Tag Archives: Anti-Kickback

Compounding Pharmacies and Alleged Tricare Abuses Back in the Spotlight

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compounding pharmacyBy: Jacqueline Bain

On Thursday, February 11, 2016, the United States Attorneys’ Office from the Middle District of Florida announced a $10 million settlement with 4 physicians and 2 pharmacies regarding alleged abuses of Tricare program.  The case against these physicians and pharmacies was prosecuted as part of the United States government’s large-scale effort to combat questionable compounding practices.  Investigations revealed that patients were often prescribed compounded drugs that they never used, and that Tricare paid a mark-up cost of nearly 90% for compounded drugs over and above the pharmacy’s actual costs of making the drug.  Roughly 40% of the claims submitted by the pharmacies in question were written by 4 physicians with an ownership or financial interest in the pharmacies.

Tricare is a federal health care program designed to insure active duty military service members, reservists, members of the National Guard, retirees, survivors and their families.  Tricare outpatient costs have almost doubled in the last 5 years, and compound drugs have accounted for a large portion of that increase.  Continue reading →

A Legal Look at The Healthcare Landscape in 2016

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By: Jeff Cohen

MACRA 

The Medicare Access and CHIP Reauthorization Act was enacted to replace the flawed sustainable growth rate (SGR).  MACRA contains performance measures for new payment models that will go in place in 2017.  MACRA also established the Merit-Based Incentive Payment System (MIPS).

Physicians have to begin to learn about MACRA to improve performance and to avoid payment penalties.

We also have the Physician Quality Reporting System (PQRS), which penalizes providers for failing to report quality measures data on Part B services.  To avoid a 2018 PQRS payment adjustment, for instance, providers have to report for a 12 month period.

There is also the Value Based Payment Modifier (VM) program that rewards groups for providing high quality, low cost care.  It’s interesting to note that CMS proposes to publically report those providers who receive an upward adjustment.  It’s being waived for Pioneer ACOs.  It’s interesting to note that the measures used for the VM program are different than those used for ACOs; and this is causing a lot of confusion.

Bottom line:  an increased use of benchmark establishment for quality and cost and financial incentive programs to achieve or surpass those benchmarks.

STARK LAW CHANGES

A new compensation arrangement exception is established for timeshare arrangements for the use of office space, equipment, personnel, items, supplies and other services.  This sort of “overhead sharing” arrangement is done, but there hasn’t been a specific Stark provision for it till this year.  It’s expected to be particularly useful in physician/hospital arrangements.

This exception amplifies the existing requirements that such arrangements must (1) be located where the physician or practice sees its patients, and (2) be used for designated health services that are incidental to what the doctor does, meaning E&M services and DHS that are provided at the time of such E&M services. Continue reading →

OIG Special Fraud Alert: Laboratory Payments to Referring Physicians

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OIG crestThe Office of Inspector General of the Department of Health and Human Services today issued a Special Fraud Alert pertaining to relationships between laboratories and referring physicians.  Payments from labs to physicians who refer were targeted in the Alert.  The Alert also reiterates their suspicion of so-called “carve out” compensation relationships where state and federal healthcare program dollars are removed from the payment formula (which was previously addressed last year in Advisory Opinion 13-03).  While the Alert does not add anything new to the government’s view of such relationships, it does underscore the very suspect view the OIG has of payment relationships between labs and the physicians who refer to them.  Careful compliance with the Personal Services and Management Contracts Safe Harbor continues to be a core concern.

Justice Department Hits Physician Owned Distributorships (PODS)

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money doctorFor the first time, the Department of Justice (DOJ) has fired a shot at a physician owned distributorship (POD).  In the case, the DOJ suit claims that the ownership interest of a neurosurgeon in a spinal surgery device distributorship has caused him to perform unnecessary surgeries.

PODs have been the source of considerable controversy for years.  A couple years ago, they caught the attention of Congress.  The Office of Inspector General of the Department of Health and Human Services (“OIG”) has even issued a Fraud Alert making clear their dislike of PODs and sending a clear shot across the bow of those who are in that industry.  In 2006, the Office of the Inspector General of HHS and CMS expressed major concerns about PODs, and cited concerns about “improper inducements.”  At that time, the OIG stopped short of prohibiting them, but called for heightened scrutiny.  CMS itself has stated that PODs “serve little purpose other than providing physicians the opportunity to earn economic benefits in exchange for nothing more than ordering medical devices or other products that the physician-investors use on their own patients.”

Continue reading →

OIG Blesses Medigap Discount Policy for In-Network Hospitals

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OIG crestBy: Jackie Bain

On February 20, 2014, the Office of the Inspector General posted Advisory Opinion 14-02.  The Advisory Opinion reviews the following scenario for compliance with the Federal Anti-Kickback Statute, 42 USC § 1320a-7b.  Under the proposed scenario, a Medigap insurance provider participates with a preferred provider organization (“PPO”) which contracts with hospitals (“Network Hospitals”).  The Network Hospitals discount Medigap policy-holders’ inpatient deductibles up to 100%.  In exchange for each discount, the Medigap plan pays an administrative fee to the PPO.  The Medigap plan also pays a portion of the discounted savings directly to the policy-holder who stayed at the Network Hospital. Continue reading →

Integrating Clinical Labs Into Substance Abuse Treatment Programs: A Whole Lot of Fuss Over Pee in a Cup

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pee in a cupBy: David Hirshfeld

The recent and drastic cut in reimbursement for point-of-care urinalysis has caused just about all of our substance use treatment program clients to consider integrating clinical laboratories into their enterprise models.  These programs long for a way to restore the revenue stream that urinalysis had generated.  For sober living programs, the lost revenue often means the difference between profitability and breaking even.  For more comprehensive programs, the lost revenue can hinder their ability to expand or provide scholarships to those who could not otherwise afford treatment.  Regardless of their specific goals, our clients are amazed and dismayed at the regulatory minefield that awaits them; especially since their lab consultant (read “reagent salesperson”) makes the process sound so simple. Continue reading →

Kill H.R. 2914

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Background

H.R. 2914 is a bill filed by Congresswoman Speier that is intended (among other things) to prohibit medical practices providing the following sorts of medical services (“Non-ancillary Services”) to their own patients—

*The technical or professional component of (i) surgical pathology, (ii) cytopathology, (iii) hematology, (iv) blood banking, or (v) pathology consultation and clinical lab interpretation services

*Radiation therapy services and supplies

*Advanced diagnostic imaging studies (which include for instance MR and CT)

*Physical therapy services

Continue reading →

Split-Fee Soup: A Recipe for Disaster

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Cauldron-psd74325By: David Hirshfeld

When people ask me what I do, I used to say “I’m a transactional health care attorney.  I represent health care practitioners in their business deals.  I don’t do malpractice.”  That response does little to wipe the blank stare off my questioner’s face, and even I have to stifle the urge to yawn.  My new and improved response is that “I spend a lot of time advising health care practitioners how they can share fees with people who refer them patients.”  Now I get invited to all sorts of cocktail parties !!!

Practitioners split fees with one another for a variety of reasons; and they very often do not realize that a particular arrangement involves a split-fee arrangement, or that split-fee arrangements are often illegal in Florida.  The purpose of this article is to provide practitioners with a general overview of the concepts underlying the prohibition against split-fee arrangements in Florida, in the context of three common business arrangements. Continue reading →

Physicians & Facilities Frustrated in Upcharging Lab Fees

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Licensed healthcare providers and facilities (including many drug and alcohol recovery businesses) who enter into arrangements with clinical labs to provide services to their patients and who then wish to charge more for those lab services will be very disappointed to learn about the restrictions under Florida law.

Section 456.054, Florida Statutes prohibits “kickbacks” and reads—

(1) As used in this section, the term “kickback” means a remuneration or payment, by or on behalf of a provider of health care services or items, to any person as an incentive or inducement to refer patients for past or future services or items, when the payment is not tax deductible as an ordinary and necessary expense.

(2) It is unlawful for any health care provider or any provider of health care services to offer, pay, solicit, or receive a kickback, directly or indirectly, overtly or covertly, in cash or in kind, for referring or soliciting patients.

(3) Violations of this section shall be considered patient brokering and shall be punishable as provided in s. 817.505.

The issue involved in a provider or facility charging more for lab services than they were charged by the lab itself is that the prohibition above applies to healthcare providers and “any provider of healthcare services.”  Regulators may find any reduced fee by the lab to constitute a kickback in exchange for a volume of patient referrals.

A related issue has to do with Florida insurance laws that pertain to charging more for an item or service than the provider or facility was charged.  For instance, if Lab 1 charges the provider/facility $10 for lab work, and the provider/facility charges an insurer $20, that can be found to constitute insurance fraud.

The key Florida prohibition, however, is found in the Florida Administrative Code, which reads—

59A-7.037 Rebates Prohibited – Penalties.

(1) No owner, director, administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person either directly or indirectly, shall pay or receive any commission, bonus, kickback, rebate or gratuity or engage in any split fee arrangement in any form whatsoever for the referral of a patient. Any violation of Rule 59A-7.037, F.A.C., by a clinical laboratory or administrator, physician, surgeon, consultant, employee, organization, agency, representative, or person acting on behalf of the clinical laboratory will result in action by the agency under Section 483.221, F.S., up to and including revocation of the license of the clinical laboratory. In the case of any party or individual not licensed by the agency acting in violation of this Rule, a fine not exceeding $1,000 shall be levied and, as applicable, the agency shall recommend that disciplinary action be taken by the entity responsible for licensure of such party or individual.

(2) No licensed practitioner of the healing arts or licensed facility is permitted to add to the price charged by any laboratory except for a service or handling charge representing a cost actually incurred as an item of expense. However, the licensed practitioner or licensed facility is entitled to fair compensation for all professional services rendered. The amount of the service or handling charge, if any, shall be set forth clearly in the bill to the patient.

(3) Each licensed laboratory shall develop a fee schedule for laboratory services which shall be available to the patient, the authorized person requesting the test or agency upon request and shall be subject to subsection 59A-7.037(2), F.A.C.

In this era where healthcare providers and facilities are struggling to hold onto dwindling profit margins, it is understandable why some are considering arrangements with clinical labs.  Still, Florida providers and facilities have to be extremely cautious when entering into such arrangements.

 

Recovery Business Marketing Not Immune from Anti Kickback Exposure

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Many business people involved in some aspect of the recovery business world (e.g. IOPs, PHPs, Detox) are not aware of the punishing laws that apply to their marketing arrangements.  Simply paying someone a commission based sales compensation without fully appreciate the applicable laws is dangerous and costly.

Continue reading →