Category: Blog Posts

President Trump Signs Mental Health Executive Order

David Brust, Class of 2022, Belmont Law

On October 5, 2020, President Trump signed an executive order to address “ongoing mental- and behavioral-health concerns” magnified by the COVID-19 pandemic. In the order, President Trump stated his Administration’s goals are to prevent suicide, end the opioid crisis, and improve mental and behavioral health. The order was signed after a Center for Disease Control and Prevention survey showed that over the last week of June 2020, “40.9 percent of Americans struggled with mental-health or substance-abuse issues and 10.7 percent reported seriously considering suicide.” Overall, the order makes five calls for action to:

(1) provide “crisis-intervention services to treat those in immediate life-threatening situations;”

(2) increase “the availability of and access to quality continuing care” following the resolution of the initial crisis “to improve behavioral-health outcomes;”

(3) “permit and encourage” mentorship and support groups;

(4) increase the availability of telehealth, online mental-health resources, and online substance use resources; and

(5) “marshal public and private resources to address deteriorating mental health, such as factors that contribute to prolonged unemployment and social isolation.”

In addition to the above calls for action the order also established the Coronavirus Mental Health Working Group. This group is tasked with facilitating “an ‘all-of-government’ response to the mental-health conditions induced or exacerbated by the pandemic.” This includes suicide prevention issues and a focus on the populations most vulnerable to the pandemic. Furthermore, the group must submit to President Trump, within 45 days, an outline of a plan to improve service coordination between public and private players to help individuals in crisis receive treatment and recovery services. Lastly, the order provides grant funding to states and organizations that “permit in-person treatment and recovery support activities for mental and behavioral health.”

 

Works Cited:

https://www.whitehouse.gov/presidential-actions/executive-order-saving-lives-increased-support-mental-behavioral-health-needs/

American Hospital Association Criticizes Provision in CMS’ Inpatient Prospective Payment Systems Final Rule

Anthony Huber, Class of 2021, Belmont Law

On September 2, 2020 the Centers for Medicare and Medicaid Services (“CMS”) filed an unpublished version of the upcoming Inpatient Prospective Payment Systems (“IPPS”) Final Rule for 2021.  According to CMS, the finalized policies in the IPPS Final Rule support its key priorities such as, strengthening Medicare and fostering innovation.  CMS also claims that the policies will “help ensure that Americans continue to have access to a world-class healthcare system with access to potentially life-saving diagnosis and therapies by unleashing innovation in medical technology and removing barriers to competition.”

The final rule incorporates several important policies related to:

  • Price transparency and use of private-sector negotiated charge data in calibrating Medicare Severity-Diagnostic Related Group (“MS-DRG”) payment weights;
  • Payment rates;
  • New or revised MS-DRGs;
  • Uncompensated Care Payments; and
  • Wage index

For a summary of these policies, click here.

All provisions within the IPPS Final Rule are not without controversy, however.  Perhaps the most controversial provision is related to the price transparency and changes to MS-DRG payment weights. An MS-DRG is a classification system through which hospitals are paid for patient hospital stays.  This controversial provision, which will be in effect for cost reporting periods ending January 1, 2021 or later, would require hospitals to report on their Medicare cost report the median payer-specific negotiated rates for inpatient services by MS-DRGs for Medicare Advantage organizations.

The American Hospital Association (“AHA”) is one of the critics of this new provision.  According to a statement made by Ashley Thompson, AHA Senior Vice President for Public Policy Analysis and Development, “the AHA remains deeply disappointed that CMS continues to require hospitals and health systems to disclose privately negotiated contract terms with payers.”   Ashley Thompson further stated that “by continuing to focus on negotiated rates rather than expanding access to a patient’s out-of-pocket costs, [CMS] fails to meet the goal it set for itself—assisting consumers in becoming more prudent purchasers of health care.” As a result, Ms. Thompson opined that “[the policy] will require hospitals to divert critically needed resources during [the] pandemic to administrative tasks that will not benefit patients.

On the other hand, CMS argues that “the additional calculation and reporting of the median payer-specific negotiated charge will be less burdensome for hospitals” because the payer-specific negotiated charges used by hospitals to calculate these medians are payer-specific negotiated charges for service packages that hospitals are already required to publicize under the Hospital Price Transparency Final Rule.

 

Works Cited:

Tennessee COVID-19 Recovery Act

 

Jacob Freeland, Class of 2021, Belmont Law

Tennessee Governor Bill Lee signed into law the Tennessee COVID-19 Recovery Act on August 17, 2020. By doing this, Tennessee joins a growing list of states that have enacted state laws that provide expansive protections to various individuals and organizations from actions arising from loss, damages, injuries, or death that has arisen from the COVID-19 pandemic.

Under this act, Tennessee will provide these protections to all applicable “persons”, unless there is clear and convincing evidence of gross negligence or willful misconduct. According to the legislation, “person” covers a wide variety of entities including individuals, healthcare providers, sole proprietorships, corporations, limited liability companies, partnerships, trusts, religious organizations, associations, nonprofit organizations, and any other legal entity regardless if formed as a for-profit or not-for-profit entity.

According to the law firm of Waller, Lansden, Dortch and Davis, who’s government relations team worked very closely with the Tennessee Chamber of Commerce in passing this legislation, the Act requires a heightened pleading standard. Under this heightened standard, any claimant in any action alleging injury arising from COVID-19 is required to do the following:

    1. File a verified complaint pleading specific facts with particularity from which a finder of fact could reasonably conclude that the injury was caused by the defendant’s gross negligence or willful misconduct; and
    2. File a certificate of good faith stating that the claimant or claimant’s counsel has obtained a signed, written statement from a physician duly licensed to practice in the state or a contiguous bordering state and competent to express an opinion on exposure to or contraction of COVID-19, which confirms the physician’s belief that the alleged injury was caused by an alleged act or omission of the defendant or defendants. A claimant’s failure to comply with the above described pleading requirements will, upon motion, make the claim subject to dismissal with prejudice. In addition, the Act provides specific civil liability protection for governmental entities and public colleges and universities for any injury arising from COVID-19, unless the claimant successfully proves and complies with the pleading standards described above. The Act applies to all prospectively filed claims arising from COVID-19. In response to concerns raised about pending COVID-19 related lawsuits, legislators negotiated the addition of a “grandfather clause” that excludes claims occurring before August 3, 2020 in which:
    3. A complaint or civil warrant was filed;
    4. A notice of claim was filed with the Tennessee Claims Commission; or
    5. Notice was satisfied under state law pertaining to healthcare liability claims.

According to Governor Lee, the goal of the law is to protect businesses by preventing further economic consequences to businesses that have already been hit hard by the COVID-19 crisis, while still providing an avenue to hold bad actors accountable. Additionally, because of these expansive protections and heightened pleading standards, businesses and individuals that conform to applicable reopening guidelines stand a far better chance of being protected from liability under claims arising from COVID-19, which will hopefully provide businesses with more confidence in re-opening and helping to stimulate the Tennessee economy.

This Act is an example of the many challenges that state governments are facing in regard to the many difficulties and competing interests that have presented themselves during this pandemic. The Tennessee government feels that this Act provides a delicate balance which both ensures justice for individuals who have wrongly been injured as a result of the pandemic, while also providing business with confidence to attempt to continue operating without fear of being bombarded with lawsuits due to liability concerns.

 

Works Cited

Shani Rivaux, Ian Wahrenbrock, Tennessee Passes Broad COVID-19 Liability Shield Legislation, Pillsbury (Aug. 20, 2020), https://www.pillsburylaw.com/en/news-and-insights/tennessee-passes-broad-covid-19-liability-shield-legislation.html.

Wendy Keegan, Tennessee Governor Bill Lee signed the Tennessee COVID-19 Recovery Act, Husch Blackwell (Aug. 21, 2020), https://www.healthcarelawinsights.com/2020/08/tennessee-governor-bill-lee-signed-the-tennessee-covid-19-recovery-act/.

Nicole Watson, Tennessee Enacts COVID-19 Recovery Act, Waller (Aug. 19, 2020), https://www.wallerlaw.com/news-insights/3738/Tennessee-enacts-COVID-19-Recovery-Act.

Covid-19 Response – Temporary Altering of Nurse Practitioner Scope of Practice Requirements

David Brust, Class of 2022, Belmont Law

In response to the COVID-19 pandemic, twenty-three states made temporary changes to their scope of practice requirements for nurse practitioners (twenty-two of the states are classified as reduced or restrictive practice states). One of the most common changes states made was suspending or modifying physician supervision or collaboration requirements. These changes ranged from simply allowing physicians to supervise more nurse practitioners than normal to completely suspending the requirement that a nurse practitioner have a supervising physician. One noticeable trend is that states with larger rural areas, such as Kansas, Louisiana, West Virginia, and Wisconsin, took the more drastic step of suspending collaboration agreement requirements. Likewise, states where COVID-19 cases were initially very high, such as New York, New Jersey, and Massachusetts, also chose to suspend collaboration agreement requirements.

Other popular changes included modifications to licensure renewal or prescribing authority. For example, Kentucky temporarily waived its requirement that nurse practitioners have a supervising physician in order to prescribe controlled substances. A move that is largely unrelated to COVID-19 but allows other medical services to continue uninterrupted during unprecedented times. Moreover, South Carolina issued an emergency order that allowed nurse practitioners licensed in neighboring states North Carolina and Georgia to practice in South Carolina, so long as they continue the collaborative agreements within their home state. This change was made to allow South Carolina citizens to continue seeing their providers who live in North Carolina or Georgia by utilizing telemedicine.

Here in Tennessee, nurse practitioners authorized to prescribe medication were temporarily able to do so without a supervising physician. Additionally, Tennessee suspended notice requirements related to collaboration agreements and waived the requirement for chart reviews and monthly supervising physician visits. However, Governor Bill Lee allowed said changes to expire with Executive Orders 15 and 28 on May 12, 2020 and they have not been renewed.

Works Cited:

https://www.aanp.org/advocacy/state/covid-19-state-emergency-response-temporarily-suspended-and-waived-practice-agreement-requirements

https://llr.sc.gov/nurse/pdf/PUBLIC%20HEALTH%20STATE%20OF%20EMERGENCY%20ORDER%202020_BON_PH_2.pdf

U.S. District Court Judge Blocks Rule Requiring Drug Companies to List Prices in T.V. Ads

Amy Zink, Class of 2021, Belmont Law

On May 10, 2019, the Department of Health and Human Services (“HHS”) finalized a rule called the “WAC Disclosure Rule” that would require the disclosure of drug prices in direct-to-consumer television advertisements of drugs covered by Medicaid and Medicare. This rule was first pushed by President Trump’s Administration as one way to better regulate the high prices of prescription drugs within the U.S. HHS adopted the rule over numerous objections by pharmaceutical companies across the United States. Pharmaceutical companies’ chief complaints were that the HHS lacked the authority to promulgate this rule under the Social Security Act and that the inclusion of the price of the drug in advertisements would only increase the likelihood of misleading and confusing consumers.

Judge Amit P. Mehta, of the United States District Court in the District of Columbia, first noted that HHS did not have the express grant of authority to regulate under the Social Security Act. Therefore, Judge Mehta completed further analysis of the question to determine whether HHS had the implicit authority to regulate by Congress. By reviewing the statutory text, Judge Mehta determined that the power Congress gave to the Secretary of HHS was to establish rules and regulations for “running” or “managing” the federal public health insurance programs through CMS. However, the rule that HHS promulgated here was meant to regulate the conduct of market actors that are not direct participants in the Medicare or Medicaid programs.  Therefore, because the statutory text does not allow HHS to directly regulate the health care market itself or market actors that are not direct participants in the insurance programs, Judge Mehta concluded that HHS exceeded its authority under the Social Security Act by promulgating the “WAC Disclosure Rule” at issue here. This holding effectively blocks the HHS rule from taking effect in the United States.

Works Cited:

Merck & Co., Inc, et al. v. U.S. Dept of Health and Human Services, 385 F. Supp. 3d 81 (2019)

Judge Blocks Trump Rule Requiring Drug Companies to List Prices in TV Ads

Support for Telemedicine During Pandemic

Jessica Scott, Class of 2021, Belmont Law

The current coronavirus pandemic has overwhelmed numerous countries’ healthcare systems, including China and Italy who are unable to help all the patients that walk through the hospital doors in critical condition as a result of the coronavirus. As physical hospital locations in China are full and overflowing with patients, some telehealth services, including Ali Health, JD Health, and WeDoctor, have come forward to help coronavirus patients at home. These companies have helped aid in at home screenings and patient care while allowing most patients to stay put and avoid going out and spreading the virus.

In the midst of this pandemic, the United States passed the Coronavirus Preparedness and Response Supplemental Appropriate Act (“Act”) which waived certain Medicare requirements for telemedicine, making access more readily available to those on Medicare. The federal government is considering passing a bill to stimulate the economy that could potentially provide $1 trillion dollars to various sources. This bill contains support for telemedicine to help aid patients with coronavirus and includes proposals to relax tax rules for telehealth services in order to help keep patients out of hospitals and doctors’ offices and avoid overcrowding. On March 23, Congress democrats blocked the bill and as of right now (March 24) are renegotiating the terms.

The federal government is trying to use telemedicine to help ensure that everyone has access to healthcare in the midst of this epidemic. While this may seem temporary, this could be the stimulus that telemedicine needs in order to be readily accessible to patients long term. The Act that has already been passed will allow Medicare patients access to healthcare in their own home, and the potential bill may help fund the need for those patients and many more.

Tennessee Supreme Court Holds that Qualified Protective Order Provision Violates the Tennessee Constitution

Anthony Huber, Belmont Law, Class of 2021

Last week, on February 28, in the case Willeford v. Klepper, the Tennessee Supreme Court (“Court”) found that a statutory provision in Tennessee Code Annotated section 29-26-121(f) violated the separation of powers clause in the Tennessee Constitution. The provision struck down by the Court allowed defense counsel to conduct ex parte interviews with patients’ non-party treating healthcare providers during the course of discovery in a healthcare liability lawsuit.

Section (f)(1) of the statute provided:

Upon the filing of any “healthcare liability action,” . . . the named defendant or defendants may petition the court for a qualified protective order allowing the defendant or defendants and their attorneys the right to obtain protected health information during interviews, outside the presence of claimant or claimant’s counsel, with the relevant patient’s treating “healthcare providers,” . . . .  Such petition shall be granted under the following conditions[.]

(Emphasis added.)  The plaintiff in the case argued that the statutory provision was unconstitutional because it deprived trial courts of their inherent authority over court proceedings.  In effect, the provision mandated that trial courts must issue qualified protective orders to allow defendants to conduct ex parte interviews with claimants’ treating healthcare providers.

The Court reasoned that legislative enactment which removes the discretion of a trial judge to make determinations of logical or legal relevancy “impairs the independent operation of the judicial branch of government.”  The Court reasoned that a trial court’s discretion to grant or deny discovery requests goes straight to the heart of the judicial function.  The Court concluded that the provision, as constructed, violated the separation of powers clause of the Tennessee Constitution because it divested trial courts of their inherent discretion over discovery.

However, the court noted that the overriding purpose of the statute was within the purview of the legislature and a small portion of the statute could be elided to keep with the expressed intent of the legislature.  The Court determined that the phrase “[s]uch petition shall be granted under the following conditions” could be elided to make the provision permissive rather than mandatory on trial courts.

While the effect of this opinion remains to be determined in practice, we now know that a trial judge will have discretion over whether he/she should grant a Qualified Protective Order (“QPO”) in a case.  Perhaps trial judges will be reluctant to grant QPO’s – perhaps not.  After this decision, we will not have to wait long to find out.

Opinion:          http://www.tsc.state.tn.us/sites/default/files/willeford.rhonda.opn_.pdf

NarxCare, Pharmacies Way of Tracking Opioid Usage of Patients. What You Need to Know

Jessica Scott, Belmont Law, Class of 2021

Pharmacies try to do their part during the opioid crisis to track data of patients’ usage and find those who are at-risk. Technology is a huge part of helping pharmacists track down those who are at risk for substance misuse or abuse. Appriss Health created NarxCare, an analytic system that helps pharmacists quickly identify at risk patients. NarxCare was integrated into Walmart and Sam’s Club pharmacies, towards the end of 2018 and Rite Aid recently integrated NarxCare directly into their analytics.

NarxCare goes beyond tracking patients’ usage and prescription history but gives an objective insight into who may be an at-risk patient for substance misuse and abuse. NarxCare provides what is known as a Narx Report, the report includes a patient’s NarxScores, Predictive Risk Scores, Red Flags, Rx Graph, and State Prescription Drug Monitoring Programs (PDMP). The NarxScore are a quantified representation of the data in the PDMP ranging from 000-999, the higher the number the more likely one is to be at risk for misuse or abuse. The NarxScores take multiple factors into consideration including the number of prescribers, morphine milligram equivalents, pharmacies, and overlapping prescriptions.  If Red Flags appear in a patient’s profile, then that patient could be at risk of an unintentional overdose or other adverse events.

While most pharmacists already have access to PDMP information, NarxCare has gone a step further to make the information easier for pharmacists to analyze and keep them from overlooking potential at risk patients. NarxCare may become an essential tool for pharmacists to “identify potential problems up front, in real-time, for every customer, every time they consider a controlled substance dispensation.”

NarxCare is a step in the right direction for keeping those from taking advantage of their local pharmacies to gain access to Opioids and other controlled substances. Some find that NarxCare gives pharmacists access to more patient information than needed, the main problem is not the abuse of the pharmacies to access Opioids, and the focus should be those who are purchasing drugs illegally. However, NarxCare could be the much needed step in preventing those from misuse and abuse of the pharmacies and hopefully curving the Opioid crisis in the United States.

States Place Bans on Vaping Products: Let the Litigation Begin

Anthony Huber, Belmont Law, Class of 2021

On September 24, Massachusetts Governor Charlie Baker ordered a four-month ban on the sale of all vaping products in the state. The ban was approved by the Public Health Council and took immediate effect.  “The purpose of this public health emergency is to temporarily pause all sales of vaping products so that we can work with our medical experts to identify what is making people sick and how to better regulate these products to protect the health of our residents,” Baker explained in a statement released on September 24.

As of September 24, 2019, the CDC announced that “805 confirmed and probable patient cases of lung injury associated with e-cigarette product use, or vaping were reported by 46 states and the U.S. Virgin Islands.”  The CDC also estimated that 27% of teenagers have used e-cigarettes, double the amount who have tried regular cigarettes.

The Massachusetts ban follows on the heels of recent decisions made by New York and Michigan.  New York was the first state to ban flavored e-cigarettes on September 17, 2019.  In support of the ban, New York Governor Andrew Cuomo stated: “New York is not waiting for the federal government to act, and by banning flavored e-cigarettes we are safeguarding the public health and helping prevent countless young people from forming costly, unhealthy and potentially deadly life-long habits.”

Michigan banned the sale of flavored e-cigarettes on September 18, 2019.  The ban went into effect immediately and is set to remain until January 2020.  Retailers and online sellers were given two weeks to comply with the ban.  On September 28, Michigan Governor Gretchen Whitmer stated: “For too long, companies have gotten our kids hooked on nicotine by marketing candy-flavored vaping products as safe.  That ends today.”

No doubt, these recent developments have set the table for a flurry of litigation disputes. In fact, a number of retailers have already filed civil suits arguing that there is no justification for using an emergency rule instead of proceeding through a process such as the Administrative Procedures Act. Retailers argue that their businesses will suffer irreparable harm, and that the states should not enact an emergency ban when there is still plenty of speculation toward what exactly is causing these deaths and lung injuries.

Retailers and critics of the vaping bans claim that states do not have the authority to ban vaping products by these emergency rules. They argue that the emergency bans are arbitrary and capricious, and that the states should have given them sufficient notice and an opportunity to be heard through a public hearing. As a result, the retailers argue that the emergency bans disregard the legislative process by not allowing the business to have a voice.

Drug Resistant Infections in Skilled Nursing Facilities and Long-Term Care Hospitals

Ryland Close, Belmont Law, Class of 2020

Skilled nursing facilities and long-term care hospitals are struggling to control the spread of Candida auris, a drug resistant fungus that causes serious infections, particularly in vulnerable patients with pre-existing illnesses.[1]

Candida auris poses an especially serious threat as it is difficult to identify, spreads easily and quickly, and is difficult to treat.[2] Candida auris is one of the hundreds of different species of the common Candida fungus.[3] Candida is a type of yeast that regularly exists in the gastrointestinal tract, mucus membranes, and skin without causing any issues.[4] While Candida typically exists in our bodies without causing problems, an overgrowth of Candida causes infection known as candidiasis.[5] Historically antifungal medications have been successful at treating candidiasis; however the over-use of these medications is being blamed for the proliferation of drug-resistant pathogens such as Candida auris, for which most common antifungal medications are ineffective.[6]

Dr. Tom Chiller, the chief of CDC’s Mycotic Disease Branch, has called skilled nursing facilities “the dark underbelly of drug-resistant infection.”[7] So what makes these facilities prime breeding grounds for a drug-resistant fungus like Candida auris? One major challenge that skilled nursing home facilities face is that they are often understaffed and ill-equipped.[8] Without adequate staffing, nurses and orderlies fail to strictly adhere to protocols designed to control the spread of the infection, such as washing hands, wearing gloves, wearing protective masks, and maintaining up-to-date lists of infected patients.[9] Many skilled nursing facilities are ill-equipped to identify and remedy outbreaks of drug-resistant germs such as the Candida auris fungus.[10] Identifying Candida auris is difficult because specialized laboratory methods are needed to identify it.[11] Use of conventional laboratory testing methods can lead to Candida auris being misidentified as other types of yeast or other more common Candida species.[12] Misidentification in turn leads to mismanagement of the infection with antibacterial medication that is ineffective at treating Candida auris.[13]

Another factor that contributes to the spread of the infection in skilled nursing facilities and nursing homes is that the patients in these facilities are simply more vulnerable to infection.[14] Patients that have ventilators, breathing tubes, feeding tubes, central venous catheters, diabetes, or who have had surgery or broad-spectrum antibiotic and antifungal use are at higher risk of Candida auris infection.[15] Another troubling factor that contributes to the spread of the infection is that skilled nursing facilities frequently cycle their infected patients in and out of hospitals and back to the skilled nursing facilities, thus spreading the infections into hospitals.[16]

Although Candida auris is still rare in the United States, over the past four years nearly 800 people in the U.S. have been infected, half of whom have died within ninety days of being infected.[17] The CDC is working to control the spread of the infection by advising healthcare workers on ways to stop the spread of the infection, working with state and local agencies, healthcare facilities, and clinical microbiology laboratories to ensure that laboratories are using proper methods to detect Candida auris, and studying Candida auris strains to better understand the fungus and how it can be controlled.[18]

[1]  Matt Richtel & Andrew Jacobs, Nursing Homes Are a Breeding Ground for a Fatal Fungus, N.Y. Times, Sept. 11, 2019. Available at: https://www.nytimes.com/2019/09/11/health/nursing-homes-fungus.html.

[2] “Candida auris, General Information about Candida auris,” Last updated 9/23/2019. Available at: Centers for Disease Control and Prevention, https://www.cdc.gov/fungal/candida-auris/candida-auris-qanda.html.

[3] “Fungal Diseases, Candidiasis,” Last updated 4/12/2019. Available at: Centers for Disease Control and Prevention, https://www.cdc.gov/fungal/diseases/candidiasis/index.html.

[4] “Fungal Diseases, Candidiasis,” supra note 3.

[5] “Fungal Diseases, Candidiasis,” supra note 3.

[6] Richtel & Jacobs, supra note 1.

[7] Id.

[8] Richtel & Jacobs, supra note 1.

[9] Id.

[10] Id.

[11] “Candida auris,” supra note 2.

[12] “Candida auris,” supra note 2.

[13] Id.

[14] Richtel & Jacobs, supra note 1.

[15] Id.

[16] Richtel & Jacobs, supra note 1.

[17]  Id., See also, “Candida auris: A drug-resistant germ that spreads in healthcare facilities,” Available at: Centers for Disease Control and Prevention, https://www.cdc.gov/fungal/diseases/candidiasis/pdf/Candida_auris_508.pdf.

[18] “Candida auris: A drug-resistant germ that spreads in healthcare facilities,” supra note 15.