapists, speech-language pathologists, and qualified audiologists will continue to be able to furnish and receive payment for telehealth services as eligible distant site practitioners during the extension period.
  • Mental Health:  In-person requirements for certain mental health services will continue to be waived through the 151-day extension period.
  • Audio-Only Telehealth Services: Medicare will continue to provide coverage and payment for most telehealth services furnished using audio-only technology. This includes professional consultations, office visits, and office psychiatry services (identified as of July 1, 2000 by HCPCS Codes 99241-99275, 99201-99215, 90804-90809 and 90862) and any other services added to the telehealth list by the CMS Secretary for which CMS has not expressly required the use of real-time, interactive audio-visual equipment during the PHE.

Additionally, the 2022 CAA allocates $62,500,000 from the federal budget to be used for grants for telemedicine and distance learning services in rural areas. Such funds may be used to finance construction of facilities and systems providing telemedicine services and distance learning services in qualified “rural areas.”

Passage of the 2022 CAA is a substantial step in the right direction for stakeholders hoping to see permanent legislative change surrounding Medicare telehealth reimbursement.

Government Continues Aggressive Antitrust Enforcement in the Healthcare Space

On February 24, 2022, the U.S. Department of Justice (“DOJ”) filed suit to block UnitedHealth’s proposed acquisition of Change Healthcare. UnitedHealth owns the largest health insurer in the U.S., while Change Healthcare is a data company whose software is the largest processor of health insurance claims in the U.S. The DOJ alleges that the acquisition, if allowed to proceed, would give UnitedHealth unfettered access to rival health insurers’ competitively sensitive information, including health insurance pricing. According to the complaint, this would lessen competition and “result in higher cost, lower quality, and less innovative commercial health insurance for employers, employees, and their families.”

The DOJ’s challenge continues a recent trend of aggressive enforcement involving vertical mergers (i.e. transactions between firms at different levels of the supply chain), with the Federal Trade Commission challenging three vertical mergers in the last year alone. These enforcement efforts represent a material shift from the prior enforcement attitude, which often allowed parties to resolve competition concerns raised by vertical mergers through conduct remedies such as information firewalls or supply commitments. The DOJ’s decision to forego such a remedy (assuming one was proposed) signals the government’s intent to take a tougher stance on mergers in the healthcare space. President Joe Biden previously listed prescription drugs and healthcare services as an antitrust priority area in his July 9, 2021 executive order.

The complaint was filed in the District Court for the District of Columbia and can be accessed here: https://www.justice.gov/opa/press-release/file/1476676/download.

Christopher Gordon also contributed to this article.

© Copyright 2022 Squire Patton Boggs (US) LLP
For more articles about healthcare, visit the NLR Health Care Law section.

June 2020 New Jersey State Regulatory Developments

Here are the most recent health care related regulatory developments as published in the New Jersey Register in June 2020:

  • On June 1, 2020, at 52 N.J.R. 1150(a), the Department of Health Commissioner issued a notice of rule waiver/modification/suspension pursuant to Executive Order No. 103 (2020) related to the qualifications an administrator of an assisted living residence or comprehensive personal care home.  This waiver was issued to ensure that a sufficient number of qualified administrators are available to staff New Jersey’s assisted living facilities and comprehensive personal care homes so that the facilities can effectively address the increasing number of both staff and residents being diagnosed with or suspected of having COVID-19.  Section 8:36-3.2 has been temporarily amended to permit individuals whose Assisted Living Administration certification had become inactive within the past three years (April 1, 2017-April 1, 2020) to restore their licenses provided that they have not been disqualified, is not under an investigation by the ALA panel or other state licensing authority, does not have a suspended, revoked or restricted certification and no failed a criminal background check.  If these bars have been cleared, then the applicant must complete a 10 hour Temporary Living Administrator Program sponsored by Longtree & Associates, LLC; successfully pass a criminal background check pursuant to N.J.A.C. 8:43I-4; and pay the current Assisted Living Administrator certification fee.

This temporary rule waiver/modification, as well as any provisional certifications issued thereunder, will expire 45 days after the end of the Public Health Emergency declared by Governor Philip D. Murphy in Executive Order No. 103 (2020). After the provisional certifications issued under this subsection have expired, individuals whose Assisted Living Administrator certifications have expired will no longer be permitted to function as certified assisted living administrators. Individuals wishing to obtain full certification as an assisted living administrator will be required to successfully complete all the requirements for restoration of such certifications set forth in this section (excluding the new subsection).

  • On June 1, 2020, at 52 N.J.R. 1151(a), the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) related to the time period within which a certified medication aide candidate must sit for the medication aide exam after completing his or her medication aide training course. Pursuant to this rule waiver/modification, if a candidate’s deadline to sit for the standardized examination falls between March 1, 2020 and May 31, 2020, then the candidate shall have an additional six (6) months from the original deadline to sit for the examination. For example, if a candidate was required to sit for the examination by March 1, 2020, the deadline will be extended to August 31, 2020. The remaining provisions set forth in N.J.A.C. 8:36-9.2 shall remain in effect.

N.J.A.C. 8:36-9.2(c) requires a certified medication aide candidate to sit for the Department of Health approved standardized examination within six (6) months of successfully completing an approved medication administration training course. The standardized examinations are administered by PSI Testing Centers. In an effort to protect the community from the spread of COVID-19, PSI Testing Centers are closed and no longer administering standardized examinations. As a result, medication aide candidates that successfully completed the approved training course are not able to sit for the standardized examination within the specified time frame. Accordingly, an extension of the time period that certified medication aide candidates have to sit for the exam is warranted so that the candidates do not have to unnecessarily retake the training course to qualify for the exam and gain certification after the public health emergency concludes.

  • On June 1, 2020, at 52 N.J.R. 1151(b) the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) regarding nurse aid competency.  N.J.A.C. 8:39-43.1 sets forth certain criteria for an individual to qualify to work as a Certified Nurse Aide (CNA) in a licensed long-term care facility in New Jersey. In order to increase the number of direct care staff available to work at long-term care facilities, the Department is modifying the requirements of N.J.A.C. 8:39-43.1. Pursuant to this rule waiver/modification, Personal Care Assistants (PCA) and Certified Medical Assistants (CMA) are temporarily permitted to function in the role of a CNA in licensed long-term care facilities within New Jersey so long as the PCA or CMA meet the following conditions: (1) the CMA or PCA must complete the Temporary Nurse Aide training course at  http://educate.ahcancal.org/products/temporary-nurse-aide  prior to functioning as a CNA; (2) the facility shall provide staff a basic orientation addressing fire safety, infection control, and abuse prevention prior to allowing them to perform any duties in the facility; and (3) the facility shall maintain relevant supervision requirements for CMAs and PCAs functioning as CNAs. The remaining provisions set forth in N.J.A.C. 8:39-43.1 shall remain in effect.

Long- term care facilities that take action under the terms of this waiver/modification must also provide a written report to the Department regarding the facility’s implementation. This waiver is effective only during the period of Public Health Emergency declared by Governor Philip D. Murphy in Executive Order Nos. 103 and 119. Within 45 days after the Public Health Emergency has ended, PCAs and CMAs will no longer be permitted to function in the role of a CNA and anyone wishing to act as a CNA will be required to satisfy the competency requirements set forth in N.J.A.C. 8:39-43.1. Long- term care facilities will also be required to resume operating in accordance with all licensure standards within 45 days after the Public Health Emergency has ended.

  • On June 1, 2020 at 52 NJ.R. 1154(a) the Department of Health Commissioner issued a notice of rule wavier modification/suspension pursuant to Executive Order No. 103 (2020) related to recertification of EMTs whose certifications have expired. Pursuant to this rule waiver and modification, individuals whose EMT certification expired within the past five years (April 1, 2015 to April 1, 2020) are eligible for “COVID-19 EMT re-entry” so long as: (1) the applicant is not currently under investigation by any State EMT licensing authority; (2) the applicant does not have a proposed or final enforcement action pending or entered against him or her by any State EMT licensing authority; (3) the applicant is not excluded from acting as an EMT pursuant to a settlement reached with any State EMT licensing authority; (4) the applicant has not been cited for impersonating an EMT and/or Paramedic; (5) the applicant does not have a criminal history or pending criminal charges referenced in N.J.A.C. 8:40A-10.2; and (6) the applicant successfully completed all continuing education audits conducted by the Department while certified as an EMT. If an applicant does not fall into one of these disqualification categories, the applicant may proceed with the “COVID-19 EMT re-entry” process that is outlined in the regulations.  Upon successful completion of these requirements, the Department will issue the applicant a 6-month provisional EMT certification. To obtain full certification as an EMT, the applicant must successfully complete a New Jersey approved refresher program and achieve a passing score on the National Registry EMT-Basic Certification Examination, as set forth in N.J.A.C. 8:40A-7.6, by the end of the provisional period.  Individuals issued provisional certifications under this waiver shall only provide services as an EMT in a limited capacity as specified in the regulations.
  • On June 1, 2020, at 52 N.J.R. 1156(a) the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 8:41A-4.3, which set forth the requirements necessary for individuals to restore their paramedic certifications from inactive status to active status, pursuant to Executive Order No. 103 (2020).  Pursuant to this rule waiver and modification, individuals whose EMT-Paramedic certification was placed into inactive status within the past five years (April 15, 2015 to April 15, 2020) are eligible for the “COVID-19 EMT-Paramedic Re-Entry” so long as: (1) the applicant is not currently under investigation by any State EMT-Paramedic licensing authority; (2) the applicant does not have a proposed or final enforcement action pending or entered against him or her by any State EMT-Paramedic licensing authority; (3) the applicant is not excluded from acting as an EMT-Paramedic pursuant to a settlement reached with any State EMT-Paramedic licensing authority; (4) the applicant has not been cited for impersonating an EMT and/or EMT-Paramedic; (5) the applicant does not have a criminal history or pending criminal charges referenced in N.J.A.C. 8:41A-5.2; and (6) the applicant successfully completed all continuing education audits conducted by the Department’s Office of Emergency Medical Services (OEMS) while certified as an EMT-Paramedic and/or EMT. If an applicant does not fall into one of these disqualifying categories, then the applicant may proceed with the “COVID-19 EMT-Paramedic Re-Entry” process.  In a 2 person crew of a Mobile Intensive Care Unit, only 1 of the 2 people may possess a 6 month provisional/modified status.
  • On June 15, 2020 at 52 N.J.R. 1240(a), the Office of the Governor issued Executive Order 145 (2020) allowing elective surgeries and invasive procedures to resume on May 26, 2020.
  • On June 15, 2020 at 52 N.J.R. 1251(a), the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 8:43G-31.11 regarding the maintenance of respiratory care equipment in hospitals, pursuant to Executive Order No. 103 (2020).  The waiver is effective during the period of the Public Health Emergency declared in Executive Order No. 103 and expires forty-five (45) days after the Public Health Emergency has ended.

Pursuant to this temporary rule waiver/modification, hospitals shall perform a mechanical and electrical function test on a ventilator released from State storage or from the federal stockpile prior to placing it into service and using it for the first time. The ventilator mechanical and electrical equipment function test shall consist of the following: performance of standard preoperational checks as recommended by the manufacturer; performance of a power-on self-test; and running the ventilator for a minimum of 15 minutes. Upon successful completion of the test, the hospital shall affix a sticker indicating the date that the ventilator passed the test. Hospitals shall create and maintain records showing that each State storage or federal stockpile ventilator placed into service met these requirements prior to being placed into service.

Hospitals that take action under the terms of this waiver must also provide a written report to the Department detailing the number of ventilators placed into service and any adverse outcomes attributable to these actions.  Upon the expiration of this temporary rule waiver/modification, hospitals will be required to resume operating in accordance with all licensure standards and perform the required equipment checks and maintenance. The remaining provisions set forth in N.J.A.C. 8:43G-31.11 shall remain in effect.

  • On June 15, 2020, at 52 N.J.R. 1251(b) the Department of Health Commissioner issued a notice of rule wavier modification/suspension of N.J.A.C. 10:161B-11.10, which would permit individuals receiving opioid treatment services to receive medication that they can take at home, pursuant to Executive Order No. 103 (2020).  In order to ensure the clients of OTPs have access to needed medications, the Department is waiving the requirements of N.J.A.C. 10:161B-11.10 and permitting facilities to provide medication to clients at locations other than the location listed on their OTP facility license, in accordance with the guidance issued by the Drug Enforcement Agency (DEA078) on April 7, 2020. The intent of the guidance is to provide OTPs greater flexibility in the delivery of take-home doses of methadone to their patients. OTPs must still adhere to certain standards. Specifically, before using the unregistered off-site location, the OTP must first contact its State Opioid Treatment Authority (SOTA) and receive the SOTA’s approval to use the offsite location. Additionally, the OTP must receive approval from the local DEA field office. Once the SOTA approves the location, it should contact the local DEA field office. If the SOTA does not contact the DEA field office, the OTP must contact the field office itself. The facility must submit the approvals received from the SOTA and the DEA field office to the Department. Each day, the facility may only transport those take-home methadone doses to the off-site location that the facility reasonably anticipates will be delivered to clients that day. The facility cannot transport a reserve of methadone to the off-site location. Any methadone not delivered to clients at the off-site location must be returned to the facility’s DEA-registered location the same day. No methadone may be stored at the off-site location when a facility staff member is not present

All OTPs that take action under the terms of N.J.A.C. 10:161B-11.10 shall provide a written report to the Department detailing the extent to which the facility implemented the terms of this waiver/modification and any adverse outcomes attributable to such implementation. OTPs may operate under the terms of this waiver/modification as necessary until the conclusion of the public health emergency declared by Governor Philip D. Murphy in Executive Order Nos. 103. Upon the conclusion of the public health emergency, OTP facilities will be required to resume determining eligibility for take-home medication under the criteria set forth in N.J.A.C. 10:161B-11.10(a).

  • On June 15, 2020, at 52 N.J.R. 1253(a) the Department of Human Services Commissioner issued a notice of rule waiver modification/suspension of certain rules at N.J.A.C. 10:51-1.25(j)(3), N.J.A.C.10:167A-1.27(j)(4) and N.J.A.C. 10:167C-1.25(j)(3), which require signatures by Medicaid/NJ FamilyCare, Pharmaceutical Assistance to the Aged and Disabled (PAAD) and Senior Gold beneficiaries at the time a prescription is dispensed or delivered. During the public health emergency, beneficiaries of these programs will no longer be required to provide signatures at the time a prescription is dispensed or delivered. The pharmacist must document in the patient’s profile the date the beneficiary received the prescription.
  • On June 15, 2020, at 52 N.J.R. 1287(a), the Department of Health Commissioner issued a public notice announcing the cancellation of the call for certificate of need (CN) applications for new home health agencies in accordance with the provisions of N.J.A.C. 8:42 and N.J.S.A. 26:2H-1 et seq. In accordance with N.J.A.C. 8:33-4.1(a), the next scheduled call for new home agencies will be July 1, 2022. The Department will continue to monitor the utilization and availability of home health services and, should the need arise, issue a future call for these services prior to July 1, 2022.
  • On June 15, 2020, at 52 N.J.R. 1287(b), the Department of Health Commissioner issued a public notice of postponement of  the certificate of need call for applications for home health care services in accordance with the provisions of N.J.A.C. 8:33 and N.J.S.A. 26:2H-1 et seq., scheduled for July 1, 2019, is hereby postponed.  The Department is in the process of gathering and evaluating data to determine whether there is currently a need for home health care services. Accordingly, it is necessary to delay the call for home health care services to allow the Department sufficient time to complete its evaluation of need, and to provide potential applicants and affected parties sufficient time to respond appropriately to a certificate of need call notice in the event the Department determines that a call is appropriate. If the Department proceeds with the call, then a call for home health care services will be published in an upcoming publication of the New Jersey Register, providing the necessary time for both potential applicants and interested parties to respond to the call notice. In the alternative, if the determination is made to cancel the call, then the Department will publish a cancellation notice in the New Jersey Register.
  • On June 15, 2020, at 52 N.J.R. 1247(a), the Department of Law and Public Safety, Division of Consumer Affairs, New Jersey Board of Nursing published a notice of administrative correction to the text of N.J.A.C. 13:37-7.2, pertaining to the education requirements for certification. Effective April 20, 2020, the Board deleted then-existing N.J.A.C. 13:37-7.2(b) and recodified then-existing subsections (c) and (d) as (b) and (c). (See 51 N.J.R. 922(a); 52 N.J.R. 896(a).) As part of the April 20, 2020 rulemaking, the Board inadvertently did not update the cross-reference at subsection (c) to account for the recodifications in this section. The Board is correcting that oversight to change the cross-reference at now-codified subsection (c) to refer to the “requirements of (a) and (b) above.”
© 2020 Giordano, Halleran & Ciesla, P.C. All Rights Reserved

HHS Laboratory Data Reporting Guidance for COVID-19 Testing

On June 4, 2020, the U.S. Department of Health and Human Services (HHS) issued new Laboratory Data Reporting Guidance for COVID-19 Testing (Guidance) and related Frequently Asked Questions. Under the Guidance, in addition to providing the results of COVID-19 testing, laboratories will be required to report demographic information, including the patient’s age, race, ethnicity, sex, residence zip code, and county. The Guidance further recommends reporting the patient’s name, street address, date of birth, ordering provider address, and ordering provider phone number to state and/or local public health departments, although this data would not be collected by the Centers for Disease Control and Prevention (CDC) or HHS. Data for each test completed must be submitted within 24 hours of the results being known or determined, providing public health officials with “nearly real-time data.

Reporting is required for both diagnostic and serologic testing, and the Guidance specifically includes laboratory testing that relies on home-based sample collection. Laboratories, defined to include “laboratories, non-laboratory testing locations, and other facilities or locations offering point-of-care testing or in-home testing related to SARS-CoV-2,” must comply with the new requirements by Aug. 1, 2020. The Guidance specifies that reporting should be made through existing channels to state or local public health departments that will, in turn, submit de-identified data to the CDC.

According to HHS, “[t]he new reporting requirements will provide information needed to better monitor disease incidence and trends by initiating epidemiologic case investigations, assisting with contact tracing, assessing availability and use of testing resources, and anticipating potential supply chain issues.” HHS also indicated that the requirements may help officials understand and address disproportionate impacts of COVID-19 on certain demographic groups and ensure equitable access to testing.

Although this reporting requirement is being imposed by HHS, it is unclear what impact the new data may have at a national level. Under HHS’s COVID-19 Strategic Testing Plan issued on May 24, 2020, states are largely responsible for developing and implementing their own COVID-19 testing strategies.


©2020 Greenberg Traurig, LLP. All rights reserved.

For more on COVID-19 testing, see the National Law Review Coronavirus News section.

COVID-19 Daily Self Screening Video

Daily self-screening is one of the simplest ways to help stop the spread of COVID-19. Designed to educate employees, COVID-19 Daily Self-Screening video provides an overview of symptoms and steps a staff member can take to help break the chain of transmission, if they do get sick. Part of a series aimed at supporting a “Work Together, Healthy Together” workplace health and safety program, our videos are intended to be shared with you workforce. In connection with Polsinelli’s efforts to provide resources and support to businesses in our own communities and beyond, we hope you and your team find this valuable.


© Polsinelli PC, Polsinelli LLP in California

The CDC Warns Against Using Antibody Testing Results to Make Workplace Decisions

This week, the Centers for Disease Control and Prevention (the “CDC”) released interim guidelines addressing COVID-19 antibody testing. The CDC expressed concerns about the current accuracy of antibody testing and advised businesses against using the results of antibody testing (also known as serologic testing) to make any decisions about returning workers to the workplace.

Although the guidance notes that antibodies may offer some protection from reinfection and may decrease the likelihood that an individual infects others, the CDC has determined that there are myriad issues with the effectiveness of current antibody testing, including widespread false positive results. The CDC guidance states that “additional data are needed before modifying public health recommendations based on [antibody] test results, including decisions on discontinuing physical distancing and using personal protective equipment.” The CDC also recommends that even if individuals have tested positive for COVID-19 antibodies, they should continue to take precautionary measures (such as wearing facemasks) to prevent the spread of infection.

As the U.S. Equal Employment Opportunity Commission (“EEOC”) has not weighed in on this issue to date, it is still unclear whether employers’ use of antibody testing to inform workplace return decisions might implicate the Americans with Disabilities Act (“ADA”) or other discrimination laws.  But given the direct affirmative guidance from the CDC, employers should continue to refrain from using antibody or serologic testing results to determine which workers may return to the workplace.


©1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

ARTICLE BY Corbin Carter at Mintz.
For more CDC Guidance, see the National Law Review Coronavirus News section.

CARES Act Provider Relief Fund – Acceptance of Funds Comes with Conditions

Healthcare providers are among those financially adversely affected by the COVID-19 pandemic.

survey conducted by the Medical Group Managers Association (“MGMA”) on April 7 and 8, 2020, found that 97% of medical practices have experienced a negative financial impact directly or indirectly related to COVID-19.  MGMA also indicates that, on average, practices report a 55% decrease in revenue and a 60% decrease in patient volume since the beginning of the COVID-19 crisis.

In response to the financial impact on healthcare providers, the Coronavirus Aid, Relief, and Economic Security (“CARES”) Act, signed into law on March 27, 2020, appropriated $100 billion in relief funds to hospitals and other healthcare providers under the Public Health and Social Services Emergency Fund, also called the “CARES Act Provider Relief Fund.” On April 10, 2020, the United States Department of Health and Human Services (“HHS”) released the initial terms and conditions related to the distribution of the initial $30 billion of the $100 billion.  Rather than await the submission of applications by healthcare providers, HHS has begun a rapid delivery of relief funding to healthcare providers and suppliers that are enrolled in Medicare and received Medicare fee-for-service reimbursement in 2019.  These eligible healthcare providers are being allotted a portion of the initial $30 billion distribution based upon their proportionate share of the approximately $484 billion of Medicare fee-for-service reimbursements made in 2019.

Healthcare providers identified as eligible to receive funds from this first distribution should have received an email to that effect.  Eligible healthcare providers have begun receiving payments via the Automated Clearing House account information on file used for reimbursements from The Centers for Medicare and Medicaid Services (“CMS”).  Healthcare providers that normally receive a paper check for reimbursement from CMS will receive a paper check in the mail.

These payments are not loans and, if used consistent with the applicable terms and conditions, will not need to be repaid.  Healthcare providers must sign an attestation confirming receipt of the funds and agreeing to the terms and conditions of payment within 30 days via the online payment portal.  Should a healthcare provider choose to reject the funds, the healthcare provider within 30 days of receipt of payment must complete the attestation to indicate this and remit the full payment to HHS.  The portal will guide the healthcare provider through the attestation process to accept or reject the funds.

The healthcare provider is required to certify, among other things, that it provides or provided after January 31, 2020 diagnoses, testing, or care for individuals with possible or actual cases of COVID-19.  In a recent update, HHS clarified that to meet this requirement, care does not have to be specific to treating COVID-19, as “HHS broadly views every patient as a possible case of COVID-19.” HHS also clarified that a healthcare provider’s eligibility is not adversely affected if it ceased operations as a result of the COVID-19 pandemic, so long as the healthcare provider provided diagnoses, testing, or care for individuals with possible or actual cases of COVID-19.

In addition to imposing use restrictions for the funds and recordkeeping requirements, the CARES Act authorizes the HHS Office of Inspector General (“OIG”) to audit both interim and final payments made under the program.  Healthcare providers that elect to accept the funds must be prepared to submit to these OIG audits.  Because the funds are limited to necessary expenses or lost revenues due to the pandemic not otherwise reimbursable from other sources, there may be differences in OIG’s interpretation of whether the funds were used for an appropriate purpose.  At a minimum, this may necessitate returning certain disallowed funds following an audit.

Failure to abide by the terms and conditions could result in False Claims Act liability for healthcare providers that do not make proper use of the funds.  Thus, recipients of the funds should carefully consider their ability to comply with the terms and conditions and should ensure that proper controls are in place for proper use of the funds.


© 2020 Ward and Smith, P.A.. All Rights Reserved.

For more on CARES Act funding, see the Coronavirus News section of the National Law Review.

Price Gouging and Deceptive Advertising Practices Amidst COVID-19 Pandemic

The Federal Trade Commission, the Food and Drug Administration and state Attorneys General have bumped the protection of consumers in the midst of the COVID-19 crisis to the top of their respective lists, including, but not limited to, price gouging and unsubstantiated product efficacy claims.  The U.S. Department of Justice has also issued a broad mandate regarding criminal enforcement of deceptive, fraudulent and predatory practices.

 State Attorneys General

State Attorney General have actively been policing the advertising of claims related to products that purport to cure, treat or prevent COVID-19.  This includes both express and implied claims (e.g., immunity-based claims).

Currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter products to treat or cure.

By way of example, a group of thirty-two state attorneys general recently sent letters to executives at prominent online retailers, urging them to help police price gouging.  Additionally, the New York Attorney General has asked GoDaddy and other online registrars to halt and de-list domain names used for Coronavirus-related scams and fake remedies designed to unlawfully and fraudulently profit off consumers’ fears around the coronavirus disease.

The NY AG has also recently contacted Craigslist.com, calling on the company to immediately remove posts that attempt to price gouge users, or otherwise purport to sell items that provide “immunity” to the coronavirus or allow individuals to test for the disease.  For example, the AG’s letter referred to posts that promoted an “immunity pack,” a fake coronavirus testing kit, and face masks that are not even proven to provide coronavirus-related protection.  The AG also asked Craigslist to remove an advertisement for a bottle of Purell that was priced at over $200.

Price gouging on disinfectant products is also a priority.

State AGs and other federal agencies are actively investigating potential price gouging violations, filing enforcement lawsuits, issuing civil investigative demands (CIDs), and serving cease-and-desist warnings.  The NYC Department of Consumer and Worker Protection (DCWP) – formerly the New York City Department of Consumer Affairs (DCA) – has also been policing local business that it believes are selling necessary products (e.g., cleaning products, diagnostic products and services, disinfectants [wipes, liquids, sprays], face masks, gloves, hand sanitizers, medicines, paper towels, rubbing alcohol, soap, tissues and basic food supplies).

The State of New York’s price gouging statute prohibits the sale of goods and services necessary for the health, safety and welfare of consumers at unconscionably excessive prices during any abnormal disruption of the market.  During any abnormal disruption of the market for consumer goods and services vital and necessary for the health, safety and welfare of consumers, no party within the chain of distribution of such consumer goods or services or both shall sell or offer to sell any such goods or services or both for an amount which represents an unconscionably excessive price.

In the State of New York, whether a price is unconscionably excessive is a question of law for the court.  The court’s determination that a violation has occurred shall be based on any of the following factors:  (i) that the amount of the excess in price is unconscionably extreme;  or (ii) that there was an exercise of unfair leverage or unconscionable means;  or (iii) a combination of both factors in subparagraphs (i) and (ii).

Proof that a violation of has occurred can include, for example, evidence that:  (i) the amount charged represents a gross disparity between the price of the goods or services which were the subject of the transaction and their value measured by the price at which such consumer goods or services were sold or offered for sale by the defendant in the usual course of business immediately prior to the onset of the abnormal disruption of the market; or (ii) the amount charged grossly exceeded the price at which the same or similar goods or services were readily obtainable by other consumers in the trade area.  A defendant may be able to rebut such evidence by establishing that additional costs not within its control were imposed on the defendant for the goods or services.

Where a violation is alleged to have occurred, the AG may seek an injunctions, civil penalties and restitution.

Under the Rules of the City of New York, stores are prohibited from selling items that have been declared in short supply at excessively increased prices.  NYC has recently issued an emergency rule prohibiting price increases above 10% on various products necessary to combat the coronavirus.  New York State has now proposed legislation concerning medical supplies that includes a presumption that a price exceeding 10% of its price immediately prior to a public health emergency is to be considered unconscionably excessive.

Other states also utilize percentage-drive formulas when assessing excessive or unconscionable price increases, such as, without limitation, Arkansas, Florida, Michigan, Missouri, New Jersey, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, West Virginia, and Wisconsin.  Some states impose liability upon manufacturers and distributors.  Some states also impose civil fines and penalties for violations, in addition to potential criminal liability.

Any entity charged with price gouging during a public health emergency would be entitled to rebut an alleged violation of this new law with evidence that the additional costs not within the control of the defendant were imposed on the defendant for the consumer medical supplies.

FTC and FDA

The Federal Trade Commission and the Food and Drug Administration recently announced that it has issued joint warning letters to companies that allegedly had been disseminating unsubstantiated product advertising claims related to the coronavirus.  The letters cite efficacy claims that are not supported by competent and reliable scientific evidence, as well as issues relating to unapproved and misbranded drugs.

On March 26, 2020, FTC lawyer and Chairman Joe Simons issued a statement setting forth the agency’s enforcement efforts to protect consumers from unfair and deceptive commercial practices and to educate the public.  The FTC “will not tolerate businesses seeking to take advantage of consumers’ concerns and fears regarding coronavirus disease, exigent circumstances, or financial distress,” FTC lawyer Simons stated.

The FTC has also issued a press release calling attention to business-to-business scams that seek to exploit companies’ concerns about COVID-19, and sent letters to VoIP service providers and other companies warning them that “assisting and facilitating” illegal telemarketing or robocalls related to the coronavirus or COVID-19 pandemic is against the law.

“It’s never good business for VoIP providers and others to help telemarketers make illegal robocalls that scam people,” said FTC attorney Andrew Smith, Bureau of Consumer Protection Director.  “But it’s especially bad when your company is helping telemarketers exploiting fears about the coronavirus to spread disinformation and perpetrate scams,” Smith stated.

Department of Justice

The U.S. DoJ has issued a broad mandate with respect coronavirus-related fraud, price gouging and product hoarding.  In fact, it recently filed a number of federal criminal actions to combat fraud and other offenses related to the coronavirus pandemic.

Two of the actions were filed in California.  One involving allegations that an individual solicited investments in a company he claimed would be used to market pills that would prevent coronavirus infections, as well as market an injectable cure for those who had already contracted the virus.  The other, involving allegations that an individual mislabeled drugs that were purported to be a miracle cure for COVID-19.

Another two actions were filed in New Jersey.  One involving charges of violating the federal Anti-Kickback Statute and conspiracy to commit health care fraud.  The other, involving allegations of assault resulting from an individual who represented to have tested positive for COVID-19 that coughed on FBI agents, lied to them about his accumulation and sale of surgical masks, medical gowns and other medical supplies, and selling supplies to doctors and nurses at inflated prices.           .

The DoJ also recently filed a civil wire fraud lawsuit in a Texas federal district court against a website (coronavirusmedicalkit.com) that was purportedly offering access to bogus World Health Organization vaccines.

Digital marketers, consumer-facing businesses and others in the supply chain should consider consulting with experienced FTC defense counsel to avoid unsupported efficacy claims and inadvertently charging unlawful prices for goods and services necessary for the health, safety and welfare of consumers.


© 2020 Hinch Newman LLP

For more on FTC COVID-Actions, see the National Law Review Coronavirus News section.

The NCAA will Temporarily Allow Student-Athletes to Raise Money for COVID-19 – Here’s How They Can Protect Themselves

The NCAA will allow college student-athletes to raise money for COVID-19 related causes after some controversy over a fundraiser arranged by Clemson quarterback Trevor Lawrence. Lawrence and his girlfriend started a GoFundMe to raise money for food for those struggling during the pandemic. According to ESPN, Clemson compliance officials asked Lawrence to stop the fundraiser, believing it was violating NCAA policy around an athlete profiting from the use of their name, image and likeness. However, the NCAA released a statement that they would allow Lawrence and other student athletes to raise money related to the COVID-19 pandemic.

These types of issues may soon be a thing of the past. This month, the NCAA’s Federal and State Legislation Working Group is expected to report their recommendations on how to allow athletes to profit for the use of their name, image and likeness.

This month, the NCAA Board of Governors is receiving updated recommendations from their Federal and State Legislation Working Group after they ruled in Oct. 2019 that they would allow student athletes the opportunity to profit for the use of their name, image and likeness. The three divisions of the NCAA are analyzing their rules, which they must complete by January 2021.

While we wait for details, there are important topics college student-athletes should begin to understand. One critical legal issue that college student-athletes need to consider is the importance of protecting their potential intellectual property early in their athletic career. Oftentimes, college student-athletes wait to focus on their image and intellectual property until they have declared their entrance into a professional league’s draft. It is during this time period when athletes begin thinking about entering into licensing deals, developing their brand, and preparing trademarks for the commercialization of their brand and image. With the pending changes to the NCAA rules, this timeline moves up and college student-athletes and their families need to start focusing on the following intellectual property issues.

Brand and Image

Given the new stance taken by the NCAA, the development, management and protection of an athlete’s brand will be more important than ever before. With the explosion of social media over the last decade, athletes are more aware of the brand they present to the world; however, the question these athletes need to analyze is: how do they want the public to view them? The outcome of this analysis will help them understand what types of marketing and endorsement deals should they enter into and for how long.

Understanding some of the typical provisions of an endorsement deal are critical for the protection of an athlete’s brand. Does the agreement establish category exclusivity? How long is the term? What is required of the athlete? How does a particular sponsorship or endorsement deal align, or not align, with their college’s sponsorship deals? If a conflict exists, how is it addressed? All of these questions should be addressed in the written marketing agreement. Further, an athlete should to seek advice on ensuring that these provisions are addressed, and addressed in a way that protects the athlete.

Another question that athletes will have to address is whether they are being fairly compensated for the use of their name, image and likeness. Ultimately, the market will determine what it is willing to pay a college student athlete. The metrics for making this decision already exist through looking at social media followers, name recognition, etc. The more of a celebrity an athlete is, the more they will be able to demand in endorsement deal compensation.

Trademarks

Another aspect of the name, image and likeness discussion that will impact college student-athletes is the need to protect their intellectual property. As athletes build their brand, trademark protection might become a necessity. A trademark can range from a players own name, nickname, brand name or logo, or even slogan or phrase that they have used (e.g. NBA’s Kawhi Leonard applying for the trademark “What It Do Baby” after gaining serious popularity in memes and social media postings following the 2019 NBA Finals). A trademark filing will be important, for those student-athletes who have a name, attribute or phrase that they want to commercialize (e.g. NBA’s Anthony Davis’ registered trademark for “Fear The Brow” playing on the nickname of his eyebrows).

When a student-athlete protects his or her brand by filing for a trademark registration, it allows the athlete to stop anyone else from using their intellectual property without their permission. Additionally, thinking about a potential company that wants to use a student-athlete as an endorser, the company will need to ensure it has an appropriate license to use that student-athlete’s intellectual property in its marketing and promotions. In order to protect itself, such a company will likely require that the athlete has protected their own intellectual property.

Domain Names

One additional area of intellectual property protection that college student-athletes (even high school athletes) should understand is domain name registration. An athlete can reserve their own domain name for a minimal amount, typically $15 – $40 per year. However, if they wait too long, they may find the domain name was reserved by someone else.

Some athletes have had the domain name for their own name reserved by someone else and when trying to secure that name, the original owner tries to sell it to the athlete for sometimes tens of thousands of dollars. In 2009, Chris Bosh brought a lawsuit and won in federal court against an organization that had reserved www.ChrisBosh.com and many other athlete domain names.

The Anti-cybersquatting Consumer Protection Act (ACPA), 15 U.S.C. § 1125(d), creates a cause of action for someone registering or using a domain name confusingly similar to a trademark or personal name. The law was established to try and stop “cyber squatters” who register domain names solely with the intention of selling the domain name to the person whose name it references at a profit.

While the law provides this protection, an athlete has to determine whether filing a lawsuit is worth the time and expense to get the domain name back. Oftentimes an athlete will simply use an alternate domain name, an uncommon top-level domain or create their own top-level domain. The lesson here is that athletes, at all levels, should register their name as their domain name in order to avoid these challenges.

Conclusion

While athletes like Trevor Lawrence have the temporary approval to fundraise during the COVID-19 crisis, profiting or from their name, image and likeness will become a reality for all student athletes over the next year. Athletes must protect themselves and ensure they take the appropriate precautions to protect their intellectual property.


© 2020 Porter Wright Morris & Arthur LLP All Rights Reserved.

CARES Act Brings Changes to Federal Substance Use Disorder Privacy Law

The Coronavirus Aid, Relief, and Economic Security Act (CARES Act), enacted March 27, 2020, rewrote significant portions of 42 U.S.C. § 290dd-2, the federal statute governing the confidentiality of substance use disorder (SUD) records that is more commonly known by its implementing regulations at 42 C.F.R. Part 2 (Part 2). Among other changes, the CARES Act revises the permissible uses and disclosures of SUD records to more closely align with the HIPAA Privacy Rule, 45 C.F.R. § 164.500, et seq., when a Part 2 program obtains the patient’s prior written consent.

Historically, Part 2 programs have been restricted in their ability to share SUD records by the Part 2 regulations, which require written patient consent for each disclosure of SUD records and prohibit re-disclosure of such SUD records except in limited circumstances. The CARES Act directs the Secretary of the U.S. Department of Health and Human Services (HHS), in consultation with appropriate federal agencies (which may include the Substance Abuse and Mental Health Services Administration (SAMHSA)) to revise the Part 2 regulations as necessary to implement and enforce the statutory revisions contained in the CARES Act effective March 27, 2021. The forthcoming revisions to the Part 2 regulations may be substantial given these CARES Act changes to the federal statute.

Another significant change to the federal SUD confidentiality statute addresses the ability of health care providers to use SUD records for treatment, payment, and health care operations purposes (except for certain provider fundraising activities) in a manner more consistent with the allowances provided for protected health information under HIPAA. Specifically, the CARES Act authorizes a Covered Entity or Business Associate (as those terms are defined in the HIPAA Privacy Rule) or Part 2 Program (as defined by the Part 2 regulations) to use, disclose, or re-disclose SUD records with the patient’s written consent for treatment, payment, and health care operations as permitted by the HIPAA regulations, 45 C.F.R. Parts 160, 162, and 164, and Sections 13405(a) and (c) of the Health Information Technology and Clinical Health Act (42 U.S.C. § 17935(c)) (HITECH Act). Under the revised statute, a patient can provide written consent once that will then authorize all such future uses or disclosures for purposes of treatment, payment, and health care operations until such time as the patient revokes such consent in writing.

Additionally, the CARES Act incorporates the following privacy protections for SUD records:

  • Except as otherwise authorized by court order or by written patient consent, SUD records or testimony relaying information from the SUD records may not be disclosed or used in any civil, criminal, administrative, or legislative proceedings conducted by any federal, state, or local authority.
  • Penalties applicable to HIPAA violations (42 U.S.C. §§ 1320d-5 and 6) shall apply to a violation of 42 U.S.C. § 290dd-2.
  • The breach notification provisions of Section 13402 of the HITECH Act shall apply to SUD records.
  • By March 27, 2021, HHS will update the HIPAA Privacy Rule to require that Part 2 programs provide notice of privacy practices, written in plain language, describing the patient’s rights with respect to the Part 2 records and how the patient may exercise those rights, and describing each purpose for which the Part 2 program is permitted or required to use or disclose the SUD records without the patient’s written authorization.
  • Part 2 providers can disclose information, regardless of whether the patient gives written consent, to a public health authority (as defined by HIPAA), if the content is de-identified in accordance with the HIPAA de-identification standards set forth at 45 C.F.R. § 164.514(b).
  • Patients shall have the right to request a restriction on the use or disclosure of SUD records for treatment, payment, or health care operations.
  • Patients shall have the right to request an accounting of disclosures of SUD records consistent with the HITECH Act and HIPAA.
  • Entities shall be prohibited from discriminating against an individual on the basis of information received, whether intentionally or inadvertently, from SUD records in: (a) admission, access to, or treatment for health care; (b) hiring, firing, or terms of employment, or receipt of worker’s compensation; (c) the sale, rental, or continued rental of housing; (d) access to federal, state, or local courts; or (e) access to, approval of, or maintenance of social services and benefits provided or funded by federal, state, or local governments.
  • Recipients of federal funds shall be prohibited from discriminating against an individual on the basis of information received, whether intentionally or inadvertently, from SUD records, when offering access to services provided with such funds.

The CARES Act provides that the above-summarized amendments to the federal SUD statute will apply to uses and disclosures of information on or after March 27, 2021. While these changes implement long-awaited alignment efforts to enable data sharing across providers in a manner consistent with the allowances permitted under HIPAA, the real impact of these changes will come from the forthcoming implementing agency regulations from, which are also due to be issued by March 27, 2021.


©2020 Greenberg Traurig, LLP. All rights reserved.