prescription drug abuse | The Health Law Firm Blog

DEA Offers New Prescription Drug Return Policy

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Looking to improve the prescription drug abuse epidemic in the United States, the Drug Enforcement Administration (DEA) announced September 8, 2014, that it would permit patients to return their unused prescription medications to pharmacies. This new rule, covering all types of prescription drugs, will give patients the option of mailing unused prescriptions to an authorized collector using packaging provided by the pharmacy.

Hopefully this will help to eliminate many of the problematic situations that pharmacists and physicians found themselves in when they accumulated returned or unused medications from patients for destruction.

This move intends to address the rising number of injuries and deaths associated with controlled substance drugs, particularly opioids. Reducing the stockpile of unneeded prescription drugs from American homes will limit teenagers’ accessibility to their parents’ medications and reduce burglaries for such substances. According to The New York Times, this demographic is known to be the most prevalent abuser of such controlled substances.

To read the full story from The New York Times, click here.

Prior Methods of Prescription Drug Disposal.

Under the Controlled Substances Act, patients were only allowed to dispose of unused drugs themselves or surrender them to law enforcement. Personal disposal of controlled substances typically means flushing pills down a toilet or throwing them in the trash. Because this can pose a risk toward animals and clean drinking water, these methods are frowned upon by environmentalists and the Environmental Protection Agency (EPA).

Drug “take back” programs are another option when it comes to disposing of unused prescription drugs. These events are organized by the DEA and are held twice a year at local police departments across the country. During these programs, citizens can anonymously drop off any unused prescription drugs. According to The Wall Street Journal, the Department of Justice (DOJ) reported that a nationwide event in April 2014 brought in 390 tons of prescription drugs at more than 6,000 sites. In the past four years, these collection events have removed from circulation more than 4.1 million pounds of prescription medication from across the country.

Although these events prove successful, many healthcare professionals are optimistic for the bigger impact the pharmacy “take back” programs may have. Providing consumers convenient year-round access to medication disposals will be positive reinforcement to regularly dispose of unused prescription medications. This method is believed to be more likely to accomplish the mission of shrinking the pool of unused and potentially fatal controlled substances in American homes.

To read the full article from The Wall Street Journal, click here.

Ironing Out Details of the New Plan.

There are many logistics to consider to ensure these pharmaceutical “take back” programs will be successful. The programs will not be mandatory, as the decision to take part will be the under the sole discretion of each company. The pharmacies must voluntarily choose to register with the DEA in order to start receiving the leftover prescriptions. In the past, pharmacies have not generally wanted to accept the hassle of offering such a program. However, the DEA expects many pharmacies to jump on the bandwagon to showcase good-faith effort of keeping drugs out of the wrong hands.

DEA-approved organizations collecting the unused drugs will include hospital pharmacies, narcotic treatment programs, and companies contracted by other collectors to destroy controlled substances.

There are concerns circling the initiative. Some pharmacies do not have the resources required to accommodate incinerators, thus limiting the locations available to consumers. In addition, professionals are concerned with the lack of regulations listed in the new plan. There are no set requirements on how the prescriptions should be destroyed. The rules simply mandate that the drugs are altered into a permanent, irreversible state.

The burden of payment has also not been discussed or outlined in the new plan. Who will cover the cost of packaging and disposal has yet to be decided. Also, to be considered is the challenge of keeping the returned prescriptions safe until destruction. An unsecured, unmonitored return site containing stock piles of addictive drugs would be a gold mine for many addicts and criminals. Should a theft occur at one of these drop-off receptacles, who would be held liable? The American Pharmacists Association has already expressed concern of pharmacy legal liability.

The biggest obstacle of all, however, may be convincing the general public that returning unused pills is a necessary moral obligation.

Comments?

Would you participate in this type of prescription drug return program? As a pharmacist or someone who works at a pharmacy, what are your concerns with this take back program? Please leave any thoughtful comments below.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide deposition coverage to pharmacists, pharmacies and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals. We can review business referral arrangements and provide legal counsel on whether they are not in violation of federal and state anti-referral laws. The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants and other health professionals in investigations and at Board of Pharmacy hearings.

To contact The Health Law Firm, please call (407) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Barrett, Devlin. “U.S. to Allow Pharmacies to Take Back Unused Prescription Drugs.” The Wall Street Journal. (September 08, 2014). From: http://online.wsj.com/articles/u-s-to-allow-pharmacies-to-take-back-unused-prescription-drugs-1410186602

Saint Louis, Catherine. “D.E.A. to Allow Return of Unused Pills to Pharmacies.” The New York Times. (September 08, 2014). From: http://www.nytimes.com/2014/09/09/health/unused-pills-return-to-pharmacies.html?_r=0

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

“The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2014 The Health Law Firm. All rights reserved.

Dentists: Tightened Controls on Prescribing to Medicare Part D Patients Could Affect Your Practice

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

Starting June 1, 2015, Medicare Part D will no longer reimburse patients or pharmacies for prescriptions unless the dentist opts in and enrolls in Medicare, or opts out and enters into a private contract with the patient. This measure is part of a rule finalized by the Centers for Medicare and Medicaid Services (CMS). The purpose of the rule is to assist CMS in cracking down on doctors, dentists and other health care providers that are improperly prescribing drugs to Medicare patients.

Medicare Part D plans provide supplemental optional coverage for prescription medication used in dentistry, are administered by private health plans and are paid for by way of premiums. As a dentist, if you have patients with Medicare Part D, you need to choose whether to enroll as a Medicare provider or to opt out. Click here to read the final rule from CMS.

Specifics of the New Rule.

Dentists have until June 2015 to either enroll in Medicare or formally opt out. When a dentist enrolls, the government verifies his or her professional license and credentials, and checks his or her criminal history. In addition, the final rule expands rewards and incentive programs focusing on participation in activities that promote improved health, efficient use of health-care resources and preventing injuries and illness.

One new stipulation is that the federal government has the authority to expel physicians from Medicare if found to be prescribing drugs in an abusive manner or in violation of Medicare rules. In addition, CMS will be able to terminate a dentist’s Medicare enrollment if his or her Drug Enforcement Administration (DEA) certification has been revoked, or if the state licensing board has stripped his or her authority to prescribe drugs.

To read more on how abusive prescribing patterns will be determined, click here.

Enrolling Versus Opting Out.

If you enroll in Medicare Part D as a treating provider, then you are going to be subject to increased oversight and regulations, including:

– Fraud investigations;
– The minimum patient record retention increases from four to five years;
– You must be careful when denying services to Medicare recipients;
– You can’t charge Medicare for missed appointments; and
– You may have a percentage of your Medicare reimbursement withheld beginning next year if you don’t have electronic health records (EHRs).

On the other hand, if you opt out of part of Medicare, then you opt out of other parts as well, which may lead to a loss in revenue and disgruntled patients.

Examine Your Practice and Make Your Own Decision.

Your decision to enroll in or opt out of Medicare should be determined by the types of patients you treat and the services you provide. If your practice consists of patients under the age of 65, you may be unaffected by this rule. However, if you practice in an area with an older population, Medicare coverage is more likely to be part of your practice. The important point is to understand how it may or may not affect your practice’s bottom line. If you need some guidance or have questions, call an attorney experienced in representing dentists.

Comments?

Will this final rule affect you? If so, how? Please leave any thoughtful comments below.

Consult With An Attorney Experienced in the Representation of Dentists.

We routinely provide deposition coverage to dentists, dental hygienists and other health professionals being deposed in criminal cases, negligence cases, civil cases or disciplinary cases involving other health professionals.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing dentists and dental hygienists and other health professionals in investigations and at Board of Dentistry hearings. Call now or visit our website www.TheHealthLawFirm.com.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

The Health Law Firm” is a registered fictitious business name of George F. Indest III, P.A. – The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1999-2015 The Health Law Firm. All rights reserved.