Memory Care Unit Has Unique Legal Risks

Many of the risks seen in Memory Care are the same risks that arise in skilled nursing and assisted living.  However, there are unique legal risks inherent in the provision of memory care services that leadership should not ignore.  While this article is not an exhaustive list of those risks, some of the often-overlooked enhanced risks are identified below.

By: Karen Davila

Memory Care in the CCC

The existence of a Memory Care Unit allows residents to remain in the CCC longer, but the risks of caring for those individuals increases substantially.  Memory Care services are generally provided in a secure (“closed”) unit with staff with specialized trained to understand the unique needs of residents with dementia.  Risks are different from those elsewhere in the CCC in part due to (a) the geographic and physical isolation (restricted ingress/egress) that are common for Memory Care Units; and (b) the unique capabilities and vulnerabilities of residents, rendering them unable to comply with safety guidance and participate meaningfully in analysis of any adverse event.  Because of this, leadership should recognize and attempt to mitigate risks associated with falls, elopements, aggressive/disruptive behaviors, infectious disease, adequacy of staff training, and 24/7 staff supervision, among others.  Additional thoughts and considerations on each of these are discussed below.Continue reading

Controlled Substances Dispensing Gets Pharmacy in Trouble – AGAIN!

Yet another pharmacy owner was just convicted of unlawfully dispensing over 1.5 million doses of controlled substances, primarily oxycodone and hydrocodone. 

By: Karen Davila

In my last couple of articles, I’ve focused on the controls necessary to safely operate a pharmacy and dispense appropriate prescribed medications, including controlled substances.  And those of you who heed that kind of advice are likely to avoid the unwanted attention of law enforcement.  However, for those who continue to think they can operate with impunity, heads’ up:  the war against opioids in the U.S. is ongoing and enforcement activities are not slowing down.  Below is an article about this recent case out of Texas and some lessons we can all take away from what was reported.

In this most recent case, a federal jury in Texas convicted a Texas pharmacy owner (Carr) on March 7 of one count of conspiracy to unlawfully distribute and dispense controlled substances, four counts of unlawfully distributing and dispensing controlled substances, one count of conspiracy to launder money, and two counts of engaging in transactions in property obtained from the illicit activity.  Carr now faces up to 140 years in prison, among other consequences.Continue reading

Controlled Substances Policies Help Identify Risks Before the DEA Comes Knocking

Today’s Pharmacy Law Topic:  Did you know that your controlled substances policies should be protecting your pharmacy and helping you identify risks before the DEA comes knocking?

By: Karen Davila

As I’ve said in earlier articles, controlled substances are a big part of the business and create significant risks faced by retail pharmacies.  But many of those risks can be mitigated through written policies and procedures and consistent adherence to those policies and procedures.  These are the first line of defense and one of the most important strategies to identify and mitigate the risk of regulatory enforcement action before the DEA comes knocking.

Regardless of the size of your pharmacy, you should have written policies and procedures addressing the core requirements of both federal and state law.  Below is a list of essential controlled substances policies relating to inventory controls, dispensing and destruction/reverse distribution.  Although not an exhaustive list, these are key to decreasing the myriad risks inherent in stocking and dispensing controlled substance prescriptions.Continue reading

Reducing Risks in CCCs with Personal Caregiver Handbooks

Developing a Personal Caregiver Handbook that spells out expectations and accountabilities of both the resident hiring the caregiver as well as the caregiver is one of the best defenses to issues of liability that may arise.  But where do you start in building out the Handbook?  Here are some key considerations as well as areas that should be covered in the Handbook:

Prior to Developing Handbook

Because the CCC’s relationship with its residents is governed by each resident’s agreement and any move-in documents that accompanied that agreement, it is important first to review those documents to determine if there are any barriers to implementation.  Because each resident contract might be different, this process might require review of all versions in effect for any current residents.

Assuming the resident contracts do not require any additional steps before rolling out such a program, the CCC can move to the drafting of the Personal Caregiver Handbook.Continue reading

Real Risks of Caregivers on Continuing Care Community Property

Providing a high-quality and safe environment and care for vulnerable seniors is a top priority for continuing care communities (CCCs).  Senior communities that provide a full continuum for seniors aging in place (including independent living, assisted living, skilled nursing, and memory care) often focus their safety concerns and resources on the licensed areas of the community, where falls and skin breakdown are the subject of lawsuits.  Sometimes overlooked are the risks that arise when independent living residents bring their own personal caregivers into the community to support their needs.

Growing Use of Personal Caregivers

More and more seniors are finding safety and security in CCCs throughout the country.  And, as they age in place, maintaining that independence often involves the use of personal caregivers who come into the CCCs and create additional risks.  Each time a personal caregiver is allowed admittance to the CCC, real risk is created- and that risk can lead to legal liability, including:

  • Injury to other residents
  • Injury to the resident that hired the caregiver
  • Injury to the caregiver caused by other residents
  • Slip, trip and fall (or other general liability claims) by the caregiver against the CCC
  • Theft/damage to property

But there are a few basic steps that a CCC can do to reduce those risks, while still allowing residents their independence.  Here are some simple considerations:Continue reading

Telemedicine Pharmacy Fraud Trial Ends in Convictions

Telemedicine pharmacy arrangements continue to be of significant interest to fraud enforcement.  A 2018 case in which four individuals and seven companies were indicted ended in a month-long jury trial of one of the individuals, a Florida pharmacy owner.  The federal jury trial in the billion-dollar telehealth pharmacy fraud scheme resulted in conviction on 22 counts of mail fraud, conspiracy to commit health care fraud and introduction of misbranded drugs into interstate commerce.  Sentencing in the case is set for May of 2022.  Other co-conspirators entered plea agreements along the way, pleading guilty to various charges including felony conspiracy to commit health care fraud, felony misbranding, conspiracy to commit wire fraud, and fraudulent telemarketing of dietary supplements, skin creams and testosterone.  Many of these are still awaiting sentencing, also expected to be scheduled sometime in 2022.

THE SCHEME

The scheme involved several individuals, compounding pharmacies and telemarketers engaged in a conspiracy to commit health care fraud, mail fraud and introducing misbranded drugs into interstate commerce.  Peter Bolos, along with two other co-conspirators, owned and operated Synergy Pharmacy in Palm Harbor, Florida.  Working with HealthRight, a telemarketer, the co-conspirators generated prescriptions for drugs such as pain creams, scar creams, and vitamins.  Using the HealthRight telemarketing platform, they would call consumers and deceive them into providing their personal insurance information and accept the drugs. HealthRight then communicated the prescription requests to physicians who authorized the prescriptions without ever interacting with the patients, and paid those physicians for issuance of the prescriptions. Through this scheme, the co-conspirators were able to solicitate insurance coverage information from consumers across the county for prescription pain creams, fraudulently obtain prescriptions, mark up the prices of the drugs and bill private insurance carriers.Continue reading

Compounding Pharmacies Remain at the Tip of the Enforcement Spear

Compounding pharmacies are subjected to special licensing and permitting rules because of the heightened risk of the very nature of what they do- customizing a prescription by combining, mixing or altering ingredients to create a sterile or non-sterile medication for a given patient.  Pharmacies may only compound drugs where a commercially available drug/dose/formulation is not available.  Because of the heightened risk coupled with the high cost of compounded drugs and the increased prescribing of these expensive drugs, compounding pharmacies continue to be at the tip of the enforcement spear and a target for investigations.   This and the fact that the number of compounding pharmacies is only a fraction of the number of licensed pharmacies in the U.S., contributes to the increasing visibility when the U.S. Department of Justice prosecutes violators.

Growth of Compounding

From 2006 to 2015, the U.S. experienced a sevenfold increase in the prescribing of compounded drugs.  Recently, the compounding pharmacies market was valued at more than $9 billion and is projected to grow by another $5 billion over the next 30 years.Continue reading

Evaluating Hidden Pitfalls in Contracts

Contracts are a fact of life for all businesses.  But many businesses have in-house attorneys or contract specialists that manage the review and negotiation of the terms and specific conditions of each contract.  Smaller health care providers may not have the luxury of someone on staff to assist with contracting, someone who is particularly astute with contract language and pitfalls.

To evaluate and avoid some of the more common pitfalls, it is critical to review each contract in its entirety, whether the contract is to lease your office space, for internet service in your office, or rental of highly sophisticated medical equipment.  Having an attorney familiar with healthcare law review your agreement is certainly one way to identify and avoid the most common pitfalls.

Some common contracts that health care providers may encounter include:Continue reading

Mandatory COVID-19 Vaccine and Incentives

Can an employer mandate a COVID-19 vaccination?  And if so, are there exceptions/exclusions that must be addressed?  Since the COVID-19 vaccines were first approved for emergency use, the debate has raged as to whether employers can or should require employees (as a condition of employment) to be vaccinated.  And, with large numbers on both sides of the debate, the answer, while clear from a legal standpoint (at least for the moment at the federal level) is not without controversy or consequences.

Requirements for Mandatory Vaccine Policies

Health care employers have long required flu vaccines of their employees, absent a medical reason or religious belief.  Accommodations have been made as required for those who cannot receive the vaccine.  And mandatory vaccines in the health care industry provide some protection for the health and safety of patients and the care providers. The same rationale and rules apply to the COVID-19 vaccine. Continue reading

Health Care Fraud Enforcement Continues to Rock Pharmacy Industry

pharmacy fraud

pharmacy fraudBy: Karen Davila

Yet again, the fraud enforcement arm of the DOJ strikes out against fraud in the pharmacy industry.  Two new cases shed continuing light on the ongoing fraud.

Announced last week by the DOJ, the owner/operator of five pharmacies in New York pled guilty to charges stemming from a scheme to defraud Medicare and Medicaid by billing for prescription drugs that were not dispensed, not prescribed, not medically necessary or dispensed when the pharmacy had no authority to dispense the prescription drugs.  This blatant disregard for the law was magnified when the owner/operator used the ill-gotten gains of her scheme to purchase luxury items like cars and jewelry.  Nothing screams “come and get me” like openly flaunting the money taken from the government.Continue reading