A young man using his laptop to video chat with his doctor through telehealth

Telehealth Law & COVID-19: Changes To Look Out for in 2021

Telehealth and telemedicine have been on the rise over the past decade for those in the healthcare industry. As technology improves, more patients opt for remote medical care to alleviate the costs and inconveniences associated with in-person care. 

Recently, this area of medical services has received a metaphorical shot in the arm because of the global coronavirus pandemic, leading to increased patient volume and legal complexity in this budding area of medicine. 

This influx of change affects not only the care side of telehealth but also the legal rules and regulations that guide the trajectory of telemedicine as a whole. Our firm—which has built a niche in healthcare law—is closely monitoring how the pandemic has acted as a catalyst for change in this area of medical care. 

In this blog, we will address some of the more recent changes on the legal side of telehealth on a state and federal level and speculate on future changes. 

A Snapshot of Telemedicine in the U.S. 

Over the past five years, the number of telehealth services has increased by almost 10% per year. Records show that between 2010-2017, there was a nearly 50% boost in hospitals that utilize telehealth services and communication. 

As of now, over 75% of U.S. hospitals are using telehealth services to connect with patients and practitioners. Medicaid programs now have some form of coverage for these services. However, it has lagged behind other payers due to the limits on coverage and payment for telehealth services. These limitations have slowed how efficient telehealth technology has evolved. This, along with the challenge of many practitioners needing cross-state licenses, continues to be an overall disruption in progress. This has led to a significant push for the government to open up more and increase the use of telehealth. 

Telemedicine in the Age of COVID 

Since COVID hit, there has been a dramatic spike in telehealth usage. It’s proven that practitioners can diagnose and help patients while conserving medical supplies and reduce the strain on office and facility capacity. 

As our current global pandemic continues, practitioners have pushed to maintain the expansion of telehealth services. Practitioners who have expected telehealth to decrease have cited that coverage concerns and patients wanting in-person visits now that a vaccine is being administered are the primary causes. 

The Impact Of The Pandemic On Telehealth Regulations in 2020

At the beginning of the global pandemic, we saw a flurry of telehealth and telemedicine laws being passed to provide immediate relief for both patients and medical providers. One such bill, named the Telehealth Modernization Act, aimed to do the following: 

  • Remove geographic and originating site restrictions from Medicare coverage of telehealth services;
  • Ensure that Medicare covers telehealth services at federally qualified health centers (FQHCs) and rural health clinics (RHCs);
  • Give the Health and Human Services Secretary the authority to permanently expand the types of telehealth services covered by Medicare (the list now stands at 135) and the types of care providers who able to deliver those services; and
  • Enable Medicare to cover more telehealth services used for hospice and home dialysis care.

The bill was supposed to be a three-pronged approach to improve the healthcare landscape. This bill joined a flurry of other bills in 2020 that all aimed to make telehealth services more affordable and accessible to millions who may need them. 

Predictions For The Future Of Telehealth Legislation

As the healthcare landscape continues to shift around the pandemic and improving technology, we can expect to see more legislation addressing telemedicine and telehealth. 

Given how there was a significant expansion of Medicare and Medicaid coverage in the realm of telemedicine and telehealth, it may be helpful to try to chart the trajectory of the field for 2021 and beyond. 

Judging by legislation proposed in 2020 and earlier this year, we can make a few educated predictions about how this area of medicine will continue to evolve. 

Reducing Barriers To Care

At the onset of the coronavirus pandemic, legislators looked to reduce the barriers to care for practitioners and patients. States offered temporary waivers to suspend medical licensing requirements, which allowed practitioners to deliver services across state lines. We could see some states attempt to make these permanent to keep the barriers to care low. 

In 2020, we already saw bills advance like the Telehealth Expansion Act of 2020, the Advancing Telehealth Beyond COVID-19 Act, and the Protecting Access to Post-COVID-19 Telehealth Act that attempt to make key changes permanent. 

As with most things, reducing barriers has led to some pushback from traditional practitioners who may be invested in conventional licensing requirements. Legislators in many states are currently weighing the pros and cons of loosening the barriers, with many leaning towards loosening them in the face of a drastically-altered healthcare landscape. We can expect to see an increase in lobbying efforts from both sides of this issue in the coming years. 

A Focus On Privacy 

The issue of privacy is one that Congress has been grappling with since the technology boom of the 90s. The world of telehealth is no exception to this, with some companies coming under fire over the years for mishandling patient information. We could expect to see substantial changes to HIPAA laws and state consumer privacy laws to reflect the changing healthcare climate. On both the state and federal levels, we can expect the introduction of robust privacy laws and enhanced enforcement by the FCC. 

Technology-Neutral State Laws

At the onset of the coronavirus pandemic, many prior laws surrounding allowable modalities, practice standards, and other aspects of telehealth were relaxed to aid patients and medical professionals. One consequence of these temporary changes was that telehealth was allowed to focus more on quality of care than modalities of care delivery. Given the generally positive reaction to these changes, we may see legislation that continues towards technology-neutral telehealth laws. 

Stay Up-To-Date With Weiss Zarett!

As a firm with decades of experience in healthcare law, we make it a point to keep up with the rapid pace of changes in telehealth and telemedicine. Our attorneys keep a close eye on developments on a state and federal level so we can best guide our clients. 

To learn more about our services or how your practice may be affected by this changing landscape, contact us today to speak with an attorney! 

Compliance Concerns Rise as Information Blocking Rules Become Fully Mandatory

By Mathew J. Levy, Esq. & Zoila Sanchez, J.D., M.P.H.

Health care providers constantly strive to do what is best for the patient. However, sometimes a practice’s policies and procedures may unintentionally fall short of this goal. For example, when a patient experiences challenges accessing his/her laboratory results and must wait until her physician has had a chance to review, this delaying of access could be considered preventing patient access to their own electronic health information (EHI). As a result, the provider may fall out of compliance with a new fully enforced rule on “Information Blocking.” 

Information Blocking is the interference with access, exchange, or use of EHI which can occur, for example, by a delayed lab result to a patient as illustrated above or charging excessive fees for patients to obtain their own records. The purpose of the regulation by the Office of the National Coordinator for Health Information Technology (ONC), is to promote patient control over their own health information by improving the facilitation of electronic access, exchange, and use of health information.

While the ONC information blocking regulations have been in full effect since April 5, 2021, many physicians, healthcare IT developers, and health information networks, are reportedly unprepared. In fact, a recent survey by Life Image, a health care interoperability company, discovered that most clinical, technology, and administrative healthcare leaders are unprepared to comply with the rule’s prohibition on information blocking. While 70% of participants reported to awareness of the rule, 50% of participants are reportedly unaware of the practices that constitute information blocking with reports of engaging in noncompliant practices such as sharing paper records or sharing records on CDs. Almost half of the participants responded that they either had not made any changes or did not know how to meet the requirements.  

Most concerning is that of those surveyed, 39% were unaware that noncompliance with information blocking practices could result in civil monetary penalties. OIG recently proposed that noncompliance with the rule could face penalties of up to $1 million. These penalties are significant, and it is imperative for providers to focus their attention on (1) understanding the requirements and exceptions (2) having a compliance program in place that integrates the rules into your practice and (3) maintaining your compliance program. New York no longer permits a per page copying charge when producing electronic records per patient request– providers can only charge for the time it takes to retrieve the record from its server which is usually de minimus. A reference for you to review related to this topic is “21st Century Cures Act Has Taken Effect” and “Understanding Compliance.”

About the Authors: 

Mathew J. Levy is a Partner of the firm and co-chairs the Firm’s corporate transaction and healthcare regulatory practice. Mr. Levy has extensive experience in, defending healthcare professionals in actions brought by State licensing authorities and the Federal agencies (OIG, Medicare, OMIG, Medicaid, DEA, OSHA, OCR OSHA, Hospital Review Boards, Office of Professional Medical Conduct and Office of Professional Discipline.) Mr. Levy has successfully defended numerous healthcare providers in actions involving the US Attorney’s Office investigations, Medicare Fraud Waste and Abuse investigations, Medicaid Fraud Control Unit investigations, OPMC, OPD, Medicare, Medicaid as well as commercial insurance audits including Prepayment Review, Post Payment Review, Medicare Hearings and Hospital Discipline Investigations.

Mr. Levy has successfully structured and negotiated joint venture agreements, private equity transactions, venture capital transactions, stock purchase agreements, asset sale agreements, shareholders agreements, partnership agreements, employment contracts, managed care agreements and commercial leases. Among the areas in which he focuses are coordinating mergers and acquisitions, compliance programs, ambulatory surgery centers, the establishment of diagnostic and treatment centers, HIPAA privacy regulations, fee-splitting issues, Stark law issues, fraud and abuse rules and regulations and Medicare/ Medicaid, Oxford, Americhoice, Fidelis, Healthfirst and other third-party payor settlements.

Zoila Sanchez, J.D., M.P.H. joined the Firm full-time upon graduating with her Juris Doctor degree from the Maurice A. Deane School of Law at Hofstra University. During law school, Ms. Sanchez served as a Legal Clerk with the U.S. Department of Health and Human Services Office of Counsel to the Inspector General in Washington, DC, where her work focused on health care fraud and abuse. Ms. Sanchez has experience in supporting the Firm’s business and health care law, and litigation practice areas. 

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES. 

Ambulatory Surgery Centers As Investments

By Mathew J. Levy, Esq. and Mauro Viskovic, Esq

Investments in ambulatory surgery centers (“ASC”) appear to be on the rise. On April 29, 2021, the Office of Inspector General (“OIG”) posted an important advisory opinion¹ in which it concluded that a specific investment in an ASC by certain medical providers would not result in sanctions under the Anti-Kickback Statute (“AKS”)².

The transaction at issue involved a health system, individual surgeons and a medical management company that wished to invest in an ASC. As a general matter, AKS prohibits medical providers from paying or receiving kickbacks, remuneration, or anything of value in exchange for referrals of patients who will receive treatment paid for by government healthcare programs such as Medicare and Medicaid, and from entering into certain kinds of financial relationships.  As such, AKS would be a potential impediment to the contemplated investment because the offer or payment of investment returns from an ASC to an investor constitutes remuneration under AKS.      

In concluding that the transaction would not result in sanctions under AKS, the OIG cited numerous factors mitigating the risk that the investment returns to the medical providers would be problematic under AKS, including the following factors:

  • All ASC investors would invest directly in the ASC.  That is, no investor would hold any ownership through a pass-through entity, which could be used to redirect revenues to reward referrals or otherwise erode the safeguards provided by direct investment.
  • The management company certified that it would not make or influence referrals, directly or indirectly, to the surgeon investors or to the new ASC; and (ii) no surgeon investor has or would have ownership in the management company.
  • The health system certified that the surgeon investors would use the new ambulatory surgery center on a “regular basis” as part of their medical practices. In referring to this aspect, it is interesting to note that OIG concluded the surgeon investors would fail to meet the hospital-physician ASC safe harbor provision requirement that a physician investor derive at least one-third of his or her medical practice income for the previous fiscal year or previous 12-month period from the performance of ASC-qualified procedures.
  • The contemplated arrangement would contain certain safeguards to reduce the risk that the health system would make or influence referrals to the ASC or the surgeon investors. For example, the health system certified that any compensation paid by the health system to its affiliated physicians for services furnished would be consistent with fair market value and would not be related, directly or indirectly, to the volume or value of referrals such affiliated physicians may make to the ASC or its surgeon investors. In addition, the health system certified that it would refrain from any action to require or encourage its affiliated physicians to refer patients to the ASC or to its surgeon investors and would not track referrals made to the ASC by its affiliated physicians.
  • Neither the ASC, nor any investor, would loan funds to or guarantee a loan for any investor to obtain ownership in the ASC. The ASC would not offer ownership to any party based on the previous or expected volume or value of referrals made. In addition, capital contributions and profit distributions would be made in proportion to an investor’s ownership in the ASC. 
  • Certain safeguards would be implemented to reduce the risk that the ASC’s investors would receive profit distributions for referrals of patients to the ASC. The health system certified that any space or equipment leased by the ASC from the health system or an affiliated real estate company would comply with AKS safe harbors for space rental and equipment rental, as applicable, and any services performed by the health system or the real estate company for the ASC would comply with the safe harbor for personal services and management contracts and outcomes-based payments. 
  • Additional safeguards would be adopted that are designed to reduce fraud and abuse risks (e.g., improper billing). The ASC, the health system, the surgeon investors, and the management company would treat patients receiving medical benefits or assistance under any Federal health care program in a nondiscriminatory manner. Further, the health system certified that all ancillary services provided to Federal health care program beneficiaries performed at the ASC would be related directly and integrally to primary procedures performed at the ASC and would not be billed separately to Medicare or any Federal health care program. The health system also certified that it would not include on any cost report or any claim for payment from a Federal health care program any costs associated with the ASC, unless such costs are required to be included by a Federal health care program.
  • The ASC and its investors would provide written notice to patients referred by ASC investors to the ASC of the referral source’s investment interest in the ASC.

This OIG Advisory Opinion provides helpful guidance for analyzing the AKS implications of a contemplated ASC investment by a medical provider.  It is critical to note, however, that the advisory opinion is limited in scope to the specific arrangement described therein, has no applicability to any other arrangements, and cannot be relied on by other parties.

Should you have any questions regarding the structuring of investments in ambulatory surgery centers, please contact Mathew Levy at 516-926-3320 or MLevy@weisszarett.com.

About the Authors: 

Mathew J. Levy is a Partner of the firm and co-chairs the Firm’s corporate transaction and healthcare regulatory practice. Mr. Levy has extensive experience in, defending healthcare professionals in actions brought by State licensing authorities and the Federal agencies (OIG, Medicare, OMIG, Medicaid, DEA, OSHA, OCR OSHA, Hospital Review Boards, Office of Professional Medical Conduct and Office of Professional Discipline.) Mr. Levy has successfully defended numerous healthcare providers in actions involving the US Attorney’s Office investigations, Medicare Fraud Waste and Abuse investigations, Medicaid Fraud Control Unit investigations, OPMC, OPD, Medicare, Medicaid as well as commercial insurance audits including Prepayment Review, Post Payment Review, Medicare Hearings and Hospital Discipline Investigations.

Mr. Levy has successfully structured and negotiated joint venture agreements, private equity transactions, venture capital transactions, stock purchase agreements, asset sale agreements, shareholders agreements, partnership agreements, employment contracts, managed care agreements and commercial leases. Among the areas in which he focuses are coordinating mergers and acquisitions, compliance programs, ambulatory surgery centers, the establishment of diagnostic and treatment centers, HIPAA privacy regulations, fee-splitting issues, Stark law issues, fraud and abuse rules and regulations and Medicare/ Medicaid, Oxford, Americhoice, Fidelis, Healthfirst and other third-party payor settlements.

Mauro Viskovic is a Partner in the Firm’s corporate and transactions practice group, where he focuses on providing high quality and cost-effective solutions to clients’ legal matters.  He represents entrepreneurs through all stages of their ventures’ development, including advice on structure, initial company formation and organization, private financings, commercial transactions, mergers and acquisitions and liquidity events.  In addition, Mauro represents investors in all aspects of corporate finance transactions and also focuses his practice on the representation of private investment fund advisers and portfolio managers

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

¹OIG Advisory Opinion 21-02.
²42 USC § 1320a-7b(b).

PODCAST: WHEN THE DOCTOR MIGHT NEED A LAWYER WITH MATT LEVY.

More than 70% of medical practices are committing healthcare fraud, but they are not all criminals. According to healthcare attorney Mathew J. Levy, Esq., Shareholder and Director of Weiss Zarett Brofman Sonnenklar & Levy, PC and co-chair of the Firm’s corporate transaction and healthcare regulatory practice, many providers are simply using out of date codes, or may have been flagged by an insurance company algorithm because their billing practices are outside of the statistical norm. When does a practice need outside legal assistance? Mr. Levy breaks down a few common scenarios and offers valuable advice. 

To listen to the podcast, click here. Should you have any questions or comments, you can reach Mr. Levy at mlevy@weisszarett.com and 516-926-3320.

Adult-Use Cannabis Now Legal in New York

By Stacey Lipitz Marder, Esq.


A summary of the key provisions of the new law is set forth below.

Office of Cannabis Management:

The new law establishes the Office of Cannabis Management (OCM), which will be part of the New York State Liquor Authority. The OCM will be responsible in crafting and overseeing the corresponding regulations covering medical, adult-use, and cannabinoid hemp. 

On March 31, 2021, the highly anticipated Marihuana Regulation and Taxation Act (S.854-A/A.1248-A) was signed into law by Governor Andrew Cuomo, adding New York to the list of states where adult use of cannabis is legal. It is unclear when dispensaries will open and sales will begin, although there has been speculation that this will not occur until at least 2022. The cannabis market is expected to be incredibly lucrative and provide lots of new opportunities. 

Licenses:

As per the law, licenses will be issued for growers, distributors, and retailers. Microbusinesses will be allowed to be vertically integrated, although the criteria for a microbusiness has not yet been established. The law also sets a goal whereby 50% of licenses will be issued to social equity applicants, including those individuals disproportionately impacted by cannabis enforcement, minority and women-owned businesses, financially distressed farmers, and service-disabled veterans. Cities, towns, and villages may opt-out of allowing dispensaries and will have until the end of the year (December 31, 2021) to do so. 

Existing Medical Marijuana Business:

The new law will also expand New York’s existing medical marijuana program in order to make it less restrictive. For instance, additional medical conditions will be covered, patients will not be restricted from smoking medical marijuana, the current supply cap will be increased, and home cultivation for medical cannabis patients will be permitted. Furthermore, medical marijuana companies will be able to add additional sites where they can operate (provided certain conditions are met), as well as apply for recreational licenses.  

Taxes:

Due to the significant economic opportunities associated with the new legalization, it is anticipated that tax collections from the adult-use cannabis program will reach $350 million annually. The legislation establishes a 13% sales tax; 9% of which is allocated to the state, and 4% to localities. In addition, distributors would collect an excise tax based on THC content. The taxes already imposed on marijuana sold for medical purposes will remain unchanged.

Traffic Safety:

The legislation also includes additional funding for drug recognition experts and law enforcement to ensure safe roadways. The Department of Health has been tasked with studying devices that determine if a person is impaired from marijuana. The use of cannabis by drivers will remain prohibited and will be subject to the penalties currently in effect. 

Personal Possession and Home Cultivation:

Although legal, the new law sets limits with respect to the amount of cannabis that can be grown at home and personal possession of cannabis outside the home. Six plants may be cultivated for personal use, provided only three are mature at a time. Adults are now permitted to possess up to three ounces of cannabis for recreational use or twenty-four grams of concentrated cannabis.

Criminal Justice and Record Expungement:

Under the new law, the records of people previously convicted of crimes relating to cannabis that would now be legal will be expunged. Reduced penalties will also be implemented for possession and sale.

Public Health:

As per the new legislation, OCM will be responsible for establishing a public health and education campaign in order to ensure the health and safety surrounding those affected by the new law. 

While the legalization of adult cannabis can provide new, lucrative opportunities for individuals and businesses, a thorough due diligence review should be completed before entering into the cannabis space. Furthermore, it is imperative that all potential business arrangements be reviewed not only from a compliance standpoint but also from a business standpoint in order to maximize benefit and minimize risk. 

Should you have any questions regarding the new cannabis laws or potentially entering into the cannabis space, please contact Stacey Marder at 516-926-3319 or SMarder@weisszarett.com

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

Medicare Payments on Hold Pending Congressional Sequester Fix

By Mathew J. Levy, Esq and Zoila Sanchez, MPH, JD

Participating Medicare providers already experiencing financial hardship due to the pandemic would be further hit by a 2% payment cut until Congress takes action next month with the passage of a sequester fix. To address this issue, the Centers for Medicare & Medicaid Services (“CMS”) is temporarily pausing Medicare payments to providers.

CMS recently announced “Temporary Claims Hold Pending Congressional Action to Extend 2% Sequester Reduction Suspension” in a special news edition of its MLN Connects newsletter, available here. CMS’ notification instructs Medicare Administrative Contractors (“MACs”) to temporarily pause all claims with dates of service on or after April 1, 2021, for a short period, without affecting providers’ cash flow.

Additionally, the change is intended to minimize the number of claims that MACs must reprocess if Congress were to extend the suspension. Further, CMS assures that if necessary, the MACs will automatically adjust. Additionally, the MACs will reprocess any claims that were paid with the reduction applied.  

If you are a participating Medicare provider, you can find your MAC Provider Contact Center at this website

Importantly, if you are a provider seeking clarification on how these changes may affect you, you can contact Mathew J. Levy at 516-926-3320 or mlevy@weisszarett.com.

Mathew J. Levy is a Shareholder/Director of Weiss Zarett and co-chairs the Firm’s corporate transaction and healthcare regulatory practice. Mr. Levy has extensive experience in defending healthcare professionals in actions brought by state licensing authorities and federal agencies. Mr. Levy has successfully defended numerous healthcare providers in actions involving the US Attorney’s Office investigations, Medicare Fraud Waste and Abuse investigations, Medicaid Fraud Control Unit investigations, OPMC, OPD, Medicare, Medicaid as well as commercial insurance audits. Mr. Levy has successfully structured and negotiated joint-venture agreements, private equity transactions, venture capital transactions, stock purchase agreements, asset sale agreements, shareholders agreements, partnership agreements, employment contracts, managed care agreements, and commercial leases.

Zoila Sanchez, J.D., M.P.H. joined Weiss Zarett full-time upon graduating with her Juris Doctor degree from the Maurice A. Deane School of Law at Hofstra University. During law school, Ms. Sanchez served as a Legal Clerk with the U.S. Department of Health and Human Services Office of Counsel to the Inspector General in Washington, DC, where her work focused on health care fraud and abuse. Ms. Sanchez has experience in supporting Weiss Zarett’s business and health care law and litigation practice areas. 

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.

MATHEW J. LEVY, ESQ. WILL BE PARTICIPATING IN A DC-NP INTEGRATION WEBINAR.

On Tuesday, April 6, 2021Mathew J. Levy, Esq. will be participating in a DC-NP integration webinar. The presentation is about Chiropractors and Nurse Practioners structure-integration, set-up, documentation and compliance.

The event will take place from 2 PM to 3 PM EST followed by a question and answer period.

Click here to register for FREE!

HHS Exercises Discretion and Declines to Enforce HIPAA Privacy Rules for Use of Web-Based COVID-19 Vaccine Appointment Scheduling Platforms

By Seth A. Nadel, Esq.
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On January 19, 2021, the U.S. Department of Health and Human Services (HHS) issued a notification that the Office of Civil Rights (OCR), the entity responsible for enforcement of HIPAA privacy rules, would exercise its discretion and decline to impose penalties against certain covered entities or their business associates with respect to the use of online scheduling applications to schedule individual patient appointments to receive a COVID-19 vaccination. 

Per the notification, OCR recognizes that certain covered health care providers or their business associates have chosen to use web-based scheduling applications (“WBSA’s”) to schedule patients in connection with large-scale COVID-19 vaccination efforts. These WSBA’s are “non public facing,” in that they are not viewable by the public and are only intended to be viewed by the patient, provider and scheduling entity. WSBA’s and the companies which provide them, by their very nature, are also considered “business associates” of the HIPAA-covered healthcare entities which use their platforms.

Generally, the HIPAA Privacy Rules allow a covered entity to share Protected Health Information (PHI) with a business associate, but only pursuant to a written business associate agreement (BAA) or in accordance with pre-existing federal regulations established by HHS. However, recognizing the public need to schedule large numbers of COVID-19 vaccine appointments within  a short period of time, OCR has opted not to impose penalties for noncompliance with these regulatory requirements when either covered entities or their business associates are, in good faith, using WSBA’s to schedule such appointments.

As to the requirement of good faith, the notification outlines the recommended and reasonable safeguards that these entities should employ in their use of WSBA’s, which mirror the general requirements for the handling of HIPAA-protected information. These include: (1) using and disclosing only the minimum PHI necessary for the purpose of scheduling; (2) use of encryption technology; (3) enabling maximum privacy settings on the scheduling software; (4) ensuring that storage of PHI is only temporary; and (5) ensuring that WBSA vendors do not disclose PHI to any third party in a manner which is inconsistent with HIPAA rules.

HHS explicitly states that “[failure] to implement recommended reasonable safeguards above will not, in itself, cause OCR to determine that a covered health care provider or its business associate failed to act in good faith” for the purposes of the notification. However, from a practical compliance standpoint, a covered entity or business associate should still take tangible steps to implement reasonable safeguards, such that they may more easily be able to show good faith efforts in meeting OCR’s requirements should they later be required to do so. HHS also encourages covered health care providers to use WBSA’s which explicitly represent that they support compliance with applicable HIPAA rules.

It should be noted that the scope of the notification does not extend to appointment scheduling technology that links directly to a covered entity’s EHR system. The notification likewise does not extend to any activities other than the scheduling of COVID-19 vaccinations, including other activities related to COVID-19 vaccination or treatment in any other respect. This includes determining an individual’s eligibility for receiving a COVID-19 or screening a patient for COVID-19 prior to an appointment. The notification also does not extend to activities undertaken without any reasonable safeguards in place, underlining the importance of documenting that at least some manner of safeguarding is implemented.

Although announced in late-January, the notification is retroactive to December 11, 2020, and will remain in effect until the expiration of the public emergency declaration, or until HHS determines in its discretion that the public emergency no longer exists. A copy of HHS’s notification may be found here.

Weiss Zarett has assisted numerous physicians and health-related businesses in connection with concerns regarding HIPAA compliance and other regulatory issues. If you have questions about any such issues, please reach out to Seth A. Nadel, Esq. at snadel@app-60705ed4c1ac183264fb7857.closte.com or 516-627-7000.

Weiss Zarett Brofman Sonnenklar & Levy, P.C. is a Long Island law firm providing a wide array of legal services to the members of the health care industry, including corporate and transactional matters, civil and administrative litigation, healthcare regulatory issues, bankruptcy and creditors’ rights, and commercial real estate transactions.

ATTORNEY ADVERTISING: PRIOR RESULTS DO NOT GUARANTEE FUTURE OUTCOMES.