Category Archives: Department of Health

SHOOT, READY, AIM: Palm Beach County’s Blind Shot at the Addiction Treatment Industry

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addiction treatment industryBy: Jeff Cohen

We should all be afraid when there is a “war” declared on anything in our culture because it usually means the complex will be simplified, the innocent will be presumed guilty, details will be ignored and the baby will be thrown out with the bathwater.  Nowhere is that more apparent than the current War on Sober Homes in Palm Beach County.

When we read the stories published by the Palm Beach Post, we learn things like–

  • It is illegal for a sober home to receive payment from an addiction treatment facility for providing so called “case management” services;
  • Addiction treatment providers unethically bill thousands of dollars for urine tests that could be provided for pennies via a cup for sale at Walgreens; and
  • The Patient Brokering Act, a state criminal law, is being broken left and right by sober homes and addiction treatment providers.

Hooey!  It’s completely misleading.  Here’s why:

Case Management Issue.  The arrangement reported In the Post and described in charging documents describes a business arrangement where sober homes are paid by state licensed addiction treatment providers for helping addicts along their path of recovery.  Addiction treatment sees these patients maybe 20 hours a week.  Where are they the rest of the time?  What are they doing?  Addicts seeking treatment often have soft life skills from being off the grid, are often receiving assistance from supportive staff at sober homes who help them get on their feet.  They often come into treatment with no clothes, no money, no food, no job skills and a whole host of medical and psycho social needs.  And addiction treatment facilities want (and sometimes pay for) sober home staff to serve a function in the continuum of care, sometimes want to give them food cards, clothing, cigarettes and whatever they need to accept treatment.  And our sole focus is to do what, focus our regulatory attention on a business relationship that may exist in the treatment industry?  Continue reading →

T’was the night before the First Tuesday after the First Monday in March, and all through the House (and the Senate…)

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FLBy: Dave Davidson

It’s that time of year.  People are scrambling around, deciding what they want to give and what they want to get.  Brand new packages are being wrapped up and filed away.  Excitement and tension fill the air. Everyone can’t wait for the big day; but in this season that big day doesn’t happen until the first Tuesday after the first Monday in March.  But it’s never too early to start getting ready, right?  In fact, the Florida Legislature is currently in session, drafting and filing bills that the sponsors hope will be considered in March and will become law in 2016.  And as usual, health care is on a lot of legislative wish lists.  Although all of these bills are subject to significant revision, and some may never make it out of a subcommittee, here’s a sneak peek of some of the proposed health care legislation (without editorial – for now).

Scope of Practice Expansion

Three categories of health care professionals may see significant expansion of the scope of their practice.

Both Advanced Registered Nurse Practitioners and Physician Assistants would gain the right to prescribe controlled substances pursuant to Senate Bill 676.  Most of the details about specific medications and dosages is left to an administrative committee, but the bill seems to anticipate broad authority.  The bill also adds references to ARNPs and PAs throughout the Florida Statutes, indicating a willingness to accept these professionals into a significant role in the delivery of care.  Additionally, SB 572 would add PAs and ARNPs to the list of providers who can certify that an individual meets Baker Act criteria to justify a patient’s involuntarily confinement for mental health reasons. Continue reading →

Fall 2014 HIPAA Audits: Is Your Business Ready?

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hipaa-audits-imageFile-3-a-7296By: Jackie Bain

Section 13411 of the HITECH Act authorizes and requires the Department of Health & Human Services Office for Civil Rights (“OCR”) to provide for periodic audits to ensure that covered entities and business associates comply with the HIPAA Privacy and Security Rules. OCR conducted its first round of those audits in 2011 and 2012, and has announced that it will begin a second phase.  Unlike the first phase of audits, which were limited to covered entities, both covered entities and business associates are intended to be audited during this second phase.

How will audited businesses be selected?

This fall, OCR will deliver pre-audit surveys to between 550 and 800 covered entities.  OCR is attempting to obtain a fair snapshot of all covered entities, so these pre-audit surveys will be sent to health care providers, health plans, and health clearinghouses. Moreover, the audits will span the gamut of business sizes, from large corporations to solo practitioners. After pre-audit surveys are returned, OCR will randomly select 350 of those covered entities for a full audit.  As a part of these full audits, covered entities will be asked to identify their business associates.  OCR will then select 50 business associates to participate. Continue reading →

$800,000 HIPAA Settlement for Leaving Patient Records on Physician’s Front Porch

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HIPAAThe Department of Health and Human Services announced this morning that it has entered into a settlement agreement with Parkview Health System, Inc., an Indiana medical group caught up in HIPAA violation case.  Parkview was assisting a retiring physician to transition her patients to new providers.  Parkview was also considering purchasing some of the physician’s patient records.  When Parkview attempted to return between 5,000 and 8,000 patient records to the physician, she was not home to accept their return.  Parkview employees left cardboard boxes containing between 5,000 and 8,000 patient medical records outside of the physician’s home, and within twenty feet of a public road.  In settlement and release of HHS’ claims against Parkview for such a HIPAA violation, Parkview agreed to pay the Department of Health and Human Services $800,000 and enter into a Corrective Action Plan.  The entire Resolution Agreement between Parkview and HHS is available here.

Physicians in the Middle of the Marijuana Battle

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medical marijHow physicians became the gatekeepers between cannabis and the public and how physicians should approach cannabis as a form of treatment

By: Jacqueline Bain

The Federal Government lists marijuana as a “Schedule I” controlled substance, meaning it has a high potential for abuse and no currently accepted medical use.  21 USC § 812(b)(1).  Because there is no current accepted medical use, Federal law prohibits physician from issuing prescriptions for marijuana.  21 CFR § 1306.04(a).  However, the Federal Government has traditionally deferred to the States to prosecute small-scale marijuana violations.  This lack of Federal enforcement has encouraged the States to enact less stringent controls on the marijuana industry. Continue reading →

OIG Comes Down Hard on Physician Owned Distributorship (POD) Arrangements

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OIG crestOn October 24, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released its long-awaited report on the prevalence of physician-owned distributorships (PODs) and the increased costs incurred by Medicare following the rise of these entities. The U.S. Senate and OIG’s investigation of PODs began in earnest in 2011 with the release of the Senate Finance Committee’s POD overview and inquiry.1 This was followed by a Special Fraud Alert issued by OIG, which characterized PODs as “inherently suspect under the anti-kickback statute.”2

Is The End of Stark (and IOAS) Near?

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gavel

Background

Since its passage in 1989, the now ubiquitous federal law known as the Stark Law has driven the business behavior of health care providers of many kinds.  Recent developments, however, make us wonder whether the end of Stark is near, and if so, whether that’s a good thing.

By way of background, the Stark law has two components:  part one, a self referral prohibition, generally forbids physicians from referring to a provider of any “designated health service” (DHS) (e.g. MRI, PT, clinical lab) if the physician or his/her immediate family member has a financial relationship (including ownership interest) with the provider of the service.  Part two mandates that certain compensation arrangements between healthcare providers meet certain requirements.  Things like medical director agreements, management agreements, employment and independent contractor arrangements have been regulated by the law since its inception.  Most notably, for purposes of this article, one provision (the “In Office Ancillary Services” exception or “IOAS”, also known as the “Group Practice Exception”) has allowed medical practices to provide all sorts of “ancillary services” to their own patients.  That is the key aspect of the law that is lately coming under serious attack. Continue reading →

The Stark Law Regulations: A Review

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The Stark Regs (1) forbid doctors and their immediate family members from referring their patients to businesses they own which provide “designated health services,” and (2) contains a long list of permitted financial relationships between health care providers.  The list of what constitutes a “designated health service” (DHS) includes PT, rehab, diagnostic imaging, clinical lab, DME, and home health.  A “physician” means an M.D., D.O., chiropractor, podiatrist, optometrist or dentist.  An “immediate family member” is a husband or wife; birth or adoptive parent, child, or sibling; stepparent, stepchild, stepbrother, or stepsister; father-in-law, mother-in-law, son-in-law, daughter-in-law, brother-in-law, or sister-in-law; grandparent or grandchild; and spouse of a grandparent or grandchild.  In short, if you or your family member owns a DHS, don’t refer to it.  Unless of course your situation falls within one or more of the gazillion exceptions.

A few key changes from the third set of revisions (so called Stark III) which affect physicians are helpful to keep in mind.  For instance, the way fair market value of physician compensation is determined  in the Stark II regs has been simplified and now depends on an amorphous consideration of the transaction, its location and other factors.  The clear formulas contained in Stark II was dropped and this makes the need for an expert FMV study even more compelling. 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 →