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Posts Tagged ‘Opioid Prescribing’

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.

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

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