Category: Health Care Law

President Trump Issues Proclamation Suspending Entry of Immigrants Who May Burden the U.S. Healthcare System

On Oct. 4, 2019, President Trump issued a Proclamation, that will be effective on Nov. 3, 2019, suspending the entry of immigrants who will financially burden the United States healthcare system. The reasoning behind the issuance of this Proclamation is to not burden American taxpayers with immigrants who utilize the U.S. healthcare system without payment and who allegedly contribute to overcrowding of emergency rooms and hospitals. The Proclamation includes a reference to data that shows lawful immigrants being three times more likely than U.S. citizens to lack health insurance, and while the United States will still continue to welcome immigrants, the country must protect its own citizens.

President Trump, through the Proclamation, declares the following:

    1. – The immediate suspension of immigrants entering the United States who does not have approved health insurance, within 30 days of entry, or unless the alien possesses the financial resources to pay for medical costs. Approved health insurance is defined in the Proclamation, which can be found here.
    2. – The Proclamation only applies to those who are seeking immigrant visas, as opposed to those seeking nonimmigrant visas.
      1. The Proclamation will not apply to those who hold a valid immigrant visa issued before the effective date of the proclamation; those who are seeking to enter the United States pursuant to a Special Immigrant Visa, who is a national of Afghanistan or Iraq, or any alien who is the child of a U.S. citizen seeking to enter the U.S. pursuant to the following categories: SB-1, IR-2, IR-3, IR-4, IH-3, IH-4, and IR-5 (with limitations).
      2. b. The Proclamation will also not apply to those aliens under 18, and any other aliens whose entry would be in the national interest.
      3. c. The Proclamation will not affect those who are lawful permanent residents (e.g., already received green cards), and will not affect eligibility regarding asylum, refugee status, etc.
    3. – The Proclamation will be implemented and enforced immediately, and a report must be submitted within 180 days of the effective date.

 

©2019 Greenberg Traurig, LLP. All rights reserved.

For more on the topic, see the National Law Review Immigration Law page.

Mayo Clinic Reports Vaping Injuries Resemble Chemical Burns

The Centers for Disease Control and Prevention (CDC) announced that over 1,000 people became ill from vaping e-cigarettes, including 18 deaths. Now, research by the Mayo Clinic of Arizona suggests the lung damage may be the result of chemical burns.

The CDC announced that 77% of the injured vapers were using e-cigarettes with tobacco and THC products, and 17% were using only nicotine. The CDC partnered with state-based health care services and research hospitals to try to determine the cause of the recent spike in vaping lung damage cases.

The Mayo Clinic of Arizona is one of the first to release data derived from recent cases. The research team tested lung biopsy samples from 17 patients, including two who have since died from the condition. All 17 biopsies suggested that the lung injuries were most likely caused by “direct toxicity or tissue damage from noxious chemical fumes.” These fumes are generated from the vaporized e-cigarette liquids. Researchers said it does not appear that the build-up of lipids, reported earlier as a possible cause of the lung damage, was a factor in these 17 patients.

According to Dr. Larsen, the senior author of the study, “It would seem prudent based on our observations to explore ways to better regulate the industry and better educate the public, especially our youth, about the risks associated with vaping.”

COPYRIGHT © 2019, STARK & STARK

For more on vaping regulation, see the Nationa Law Review Biotech, Food & Drug law page.

Giving It Your Best Shot: Maintaining a Compliant Vaccination Program in the Healthcare Sector

Workplace vaccination programs are not new. While many focus on influenza, healthcare employers often impose more robust requirements to protect employees and vulnerable patient populations. The Centers for Disease Control and Prevention (CDC) recommends healthcare workers receive several vaccinations, including: hepatitis B; influenza; measles, mumps, and rubella (MMR); varicella (chickenpox); tetanus, diphtheria, and pertussis (Tdap); and meningococcal. Many states have enacted laws requiring such vaccinations for healthcare workers. (The CDC maintains a list of state requirements.) Indeed, because healthcare workers can be at a heightened risk for both exposure and transmission of disease to patients, families, and coworkers, prominent medical groups such as the Infectious Diseases Society of America (IDSA) recommend mandatory vaccinations consistent with CDC recommendations as part of an effective infection prevention and control program.

Recent outbreaks of vaccine-preventable diseases, such as measles and pertussis, have focused public attention on the need for employee vaccine programs. For example, the CDC reports that between January 1, 2019 and August 8, 2019, there were a total of 1,215 confirmed cases of measles in the United States, the highest number since 1994. This is despite the fact that measles was eliminated in the United States in 2000, due to an effective MMR vaccination program. The World Health Organization (WHO) reports that the rise of measles cases is likely due to a decline in people getting the vaccine. (The CDC has additional information about measles and the safety and efficacy of the MMR vaccine.)

Healthcare institutions are increasingly mandating that employees receive vaccinations, such as Tdap and MMR. But, while mandatory vaccination programs are on the rise, so are challenges from employees. Employee objections to vaccines (strengthened by misinformation about vaccines such as MMR), and thus litigation, have increased in recent years. While employers may not always have to accommodate generalized or unfounded objections to vaccinations, employees do have legally cognizable objections to being vaccinated under certain circumstances. Specifically, the Equal Employment Opportunity Commission (EEOC) takes the position that Title VII of the Civil Rights Act of 1964 and the Americans with Disabilities Act (ADA) require employers to provide exemptions from mandatory vaccination policies or other accommodations to employees with religious objections and disabilities.

Just as wise employers seek to immunize their workforces from harmful pathogens, employers may also seek to immunize their vaccination programs from common legal claims. Employers may want to take into consideration the following issues:

Is the vaccination program mandatory?

Will the vaccination program be voluntary, mandatory, or a hybrid based on employee classification and work setting? Voluntary programs are attractive from the standpoint of avoiding employee objections and ADA/Title VII accommodation issues, but compliance rates may be inadequate or the healthcare setting may favor a mandatory program for some or all healthcare workers. Employers may want to consult the CDC’s recommendations, review applicable state vaccination laws, and assess the risks posed in their facilities in coordination with their infection prevention and control programs.

Is the workforce unionized?

Are nurses or other employees represented by a labor union? Employers with unionized workforces generally must bargain with the unions before imposing mandatory vaccination programs.

Who is covered?

In deciding whether to adopt a mandatory program, what is the scope of the mandate? Is it necessary to require vaccines for all employees (including clerical workers, etc.), or is it more appropriate to reserve the mandatory program for healthcare workers involved in direct patient contact or healthcare workers in vulnerable patient settings, such as the neonatal intensive care unit (NICU), pediatric intensive care unit (PICU), emergency department, or operating room? Some employers may find it more effective to implement a mandatory program with respect to a subset of healthcare workers in patient-contact roles, while offering an incentivized voluntary program to others.

Will the program permit exceptions or accommodations?

What accommodations will be permitted, and what is the process for evaluating such requests? In particular, employers should consider having a process to receive and evaluate employee requests for exemption or accommodation due to disability or sincerely held religious beliefs.

  • Under the ADA, a reasonable accommodation may be required for an employee with a disability, unless it would result in an undue hardship or a direct threat to the safety of the employee or the public. In these cases, employers can work with their infection-control team to determine the risks of exposure and transmission. For example, with employees objecting to a Tdap or MMR vaccine, the risk for a nurse working in the NICU may be very different than that of an office assistant in the back office. The ADA analysis for undue hardship and direct threat are fact specific and complicated.
  • Under Title VII, an accommodation may be required for sincerely held religious beliefs, unless doing so would pose an undue hardship. Employers should be aware that the EEOC and courts interpret “religion” broadly, and the term is not limited to major faiths but may include “religious beliefs that are new, uncommon, not part of a formal church or sect, only subscribed to by a small number of people, or that seem illogical or unreasonable to others.” Under Title VII, an undue hardship may exist where there is more than a de minimis cost or burden. The EEOC has considered several factors when determining whether an undue hardship exists, such as (1) the assessment of the public risk at that time, (2) the availability of other means of infection control, and (3) the number of accommodation requests.
  • Employers must maintain medical information and vaccination records collected from employees as confidential files in accordance with ADA requirements.
  • State vaccination laws—including where certain vaccines are mandatory for certain categories of healthcare workers—may also be relevant in designing and implementing a workplace vaccination policy.

What types of accommodations would be permitted?

Where an employer decides, after a case-by-case analysis, that an accommodation is required, it may consider is viable in the healthcare setting. Some common options include the following:

  • Requiring an employee to wear a mask, gown, or other safety gear. This option may depend on the nature of the risk, as a mask may be a reasonable accommodation for influenza in some settings, but it may not be sufficient in a setting with particularly vulnerable patients or with other pathogens that have multiple means of transmission.
  • Modifying an employee’s duties to remove at-risk activities, such as direct patient contact.
  • Temporary or permanent transfers to other positions or work areas that do not contain the same risks to patient safety.
  • Providing alternative vaccines. For example, some employees might have religious objections based on the contents of a vaccine itself, such as its use of swine products or fetal cell lines. In some cases, it may be possible to provide an alternative vaccine from a different manufacturer that does not contain the objectionable ingredient.

Healthcare employers may have legitimate reasons for requiring employee vaccinations and may want to give thoughtful consideration to federal and state employment law protections, as well as the objective medical risks applicable to specific employee groups, healthcare settings, and patient populations, before imposing sweeping mandatory policies. Such organizations may consider reviewing their vaccination programs to avoid unnecessary exposure to discrimination claims.

© 2019, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.
For more vaccination legal considerations see the National Law Review Biotech, Food, Drug law page.

Third Circuit Upholds Decision Blocking Trump Administration’s Birth Control Rules

OVERVIEW

A Third Circuit appeals panel upheld the lower court ruling in Commonwealth of Pennsylvania v. President United States of America et al. No. 17-3752. This ruling grants a nationwide preliminary injunction against the religious and moral exemptions for employers to the ACA’s birth control mandate, so employers may want to take a cautious approach toward limiting contraceptive coverage.

IN DEPTH

A Third Circuit appeals panel upheld the lower court ruling in Commonwealth of Pennsylvania v. President United States of America et al. No. 17-3752, a ruling granting a nationwide preliminary injunction against the religious and moral exemptions for employers to the ACA’s birth control mandate. The decision was passed down in January by a Pennsylvania federal judge, and follows a sequence of similar appeals cases brought in the Ninth Circuit.

In an opinion written by Circuit Judge Patty Shwartz, the panel found that the plaintiffs had proved particularized injury—rejecting the Trump Administration’s argument that the states lacked standing. The panel found there was evidence in the record showing the exemptions would result in increased spending of state-funded services either from women who have lost coverage or states bearing the costs of unintended pregnancies. This holding goes farther than the recent Ninth Circuit decision in The Little Sisters of the Poor Jeanne Jugan Residence v. California, et al. No. 18-1192, which limited injunction to the select states that brought the litigation because there was not a sufficient showing of economic injury.

The appeals panel ruled it was necessary to halt the implementation of the rules until it has been decided whether or not the agencies responsible for the rules—the Departments of Health and Human Services, Treasury and Labor—followed the Administrative Procedure Act. The panel was not convinced by either argument presented: that there was good cause sufficient to avoid notice and comment or that the Religious Freedom Restoration Act required a religious exemption.

Whether any appeal to the Supreme Court is in progress has yet to be determined. Accordingly, employers may want to take a cautious approach toward limiting contraceptive coverage.

© 2019 McDermott Will & Emery
Article by Judith Wethall of McDermott Will & Emery. Teal Trujillo, a summer associate in our Chicago office, also contributed to this On the Subject.
For more in healthcare regulation, see the National Law Review Health Law & Managed Care page.

Medical Marijuana Is Now Available in Louisiana

After four years of policy debate, rulemaking, testing, and approval, medical marijuana became available for purchase at nine Louisiana pharmacies yesterday.

Passed in 2015, the Therapeutic Use of Marijuana Act allows specially licensed Louisiana physicians to recommend medicinal marijuana for therapeutic use to Louisiana residents suffering from debilitating medical conditions. The Louisiana Legislature, the Louisiana State Board of Medical Examiners, the Louisiana Board of Pharmacy, and the Department of Agriculture have worked together over the past four years to clearly define the parameters in which the alternative medical treatment can be manufactured, prescribed, sold, and used.

The problem, however, is that Louisiana’s medical marijuana law fails to address the employment relationship, and thus creates a potential cause of action against employers who discriminate against medical marijuana users. Put simply, we don’t know for sure whether Louisiana law requires employers to accommodate medical marijuana use by employees with qualified disabilities.

While current marijuana users are excluded from federal protections under the Americans with Disabilities Act, some state courts have determined that employers must accommodate medical marijuana users who occupy non-safety sensitive positions. This is a very fact-intensive issue that requires consideration of both the industry and state in which the employer operates, as well as the specific duties of the employee. Eventually, the issue will be addressed by a Louisiana court. Until then, Louisiana employers can take steps to avoid potential liability by contacting counsel, evaluating their current policies, and clearly defining their safety-sensitive positions.

© 2019 Jones Walker LLP
Article by Jason Culotta of Jones Walker LLP.
For more marijuana legislative updates see the National Law Review Biotech, Food & Drug law page.

U.S. District Court Upholds Short-Term Limited Duration Insurance Rule

The U.S. District Court for the District of Columbia upheld a rule that expanded the maximum length of time for short-term, limited duration insurance (STLDI).

STLDI is coverage that lasts a limited period of time and is exempt from many of the requirements that apply to plans in the individual health insurance market. Concerned that STLDI was drawing healthy lives away from the individual health insurance market that the Affordable Care Act (ACA) sought to support, the Obama administration shortened the length of time an individual could enroll in STLDI from 12 months to three months. Seeing STLDI as a low cost alternative to individual insurance, the Trump administration reversed course. Final regulations issued last year restored the period to 12 months and allowed for up to two renewals, for a total period of 36 months of coverage. One month later, seven organizations representing small health insurers, mental health patients and providers, and others brought suit challenging these regulations.

The court denied the challenge. It found that the ACA–and HIPAA, which first introduced STLDI–did not define the length of time STLDI could remain in effect and that the U.S. Departments of Treasury, Labor, and Health and Human Services could extend the length of time STLDI may remain available to enrollees without posing a threat to the ACA’s “structural core.”

The plaintiffs have already expressed their intent to appeal the decision. In the meantime, states continue to consider the question of whether and how to regulate the availability and terms of STLDI policies issued within their borders.

Copyright © by Ballard Spahr LLP
This article is by Edward I. Leeds  and Paige A. Haughton of Ballard Spahr LLP.
For more on health insurance, please see the National Law Review Health Law & Managed Care page.

Lessons in Becoming a Second Rate Intellectual Power – Through Privacy Regulation!

The EU’s endless regulation imposed on data usage has spooled over into academia, providing another lesson in kneecapping your own society by overregulating it. And they wonder why none of the big internet companies arose from the EU (or ever will). This time, the European data regulators seem to be doing everything they can to hamstring clinical trials and drive the research (and the resulting tens of billions of dollars of annual spend) outside the EU. That’s bad for pharma and biotech companies, but it’s also bad for universities that want to attract, retain, and teach top-notch talent.

The European Data Protection Board’s Opinion 3/2019 (the “Opinion”) fires an early and self-wounding shot in the coming war over the GDPR meaning and application of “informed consent.” The EU Board insists on defining “informed consent” in a manner that would cripple most serious health research on humans and human tissue that could have taken place in European hospitals and universities.

As discussed in a US law review article from Former Microsoft Chief Privacy Counsel Mike Hintz called Science and Privacy: Data Protection Laws and Their Impact on Research (14 Washington Journal of Law, Technology & Arts 103 (2019)), noted in a recent IAPP story from Hintz and Gary LaFever, both the strict interpretation of “informed consent” and the GDPR’s right to withdraw consent can both cripple serious clinical trials. Further, according to LaFever and Hintz, researchers have raised concerns that “requirements to obtain consent for accessing data for research purposes can lead to inadequate sample sizes, delays and other costs that can interfere with efforts to produce timely and useful research results.”

A clinical researcher must have a “legal basis” to use personal information, especially health information, in trials.  One of the primary legal basis options is simply gaining permission from the test subject for data use.  Only this is not so simple.

On its face, the GDPR requires clear affirmative consent for using personal data (including health data) to be “freely given, specific, informed and unambiguous.” The Opinion clarifies that nearly all operations of a clinical trial – start to finish – are considered regulated transactions involving use of personal information, and special “explicit consent” is required for use of health data. Explicit consent requirements are satisfied by written statements signed by the data subject.

That consent would need to include, among other things:

  • the purpose of each of the processing operations for which consent is sought,
  • what (type of) data will be collected and used, and
  • the existence of the right to withdraw consent.

The Opinion is clear that the EU Board authors believe the nature of clinical trials to be one of  an imbalance of power between the data subject and the sponsor of the trial, so that consent for use of personal data would likely be coercive and not “freely given.” This raises the specter that not only can the data subject pull out of trials at any time (or insist his/ her data be removed upon completion of the trial), but EU Privacy Regulators are likely to simply cancel the right to use personal health data because the signatures could not be freely given where the trial sponsor had an imbalance of power over the data subject. Imagine spending years and tens of millions of euros conducting clinical trials, only to have the results rendered meaningless because, suddenly, the trial participants are of an insufficient sample size.

Further, if the clinical trial operator does not get permission to use personal information for analytics, academic publication/presentation, or any other use of the trial results, then the trial operator cannot use the results in these manners. This means that either the trial sponsor insists on broad permissions to use clinical results for almost any purpose (which would raise the specter of coercive permissions), or the trial is hobbled by inability to use data in opportunities that might arise later. All in all, using subject permission as a basis for supporting legal use of personal data creates unnecessary problems for clinical trials.

That leaves the following legal bases for use of personal data in clinical trials:

  • a task carried out in the public interest under Article 6(1)(e) in conjunction with Article 9(2), (i) or (j) of the GDPR; or

  • the legitimate interests of the controller under Article 6(1)(f) in conjunction with Article 9(2) (j) of the GDPR;

Not every clinical trial will be able to establish it is being conducted in the public interest, especially where the trial doesn’t fall “within the mandate, missions and tasks vested in a public or private body by national law.”  Relying on this basis means that a trial could be challenged later as not supported by national law, and unless the researchers have legislators or regulators pass or promulgate a clear statement of support for the research, this basis is vulnerable to privacy regulators’ whims.

Further, as observed by Hintze and LaFever, relying on “the legal basis involves a balancing test between those legitimate interests pursued by the controller or by a third party and the risks to the interests or rights of the data subject.” So even the most controller-centric of legal supports can be reversed if the local privacy regulator feels that a legitimate use is outweighed by the interests of the data subject.  I suppose the case of Henrietta Lacks, if arising in the EU in the present day, would be a clear situation where a non-scientific regulator can squelch a clinical trial because the data subjects rights to privacy were considered more important than any trial using her genetic material.

So none of the “legal basis” options is either easy or guaranteed not to be reversed later, once millions in resources have been spent on the clinical trial. Further, as Hintze observes, “The GDPR also includes data minimization principles, including retention limitations which may be in tension with the idea that researchers need to gather and retain large volumes of data to conduct big data analytics tools and machine learning.” Meaning that privacy regulators could step in and decide that a clinician has been too ambitious in her use of personal data in violation of data minimization rules and shut down further use of data for scientific purposes.

The regulators emphasize that “appropriate safeguards” will help protect clinical trials from interference, but I read such promises in the inverse.  If a hacker gains access to data in a clinical trial, or if some of this data is accidentally emailed to the wrong people, or if one of the 50,000 lost laptops each day contains clinical research, then the regulators will pounce with both feet and attack the academic institution (rarely paragons of cutting edge data security) as demonstrating a lack of appropriate safeguards.  Recent staggeringly high fines against Marriott and British Airways demonstrate the presumption of the ICO, at least, that an entity suffering a hack or losing data some other way will be viciously punished.

If clinicians choosing where to set human trials knew about this all-encompassing privacy law and how it throws the very nature of their trials into suspicion and possible jeopardy, I can’t see why they would risk holding trials with residents of the European Economic Zone. The uncertainty and risk involved in the aggressively intrusive privacy regulators now having specific interest in clinical trials may drive important academic work overseas. If we see a data breach in a European university or an academic enforcement action based on the laws cited above, it will drive home the risks.

In that case, this particular European shot in the privacy wars is likely to end up pushing serious researchers out of Europe, to the detriment of academic and intellectual life in the Union.

Damaging friendly fire indeed.

 

Copyright © 2019 Womble Bond Dickinson (US) LLP All Rights Reserved.

Privacy Concerns Loom as Direct-to-Consumer Genetic Testing Industry Grows

The market for direct-to-consumer (“DTC”) genetic testing has increased dramatically over recent years as more people are using at-home DNA tests. The global market for this industry is projected to hit $2.5 billion by 2024.  Many consumers subscribe to DTC genetic testing because they can provide insights into genetic backgrounds and ancestry.  However, as more consumers’ genetic data becomes available and is shared, legal experts are growing concerned that safeguards implemented by U.S. companies are not enough to protect consumers from privacy risks.

Some states vary in the manner by which they regulate genetic testing.  According to the National Conference of State Legislatures, the majority of states have “taken steps to safeguard [genetic] information beyond the protections provided for other types of health information.”  Most states generally have restrictions on how certain parties can carry out particular actions without consent.  Rhode Island and Washington require that companies receive written authorization to disclose genetic information.  Alaska, Colorado, Florida, Georgia, and Louisiana have each defined genetic information as “personal property.”  Despite these safeguards, some of these laws still do not adequately address critical privacy and security issues relative to genomic data.

Many testing companies also share and sell genetic data to third parties – albeit in accordance with “take-it-or-leave-it” privacy policies.  This genetic data often contains highly sensitive information about a consumer’s identity and health, such as ancestry, personal traits, and disease propensity.

Further, despite promises made in privacy policies, companies cannot guarantee privacy or data protection.  While a large number of companies only share genetic data when given explicit consent from consumers, there are other companies that have less strict safeguards. In some cases, companies share genetic data on a “de-identified” basis.  However, concerns remain relative to the ability to effectively de-identify genetic data.  Therefore, even when a company agrees to only share de-identified data, privacy concerns may persist because an emerging consensus is that genetic data cannot truly be de-identified. For instance, some report that the existence of powerful computing algorithms accessible to Big Data analysts makes it very challenging to prevent data from being de-identified.

To complicate matters, patients have historically come to expect their health information will be protected because the Health Insurance Portability and Accountability Act (“HIPAA”) governs most patient information. Given patients’ expectations of privacy under HIPAA, many consumers assume that this information is maintained and stored securely.  Yet, HIPAA does not typically govern the activities of DTC genetic testing companies – leaving consumers to agree to privacy and security protections buried in click-through privacy policies.  To protect patient genetic privacy, the Federal Trade Commission (“FTC”) has recommended that consumers withhold purchasing a kit until they have scrutinized the company’s website and privacy practices regarding how genomic data is used, stored and disclosed.

Although the regulation of DTC genetic testing companies remains uncertain, it is increasingly evident that consumers expect robust privacy and security controls.  As such, even in the absence of clear privacy or security regulations, DTC genetic testing companies should consider implementing robust privacy and security programs to manage these risks.  Companies should also approach data sharing with caution.  For further guidance, companies in this space may want to review Privacy-Best-Practices-for-Consumer-Genetic-Testing-Services-FINAL issued by the Future of Privacy Forum in July 2018.  Further, the legal and regulatory privacy landscape is rapidly expanding and evolving such that DTC genetic testing companies and the consumers they serve should be watchful of changes to how genetic information may be collected, used and shared over time.

 

©2019 Epstein Becker & Green, P.C. All rights reserved.
This article written by Brian Hedgeman and Alaap B. Shah from Epstein Becker & Green, P.C.

Medicaid Billing Upcharges Prompts Oklahoma Nurse to Blow the Whistle on Hospital

Oklahoma Heart Hospital (OHH) has agreed to pay $2.8 Million to settle U.S. and Oklahoma government claims that the hospital committed Medicaid Fraud. Jennifferr Baird, a retired registered nurse, filed the complaint, which reported that her former employer, OHH was consistently billing  Oklahoma’s Medicaid insurance program inpatient rates for outpatient procedures – regardless of whether a doctor ordered inpatient care or not.

Ms. Baird’s 2015 complaint, filed under the False Claims Act (FCA) and a similar Oklahoma law because Oklahoma administers its Medicaid program with federal funds. The practice of billing inpatient rates for outpatient service is more commonly known as “upcoding” and is a form of fraud. Specifically, in question was the hospital’s tendency to bill stent procedures at higher inpatient rates, which, according to Ms. Baird, are typically performed on an outpatient basis. According to the prosecutors who investigated the claim, the fraud lasted at least seven years.

Private citizens, like Ms. Baird, play a crucial role in holding healthcare providers accountable for their fraud by acting as whistleblowers on behalf of the government.  These whistleblowers do not go without reward for their assistance. Successful whistleblowers receive up to 25 percent of the settlement amount of the case. “Under the False Claims Act, private citizens, also known as relators, can bring a suit on behalf of the United States and share in any recovery. … [These] relators are awarded 15 to 25 percent of the settlement amount depending on the extent to which the relator substantially contributed to the recovery.”

“Jennifferr did her best to resist the administrators who pushed this fraudulent billing scheme,” said R. Scott Oswald, managing principal of The Employment Law Group. “And she urged everyone she managed to do the same. But when she realized she was fighting a losing battle—and that the true victims were U.S. taxpayers—she appealed to a higher power: The U.S. legal system, which welcomes whistleblowers like her. I am pleased that it delivered.”

While OHH did not admit to fault outright in the matter of overbilling, the hospital operator did agree to settle the case, paying $2.8 million to both U.S. and Oklahoma government coffers.  Additionally, the hospital operator has vowed to follow a new “Corporate Integrity Agreement” that will be enforced by the Inspector General of the U.S. Department of Health and Human Services.

“I’m hopeful that the culture at Oklahoma Heart Hospital now will change,” said Ms. Baird. “The frontline medical team has always been great, but I think some hospital officials cared more about dollar signs than vital signs.”

Unfortunately, Ms. Baird’s “dollar signs and vital signs” sentiment is laced with fact as, historically, there have been many instances where whistleblowers have exposed healthcare providers that were taking financial advantage of the Medicaid system.

 

© 2019 by Tycko & Zavareei LLP
For more on Medicaid-related cases see the National Law Review Health Law & Managed Care page.

The VA Mission Act: Expanding Access to the VA Telemedicine System

On June 6, 2018, President Trump signed the “John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Networks Act” a.k.a. the VA MISSION Act of 2018 (“VAMA”) into law, a $52 billion reform bill aimed at improving access to, and the quality of, medical services provided to veterans by the Department of Veterans Affairs (the “VA”).  We explored the pros and cons associated with VAMA in a June 12, 2019 blog article that we have linked here.

Contrary to VAMA’s primary goal of increasing access, and the quality of, medical services provided to veterans by the VA, as currently drafted, VAMA only allows VA covered practitioners (which only includes physicians) to provide telehealth services via the VA’s telemedicine system. It does not allow trainees, including interns, residents, fellows and graduate students from providing care via the VA’s the telemedicine system.  This seems contrary to one of the main goals of VAMA, which is to increase access to telemedicine services by veterans.

On June 12, 2019, Congressman Early L. Carter introduced legislation to increase veterans’ access to telemedicine by expanding the types of health care providers that would be eligible to provide telemedicine services under VAMA.  The proposed bill would allow trainees who participate in professional training programs (i.e., residents, interns and fellows) to use the telemedicine system available under VAMA so long as they are supervised by a credentialed VA staff member.  Congressman Carter has indicated that his goal is to improve telehealth training at VA health centers and to increase access to care by increasing the eligible providers.

While there is general bi-partisan support for this new legislation, there are still concerns relating to the costs associated with VAMA. It is, therefore, likely that the approval process of this new legislation will be slow as any additions to VAMA undergoes a high level of scrutiny.

Copyright © 2019, Sheppard Mullin Richter & Hampton LLP.