Permissible Payments For Referrals Under The Federal Anti Kickback Statute

anti kickback

anti kickbackBy: Karen Davila

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.Continue reading

Health Care Fraud Enforcement Got You Worried?

healthcare fraud in 2020

healthcare fraud in 2020By: Karen Davila

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:

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What to Do When The Government Comes Knocking

business meeting between healthcare professionals and goverment

business meeting between healthcare professionals and govermentBy: Karen Davila

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.Continue reading

Florida Healthcare Law Firm Begins the New Year with the Addition of Attorney Karen Davila, Pharmacy Law Specialist

fhlf karen davilaFollowing 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.Continue reading

How to Protect Your Pharmacy From Risky Prescriptions

fhlf protect your pharmacyBy: Karen Davila

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:

  1. 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).
  2. 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.Continue reading