Posted On Monday, June 11, 2018
By:
What Happened?
Although signed into law in April 2016, Pennsylvania’s Medical Marijuana Program is still very much a work in progress. Pennsylvania patients have only recently been able to receive medical marijuana at approved dispensaries – and only for approved “serious medical conditions.” There are 17 – soon to be 21 – approved conditions which include ALS, autism, cancer, Crohn’s, glaucoma, HIV/AIDS, multiple sclerosis, Parkinson’s and PTSD.
The Rundown
Interested patients must register by completing an online profile on the Pennsylvania Department of Health’s website called the “Patient and Caregiver Registry” – before obtaining a physician’s certification stating that he or she has one of the approved conditions. This month, opioid addiction disorder was approved by the Department of Health as a “serious medical condition” for use of medical marijuana. Pennsylvania is one of the first states to approve medical marijuana for opioid addiction.
With physician certification, the patient returns to the Registry to purchase a medical marijuana identity card. The card will allow the patient, or his or her caregiver, to obtain medical marijuana from an approved dispensary. Caregivers needing to provide medical marijuana to a minor follow a similar process, but may also request a Safe Harbor letter.
The Pennsylvania Department of Health is quick to emphasize that participation in the Medical Marijuana Program does not provide immunity from federal prosecution. As readers likely know, the federal government still lists marijuana as a Schedule I substance, like heroin and cocaine – indicating their view that marijuana has no legitimate medical use and a high potential for abuse. However, Pennsylvania Department of Health literature also notes that criminal investigations and charges or civil enforcement actions, “may be unlikely” as long as the patients, physicians, dispensaries and growers/processors are in conformance with the Medical Marijuana Program’s laws. The Department points to U.S. Department of Justice guidance for that statement which can be found here.
Physicians interested in certifying patients under the program follow a similar process; They register on the state’s Physician’s Registry which triggers a validation of the physician’s medical license. The physicians must then complete a mandatory 4-hour training course provided by an approved Department of Health provider. The last step is a final review and approval by the Department of Health to become an approved “Practitioner” able to issue patient certifications for the approved serious medical conditions.
Medical marijuana will only be dispensed from approved dispensaries, not pharmacies. The approval process requires aspiring dispensaries to obtain a permit through demonstration of sufficient controls to prevent diversion, abuse, or illegal conduct, sufficient capital (at least $150,000), a diversity plan, and payment of a non-refundable fee of $5,000 and a $30,000 fee that’s refundable if the permit isn’t granted. Successful permit applicants must complete a 2-hour training course. Growers and processors use a similar process to obtain a permit by showing sufficient controls, proof of at least $2 million in capital and payment of a $100,000 non-refundable fee and a $200,000 fee that is refundable if the permit isn’t approved.
The Take Away
As of this writing, there are over 10,000 approved patients, 200 approved physician “Practitioners,” 16 approved dispensaries, and 12 approved growers/processors. If you need assistance in completing and complying with the paperwork for your dispensary, please contact a member of our Business Group. If you need assistance navigating an investigation or civil enforcement action, please do not hesitate to contact a member of our White-Collared team today.
Posted On Wednesday, June 6, 2018
By:
What Happened?
In the past several years, the prescription and distribution of opioids have been increasingly scrutinized by federal and state law enforcement agencies, insurance companies, the media and the medical profession itself. The Department of Justice (DOJ) is using everything in its toolbox to fight the opioids crisis – from criminally prosecuting low level drug dealers to prosecuting medical professionals for prescribing pain killers. Numerous grand jury indictments have been presented charging physicians, nurses, pharmacists, and others in the industry with distribution of narcotics, conspiracy, health care fraud, mail fraud, bribery, anti-kickback laws, RICO and other related charges. In addition to the aggressive criminal prosecutions, in its latest intervention, the Department of Justice filed a motion to participate in settlement discussions in civil litigation filed by numerous cities and counties in the United States against drug manufacturers and distributors. It seeks to provide expertise to the court and help craft non-monetary remedies to fight the opioid epidemic.
In addition to DOJ’s aggressive prosecutions, the Center for Medicare and Medicaid (CMS), who is Medicare and Medicaid’s watchdog, has been heavily criticized for its lack of supervision over the prescriptions of opioids under the Medicare and Medicaid programs. On May 29, 2018 U.S. Senator Pat Toomey, who chairs the U.S. Senate Committee on Finance’s Subcommittee on Health Care, convened a hearing in Bensalem, PA where a number of health care professionals and government personnel testified about Medicare and Medicaid’s oversight, or lack of oversight, over opioid prescription. Testimony revealed that CMS failed to identify more than 90 percent of patients who were at risk for addiction. It should be expected that CMS will be more diligent in their supervision of the Medicare Part D and Medicaid and refer more cases of suspected fraud or abuse to the Department of Justice for criminal enforcement.
What to do if law enforcement comes knocking at your door
With the increase in criminal, civil and administrative enforcement, medical professionals need to understand their rights in case of an investigation. There are many ways a medical provider who has become a “target” or “suspect” of an investigation learns of an ongoing investigation. He or she may hear from a third party that law enforcement officers, such as the FBI or DEA, have been visiting the medical provider’s employees or business associates and inquiring about his or her business practices. He or she may hear from the Medical Board about an investigation. In some instances, law enforcement may make a surprise “friendly” visit to the medical provider’s office or home. Other times, law enforcement may arrive at the medical provider’s office or home with a platoon of agents and armed with a search warrant. Many times when search warrants are executed, the information is leaked to the press and targets of investigations find themselves on the six o’clock news.
If you learn of an investigation – don’t panic. Contact an attorney who has experience with government enforcement actions and who can adequately advise you. If law enforcement agents pay you a “friendly” visit, please remember that they have a purpose to that visit. They want information that they may use against you at a later date. You should politely thank them for their visit, ask for their business cards and tell them that your attorney will contact them. They may try to convince you to speak to them by telling you that you have nothing to worry about. Again, be polite and tell them that your attorney will be calling them. You do not have to speak to them.
If law enforcement arrives with a search warrant, read the warrant and make sure it is for your premises. Once you have determined that the search warrant is accurate, allow them to enter and conduct the search. You are not required to speak to them. Advise them that you would like to contact your attorney. Some agents will allow you to use the phone. If so, contact your attorney immediately and he/she should instruct you on what to do. If your attorney does not practice in the area of federal criminal law, or if the agents do not allow you to call an attorney, advise the agents that any questions they may have will be handled by your attorney at a later date. Again, take their contact information and allow them to conduct the search.
The Take Away
You may not be present when the government comes knocking at your door with a search warrant or stops by for a “friendly visit”. Have a plan of action for your employees to follow. Your staff should be trained on that plan. Information gathered by government officials at any meetings with you, your employees or family members can serve as a weapon against you. Being well informed of your rights and knowing what to do in case you are a target or subject of an investigation will protect you from overzealous prosecution.
