Regulations

Telehealth Report Offers Glimpse Into Variety and Complexity of State Telehealth Laws and Policies

Posted by Rene Quashie on November 13, 2017
Regulations, Telehealth, Telemedicine / No Comments

In the recently published fall update of the fifth annual edition of its telehealth report, the Center for Connected Health Policy, the federally designated National Telehealth Policy Resource Center, provides a current summary guide to telehealth-related laws, regulations, and policies for all 50 states and the District of Columbia, and tracks a number of telehealth trends. The report offers a revealing glimpse into the scope and complexity of state laws and policies governing telehealth. The authors conclude, however, that despite the fact that state laws and Medicaid policies “differ significantly” certain trends are coming into relief. Here are some highlights of the report:

  • 48 states and the District of Columbia provide reimbursement for live video consults in their Medicaid fee-for service programs.
  • States alternate between the terms “telemedicine” and “telehealth,” and in some states, both terms are explicitly defined in statute or regulation.
  • 15 state Medicaid programs reimburse for store-and-forward services.
  • 21 Medicaid programs reimburse for remote patient monitoring.
  • 36 states and the District of Columbia have laws governing coverage by private payers of telehealth services.
  • In the 2017 legislative session, 44 states introduced over 200 telehealth-related pieces of legislation addressing issues such as reimbursement and the standard of care.
  • 30 jurisdictions have telehealth informed consent requirements (depending on the state, may apply to Medicaid only, certain specialties, or to all telehealth transactions in the state).
  • 22 states are now part of the Federation of State Medical Boards’ Interstate Medical Licensure Compact facilitating multi-state licensure for physicians in those states.
  • 32 states reimburse a transmission fee, facility fee, or both.
  • 9 state medical/osteopathic medical boards issue special licenses/certificates related to telehealth.

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New Grower/Processor Regulations Released

Posted by Chris Raphaely on August 22, 2016
DOH, Pennsylvania, Regulations / No Comments

On August 18, 2016, the Secretary of Pennsylvania’s Department of Health (“DOH”), Dr. Karen Murphy, announced that the DOH has posted draft temporary regulations (“Regulations”) focusing on the 25 medical marijuana grower/processor permits that will become available under Pennsylvania’s Medical Marijuana Act (“Act”) that was passed last April.

The Regulations state the general application requirements for medical marijuana organizations, which requirements include detailed information about principals and financial backers of such organizations. Medical marijuana organizations include not just grower/processors, but also clinical registrants and dispensaries. The application requirements also contain a clear commitment to foster diversity. The Regulations establish procedures for promoting and ensuring that medical organizations foster diversity through participation of diverse groups in all aspects of the medical organization’s operations. This includes but is not limited to requiring each organization to have a diversity plan. Diverse groups are defined under the Regulations as “disadvantaged business[es], minority-owned business[es], women-owned business[es], service-disabled veteran-owned small business[es] or veteran-owned small business[es] that ha[ve] been certified by a third-party certifying organization.”

The Regulations also contain specific requirements for grower/processor permits. Application forms for permits will be posted on the DOH website in the future. Among the requirements is that a grower/processor notify DOH within six months of being issued an initial permit that it is ready, willing and able to begin production.

The Regulations prohibit executive level employees of the Commonwealth and their immediate family members from being employed by or holding an interest in medical marijuana organizations while employed by the Commonwealth and for one year thereafter.

The Regulations are not final and are open for public comment until August 26, 2016.

Although Pennsylvania joins 23 other states and the District of Columbia to legalize medical marijuana, marijuana is still classified as a Schedule I controlled substance by the U.S. Drug Enforcement Agency, and as such it remains a crime under federal law to grow, sell and/or use marijuana. Any content contained herein is not intended to provide legal advice in connection with the violation of any state or federal law.  Although the Act provides for the legalization of medical marijuana in the Commonwealth of Pennsylvania, one should obtain legal advice with respect to any such compliance issues.

Stay tuned for details regarding an upcoming Cozen O’Connor webinar on these Regulations.

For more information about the Regulations or the Act, contact Chris Raphaely, J. Nicole Martin or another member of Cozen O’Connor’s Cannabis Industry Team.

Chris Raphaely

Chris Raphaely

R. Christopher Raphaely joined Cozen O'Connor's Philadelphia office in 2014 as co-chair of the Health Care Practice Group. Chris joins the firm from Jefferson Health System, where he served as deputy general counsel and general counsel to the system’s accountable care organization and captive professional liability insurance companies.

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The E-Cigarettes Industry Fights Back Challenging the FDA in Federal Court

Posted by Ryan Blaney on May 16, 2016
E-Cigarettes, Food and Drug Law, HHS, Regulations / No Comments

e cig

Days after the publication of the Food and Drug Administration’s controversial final rule regarding e-cigarettes (and other nicotine-delivering products), a company called Nicopure Labs LLC filed a lawsuit challenging it in the U.S. District Court for the District of Columbia.  Nicopure seeks to have the rule vacated and declared unlawful, and has requested a preliminary injunction barring enforcement of the rule and prohibiting the FDA from taking any action under the rule pending resolution of the lawsuit.

The final rule, which will take effect on August 8, 2016 absent an injunction, grants the FDA authority to regulate electronic cigarettes and other vaping products and imposes rules on the industry that many insiders fear will leave it decimated.  These rules include banning sales to anyone younger than 18 years of age, requiring extensive warning labels on packing and — most significantly — subjecting all products (even those currently on the market) to the FDA approval process and the FDA’s reporting and recordkeeping requirements.  The price tag associated with the FDA approval process alone likely will pose an insurmountable barrier for the small vape shops, device manufacturers and e-liquid producers that currently drive most of the industry.

Nicopure, a Florida company that distributes battery-powered vaping devices and manufactures and distributes e-liquid, seeks to have the Final Rule vacated on several grounds.  First, Nicopure alleges that the deeming rule defines “tobacco product” so broadly that it constitutes an unreasonable construction of the authority granted under the Administrative Procedure Act (APA).  Additionally, Nicopure contends that the rule should be vacated as arbitrary and capricious in violation of the APA.  Finally, Nicopure brings a constitutional challenge, arguing that the rule violates the First Amendment by prohibiting manufacturers from “making truthful and nonmisleading statements regarding vaping devices, e-liquids and related products” and from “engaging in other forms of protected expression, including by distributing free samples of vaping devices or e-liquids.”

As of this writing, the FDA has not responded to Nicopure’s complaint, but the case (Nicopure Labs, LLC v. Food and Drug Administration, et al.,1:16-cv-00-878) will no doubt be closely watched by the rule’s proponents and detractors alike.

For more information you can contact Ryan Blaney or another member of Cozen O’Connor’s Health Law team.

 

Ryan Blaney

Ryan Blaney

Ryan Blaney joined Cozen O'Connor as a member of the firm's Health Law group. Ryan practices in the firm's Washington, D.C., office. He focuses his practice on representing clients in the health care and life sciences industries in a wide range of matters, including health care fraud and abuse, civil and criminal government investigations, qui tam and whistle-blower disputes under the False Claims Act and other federal and state laws and regulations, HIPAA privacy and data security, compliance and transactional services, and antitrust matters.

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Not Much New … But a Good Reminder for Medical Director Relationships

Posted by Ryan Blaney on June 15, 2015
CMS, Hospital, OIG, Regulations / No Comments

After a sigshutterstock_272707754nificant number of settlement agreements between the U.S. Department of Health and Human Services Office of Inspector General (OIG), OIG decided to release a Fraud Alert reminding physicians, practices and hospitals about the significant compliance risks with medical director agreements. The June 9, 2015 Fraud Alert highlights four issues of concern in medical director agreements and relationships:

 

  1. Agreements providing for medical director compensation based upon a calculation taking into account the volume of a medical director’s referrals to the entity he or she is serving as medical director.
  2. Agreements providing for medical director compensation above fair market value for the services to be rendered by the medical director.
  3. Medical directors failing to actually render the services set forth in medical director agreements, yet still being compensated for such services.
  4. Agreements providing that affiliated health care entities pay for a medical director’s front office staff, thereby relieving the medical director of a financial burden such medical director would otherwise have incurred.

This Fraud Alert offers nothing new in terms of Anti-Kickback regulation and enforcement, reiterating to providers that the Anti-kickback statute generally prohibits a provider from being paid any form of remuneration for referring a patient for federal healthcare business.  It appears to be a not-so-friendly reminder that “remuneration” can come in many shapes and sizes and physicians must continue to be vigilant in their negotiating and entering into medical director agreements, as well as their adherence to same. A physician considering entering into any business venture in the health care sector should proceed with caution, and always confer with a health care attorney before signing on the dotted line.  The complete June 9, 2015 Fraud Alert can be found here: http://oig.hhs.gov/compliance/alerts/guidance/Fraud_Alert_Physician_Compensation_06092015.pdf.

For further information contact a member of Cozen O’Connor’s health care team.

Authored by Ryan Blaney (Washington, DC) and Marc Goldsand (Miami, FL).

Ryan Blaney

Ryan Blaney

Ryan Blaney joined Cozen O'Connor as a member of the firm's Health Law group. Ryan practices in the firm's Washington, D.C., office. He focuses his practice on representing clients in the health care and life sciences industries in a wide range of matters, including health care fraud and abuse, civil and criminal government investigations, qui tam and whistle-blower disputes under the False Claims Act and other federal and state laws and regulations, HIPAA privacy and data security, compliance and transactional services, and antitrust matters.

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