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

Genetic Testing: Be Hopeful but Wary

Genetic tests are valuable because they can provide important information to patients and their medical providers regarding diagnoses, treatment, and disease prevention. However, the rapid growth in the number of tests ordered, especially in light of the telemedicine expansion during the pandemic, has invited well-earned scrutiny to the industry.

Make no mistake: genetic testing is heavily regulated (and enforced). The Federal Anti-Kickback Statute, Eliminating Kickbacks in Recovery Act, and Commercial Insurance Fraud Law have all been used to prosecute unscrupulous marketers, call centers, and telemedicine providers in the last few months. Kickbacks in exchange for genetic specimens are just as illegal as kickbacks for patients. Three months ago, a Florida man was sentenced to 10 years in prison for conspiracy to commit health care fraud. His actions resulted in the submission of approximately $3.3 million in fraudulent claims to Medicare for genetic testing.Continue reading

The Case Against Cloning (Medical Records)

medical records cloning

medical records cloningBy: Jacqueline Bain

The transition from paper medical records to electronic medical records has brought with it many conveniences and some unintended consequences. One example of an unintended consequence is cloning in the medical record. Cloning is copying and pasting previously recorded information from a prior patient note into a new patient note.

Providing quality medical care is only one part of the job. Appropriately documenting that care in order to be paid for your efforts is another. And while medical professionals are trained at length to provide care, hardly any are aware of the potential pitfalls associated with improper documentation.

In late 2015, CMS advised that cloning “is a problem in health care institutions that is not broadly addressed.” CMS specified that cloning records may indicate fraud, waste and abuse in inquiries and audits and that each part of a “medical record must contain documentation showing the differences and the needs of the patient for each visit or encounter.”Continue reading

CERT Review and Top Five Medicare Documentation Errors

By: Matthew Fischer

In CMS’ latest “MLN Connects” newsletter, the agency discusses the Comprehensive Error Rate Testing (CERT) program and the top five documentation errors committed by providers.  Providers should pay close attention when CMS releases these types of notices.  If selected for CERT review, providers are subject to potential action such as post-payment denials, payment adjustments, or other actions depending on the results of the review.  Therefore, providers should ensure they fully understand Medicare’s documentation requirements and how to meet these demands. Continue reading

Role of Laboratories in Determining Medical Necessity

medical necessity laboratoryBy: Karina Gonzalez 

A recent whistleblower action (by UnitedHealthcare Medical Director, Tina Groat) against Boston Heart (laboratory) was brought under the federal False Claims Act and deals with medical necessity issues.  As part of the analysis, the Court reviewed whether a laboratory [or supplier like DME] must determine the medical necessity of the ordering physician.  Boston Heart contended that a doctor, not a laboratory, determines the medical necessity of a test.  Boston Heart argued that when a laboratory bills Medicare for testing ordered by a physician, it must only maintain documentation it receives from the ordering physician and ensure that the information that it submitted with the claim accurately reflects the information it received from the ordering physician. It noted that the CMS-1500 form certification does not require that the billing lab to make the medical necessity determination. The lab certifies that the services are medically necessary by relying on the clinical determination of the treating physician.Continue reading

Copay Waiver Questions: OIG Opines that Charities Allowed to Help with Patients’ Insurance Obligations

financial hardshipBy: Jacqueline Bain

In the healthcare business, giving a patient a break on a health insurance copay is often viewed as suspicious. The reasoning for the suspicion is that the financial incentive may give one provider a competitive advantage over another, or persuade a patient to seek services that might not be medically necessary.  Moreover, any person who interferes with a patient’s obligations under his/her health insurance contract may be viewed as tortuously interfering with that contract. However, in an advisory opinion issued on December 28, 2016, the OIG opined that, in certain instances, a non-profit, tax-exempt, charitable organization could provide financial assistance with an individual’s co-payment, health insurance premiums and insurance deductibles when a patient exhibits a financial need.

The party requesting the advisory opinion was a non-profit, tax-exempt, charitable organization that did not provide any healthcare services and served one specified disease. The non-profit, tax-exempt, charitable organization is governed by an independent board of directors with no direct or indirect link to any donor. Donors to the non-profit, tax-exempt, charitable organization may be referral sources or persons in a position to financially gain from increased usage of their services, but may not earmark funds and or have any control over where their donation is directed.Continue reading

Medical Necessity: It’s a Clinical Documentation Necessity

medical necessityBy: Jacqueline Bain

Recently, a Florida-based physician practice specializing in pain management was ordered to pay the Federal Government $7.4 after it was determined that the group’s physicians were ordering medically unnecessary drug screens and billing Medicare for those tests. Federal prosecutors contended that the group’s physicians had appropriately ordered initial drug screens on many patients, but had inappropriately ordered more extensive (and more expensive) follow up tests nearly 100% of the time. Moreover, patient medical records did not reflect the need for more extensive testing.Continue reading

ASAM & Cigna to Collaborate on Performance Measures in Addiction Treatment

Recruitment and Retention Agreements

cigna asamBy: Karina Gonzalez

ASAM and announced a collaborative effort with  Brandeis University to test and validate three ASAM performance measures for addictions treatment. ASAM hopes that this project will provide measure testing of performance measures that will be accepted and adopted in the treatment of patients with addiction.

Three measures will be tested using two years of de-identified Cigna claims data  for  substance abuse.  The measures to be  tested in the study will be: use of pharmacotherapy for individuals with alcohol use disorders; pharmacotherapy for individuals with opioid use disorders and follow-up after withdrawal.  This is expected to be a six month project.Continue reading

Addiction Treatment Attack by Payers Grows

money viseBy: Jeff Cohen

Addiction treatment providers continue to react to an assault by payers to run them “out of town.”  The first round of attacks (in the Fall of 2014) focused on the practice of copay and deductible write offs.  The phrase cooked up by lawyers for Cigna, “fee forgiveness,” wound its way into the courts system in Texas in a case (Cigna v. Humble Surgical Hospital, Civ. Action No. 4:13-CV-3291, U.S. Dist. Ct., S.D. Tex., Houston Division) against a surgery center, where Cigna argued that the practice of a physician owned hospital in waiving “patient responsibility” relieved the insurer from paying ANYTHING for services needed by patients and provided to them.  Though the case did not involve addiction treatment providers, it gave addiction treatment lawyers a look into what was going to come.  The same argument made in the Texas case was the initial attack by Cigna in a broad attack of the addiction treatment industry, especially in Florida.

As addiction treatment providers fielded Cigna’s “fee forgiveness” attack in the context of “audits,” providers held firm to the belief that justice would prevail and that they would soon restore a growing need for cash flow.  “If we just show them that we’re doing the right thing,” providers thought, “surely they will loosen up the purse strings.”  After all, this was a patient population in terrific need of help, with certain [untested] protection by federal law (the Mental Health Parity Act).Continue reading

Audit Decisions Leading to Absurd Outcomes

healthcare businessBy: Karina Gonzalez

Commercial plans continue their audit activity in 2016 demanding many changes and adjustments yet giving little in return. The 2015 audits have not been completed for the majority of substance abuse providers in South Florida, yet the commercial plans have arbitrarily stopped paying new claims even though it takes them at least 6 months to complete a post payment audit.  If and when a provider finally gets an audit result, payors are imposing requirements that just are impossible to meet.

Payors do not appear to be paying attention to the public health crisis of substance abuse addiction and the ever growing need for treatment.   The assumption is being made by the payors that all providers in this space are over utilizing services and engaged in fraudulent practices, despite the reality that  many providers are doing just the contrary.   Continue reading