Pharmacy Enforcement Remains Top Priority

Today’s Topic:  Did you know that pharmacies and pharmacists continue to be a top enforcement priority for the U.S. Department of Justice and the myriad health care fraud task forces around the country?

Recent Sentencing in Compounding Pharmacy Fraud Case

This past week, a Mississippi pharmacist was sentenced to 5 years in prison for defrauding TRICARE (the government healthcare payer for the U.S. military and veterans) and some private insurance companies of $180 million through various kickback schemes.  These schemes might sound familiar because they all take on common characteristics- essentially payments to someone in exchange for referral of prescriptions to boost the pharmacy’s numbers.  And, more often than not, these prescriptions are medically unnecessary and driven by the greed of the people involved instead of the best interests of the patients.

This particular case became known as the “Mississippi Pain Cream Scheme” and led to three individuals who pled guilty, were sentenced to jail time and lost virtually everything. This past week’s announcement involved the sentencing of David “Jason” Rutledge, a pharmacist and co-owner of several compounding pharmacies.  Two others pled guilty earlier, including a Louisiana veteran, Tommy Shoemaker, who in December was ordered to pay $1.7 million in restitution and forfeit proceeds from the sale of his luxury vehicles.  And the Florida connection- Mitchell “Chad” Barrett of Gulf Breeze, was the mastermind behind this scheme as well as a larger national scheme that resulted in more than $1.5 BILLION in fraud nationwide!  It’s no wonder the government is on the hunt.Continue reading

Compounding Pharmacy Enforcement Shows no Signs of Slowing

There’s certainly a lot of enforcement activity against compounding pharmacies these days.  The ramp-up began around 2012 after a fungal meningitis outbreak that caused 64 deaths and many more infections related to the compounding activities at New England Compounding Centers.  That heightened scrutiny continues to rock the compounding pharmacy world, not just from the drug quality, safety, and security standpoint, but also from the standpoint of the potential fraud and abuse inherent in the pricing of ingredients and the final compounded product as well as relationships between compounding pharmacies and the physicians who refer to them.

LATEST ENFORCEMENT ACTION

Announced yesterday by the U.S. Department of Justice (DOJ), the latest enforcement action is against Professional Compounding Centers of America Inc. (PCCA), a Houston-based supplier of wholesale compounding ingredients to other pharmacies.  In many prior enforcement actions, compounding pharmacies have been charged in various schemes to defraud the federal government by filing false claims for prescriptions that were not medically necessary or not requested by patients and paying kickbacks to prescribing physicians.  While similar in some ways to prior enforcement actions, this one differs because in this case, the DOJ reached back to the wholesaler of the compounding ingredients that were sold to the pharmacies that then submitted inflated claims to TRICARE.  Here, the DOJ nabbed PPCA in a complaint alleging False Claims Act violations, specifically that PCCA reported fraudulent and inflated Average Wholesale Prices (AWPs) for the compounding ingredients that it sold to pharmacies.  Those inflated AWPs resulted in pharmacies submitting inflated claims to TRICARE, the federal payer for military personnel and their dependents.Continue reading

Operation Double Helix – Unprecedented Genetic Testing Fraud

By: Karina P. Gonzalez 

According to the Department of Justice (DOJ) genetic testing is the next frontier for healthcare fraud.

In a fraudulent operation that the Department of Justice calls, “unprecedented”, elderly or disabled patients nationwide were lured into providing their DNA for testing in a widespread genetic testing fraud scheme powered by a large telemarketing network. The doctors involved were paid to write orders prescribing the testing without any patient interaction or with only a brief telephone conversation.Continue reading

OIG Unveils Latest Tool for Evaluating Fraud Risk

OIG fraud risk
OIG fraud risk
https://oig.hhs.gov/compliance/corporate-integrity-agreements/risk.asp

By: Karina Gonzalez

The Office of Inspector General (OIG) announced the launch of a new tool on its website titled the “Fraud Risk Indicator”.  The OIG has stated that the purpose for the tool is to provide guidance on how it has evaluated risk in settling False Claims Act (FCA) cases and to publicize information about where FCA defendants fall on the OIG’s risk spectrum.  This tool can benefit patients, healthcare industry professionals and other individuals who may find this information relevant.   This tool will also benefit the public with information about providers charged under the FCA that are at high risk for committing healthcare fraud. The Indicator shows the Risk Spectrum from Highest Risk to Lower Risk.Continue reading

Behavioral Analysis Medicaid Providers: Florida’s Latest Enforcement Target

behavioral analysis medicaid

behavioral analysis medicaidBy: Matt Fischer

Florida’s Agency for Health Care Administration (“AHCA”) is the state’s chief health policy and planning organization.  AHCA is also responsible for the state’s Medicaid program.  One of the agency’s latest targets are behavioral analysis providers who treat children with autism.  Recently, AHCA imposed a temporary six-month moratorium on enrollment of new providers due to newly discovered fraud and abuse.  AHCA states that the temporary moratorium will allow the agency the time to complete a full assessment of the current provider population.  In other words, all behavioral analysis providers will experience heightened scrutiny in the coming months if not already.  This can include in-person interviews and requests for records.  Given this increased regulatory action, it is important for behavioral analysis business owners to be aware of the audit process and to prepare for likely future reviews.

Here are a few of the notable findings cited by AHCA regarding the identified fraud and abuse:Continue reading

Haven’t Thought Much About Compliance Lately? The Government Has


It is estimated that health care fraud is a $60 billion a year business fueled by illegal conduct such submitting false claims and paying kickbacks to physicians and suppliers. Until recently, if large health care organizations were the targets of fraud investigations, these companies, as their penance, typically wrote a big check to the government and continued business as usual. Things have changed.

While indicting and convicting health care executives is not a new practice, officials at the Department of Health and Human Services (“DHHS”) and the Department of Justice (“DOJ”) are said to be frustrated with the frequent occurrence of repeat violations and they are ramping up their strategy. Lately there have been aggressive new initiatives rolling out to combat rampant health care fraud and the government is increasingly bringing criminal charges against executives even if they were not complicit in the fraud scheme, but could have stopped it if they had known.

What’s more striking is that in addition to civil monetary penalties and criminal indictments, the government is taking great efforts to exclude convicted executives from being involved in companies that do business with federal health programs. A recent bill introduced to Congress under the name of the “Strengthening Medicare Anti-Fraud Measures Act of 2011 (the “Act”), increases DHHS’ existing powers and allows them to seek to exclude owners, officers and mangers of companies that are convicted of health care fraud from federal healthcare programs even if they left the company prior to any conviction of the entity.

In addition to the expansion of the permissive exclusion afforded by the Act to DHHS, regulators and law enforcement officials are going to be increasingly utilizing current permissive exclusion remedies. DHHS’ bold move appears to be based on the rationale that the permissive authority of Secretary of DHHS or the Office of the Inspector General of DHHS to exclude individuals is a much easier process than criminal proceedings.

The impact of this aggressive new government strategy will likely have even further reaching consequences for convicted healthcare business owners and executives. For instance, an exclusion from being part of a business that works with federal health care programs would be a career ending blow for most executives. It should also be emphasized that smaller organizations are not in any way immune from enforcement activity. In fact, with newly increased enforcement budgets, authorities have the means and the time to target organizations of all sizes.

Law makers and regulators are hopeful that by ramping up the enforcement of existing laws and expanding the scope of DHHS’ power, it will act as a powerful deterrent against overt acts and will compel corporate executives to take proactive steps in preventing fraudulent activities and affirmatively addressing fraudulent practices when discovered. It is vitally important now more than ever, to have an active compliance program in place. A strong compliance program can not only detect and prevent fraudulent or negligent activities but also will typically be considered as a mitigating factor if an organization is culpable of fraudulent activity. The Florida Healthcare Law Firm works with health care organizations of all sizes to assist in the audit, development and implementation of effective compliance programs.


D.C./M.D. Arrangements Share Legal Issues Nationwide

chiropractic medicare

Chiropractors and medical doctors (or D.O.s) have had a long and somewhat complex relationship. Though they approach healthcare issues differently, there are many instances where they share care or even work together. Such “M.D./D.C.” relationships are legally complex, but often prove to be rewarding in many respects. Properly constructing the arrangements is critical, especially since government regulators and payers tend to view such arrangements with skepticism, alleging that the true reason for the combination is for chiropractors to avoid coverage restrictions.

The core legal issues the parties need to be aware of include:Continue reading

OIG Advisory Opinion Nicks the Heels of "Company Model" Arrangements

palm beach county task force

A “company model” arrangement is reasonably popular in surgery centers these days. The model entails a legal entity owned by both anesthesiologists and referring surgeons, which performs anesthesia. Why not just have the surgery center contract with an anesthesia group to performs those services? Because the referring surgeons who are owners of the surgery center want to share some of the anesthesia fees. Does it raise fee splitting and fraud and abuse issues? You bet, but there is no real clear or direct legal guidance from any governmental body yet. A recent OIG Advisory Opinion will have physicians and healthcare lawyers alike buying new spectacles to keep a closer watch on how the legal issues unfold.Continue reading

2010 Has Already Been a Huge Year in Healthcare

             Healthcare reform alone is enough of a Rubik’s Cube, but CMS and the OIG has been especially well-staffed these days, enough so that their offices are turning out new laws and interpretations at an alarming rate.  Though it may seem overwhelming, physicians need to work harder than ever to stay on top of the changes.

Health Information Technology (HIT)

            The physician incentive payments/penalty provisions that piggybacked their way onto the federal healthcare reform law have physicians concerned and scrambling.  IT vendors and advisors are drawn to the opportunities the new law has created; and physicians need to be educated and wise. 

             The so called “HITECH” provisions of the federal healthcare reform law create a pot of about $34 Billion worth of incentive payments for eligible professionals and hospitals that attain meaningful use of certified electronic healthcare records (EHR) technology.  To obtain any money, eligible parties will have to demonstrate full compliance no later than 2015, and earlier (2011!) if they want the full benefit.  Medicare has allocated roughly $44K worth of incentives for each compliant physician; and Medicaid offers another $20K roughly, but the real incentive is not the money; it’s the fact that financial penalties apply if you don’t comply by 2015.

             Financial incentives are available for eligible professionals who use certified HIT which satisfies the “meaningful use” regulations, which were issued August 2010. They are complex and limited by time lines which industry insiders claim to be unreachable. Vendors are, nevertheless, selling and physicians are buying software and solutions in hopes they will qualify for the incentive payments.  Physicians should make sure that their contracts with such vendors protect them by requiring the solutions to be certified and meet the meaningful use guidelines. 

Healthcare Reform

            Though everyone is scared about how healthcare reform will unfold, remembering the past may help.  The fact is the concepts in the Act are not new.  For instance, IPAs, PHOs, capitation and the like are the cornerstone of the reform.  Physicians have seen these before, though not on a government mandated basis.  Moreover, where those models were once purely financial, there is a heavy clinical outcome component woven into the regulations. 

            No matter how one views it, the Act creates huge opportunities for physicians and others.  Risk based compensated Accountable Care Organizations (ACOs) are slated to be the new platform for healthcare delivery.  Good news for PCPs:  regulators and think tankers think that physicians, especially primary care physicians, are the best positioned to lead the ACO development charge.  That said, the form the ACOs will take is completely unclear and is expected to unfold over a period of ten years.  Like technology vendors, physicians have to be wary of anyone who has something to sell at this time.  One size does not fit all!  IPAs might be a great vehicle to start.  Capitated models are familiar, but a bundled payment methodology may work better in some circumstances.  One thing that is certain:  whatever business model a physician explores ought to be able to bear financial risk (e.g. capitation or bundled payments) and measure clinical outcomes, because both elements will form the basis of payments of the future.  Though specifics about the future of healthcare are unavailable, the following is a fair list of what’s likely:

  1. Movement away from fee for service payment to risk based compensation;
  2. The prevalence of IT & EMR;
  3. The need to demonstrate clinical effectiveness;
  4. An expanded role of primary care physicians;
  5. Expansion of concierge type services;
  6. Employment of physicians by hospitals;
  7. The development of larger medical practices;
  8. More patients (through insurance mandates and expansion of Medicaid     eligibility);
  9. Expanded use of “physician extenders” (as the PCP shortage worsens); and
  10. Increased enforcement in the area of healthcare fraud (civil & criminal).

OIG and CMS Pronouncements

            May was a busy month for healthcare regulators.  SMS issues the Ambulatory Surgery Center Waiting Area Separation Requirements, which has had the effect of preventing creative business opportunities between ACSs and other healthcare businesses.

            Additionally, the OIG recently issued an Advisory Opinion which makes it very difficult for imaging centers to do prior authorizations for referring physicians.

Fraud and Abuse

            If the first 2/3 of 2010 are any indication of the future in healthcare law, healthcare business professionals have a lot to keep up with. Enforcement by the Justice Department and the Office of Inspector General is in full swing. Already, for instance, nearly $2 million has been repaid as the result of employing a person who has been excluded from a federal healthcare program. Examples include:

Read On at www.FloridaHealthcareLawFirm.com