Tag: health care

Health Law Section Report – September-December 2019

  • On September 16, 2019, at 51 N.J.R. 1462(a), the Department of Human Services, Division of Medical Assistance and Health Services, published an adoption of a correction to an error in the text of the definition of “nurse delegation” in the definitions set forth in N.J.A.C. 10:60-1.2. During the comment period, Disability Rights New Jersey (DRNJ) submitted a comment pertaining to the definition of nurse delegation. As part of the comment, DRNJ requested DMAHS to add “pursuant to N.J.A.C. 13:37-6.2” after “selected nursing tasks” to clarify what selected nursing tasks referred to (see Comment 16). DMAHS agreed to the change; however, in making the addition upon adoption, DMAHS inadvertently added the cross-reference as “N.J.A.C. 10:37-6.2.” The adoption corrects the error and inputs pursuant to N.J.A.C. 13:37-6.2.
  • On October 7, 2019, at 51 N.J.R. 1493(a), the Department of Human Services, Division of Medical Assistance and Health Services, published a rule proposal for a new chapter, N.J.A.C. 10:52B, to implement The County Option Hospital Fee Pilot Program. The purpose of the pilot program is to increase financial resources through the Medicaid/NJ FamilyCare program to support local hospitals in providing necessary services to low-income residents. The pilot program shall be in effect for a period of five years from April 30, 2019 and will end on April 30, 2024.
  • On October 7, 2019, at 51 N.J.R 1514(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners, adopted an amendment to the athletic trainer continuing legal education requirement at N.J.A.C. 13:35-10.21, to require one credit in topics concerning prescription opioid drugs, including the risks and signs of opioid abuse, addiction, and diversion, commencing with the biennial renewal period beginning on February 1, 2019.
  • On October 7, 2019, at 51 N.J.R 1546(a), the Commissioner of the Department of Health published a notice of petition for rulemaking submitted by the New Jersey Hospital Association to make certain amendments to N.J.A.C. 8:43G Hospital Licensing Standards, Subchapter 14 Infection Control, N.J.A.C. 8:43G-14.9, Sepsis protocols, as recommended by CMS and the Surviving Sepsis Campaign, known as Sepsis-1.
  • On October 21, 2019 at 51 N.J.R. 1568(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Physical Therapy Examiners, published a proposal to amend rules for supervision of licensed physical therapy assistants to clarify the record keeping regulations (N.J.A.C. 13:39A-7.2 and 7.3) in a manner that in the event patient records are maintained on computer recordkeeping systems that do not permit a supervising licensed physical therapist to sign a licensed physical therapist assistant’s notes, the supervising licensed physical therapist will be able to enter a separate note in the record indicating that he or she reviewed the licensed physical therapist assistant’s notes or the plan of care with the physical therapist assistant. This is meant to avoid a de facto dual signature requirement.
  • On November 4, 2019 at 51 N.J.R. 1597(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Medical Examiners proposed amendments to its existing rules concerning graduate medical education programs in order to update the eligibility requirements for graduates of international medical schools who seek licensure or authorization to engage in the practice of medicine as residents. The proposed amendments would replace outdated restrictions on graduates of international medical schools pursuing licensure or authorization in New Jersey and allow the Board to rely on recognized accrediting bodies for international medical schools that adhere to standards substantially similar to the bodies that accredit domestic medical schools. By expanding eligibility, the proposed amendments may positively affect the supply of physicians practicing in the State. The proposal seeks to amend N.J.A.C. 13:35-1.5, 3.11, and 3.11A.
  • On November 4, 2019 at 51 N.J.R. 1600(a) the Department of Law and Public Safety, Division of Consumer Affairs, Audiology and Speech-Language Pathology Advisory Committee (Committee) proposes new rules to effectuate the provisions of the telemedicine and telehealth statute for licensed audiologists and/or speech-language pathologists. The proposed new rules would be codified at N.J.A.C. 13:44C-11.
  • On November 18, 2019, at 51 N.J.R. 1638(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Dentistry, proposed amendments, repeals, and new rules to: 1) implement new laws; 2) update rules, terminology, citations, website addresses, and the names of the licensure examinations; and 3) clarify and codify current standards of practice and licensure and registration requirements. The rulemaking reflects updates related to statutory changes, additions to enhance the safety of patients receiving dental services and those working in the profession, and identifies continuing education courses that must be completed in each renewal period. In response to adverse incident reports and news articles from across the country, the Board is proposing amendments to the sedation rules to enhance the safety of patients receiving dental services. Because the Board is seeing incidents of trained individuals achieving a deeper level of sedation than intended, the Board wants to provide more guidance to the regulated community as to what is expected so as to enhance patient safety. See N.J.A.C. 13:30. Comments due January 17, 2020.
  • On November 18, 2019, at 51 N.J.R. 1664(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Acupuncture Examining Board (Board) proposed to amend N.J.A.C. 13:35-9.20 to require licensed acupuncturists to hold current certification in cardiopulmonary resuscitation (CPR), first aid, and the use of an automated external defibrillator (AED) as part of continuing education required to renew licensure. The certification must be from the American Heart Association, or a substantially similar course approved by the American Red Cross, National Safety Council, Coyne First Aid, Inc., American Safety and Health Institute, EMP International Inc., or EMS Safety Services Inc. In recognition of the hours required to obtain the certification, the Board proposes to reduce the number of required continuing education hours from 30 to 26. The Board is changing the total credits that could be obtained by certain methods to reflect that half of the total required hours will be 13 rather than 15. The Board also proposes to allow licensees who complete more than the continuing education hours required to renew licensure to apply those additional hours to the immediately succeeding biennial license renewal period. See N.J.A.C. 13:35-9.20.
  • On November 18, 2019, at 51 N.J.R. 1666(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Massage and Bodywork Therapy proposed amendments that would require applicants for licensure and licensed massage and bodywork therapists to physically attend CPR, first aid, and use of an automated external defibrillator (AED) courses, would require licensed massage and bodywork therapists to complete continuing education in laws and rules pertinent to the practice of massage and bodywork therapy, and would end recognition of continuing education courses provided by schools, colleges, or universities. See N.J.A.C. 13:37A-2.1, 2.2, 2.3, 4.1, and 4.2.
  • On November 18, 2019, at 51 N.J.R. 1674(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board Of Marriage And Family Therapy Examiners, Art Therapists Advisory Committee adopted new rules at N.J.A.C. 13:34D requiring licensure of art therapists and providing rules governing licensed art therapists. The new rules require licensed art therapists to preserve the confidentiality of information obtained from a client in the course of professional treatment unless disclosure is required by Federal law and requires an art therapist whose client has explicitly waived the art therapist-client confidentiality privilege to release client information to a third-party payor whose benefit plan is qualified under the Federal Employee Retirement Income Security Act (ERISA). In addition, the new regulations provide that failure to comply with Federal laws related to the practice of art therapy will be deemed professional misconduct. See N.J.A.C. 13:34D.
  • On November 18, 2019, 51 N.J.R. 1688(a), the Department of Law and Public Safety, Division of Consumer Affairs, Board of Massage and Bodywork Therapy readopted rules with amendments, adopted repeals and new rules regarding licensure, reinstatement and reporting of misconduct, record keeping and business registration. See N.J.A.C. 3:37A.
  • On November 18, 2019, 51 N.J.R. 1691(a), the Department of Law and Public Safety, Division of Consumer Affairs, Orthotics and Prosthetics Board adopted a new rule regarding the abandonment of license applications due to incomplete information on the application or a one year lapse in submission of information requested by the Board. See N.J.A.C. 13:44H-3.5A.
  • On November 18, 2019, 51 N.J.R. 1691(b), the Department of Law and Public Safety, Division of Consumer Affairs, Orthotics and Prosthetics Board adopted a new rule to implement the telemedicine statute and to permit the use of telemedicine and telehealth by licensed orthotist, orthotist assistant, pedorthist, prosthetist, prosthetist assistant, prosthetist-orthotist, or prosthetist-orthotist assistant. See N.J.A.C. 13:44H-11.
  • On December 2, 2019, at 51 N.J.R. 1761(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board Of Marriage And Family Therapy Examiners, Alcohol & Drug Counselor Committee adopted amendments to the rules regarding who may provide clinical supervision to interns and counselors. See N.J.A.C. 13:34C-6.2, 6.2A, and 6.3.
  • On December 2, 2019, at 51 N.J.R. 1806(a), the Commissioner of the Department of Health published a notice of action on rulemaking by announcing that more time is required for deliberating on the adoption of new sepsis protocols for hospitals, as proposed on October 7, 2019 at 51 N.J.R 1546(a).
  • On December 16, 2019, at 51 N.J.R. 1841(a), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Physical Therapy Examiners proposed an amendment and new rule recognizing the provisions of the Compact privileges that would require physical therapists and physical therapist assistants working in New Jersey, under Compact privileges, to comply with Board rules, except for those governing credentialing of applicants, license renewal, and continuing education. The proposed amendment and new rule require those seeking to work in New Jersey, pursuant to Compact privileges, to pass the State jurisprudence examination and to pay the Compact privilege fee ($40).
  • On December 16, 2019, at 51 N.J.R. 1849(ab), the Department of Law and Public Safety, Division of Consumer Affairs, State Board of Medical Examiners adopted amendments to the rules regarding continuing medical education that would permit up to 10 hours volunteer medical service to uninsured low income patients to count towards the required CME requirement. See N.J.A.C. 13:35-6.15.

© 2020 Giordano, Halleran & Ciesla, P.C. All Rights Reserved

For more health care developments in New Jersey and other states, see the National Law Review Health Law & Managed Care section.

 

Five Suggestions for Elder Care If You or Your Elderly Parents Have “One Foot on the Banana Peel”

Shana and I recently had a new client, “Jane,” that came to see us because she was concerned about her elderly parents. Both are in their 90s and although they are still living independently, she is noticing both a physical and cognitive decline in both.  She described them as having “one foot on the banana peel,” recognizing that they are one fall or illness away from no longer being able to maintain their current lifestyle.

As with many of our clients, they are resistant to making any changes and she is worried about what will happen. Jane lives a distance from her parents, works full time, and has her own teenage children. She came to us for assistance in understanding what she can do to help them. Here are five suggestions we made for her:

1. Changes to Powers of Attorney and Health Care Proxy

Jane’s parents’ existing legal documents have each other as primary agents and neither is able to act in that capacity. Jane is handling their bill paying and taking them to MD appointments and it will be easier for her to continue this role with the appropriate legal documents naming her as the primary agent.

2. Financial Planning

Jane’s parents have limited liquid assets and own their home. Their monthly income does not cover their expenses, so they are drawing from those assets every month. This plan will not work long term if either needs to hire a caregiver to help them at home due to the high cost. We helped Jane to understand the realities of paying for care and the limited coverage of Medicare. We also explained the criteria for Medicaid eligibility, the application process and the problem with using Medicaid to pay for home care. We stressed the importance of Jane and her parents exploring alternative living situations that may better meet their needs while they still had funds and ensuring that they found a facility that would allow them to spend down to Medicaid when their funds are exhausted.

3. Home Evaluation

Jane’s parents live in a bi-level home with stairs to enter and Jane is very concerned about their safety. We recommended a home evaluation to determine what modifications can be done to the home to make it safer. These modifications can be simple such as a tub bench, so they don’t have to step over the tub to get into the shower or more complex such as a stairlift or emergency alert system.

4. Medication Management

Jane’s parents have multiple medical conditions and each takes many medications. They often forget to take their medications or take them incorrectly. This is a very serious issue and often leads to unnecessary hospitalization which can precipitate a downward spiral. We discussed a variety of options, including a visiting nurse and an automatic medication dispenser.

5. Take a Deep Breath

As with all our clients, Jane loves her parents and wants what is best for them. However, her vision of what is best for them doesn’t necessarily coincide with their vision. As a caregiver-child myself, I can very much relate to her frustration of having a clear idea of what will improve an elderly parent’s quality and/or quantity of life and having that parent refuse to make a change. Sometimes small changes are acceptable and they can make a difference and prolong stability. But very often the best we can do is to plan for the emergency and know we have done the best we can.

©2020, Norris McLaughlin & Marcus, P.A., All Rights Reserved

For more on caring for elderly relations, see the National Law Review Family Law, Divorce & Custody type-of-law section.

HHS HIV Drug Lawsuit: Setting Precedent for Other High Priced Medications or Government Collaborations?

On November 6, 2019, the bonds between the U.S. government and pharmaceutical companies were stretched when the U.S. Department of Health and Human Services (“HHS”) filed a patent infringement lawsuit against Gilead Sciences in Delaware federal court regarding Gilead’s popular HIV drugs, Truvada® and Descovy®.  HHS rarely sues for patent infringement.  In fact, the U.S. government and pharmaceutical companies typically have collaborative relationships.  For example, Gilead provided the Center for Disease Control and Prevention (“CDC”) with free drugs for government experiments to expand treatment for certain diseases.  So, what happened?

In 2004, Gilead—after receiving patent protection—began selling Truvada® to treat people already infected with HIV.  The CDC later investigated whether Truvada® could be used as a prophylactic to prevent HIV in monkeys and received patent protection for four key patents that “generally cover processes for protecting a primate or human host from a self-replicating infection by an immunodeficiency retrovirus, including HIV.”  (Complaint, ¶ 196).  Specifically, the claimed inventions provide protection “by a combination of nucleoside reverse transcriptase inhibitor, such as FTC, and a nucleotide reverse transcriptase inhibitor, such as tenofovir, or esters/prodrugs of tenofovir, such as TDF or TAF.” Id. Gilead donated the FTC, TDF, and tenofovir used in the CDC’s research, but its personnel do not appear to have otherwise assisted in the research.

The government alleges that first, it helped develop the drug with Gilead, and second, that Gilead “repeatedly refused to obtain a license from CDC to use the patented regimens” and “profited from research funded by hundreds of millions of taxpayer dollars[,]” without paying any royalties to the CDC.  HHS seeks damages and royalties for Gilead’s alleged infringement.  Many speculate that HHS’s motivation goes beyond royalties to something deeper: to increase access and decrease the price of Truvada® and Descovy® for pre-exposure prophylaxis (“PrEP”).

One goal identified by the Trump administration is to eradicate new cases of HIV and AIDS by 2030.  In fact, the administration requested $291 million for this initiative in May 2019. Truvada® and Descovy® play a critical role in PrEP.  PrEP is stated to be a highly-effective HIV prevention strategy that may play a vital role in ending the global HIV and AIDS epidemic.  However, PrEP is not as widely used as it could be.  Some allege that the limited use is related to limited access to the drugs—which in turn could be due in part to the high cost.  In the United States, Truvada® costs roughly $1,782 a month.[1]  Some have speculated that this suit is part of the Trump administration’s initiative to lower PrEP prices and end the HIV epidemic in the United States.  But is there more?

Political anger and public outcry over drug costs has increased over the years.  Three years ago, a national controversy erupted over the price of EpiPen injectors manufactured by Mylan pharmaceuticals.  In 2008, EpiPens cost about $100.  In 2016, that price rose to $600.  This price increase outraged customers and put the company at the forefront of the debate over drug costs.  Public outrage, coupled with a whistleblower lawsuit, led Mylan to finalize a $465 million settlement with the U.S. Justice Department over claims that it overcharged the government for EpiPens.

The EpiPen controversy, coupled with the HHS lawsuit against Gilead, may signal to pharmaceutical companies across the country that the U.S. government is ready and willing to step in and demand lower drug prices.  Accordingly, this case may be an important bellwether and should be followed by those with interests in these areas.

[1] Descovy® is new to the market, so the average monthly cost is unknown.

©1994-2019 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

ARTICLE BY Aarti Shah and  Kara E. Grogan of Mintz.
For more on drug patents, see the National Law Review Intellectual Property law page.

CMS Issues Final Regulations For Hospital Price Transparency

On November 15, 2019, the U.S. Department of Health and Human Services (HHS) Centers for Medicare and Medicaid Services (CMS) announced final regulations implementing greater price transparency requirements for hospitals. Issued on the heels of a Trump Administration Executive Order directing HHS to propose regulations on increased price transparency, the new regulations modify and finalize CMS’ earlier guidance implementing section 2718(e) of the Public Health Service Act, to further expand price transparency requirements for hospitals. (See our previous analysis of the Executive Order here.) Effective January 1, 2021, the new regulations will be located at 45 C.F.R. 180.00 et. seq. and will require hospitals to make accessible specific “standard charge” pricing data for all “items and services” provided. Furthermore, the regulations include special requirements for posting pricing information about “shoppable services.” Key details are summarized below:

Important Definitions (45 CFR 180.20)

  • Hospital. The regulations apply to any institution licensed as a hospital under applicable state law.
  • Items and Services. The regulations require pricing data on all items and services “including individual items and services and service packages, that could be provided by a hospital to a patient in connection with an inpatient admission or an outpatient department visit for which the hospital has established a standard charge.”
  • Shoppable Service. The regulations define a shoppable service as a service that a consumer can schedule in advance.
  • Standard Charge. Hospitals must post the following five standard charges:
    1. Gross charge – The price on the hospital’s chargemaster with no discounts.
    2. Payer-specific negotiated charge – The charge negotiated with a third-party payer.
    3. De-identified minimum negotiated charge – The lowest charge the hospital has negotiated with all third-party payers for an item or service.
    4. De-identified maximum negotiated charge – The highest charge the hospital has negotiated with all third-party payers for an item or service.
    5. Discounted cash price – The charge for an individual who pays cash for an item or service.

Substantive Requirements (45 CFR 180.40-180.60)

All hospitals must now make public two items related to pricing; (a) a machine-readable file containing a list of all standard charges for all items and services, and (b) a consumer-friendly list of standard charges for a limited set of shoppable services. Each of these components are described in more detail below.

  • All Items and Services. Each hospital must establish a list of standard charges for all items and services they provide. This list must include a description of each item or service, the five standard charges (applicable to both inpatient and outpatient services), and any common identifier billing or accounting code used by the hospital. This information must be published on a publicly accessible website in a single searchable digital file without any barriers to access. The posting requirement will apply to each hospital location operating under the same license if the location has different standard charges.
  • Shoppable Services. Each hospital must establish a list of standard charges for 300 shoppable services. This list must include any of the 70 CMS-specified shoppable services the hospital provides and as many additional shoppable services determined by the hospital as needed to reach the 300-service threshold (unless the hospital does not provide 300, then all must be published). The list must include a plain language description of the service, indicators of CMS shoppable services that are not offered, the standard charges – except for the gross charge – for all shoppable services (the gross charge only needs to be posted if the hospital does not offer a discounted cash price), the locations where the shoppable service is provided and any location-specific pricing, and any common identifier billing or accounting code used by the hospital. The hospital may choose the format of publication, but it must be on the internet, accessible without barriers, and prominently located. Compliance with this requirement can occur if a hospital maintains an internet-based price estimator tool for the relevant services.

Enforcement (45 CFR 180.70-180.90)

CMS will monitor compliance by fielding complaints about hospitals, reviewing individuals’ or entities’ analysis of noncompliance, and auditing hospital websites. If noncompliance is detected, CMS will have the authority to issue warning letters, request a corrective action plan, and potentially impose civil monetary penalties up to a maximum of $300 per day.

The regulations go into effect January 1, 2021, giving hospitals a little more than a year to develop a plan for compliance.

Copyright © 2019 Robinson & Cole LLP. All rights reserved.

More on CMS & HHS regulations on the National Law Review Health Law & Managed Care page.

Federal Court Temporarily Blocks Health Insurance Requirement for Immigrant Visa Applicants

On November 2, 2019, the U.S. District Court for the District of Oregon issued a temporary restraining order, blocking the Trump administration from enforcing a recent presidential proclamation requiring health insurance for immigrant visa applicants. The proclamation, which had been scheduled to take effect on November 3, 2019, would have required certain immigrant visa applicants to prove that within 30 days of their entering the United States they would have approved health insurance or that they otherwise possessed the “financial resources” to cover “reasonably foreseeable medical costs.”

The restraining order will remain in effect for 28 days. In the meantime, the court will hear arguments on November 22, 2019, to determine if the proclamation warrants a preliminary injunction.

© 2019, Ogletree, Deakins, Nash, Smoak & Stewart, P.C., All Rights Reserved.

More on immigration on the Immigration Law page of the National Law Review.

CMS’s Request for Information Provides Additional Signal That AI Will Revolutionize Healthcare

On October 22, 2019, the Centers for Medicare and Medicaid Services (“CMS”) issued a Request for Information (“RFI”) to obtain input on how CMS can utilize Artificial Intelligence (“AI”) and other new technologies to improve its operations.  CMS’ objectives to leverage AI chiefly include identifying and preventing fraud, waste, and abuse.  The RFI specifically states CMS’ aim “to ensure proper claims payment, reduce provider burden, and overall, conduct program integrity activities in a more efficient manner.”  The RFI follows last month’s White House Summit on Artificial Intelligence in Government, where over 175 government leaders and industry experts gathered to discuss how the Federal government can adopt AI “to achieve its mission and improve services to the American people.”

Advances in AI technologies have made the possibility of automated fraud detection at exponentially greater speed and scale a reality. A 2018 study by consulting firm McKinsey & Company estimated that machine learning could help US health insurance companies reduce fraud, waste, and abuse by $20-30 billion.  Indeed, in 2018 alone, improper payments accounted for roughly $31 billion of Medicare’s net costs. CMS is now looking to AI to prevent improper payments, rather than the current “pay and chase” approach to detection.

CMS currently relies on its records system to detect fraud. Currently, humans remain the predominant detectors of fraud in the CMS system. This has resulted in inefficient detection capabilities, and these traditional fraud detection approaches have been decreasingly successful in light of the changing health care landscape.  This problem is particularly prevalent as CMS transitions to value-based payment arrangements.  In a recent blog post, CMS Administrator, Seema Verma, revealed that reliance on humans to detect fraud resulted in reviews of less than one-percent of medical records associated with items and services billed to Medicare.  This lack of scale and speed arguably allows many improper payments to go undetected.

Fortunately, AI manufacturers and developers have been leveraging AI to detect fraud for some time in various industries. For example, the financial and insurance industries already leverage AI to detect fraudulent patterns. However, leveraging AI technology involves more than simply obtaining the technology. Before AI can be used for fraud detection, the time-consuming process of amassing large quantities of high quality, interoperable data must occur. Further, AI algorithms need to be optimized through iterative human quality reviews. Finally, testing the accuracy of the trained AI is crucial before it can be relied upon in a production system.

In the RFI, CMS poses many questions to AI vendors, healthcare providers and suppliers that likely would be addressed by regulation.  Before the Federal government relies on AI to detect fraud, CMS must gain assurances that AI technologies will not return inaccurate or incorrect outputs that could negatively impact providers and patients. One key question raised involves how to assess the effectiveness of AI technology and how to measure and maintain its accuracy. The answer to this question should factor heavily into the risk calculation of CMS using AI in its fraud detection activities. Interestingly, companies seeking to automate revenue cycle management processes using AI have to grapple with the same concerns.  Without adequate compliance mechanisms in place around the development, implementation and use of AI tools for these purposes, companies could be subject to high risk of legal liability under Federal False Claims Act or similar fraud and abuse laws and regulations.

In addition to fraud detection, the RFI is seeking advice as to whether new technology could help CMS identify “potentially problematic affiliations” in terms of business ownership and registration.  Similarly, CMS is interested to gain feedback on whether AI and machine learning could speed up current expensive and time-consuming Medicare claim review processes and Medicare Advantage audits.

It is likely that this RFI is one of many signals that AI will revolutionize how healthcare is covered and paid for moving forward.  We encourage you to weigh in on this on-going debate to help shape this new world.

Comments are due to CMS by November 20, 2019.

©2019 Epstein Becker & Green, P.C. All rights reserved.

For more CMS activities, see the National Law Review Health Law & Managed Care page.

Court Finds Medical Bill Reimbursement Claim Subject to “Biblically-Based Mediation and Arbitration”

A Mississippi federal court granted a motion to compel arbitration of a claim for reimbursement of medical expenses from the defendant, a company that provides health care sharing plan alternatives to those of Christian faith. The plaintiff had signed a membership agreement stating that he would abide by the defendant’s guidelines, under which members, such as the plaintiff, were required to exhaust an “appeals” process for challenging bill-sharing decisions before resorting to any sort of legal procedures against the defendant. If the appeals process did not resolve the dispute, a “biblically-based mediation and arbitration” clause in the guidelines stated that any and all disputes arising out of the membership agreement shall be settled by “biblically-based mediation.” If that mediation fails, the member may submit the dispute to an independent and objective arbitrator for binding arbitration but otherwise waives his or her right to file a lawsuit.

Addressing the defendant’s motion, the court first held that the provision above constituted a valid arbitration agreement and that the subject dispute fell within the scope thereof. The court noted that the plaintiff had indeed agreed that he “will bring no suit, legal claim or demand of any sort … in the civil court system, with the sole exception of enforcing any favorable arbitration award or mediated agreement.” As such, the court explained that arbitration was required unless a federal statute or policy rendered the plaintiff’s claim non-arbitrable. Because the plaintiff failed to identify any such statute or policy, the court granted the defendant’s motion to compel arbitration.

Pettey v. Medi Share, No. 2:19-cv-00059 (S.D. Miss. Oct. 1, 2019).

©2011-2019 Carlton Fields, P.A.

ARTICLE BY Alex B. Silverman of Carlton Fields.

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.

Note To Chicago Employers: Expansive New Work Scheduling Rules Take Effect July 2020

The Chicago City Council passed the Chicago Fair Workweek Ordinance on July 23, regarding advance scheduling notice for certain employees in certain industries, including healthcare, hotels, restaurants, and retail, among others. Chicago Mayor Lori Lightfoot has already indicated that she will sign the new ordinance in short order, describing it as the most expansive worker scheduling policy in the country, including the first in the country to cover healthcare employers.

The ordinance, which goes into effect in July 2020, imposes significant administrative requirements relative to the employer/employee relationship. Chicago employers should consider familiarizing themselves with them now in order to avoid penalties in 2020.

Details and Penalties of the New Ordinance

The ordinance will require covered employers operating in the City of Chicago to provide employees with 10 days advance notice of scheduled work, generally beginning on July 1, 2020. After June 30, 2022, the period of required advance notice of the work schedule will increase to 14 days. The work schedule must be posted in a conspicuous location at the workplace, or must be emailed upon the request of the employee.

In addition, the ordinance provides a carve-out for smaller employers, only applies to employees who earn less than $50,000 annually or $26.00 per hour or less, and does not apply to independent contractors or day and seasonal laborers.

Employers generally covered by the law are those who have 100 or more employees (in total, not just in Chicago), or 250 or more employees in the case of nonprofit entities. Restaurants covered by the ordinance are those with more than 30 locations and at least 250 total employees (and franchisees with four or more locations). Of the total employee count, for the employer to be governed by the law, at least 50 of their employees must be “covered” employees.

If employers make changes inconsistent with the requirements of the ordinance, the employees must receive compensation. The amount of compensation will depend on the nature of the scheduling change.

Right to Decline Work Scheduled

Employees under the ordinance have the right to decline any work scheduled that does not comply with the required advance notice period. Further, if an employer alters an employee’s schedule after the deadline, depending on the particular circumstances, the employer may be required to pay the employee an additional hour for each altered shift. The ordinance also prohibits retaliation against the employee for exercising rights conferred by the scheduling ordinance.

A number of exceptions do apply. For example, schedule changes caused by power outages, blizzards, a mutually agreed-upon shift trade, or a schedule change that is mutually agreed upon by the employer and employee and confirmed in writing.

The Chicago Department of Business Affairs and Consumer Protection has been tasked with enforcing this new ordinance. Employers who violate this law will be subject to a fine of between $300 and $500 for each offense. The law also establishes a process by which an employee may initiate a civil action under the law, beginning with a written complaint to the department.

 

© 2019 BARNES & THORNBURG LLP
For more employment ordinances nation-wide, please see the Labor & Employment law page on the National Law Review.

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.