Author: bheidel

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.

 

CMS expands disclosure requirements and increases enforcement powers in affiliation rule

Ryland Close, Belmont Law Class of 2020; Patsy Powers and Justin Hickerson, Attorneys at Waller

The Centers for Medicare and Medicaid Services (CMS) is expanding its authority to revoke or deny providers’ and suppliers’ Medicare, Medicaid and Children’s Health Insurance Program (CHIP) enrollment based upon their affiliation with a sanctioned entity.

The rule will go into effect on November 4, 2019, and comments will be accepted until 5 p.m. on that day.

Under the new rule, providers and suppliers will be required to disclose in enrollment applications any current or previous, direct or indirect, affiliation (defined below) with a provider or supplier that:

  1. has uncollected debt;
  2. has been or is subject to a payment suspension under a federal health care program;
  3. has been or is excluded by the Office of Inspector General (OIG) from Medicare, Medicaid, or CHIP; or
  4. has had its Medicare, Medicaid, or CHIP billing privileges denied or revoked. CMS refers to these four categories as “disclosable events.”

The rule broadly defines “affiliation” as:

  • a 5 percent or greater direct or indirect ownership interest that an individual or entity has in another organization;
  • a general or limited partnership interest (regardless of the percentage) that an individual or entity has in another organization;
  • an interest in which an individual or entity exercises operational or managerial control over, or directly or indirectly conducts, the day-to-day operations of another organization, either under contract or through some other arrangement, regardless of whether or not the managing individual or entity is a W–2 employee of the organization;
  • an interest in which an individual is acting as an officer or director of a corporation; and,
  • any reassignment relationship.

The rule defines “uncollected debt” as:

(i) Medicare, Medicaid or CHIP overpayments for which CMS or the state has sent notice of the debt to the affiliated provider or supplier; (ii) Civil money penalties imposed under this title; (iii) Assessments imposed under this title. Uncollected debt must be disclosed regardless of: (i) the amount of the debt;

(ii) whether the debt is currently being repaid (for example, as part of a repayment plan); or

(iii) whether the debt is currently being appealed.

The Secretary will soon be allowed to revoke or deny enrollment based on such an affiliation when the Secretary determines that the affiliation poses an “undue risk” of fraud, waste or abuse. The rule identifies factors that CMS will use to determine whether an “undue risk” exists. Those factors are:

  • The duration of the disclosing party’s relationship with the affiliated provider or supplier;
  • Whether the affiliation still exists and, if not, how long ago it ended;
  • The degree and extent of the affiliation (for example, percentage of ownership); and,
  • If applicable, the reason for the termination of the affiliation.

CMS will also look into the affiliate’s disclosable event when determining whether the affiliation poses an undue risk. The government will examine:

  1. the type of action;
  2. when the action occurred or was imposed;
  3. whether the affiliation existed when the action (for example, revocation) occurred or was imposed;
  4. if the action is an uncollected debt — (a) the amount of the debt; (b) whether the affiliated provider or supplier is repaying the debt; and (c) to whom the debt is owed (for example, Medicare); and,
  5. if a denial, revocation, termination, exclusion, or payment suspension is involved, the reason for the action (for example, felony conviction; failure to submit complete information).

Fortunately for providers, CMS determined that it would be unduly burdensome for all providers to submit any applicable affiliation information as of the time this rule takes effect. Therefore, under the rule, a provider or supplier will be required to report any and all affiliations upon initial enrollment or revalidation or when CMS specifically requests such information from the provider.

With regard to Medicaid, CMS has adopted a “phased-in” approach to implementing affiliate disclosure requirements. This phased-in approach is aimed at achieving “a more targeted approach” that will be expanded with future rulemaking. With regard to Medicaid and CHIP providers and suppliers, each state will choose from one of two options for implementing the new affiliate disclosure requirements.

Under the first option, disclosures must be submitted by all newly enrolling or revalidating Medicaid and/or CHIP providers that are not enrolled in Medicare, while under the second option disclosures are only necessary if the state, with the consultation of CMS, determines that a disclosure is necessary and requests the disclosure from the provider.

Through this rule, CMS also expanded some of its current enforcement tools. For example, CMS plans to increase the maximum re-enrollment bar from three years to 10 years (with certain exceptions), and if a provider or supplier is revoked from Medicare for a second time, CMS may place a re-enrollment bar on that provider of up to 20 years.

Although the affiliation disclosures will be required only upon initial application, revalidation, or when specifically requested by CMS, individuals and entities that are affiliated with a number of providers and suppliers should begin the process of collecting or confirming information about its affiliates. The information required may be extensive, as the rule applies equally to for-profit and non-profit entities, and CMS has specifically stated that non-health care investors such as private equity sponsors, large mutual or pension funds will not be exempt from the affiliation disclosure requirements.

Federal appeals court backs injunction against religious, moral exemptions from contraceptive mandate

Amy Zink, Class of 2021; Kim Harvey Looney, Partner at Waller

The Court of Appeals for the Third Circuit has upheld a lower court ruling in Commonwealth of Pennsylvania v. President United States of America et al., which granted a nationwide preliminary injunction against religious and moral exemptions for employers to the Affordable Care Act’s (ACA) contraceptive mandate.

In the opinion written by Circuit Judge Patty Shwartz, the panel found that states had standing to bring the suit because they could establish a concrete and particularized injury from the exemptions. The panel found that the states would suffer concrete financial injury from the increased use of state-funded services due to women turning to state-funded services for their contraceptive needs. Further, the states would also see increased costs from the unintended pregnancies that may result from the loss of coverage due to the religious and moral exemptions.

The Third Circuit also determined the District Court correctly concluded that the states have a reasonable probability of showing that the Final Rules violate the Administrative Procedure Act (APA). The federal government argued that HIPAA allows the Secretary of Health and Human Services to issue interim final rules without notice and comment. The applicable section of HIPAA states that the Secretary “may promulgate any interim final rules as the Secretary determines are appropriate to carry out” certain provisions of HIPAA. The Third Circuit rejected that argument, holding that HIPAA did not excuse the agencies from APA procedures and therefore did not provide a basis for issuing interim final rules without notice and comment. The panel was also unconvinced that the Religious Freedom Restoration Act required a religious exemption from the Final Rules. The Third Circuit could not find infringement on the religious exercise of covered employees nor could they find a basis to conclude the accommodation process infringes on the religious exercise of any employer.

This decision is unlike the ruling in The Little Sisters of the Poor Jeanne Jugan Residence v. California, et al. in the Ninth District, which affirmed the preliminary injunction but rejected the injunction’s nationwide scope, ruling that the preliminary injunction was overbroad and that district judges must require a showing of nationwide impact to foreclose litigation in other districts. The Third Circuit found that the District Court did not abuse its discretion in concluding that a nationwide injunction is necessary because it was not more burdensome to the defendant than necessary, and the nationwide injunction was required to provide relief to the states.

VIDEO: Sanders says birth control limitation is ‘all about’ freedom of religion

Pennsylvania AG takes hard stance on nonprofit healthcare providers in the name of consumer protection

Clay Brewer, Class of 2019; Neil B. Krugman, Partner at Waller

The rise in healthcare costs and public concern about accessing adequate care has caught the eye of many government officials across the country, some of whom have increased their enforcement of consumer protection laws in response.

The Attorney General of Pennsylvania, Josh Shapiro, provides a recent example.

In 2012, the University of Pittsburgh Medical Center (UPMC), an integrated nonprofit hospital, announced that it would no longer contract with Highmark, a health insurer, due to Highmark’s recent affiliation with a large UPMC rival, Allegheny Health Network. In 2014, despite continuing disagreements, UPMC and Highmark entered into a consent decree with the Attorney General, the Pennsylvania Insurance Department and the Pennsylvania Department of Health. With the aim of protecting consumers, the decree permitted in-network access for certain groups of Highmark members (such as senior citizens) to certain unique or exception UPMC hospitals and providers.

The decree expires on June 30, 2019. With that date nearing and no resolution in sight to UPMC’s dispute with Highmark, in February 2019, General Shapiro filed a petition in Pennsylvania state court against UPMC, contending that UPMC has failed to meet its charitable purpose and seeking to require “that all charitable, nonprofit health systems contract with all health insurers who want to do business with them.”

In a recent counterclaim filed in federal district court, UPMC has labeled General Shapiro’s actions as unprecedented and illegal because they usurp the rights of nonprofit healthcare providers. Not only does the petition essentially force nonprofit providers to contract with insurers, UPMC claims, but it also allows the state to infringe upon federal government programs such as Medicare Advantage, the Patient Protection and Affordable Care Act (ACA), the Sherman Act and the Employee Retirement Income Security Act of 1974 (ERISA).

On April 3, Shapiro witnessed a setback with a Pennsylvania state court ruling that the court lacks authority to extend a consent decree without an allegation of fraud, accident or mistake or mutual consent by the parties, despite the impact the Attorney General claims it may have on the greater population. Interestingly, the court declined to rule on most of the primary issues such as whether the Attorney General has the power to regulate nonprofits and whether UPMC, in fact, violated its charitable mission.

Although an initial victory for nonprofits, this case will continue to be closely monitored for the impact it may have not only in Pennsylvania but also in the national discussion on the intersection between healthcare costs and consumer protection laws.

Shapiro says he will continue to fight for consumer protection, and submitted an appeal of the trial court’s decision to the Pennsylvania Supreme Court in early April.