Health law is the federal, state, and local law, rules, regulations and other jurisprudence among providers, payers and vendors to the healthcare industry and its patient and delivery of health care services; all with an emphasis on operations, regulatory and transactional legal issues.
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. read more
The term “payment for referral” strikes fear in the hearts of health care providers throughout the country because of the significant prohibitions under the federal Anti-Kickback Statute (AKS). And, Florida’s Patient Brokering Act (PBA) casts an even bigger shadow over arrangements involving payment in exchange for referrals. There are other statutory restrictions as well, which may apply depending upon the services for which a referral is being made. Those include but are not limited to statutes prohibiting physician fee-splitting and the federal Eliminating Kickbacks in Recovery Act (EKRA) (applicable to referrals to recovery homes, clinical treatment facilities, or laboratories in an effort to stave off growing opioid-related fraud), and the potential collateral damage of a false claim under the federal False Claims Act (FCA) if any of the above statutes are violated.
So, is there any scenario where a payment may be made by a health care provider in exchange for referrals? The answer is yes- there is a safe harbor under the AKS (42 U.S. C. §1320a-7b(b)) specifically for such arrangements. This safe harbor is not commonly used and likely means revision to existing arrangements to come into compliance with its specific requirements. But it may be worth considering if the referral (and payment for that referral) is not otherwise prohibited as noted above. read more
Healthcare fraud continues to be a significant priority for the U.S. Department of Justice. On February 24, 2021, the DOJ’s Criminal Division Fraud Section published its annual “Fraud Section Year in Review 2020.” While the Fraud Section has three separate enforcement units, the Health Care Fraud (HCF) Unit is responsible for all enforcement activities in the health care industry. The Unit’s focus is to protect against fraud and abuse in federal health care programs and recoup illicit gains.
During 2020, the HCF Unit operated 15 strike forces in 24 federal judicial districts throughout the U.S. The efforts of these strike forces led to charges against 167 individuals alleging $3.77 billion in fraudulent charges for health care paid for by federal and state programs. This should cause any health care provider to stand up and take notice. And enforcement in the health care industry is not likely to go away soon with so many schemes ripe for the government’s picking and generating recoupment on behalf of the federal health care programs.
Here are couple of the latest schemes that have landed pharmacies, pharmacists and other health care professionals squarely in the crosshairs of federal enforcement:
You do everything right. You’re careful to dot your i’s and cross your t’s. Compliance is hard-wired because you’re in an industry that’s highly regulated and you’ve built into your operations a series of compliance checks and balances. However, even with strong controls in place, compliance efforts sometimes fall short– and whether you’re a physician group, a pharmacy, a durable medical equipment company, a home health agency, or any other health care provider, someday you might find yourself face-to-face with law enforcement officials or regulatory enforcement authorities. What do you do? How do you assure the most successful outcome with minimal business disruption?
Compliance is the foundation to mitigating the risks inherent in any health care operation. Compliance can reduce the likelihood that regulators or law enforcement suddenly appear on your doorstep. But preparation for emergencies and uncertainties is the key to reducing the risk that non-compliance leads to lengthy business interruption. Although you may be saying “if”, you really should be thinking and acting more like “when”. It costs everything to be ill-prepared and it costs very little to be well-prepared. The following preparation can prevent much of the uncertainty that arises in these cases.
POLICIES AND PROCEDURES
First and foremost, make sure you have well-developed policies and procedures for what to do in such instances. You should review these policies and procedures with your employees regularly, focusing on the importance of compliance. Out of fear and uncertainty, employees can do things that create unnecessary challenges. Educating them as to what their rights and responsibilities are will mitigate those risks. Make sure your policies and procedures include the designation of who is in charge (“person in charge”) when the government does show up. read more
Following last year’s growth expansion, Florida Healthcare Law Firm in Delray Beach, FL has hired board certified attorney (in Health Law) Karen Davila, as of January 4, 2021. Karen will play an essential role representing healthcare businesses with a specialized focus on retail pharmacy owners and operators. Karen has nearly 30 years’ experience in the health law space and is licensed in both Florida and Illinois.
Florida Healthcare Law Firm has announced that they have added Karen Davila to the team. Karen brings a wealth of healthcare business expertise working with national corporate pharmacies, large hospitals and local family-run businesses. As part of the firm’s expert pharmacy law team, Karen will advise independent pharmacies on matters such as PBM audits, regulatory compliance and transactional support. She also has experience complex provider relationships, reimbursement, fraud and abuse, DEA and FDA regulatory compliance, scope of practice of health care professionals, and quality/patient safety issues across the health care continuum. read more
Pharmacies and their pharmacists are in a very tough spot in the current regulatory enforcement environment. This is particularly true with dispensing controlled substances. Headlines like the below are commonplace:
DEA RAIDS PHARMACY AS PART OF LOCAL DRUG SWEEP
PHARMACY PAYS $500,000 IN PENALTIES FOR CONTROLLED SUBSTANCES ACT VIOLATIONS
MAN ARRESTED USING DOCTOR’S PRESCRIPTION PAD TO WRITE FRAUDULENT RX’S
So, how do you avoid filling a fraudulent prescription for controlled substances? Before getting into the nitty gritty, it is important to lay the foundation of standard of care and the corresponding responsibility so pharmacies and pharmacists can evaluate what steps are most likely to mitigate these risks.
As background, federal law states that the primary responsibility for prescribing controlled substances rests with the prescriber. However, that same law places a “corresponding responsibility” on the pharmacist to assure each prescription is written for a legitimate medical purpose pursuant to a valid patient-prescriber relationship. 21 CFR §1306.04(a).
Under Florida law:
A pharmacist may not dispense a Schedule II-IV controlled substance to any patient or patient’s agent without first determining, in the exercise of her or his professional judgment, that the prescription is valid. F.S. §893.04 (2)(a).
A prescriber or dispenser must consult the prescription drug monitoring system, eForce, to review a patient’s controlled substance dispensing history before prescribing or dispensing a controlled substance.S. §893.055
Once you have a clear understanding of a pharmacist’s liability, you can then consider ways to mitigate the inherent risks in filling controlled substance prescriptions. read more
DOES YOUR BUSINESS NEED A MANDATORY VACCINE POLICY?
Given the above, does a mandatory vaccine policy make sense for your organization? This may depend on several factors, including the following:
Are your employees in direct contact with clients/customers/patients?
Is that contact prolonged and in indoor spaces where air circulation may be limited?
If one or more of your employees become ill, does that jeopardize continuity of your business?
If you answer “YES” to one or more of these questions, you may want to consider implementing a mandatory flu vaccine.
In order to effectively implement a mandatory vaccination policy, you must develop both the policy and the process to manage exceptions (i.e. requests for accommodations). The process generally involves the submission of an employer-developed form along with any additional supporting documentation. The accommodations process should include review of information submitted by the employee in support of the accommodation, request for additional information as and when appropriate, an interactive process between the employer and employee in evaluating any potential accommodation, and ultimately a determination if the requested accommodation poses an undue burden that is more than de minimis on the employer. read more
Can an employer require employees to be vaccinated against influenza? And, a COVID-19 vaccine likely will be approved in the not-to-distant future. What about that vaccine when it becomes available? These are questions with which many organizations are grappling today. With the confluence of what is expected to be a very active influenza season and the ongoing and unprecedented COVID-19 pandemic, employers are contemplating how best to protect their workforce and clients/customers/patients.
One of the most effective ways to achieve this is a mandatory vaccine policy, but is that right for your organization? Mandatory vaccination programs are not new. Depending on your business, a mandatory vaccine policy may be the industry norm. What factors should you consider? What processes would you need to develop to address exceptions?
CAN YOUR BUSINESS MANDATE VACCINATIONS?
In general the answer is yes. Although federal and state laws may vary, such programs are permissible provided any mandatory vaccination policy incorporates processes to address the required exceptions: medical accommodations under the Americans with Disabilities Act (ADA); and religious accommodations under Title VII of the Civil Rights Act of 1964 (Title VII). read more
For some reason, wearing or refusing to wear masks has become a point of personal expression and a topic charged with much emotion. We hear stories every day about confrontations with consumers in the retail industry. But what about when a patient refuses to wear a mask?
In many states and counties, face coverings are still mandated in public. Failure to wear a mask can result in civil or criminal fines or penalties. In a medical practice, even where not required by local authorities, masks may be required. In fact, some of the state Boards of Medicine have adopted minimum standards for safe practice. Those standards frequently include the requirement for both provider and patient to wear masks during all health care encounters. Where the regulations or Board of Medicine standards require all individuals to wear face coverings, a health care provider is well within his/her right to enforce those regulations within the office where health care services are being provided and to discharge a patient who refuses to comply. However, caution must be exercised when discharging a patient from a medical practice.
In general, the state Boards of Medicine do not require physicians to treat patients who are physically and mentally capable of wearing face coverings but refuse to do so. But there are circumstances where a physician may have a duty to provide care and, in such instances, exceptions to the general rule may apply. read more