Tag: health care

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.

Connecticut Enacts Law to Increase Access to Epinephrine Auto Injectors

On June 13, 2019, Connecticut Governor Ned Lamont signed into law Public Act No. 19-19 “An Act Concerning Epinephrine Auto Injectors” (PA 19-19). PA 19-19 went into effect on the same date.

This legislation expands access to epinephrine, which can be lifesaving when treating anaphylactic allergic reactions. PA 19-19 permits “authorized entities” to acquire and maintain a supply of epinephrine cartridge injectors, subject to certain conditions. With a few exceptions, authorized entities are for-profit or nonprofit entities or organizations that employ at least one “person with training.” The new legislation defines a person with training as a person who either:

  • Has completed and received a certification in a first aid course that has been approved by a “prescribing practitioner” pursuant to a medical protocol (as described below); or
  • Has received training in the recognition of the signs and symptoms of anaphylaxis, the use of an epinephrine cartridge injector and emergency protocol by a licensed physician, physician assistant, advanced practice registered nurse or emergency medical services personnel.

Prior to PA 19-19, drug wholesalers and manufacturers were permitted to sell epinephrine cartridge injectors to select categories of purchasers, including hospitals, physicians, nursing homes with a full-time pharmacist, pharmacies and certain other institutions with a full-time pharmacist.

PA 19-19 requires authorized entities who desire to acquire or maintain epinephrine cartridge injectors, together with a “prescribing practitioner,” to establish a medical protocol on the administration of epinephrine cartridge injectors by a person with training. Under PA 19-19, a prescribing practitioner is a Connecticut-licensed physician, dentist, podiatrist, optometrist, physician assistant, advanced practice registered nurse, nurse-midwife or veterinarian, authorized to prescribe medication within his or her scope of practice. The medical protocol must address, among other things, proper storage, maintenance and documentation of epinephrine cartridge injectors, and procedures for emergency medical situations involving anaphylactic allergic reactions at the authorized entity’s place of business. The authorized entity must maintain a copy of the medical protocol at the place of business to which it applies, and must annually review the medical protocol with a person with training and a prescribing practitioner.

In the event of an anaphylactic reaction, a person with training may, in accordance with the medical protocol, provide an epinephrine cartridge injector to the individual or to the individual’s parent, guardian or caregiver, or administer the epinephrine cartridge injector, regardless of whether the individual has a prescription or a prior medical diagnosis of an allergic condition. After any such administration of epinephrine, the authorized entity must notify a local emergency medical services organization as well as the prescribing practitioner.

Notably, PA 19-19 holds prescribing practitioners free from civil and criminal liability for establishing the medical protocol or for use of the epinephrine cartridge injector in accordance with PA 19-19. This legislation also holds persons with training and authorized entities free from civil or criminal liability to the individual who experienced anaphylaxis for the provision or administration, in accordance with PA 19-19, of the epinephrine cartridge injector when the person with training has a good faith belief that the individual is experiencing anaphylaxis.  However, the immunity does not apply to willful or wanton misconduct or acts or omissions constituting gross negligence.

 

Copyright © 2019 Robinson & Cole LLP. All rights reserved.
Read more about healthcare legislation on the National Law Review Health Law and Managed Care page.

340B Drug Ceiling Prices Now Available

On April 1, 2019, the Health Resources and Services Administration (HRSA) launched a secure website that lists the maximum price drug manufacturers may charge 340B-covered entities for 340B-eligible drug purchases (the 340B Ceiling Price Site).  Drug manufacturers and 340B-covered entities may access the 340B Ceiling Price Site through their HRSA Office of Pharmacy Affairs information system (the 340B OPAIS) account here: https://340bopais.hrsa.gov/

Since the creation of the 340B program in 1992, participating covered entities could not verify whether they received the correct price for medication purchased through the program. In 2010, as part of the Patient Protection and Affordable Care Act, Congress directed HRSA to create a secure database that lists the 340B ceiling price.   Nearly nine years later, HRSA launched the 340B Ceiling Price Site which allows covered entities to now access verifiable 340B drug pricing information.

The 340B ceiling price is statutorily defined as a drug’s average manufacturer price (AMP) of a drug reduced by the unit rebate amount (URA).  The URA is calculated by dividing the drug’s Medicaid drug rebate amount (DRA) by the AMP.  The 340B ceiling price can be calculated as AMP – (DRA/AMP).

To populate the 340B Ceiling Price Site, HRSA obtains AMP and URA information from the Centers for Medicare and Medicaid Services (CMS), as well as a third-party drug pricing publisher, First Databank.   Manufacturers are also tasked with providing pricing information to HRSA during quarterly price reporting windows, which will last for two weeks each calendar quarter. If there is a discrepancy between HRSA’s data and manufacturer reported data, the manufacturer may either: (1) accept HRSA’s data as its own, (2) refuse to edit the manufacturer data and provide explanations for each discrepancy, or (3) edit the manufacturer data and provide reasoning for any remaining discrepancies.  After resolving pricing discrepancies, HRSA will publish the calculated 340B ceiling price to the 340B Ceiling Price Site.

Covered entities’ access to the 340B Ceiling Price Site is limited to the covered entity’s authorizing official (AO) and primary contact (PC).  AOs and PCs are strictly prohibited from sharing 340B pricing information outside of their organization and from exporting pricing information from the 340B Ceiling Price Site. They must attest to their compliance with these obligations each time they log into the 340B Ceiling Price Site.

Although the 340B Ceiling Price Site provides covered entities with valuable pricing information, covered entities are reminded that the price they pay for 340B-eligible drugs could differ from the 340B ceiling price depending upon the covered entity’s wholesale pricing contract terms. The price paid for 340B eligible medications may vary for a number of reasons, including wholesale cost-minus/plus calculations and the availability of sub-340B ceiling pricing for drugs through the 340B Prime Vendor Program.

 

© 2019 Dinsmore & Shohl LLP. All rights reserved.
Read more drug pricing news on the Health Care type of law page.

Maryland Proposes New Telehealth Psychology and Therapy Rules

Two Maryland licensing boards – the Board of Examiners of Psychologist and the Board of Professional Counselors and Therapists – issued a pair of proposed rules setting forth practice standards for mental health services delivered via telehealth technologies. The Boards previously did not have specific practice standards or rules unique to telehealth. Once finalized, psychologists, counselors, and therapists using telehealth in their services should read and apply these new requirements to their operations and service models.

The proposed rules closely mirror each other. Both apply to professionals delivering care to patients located in Maryland. Both allow a wide range of modalities, defining telehealth as the “use of interactive audio, video or other telecommunications or electronic media,” but excluding an audio only telephone conversations, email, fax or text.  Both rules prohibit treatment based solely upon an online questionnaire.

The Board of Professional Counselors and Therapists rule allows therapists to conduct the initial patient evaluation via telehealth. The Board of Psychology rule requires an in-person initial evaluation unless the psychologist or psychologist associate documents in the record the reason for not meeting in person. (The rule doesn’t enumerate a list of acceptable or unacceptable reasons; it simply requires the reason to be documented.)

Professionals must confirm the identity of the client/patient, as well as the client’s location and contact information. The professional must also identify contact information for emergency services at the client’s location. Curiously, the rule issued by the Board of Professional Counselors and Therapists refers to the client’s location as the “practice setting.” While this could raise a suggestion that the client must be physically located in a clinical practice setting, it is more likely a drafting error because there is no mention of any originating site requirements in the rule.

Professionals must also identify everyone at the client’s location and confirm those individuals are permitted to hear the client’s health information. The use of the term “permitted” as opposed to “authorized or “legally authorized” and the absence of reference to any state or federal privacy law, suggests another person’s presence is subject to the client’s permission and not legal authority.

With regard to client consent to telehealth services, the Board of Psychology rule requires “written informed consent,” whereas the Board of Professional Counselors and Therapists rule requires the client’s “written and oral acknowledgement.” Both rules state that the standard for services delivered via telehealth is the same as services delivered in-person.

The Boards are considering comments and Maryland providers are awaiting the final regulations.  We will continue to monitor further developments including the passage of these final rules and any changes.

 

© 2019 Foley & Lardner LLP
This post was written by Emily H. Wein and Nathaniel M. Lacktman of Foley & Lardner LLP.

Federal Government Slaps $600K Fine on Wanaque Center After 11 Children Die

The federal government imposed a $600,331 fine on the New Jersey nursing center where a viral outbreak left 11 children dead and 36 sick last year. Investigators reported Wanaque nursing home’s poor infection controls, lack of administrative oversight, and slow response from medical staff “directly contributed” to the rapid spread of the virus and its related death toll.

The 114-page federal inspection report, published in December, claimed the staff at Wanaque failed to correct issues that could have controlled the outbreak, allowing residents and one staff member to contract the virus and placing others in “immediate jeopardy.”

The report alleges the center had a faulty infection-control plan, did not respond appropriately when the outbreak emerged, and failed to properly monitor the infection rate.

Multiple children at Wanaque retained high fevers for days before staff sent them to the emergency room, two of which died within hours of arriving at the hospital. At least two other children, who had been symptom-free, contracted the virus and died after staff failed to separate them from their sick roommates.

Wanaque’s pediatric medical director appeared to be absent during the crisis and claimed he did not fully understand the responsibilities of his position. The director also failed to attend quality assurance and performance meetings and had not filed monthly reports for the last four years.

The Wanaque facility is strongly disputing the findings in the federal investigation report, arguing the staff followed proper protocols and the outbreak was “unavoidable.”

New Jersey ceased all admission to the nursing home following the outbreak, but is now allowing the facility to admit new patients. A restriction does still remain in place barring Wanaque from admitting pediatric ventilator patients until federal and state officials approve the facility’s written infection-control plan.

In addition to the $600,331 federal fine, the New Jersey Department of Health is imposing a $21,000 penalty on the nursing home for each infection-control-related failure.

 

COPYRIGHT © 2019, STARK & STARK
This post was written by Jonathan F. Lauri of Stark & Stark.
Read more Malpractice Enforcement on our Professional Malpractice Page.

The Rise of the Chief Data Officer

There is a new kid on the block . . . the Chief Data Officer (CDO).  There is no surprise in our data-driven world that such a role would exist. Yet, many organizations struggle with defining the role and value of the CDO. Effective implementation of a CDO may be informed by other historical evolutions in the C-Suite.

Examining the rise of the Chief Compliance Officer (CCO) in the 2000’s mirrors some of the same frustrations that organizations faced when implementing the CCO role. While organizations were accustomed to having legal, HR, and internal audit departments working together to ensure compliance, suddenly CCOs stepped in to pull certain functions from those departments into the folds of the newly-minted Compliance department.  Integrating CDOs appears to follow a similar approach. Particularly in health care, the CDO role is still afloat, absorbing functionality from other departments as demand inside of organizations evolves and intensifies to focus on the financial benefits of their data pools.

Corporate evolution is challenging and often uncomfortable, but the writing is on the wall . . . there are two types of companies:  ones that are data-driven and ones that should be.  Which will you be?

What is a Chief Data Officer?

CDO responsibilities will vary depending on the organization. Some organizations position the CDO to oversee data monetization strategies, which requires melding business development acumen with attributes of a Chief Information Officer. In some organizations, the CDO may oversee the collection of all of the company’s data in order to transform it into a more meaningful resource to power analytical tools.

A survey of CDO positions identified three common aspirations that organizations have for the role: Data Integrator, Business Optimizer, and Market Innovator. Data Integrators primarily focus on infrastructure to give rise to innovation. Business Optimizers and Market Innovators focus on optimizing current lines of business or creating new ones. These aspirations will likely vary depending on the nature and maturity of organizations. Regardless of the specific role, CDOs can help organizations bridge the widening gap between business development, data management, and data analytics.

Further, a key component of a CDO’s activity will relate to responsible data stewardship.  CDO activities will heavily depend on developing a data strategy that complies with legal, regulatory, contractual and data governance boundaries around data collection, use and disclosure.  CDOs should work closely with legal counsel and compliance personnel to effectively navigate these challenges.  Further discussion of the legal and regulatory landscape around data use is available here.

The Importance of CDOs in Transforming Healthcare Companies

It is clear that leveraging data will be key to innovating, gaining efficiencies, and driving down costs over time.  Yet, many organizations continue to struggle with making sense of the data they possess.   For some, the CDO may be a critical driving force to advance a business into a new landscape.  Just as the CCO helped address decades of frustration with corporate ethics and practices (and was soon demanded by lawmakers and regulators), the role of the CDO has emerged in response to demand for efficiencies in business practices and the recognition that data has become the world’s most valuable commodity.

In light of the explosion of data in the healthcare industry, organizations should consider whether and how a CDO will fit into the corporate structure. Furthermore, organizations should work to understand how having a person at the table with a keen eye towards giving life to an organization’s data resources can benefit the business long term from internal and external perspectives.  The ultimate question a CDO can help solve is:  What don’t we know that, if we knew, would allow our organization to innovate or operate more efficiently or effectively?

 

©2019 Epstein Becker & Green, P.C. All rights reserved.
This post was written by Alaap B. Shah and Andrew Kuder of Epstein Becker & Green P.C.

Compliance Risk Alert: Opioid Warning Letters issued by the U.S. Department of Justice Target Prescribers

U.S. Attorney’s Offices (“USAOs”) across the country are issuing warning letters to physicians and other prescribers (collectively, “Prescribers”) cautioning them about their opioid prescribing practices (the “Warning Letters”). In just the last week, the USAO for the Eastern District of Wisconsin sent warning letters to over 180 prescribers identified by Drug Enforcement Administration (“DEA”) data as prescribing opioids at relatively high levels. The Food and Drug Administration and the Federal Trade Commission have also been issuing their own warning letters to opioid marketers and distributors over the past several months, evidencing a concerted effort to combat the opioid epidemic on a number of fronts through various federal enforcement and regulatory efforts.

The Warning Letters appear to be based entirely on review and analysis of DEA’s data with no other investigation into the patients who received opioid prescriptions or their medical conditions. Importantly, each of these USAOs has recognized explicitly that the prescribers have not necessarily broken any laws and that the prescriptions may all be medically appropriate. Nevertheless, any warning from an office wielding criminal enforcement authority should never be taken lightly, particularly when related to an issue – opioid overprescribing – that remains a top Department of Justice and U.S. government enforcement priority. While the Warning Letters themselves are issued without meaningful investigation, they may often signal that additional investigatory or enforcement action is forthcoming. In some cases, for instance, prescribers may be visited unannounced and in-person by DEA diversion investigators, special agents, or other law enforcement officers.

Prescribers who have already received a Warning Letter should contact legal counsel to assist in taking measures to assess their degree of risk and preparing for potential further government inquiry. Contacting legal counsel early and preserving privilege could be key to prevent an informal inquiry from becoming a protracted criminal investigation. Experienced counsel can help focus the government’s inquiry, provide the information in a manner that is responsive to the government’s request while also providing relevant context, and limit disruption to the provider’s practice. In collaboration with their counsel, contacted Prescribers should consider:

  • An audit of medical records related to patients who have received opioid prescriptions to confirm their propriety in light of medical documentation;
  • Correction and supplementation of any deficient records, consistent with government requirements for medical documentation to support such prescriptions; and
  • Implementing any required process improvements to mitigate future risk.

Prescribers who prescribe opioids as part of their practices but who have not received a Warning Letter should consider taking prophylactic measures in response to this increased government scrutiny, as should their employers and partners. For instance, Prescribers – and those who employ or contract with prescribers – should consider:

  • Reviewing prescribing patterns against local and national benchmarks;
  • Reviewing a sample of documentation related to opioid prescription decisions to ensure that it sufficiently supports medical necessity and provides additional training on documentation practices as needed;
  • Reviewing and implementing the most current standards of care related to opioid prescribing and patient monitoring, including recommendations issued by the Centers for Disease Control and Prevention’s Guideline for Prescribing Opioids for Chronic Pain; and
  • In larger practices, implementing or updating, as necessary, policies and procedures related to opioid prescribing.
Copyright © 2019, Sheppard Mullin Richter & Hampton LLP.
This post was written by Erica J. Kraus, Michael W. Paddock, David L. Douglass, Danielle Vrabie and A. Joseph Jay, III of Sheppard Mullin Richter & Hampton LLP.
Read more health care compliance news on the National Law Review’s Health Care Type of Law page.

Nursing Shortage Expected to Continue Through 2024: How CMS Is Easing the Burden on Hospice Agencies

The U.S. Department of Labor’s Bureau of Labor Statistics has forecast a nursing shortage through 2024, with the United States projected to need more than half a million new nurses to replace those who leave the profession. This nursing shortage stems from a convergence of factors. First, the healthcare arena has experienced an influx of new patients due to the Affordable Care Act and an aging population, increasing the demand for healthcare services. Second, many baby boomers have already reached or will soon reach retirement age. Finally, there are barriers to education for new nurses, including a lack of programs, faculty, and clinical sites to support training needs.

Extraordinary Circumstance Designation

On December 21, 2018, the director of the Quality, Safety & Oversight Group of the Centers for Medicare & Medicaid Services (CMS) issued a memorandum that officially extends CMS’s designation of the national nursing shortage as an “extraordinary circumstance.” This extension will permit hospice agencies to use contract workers to provide core nursing services through September 30, 2020.

Under 42 C.F.R. 418.64, hospice agencies “must routinely provide substantially all core services” through their own employees. Hospice agencies may use contract staff in their facilities only if there are “extraordinary or other non-routine circumstances.” These circumstances are generally unforeseen temporary events, such as “[u]nanticipated periods of high patient loads, staffing shortages due to illness or other short-term temporary situations that interrupt patient care; and temporary travel of a patient outside of the hospice’s service area.”

CMS’s designation of the nursing shortage as an “extraordinary circumstance” means that hospice agencies are exempt from the general rule requiring them to employ their own nurses to provide core nursing services. While this exemption will allow hospice agencies to hire contractors to supplement their own employee workforces, these agencies still will be responsible for all professional, financial, and administrative functions, as well as counseling, medical social services, and other core hospice services.

The memorandum also eases the paperwork burden on hospice agencies. CMS previously required that hospice agencies provide notification and a stated justification to CMS and the agency’s state survey agency whenever they used contract staff during extraordinary circumstances. Under this memorandum, the notification and justification are no longer required. Documentation, however, is still required if a hospice agency uses contract staff for other reasons and will be reviewed as part of the routine survey process.

Key Takeaways

This may be welcome news for hospice agencies struggling to care for patients, but there are some limitations these agencies may want to keep in mind. Notably, the “extraordinary circumstances” designation permits agencies to use contract staff only to supplement—not replace—their core nursing staff. Additionally, although hospice agencies may hire contract staff for core nursing functions, the exemption does not apply to other professional, financial, and administrative functions. Finally, hospice agencies should remember that they must still document their use of contract staff when it is due to a reason other than the nursing shortage.

 

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