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Archive for the ‘DEA Registration Issues’ Category

Friday, May 25th, 2018

Complying with Michigan’s New Controlled Substance Laws – The Bona-Fide Prescriber-Patient Relationship Requirement

The state of Michigan has enacted a number of separate pieces of legislation to address the opioid epidemic.  Most of these laws are directed at controlling the prescribing relationship between a physician and a patient.

Generally, Michigan requires a controlled substance license to prescribe controlled substances in the state. A holder of a controlled substance license may administer or dispense a schedule 2 to 5 controlled substance without a separate controlled substance license covering those substances. Additional requirements will attach to the prescribing relationship commencing at various intervals.

This article covers the new requirement regarding the establishment of a bona-fide prescriber-patient relationship.  Starting on the sooner of March 31, 2019 or the date that regulations are issued, a licensed prescriber will be required to have a “bona-fide prescriber-patient relationship” in order to prescribe a schedule 2 to 5 controlled substance.  In order to be considered a “bona-fide prescriber” the prescriber must review relevant medical/clinical records, complete a full assessment of medical history and current medical condition, conduct a relevant medical evaluation either in person or through telehealth, and maintain records of the patient’s condition to medically accepted standards.

All of these factors should be supported by the patient’s medical record.  There are a lot of lose ends on the definitions applicable to each of these requirements.  It is possible that additional details will be forthcoming when regulations are finalized.  Because these requirements a condition precedent to being able to prescribe schedule 2 to 5 controlled substance, it is critical that physicians and other prescribers review their documentation standards to be certain that these requirements are reflected in the patient’s chart in each instance.  Provider entities will need to consider adopting policies and procedures setting the standards for documentation and integrating the other requirements of Michigan’s new laws.  Appropriate training should also be conducted to assure that prescribers and their support staff are aware of the detailed documentation requirements.  Additionally, appropriate monitoring and auditing should be conducted to assure that prescribers are meeting the requirements.

Opioid Prescribing Results in Medicare Fraud Claim

Tuesday, May 15th, 2018

Overprescribing Opioids Without Demonstrated Medical Justification.

A settlement was recently announced by the Department of Justice that symbolizes another use of fraud enforcement by the government to combat the opioid epidemic.  Providers need to take notice of these enforcement actions as they indicate opioid related issues as significant compliance risk areas.

The government alleged that a chiropractor billed Medicare and a state Medicaid program improperly for painkillers, including Opioids. The case involved four managed pain clinics, all which were closed through the course of the case.  The settlement also required a nurse practitioner to pay $32,000 and surrender her DEA registration to settle allegations that she violated the Controlled Substances Act.

The Department of Justice issued a press release announcing the settlement that directly comments on the opioid issues involved in the case, leaving no ambiguity about what the government is up to.  The quotations are not part of the normal “canned” statements that are normally included in these settlements.  Every indication is that the opioid related language might be adopted a standard form as the government focuses in on these cases.

“More Americans are dying because of drugs today than ever before—a trend that is being driven by opioids,” said Attorney General Jeff Sessions. “If we’re going to end this unprecedented drug crisis, which is claiming the lives of 64,000 Americans each year, doctors must stop overprescribing opioids and law enforcement must aggressively pursue those medical professionals who act in their own financial interests, at the expense of their patients’ best interests.”

The government alleged that the defendants prescribed painkillers and caused pharmacy claims to be submitted where there was no legitimate medical purpose for the prescriptions.  Additionally, the government alleged that the clinics up-coded and billed Medicare for office visits that were not reimbursable at the levels sought.  In a demonstration of the commitment that the government has in this area, the clinics were also accused of billing for nurse practitioner services that were provided without the required collaboration arrangement in place.

The case was initially brought forward by a former office manager turned whistleblower who is set to earn $246,500 under the settlement.

Health Law Firm Opens Green Bay Office

Tuesday, May 1st, 2018

Green Bay Health Care Lawyer – Opening Office in Green Bay Wisconsin

I just wanted to let readers of our health care blog know that Ruder Ware will be opening a Green Bay office and that three Green Bay attorneys will be joining our firm. This will provide us with a presence in the Green Bay/Appleton Markets that will enhance our community presence and enable us to better serve our client in eastern Wisconsin. Our health care and compliance practice with be greatly enhanced as a result of this move.

This move will provide a local platform through which we can better serve our health care clients.

Health Care Law Practice – Green Bay Health Lawyers Ruder Ware

Ruder Ware has a long history of representing health care clients.  The firm recognizes that the highly regulated and complex nature of the industry demands the attention of a team of attorneys who, as a group, monitor constantly evolving laws and regulations and their impact on our health care clients.  At Ruder Ware, we offer a full-service solution to clients as our focus team consists of health care, business, employment, and litigation attorneys with knowledge of the health care industry.   As a result, we are able to take best practices from other industries and apply them to the health care industry, thereby increasing the ability to respond promptly to the rapidly changing health care environment.

Members of the focus team have served on the governing bodies of various health care organizations.  This service has provided our attorneys with the opportunity to counsel the health care community.  

Our dedicated team of attorneys represents health care providers in various matters including:

 Health Care Business Transactions and Corporate Law

Our attorneys have substantial expertise representing various health care providers such as:

Below is the official press release:

Media Contact:
Jamie Schaefer
Ruder Ware, L.L.S.C.
P: 715.845.4336

For Immediate Release

Attorneys Ronald Metzler, Christopher Pahl, and Chad Levanetz to join
Ruder Ware at its new Green Bay Office

WAUSAU, WI – April 27, 2018 – Ruder Ware is pleased to announce the opening of its Green Bay office and that Attorneys Ronald Metzler, Christopher Pahl, and Chad Levanetz will be joining the firm. The new office will be located at 222 Cherry Street, Green Bay, Wisconsin, which is the current location of Metzler, Timm, Treleven, S.C.

Attorney Ron Metzler – Having practiced law for over 30 years, Ron is a well-respected and well-known commercial attorney with close ties to the banking industry.

Attorney Chris Pahl – With his strong ties to the Green Bay community, Chris has built his practice around real estate development and condominium law as well as commercial transactions and estate planning.

Attorney Chad Levanetz – A seasoned litigation attorney, Chad counsels clients in the areas of real estate, construction, and general business disputes.

Stew Etten, Ruder Ware managing partner, stated, “Ruder Ware is always looking for outstanding attorneys to join our firm. With the opportunity to add Attorneys Metzler, Pahl, and Levanetz, the time was right to open a Green Bay office. We’re very excited to have attorneys of their caliber join our team of professionals.”

About Ruder Ware
Founded in 1920, Ruder Ware is the largest law firm headquartered north of Madison. With offices in Wausau, Eau Claire, and Green Bay over 40 attorneys provide legal and business advice to clients with operations of all sizes. Areas of practice include: Employment, Benefits & Labor Relations, Litigation & Dispute Resolution, Business Transactions, Trusts & Estates, and Fiduciary Services. Ruder Ware, Business Attorneys for Business Success.

Media Contact:
Jamie Schaefer
Ruder Ware, L.L.S.C.
P: 715.845.4336

Hiring Individuals With Access to Controlled Substances – DEA Waivers

Tuesday, March 13th, 2012

DEA Waivers Necessary For Access To Controlled Substances

What is a “Convicted Felon” in the Eyes of the DEA

Most health care providers have implemented some sort of screening process for new employees, contractors and medical staff members.  The screening process usually involves some sort of criminal background check along with review of the OIG and GSA exclusion lists.

One aspect of criminal background checks is rarely discussed and involves individuals who will have “access to controlled substances.”  The Drug Enforcement Agency has rules that prohibit any DEA registrant from employing, as an employee or agent, any party who has ever been “convicted” of a felony involving controlled substances.  No such person may ever be employed in a position where they will have “access to controlled substances” unless a waiver is obtained from the Administrator of the DEA.

I placed a few of the operative terms in quotes above for a reason.  The exact definitions of these the terms “convicted of a felon'” and “access to controlled substances” is what makes application of this rule rather tricky.  The first angle involves whether or not a potential employee, staff physician or other has had a “felony conviction” involving controlled substances.  Oftentimes someone who is accused of a drug related crime under state law will plead “no contest” to a felony but the terms of the sentence will provide that the severity of the sentence will be reduced to a misdomeaner, or sometimes even dismissed, upon completion of terms of probation.  If the terms of probation are successfully completed, a subsequent criminal record search may come up with the action having been dismissed or reduced to a misdemeanor.  No issue, right?  Common sense would dictate that there is no felony conviction and the individual can be employed. 

Wrong.  The DEA rules consider there to have been a felony conviction even though the charges may have eventually been dismissed or reduced.  This is applicable whenever there is a plea of “no contest” or “nolo contendre.”  The DEA considers these please to be an admission of and a conviction of a felony offense.  This can be highly problematic for a health care provider who is doing a record search and comes upon a case that may show up as a misdemeanor or having been dismissed.  The provider must look further to determine whether the event could still be considered to be a felony by the DEA.  If it is considered to be a felony, a Waiver must be sought from the DEA to employ or otherwise permit that individual to use the provider’s facilities.  Waivers can be difficult and costly to obtain.  There are no regulations guiding the process and the final decision is in the sole discretion of the Administrator of the DEA.  There are no meaningful appeal rights.

Another thing that should be pointed out is that once a person is convicted of a felony (as defined by the DEA) that involves controlled substances, the issue carries along with the individual forever.  A waiver only applies to a specific facility.  The employee has no standing to apply for a waiver request.  Every place that the employee wishes to work in the future will need to obtain a waiver.

It should be clarified that a waiver is only required if the individual will have “access to controlled substances.”  This is the second definition that becomes important.  There does not appear to be any regulation or case that defines when an individual is considered to have “access to controlled substances.”  The DEA takes a fairly broad view that would generally prohibit any direct patient care.  Practicing medicine in a hospital and most other settings is likely excluded.  However, this definition probably does not extend to administrative tasks that do not involve seeing patients or being located in areas of the facility that do not hold controlled substances.  Yet, the fact that there is no clear definition of “access to controlled substances” makes this rule very difficult to apply in a specific, practical situation.

The takeaway from all of this is that compliance departments, human resource departments, and credentialing departments may need to take a fresh look at this issue to be certain that they have systems in place to flag cases described in this article.  The DEA may consider even a youthful drug conviction, that shows up as a dismissal or a misdemeanor on a criminal background check to be a felony.  If the event is considered to be a felony, a health care organization cannot employ the individual in a position to have access to controlled substances without first obtaining a waiver from the DEA.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

The Health Care Law Blog is made available by Ruder Ware for educational purposes and to provide a general understanding of some of the legal issues relating to the health care industry. This site does not provide specific legal advice and you should not use the information contained on this site to address your specific situation without consulting with legal counsel that is well versed in health care law and regulation. By using the Health Care Law Blog site you understand that there is no attorney client relationship between you and Ruder Ware or any individual attorney. Postings on this site do not represent the views of our clients. This site links to other information resources on the Internet; these sites are not endorsed or supported by Ruder Ware, and Ruder Ware does not vouch for the accuracy or reliability of any information provided therein. For further information regarding the articles on this blog, contact Ruder Ware through our primary website.