Residential Substance Abuse Treatment & Life Safety Code

By: Valery Bond, RHIT

Did you know as a residential addiction substance abuse treatment provider, your facility must know what is, and what is not, above your ceiling tiles?  Does your facility have a “No Smoking” sign at the main entrance?  Do you know which way the doors are supposed to close?  Want to grow your business?  Plan on expanding?  You will need an ILSM (Interim Life Safety Measure) completed; and, the ILSM must include an infection control acknowledgment.

The Bottom Line About ILSM for Substance Abuse Treatment

In simplicity, buildings serving patients must comply with the NFPA 101 (2012 edition) Life Safety Code.  Has your substance abuse treatment organization identified a Safety Officer?  Has the Safety Officer identified Life Safety Code problems?  If your answer is “No” to these two basic questions, it may be time for your practice to implement a Life Safety program.

Known as “Minimum Fire Safety Standards for Residential Alcohol and Drug Abuse Treatment and Prevention Programs, mental Health Residential Treatment Facilities and Crisis Stabilization Units”, this rule chapter must be applied and adhered to in all 24 hour, 7 day per week healthcare facilities, just like a traditional hospital.Continue reading

Managing Medical Device Anti Kickback Risks for Physicians

By: Shobha Lizaso

Less than a year ago that medical device developer, Olympus Corp, agreed to pay a $646 million settlement to resolve claims of illegal kickbacks to physicians and hospitals. This is considered to be the largest settlement amount in the history of violations to the Anti-kickback Statute. The federal Anti-Kickback Statute (“Anti-Kickback Statute”) is a criminal statute that prohibits the exchange (or offer to exchange), of anything of value, in an effort to induce or reward the referral of federal health care program business.  Conviction for a single violation under the Anti-Kickback Statute may result in a fine of up to $25,000 and imprisonment for up to five (5) years.  In addition, a conviction will result in mandatory exclusion from participation in federal health care programs. The government may also assess civil money penalties, which could result in treble damages plus $50,000 for each violation of the Anti-Kickback Statute.

Between 2006 and 2011, Olympus offered consulting deals among many other bribes to influence physicians to order and prescribe Olympus medical devices. These consulting agreements provided for large up-front payments to physicians under the guise of medical device development. Olympus failed to focus on compliance and didn’t have policies and procedures in place to prevent illegal arrangements such as these. These physicians were retained as consultants, but most provided very little consulting services; they were utilized as device promoters. Physicians have a duty to order medical devices solely on the traditional standards of quality, price, and appropriateness for the medical conditions treated. Moreover, the ordering of medical devices by a physician must never be influenced by personal financial gain.Continue reading

HIPAA Compliance: Docs, You’ve Been Hacked. What’s Next?

HIPAABy: Jacqueline Bain

Healthcare providers have heard the HIPAA disaster stories: a laptop containing patient information is left on the counter at the coffee shop; a thumb drive with patient files goes missing; a rogue employee accesses patient information she has no business accessing; hackers get into a practice’s server and hold the patient information for ransom.

HIPAA is a federal law designed for safe disclosure of patient’s protected health information.  The news headlines showcase giant penalties for violations.  However, Florida healthcare providers should also know that Florida has its own consumer protection statute, called the Florida Information Protection Act.  So while you’re busy worrying about your HIPAA exposure in any of these situations, remember that there is potential State exposure as well.

So what should a healthcare provider do if it believes there has been a hack or some other unauthorized disclosure?  Responses vary based on the situation presented, but below is a good jumping off point:Continue reading

What is FIPA and How Is FIPA Different From HIPAA?

By: Jackie Bain

FIPA is the Florida Information Protection Act of 2014.  It became elective on July 1, 2014.  Many people consider FIPA to be Florida’s state law counterpart to the Federal Government’s Health Information Protection and Administration Act of 1996 (“HIPAA).  However, FIPA is, in many respects, more far reaching than HIPAA.  Those who transact business in the State of Florida are well-served to be knowledgeable about FIPA.

FIPA affects more than just health care providers and those in the healthcare industry.  Under FIPA, any business that acquires, stores, maintains or uses personal information must take reasonable measures to safeguard that information.  “Personal information” includes the use of a person’s first and last name (or first initial and last name) in conjunction with his or her social security number, driver’s license or other government identification number, bank account number, credit or debit card number and password or pin, medical history, or health insurance policy number.  A convenience store that might have access to a person’s name and credit card number is just as accountable under FIPA as a hospital who might store that person’s medical history and insurance information.Continue reading

Compounding Pharmacies and Alleged Tricare Abuses Back in the Spotlight

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

What's Hot on the #OIG Work Plan for 2014?

OIG crestThe U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released it’s 2014 Fiscal Year Work Plan. If you’ve got the stomach for the long version, click here. Around each fiscal year, the Department of Health and Human Services, Office of Inspector General publishes its annual Work Plan, which provides terrific insight into unique provider behavior and practices the OIG plans to target in 2014.  Medicare providers should pay particular attention to the following targeted areas:

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Controlled Substance Provider Registration – The Time is Now!

via Florida Board of Medicine 6-10-2013 —  In accordance with s. 456.44, F.S., a physician licensed under chapter 458, chapter 459, chapter 461, or chapter 466 who prescribes any controlled substance listed in Schedule II, Schedule III, or Schedule IV, as defined in s. 893.03, F.S., for the treatment of chronic nonmalignant pain must designate himself or herself as a controlled substance prescribing practitioner on the physician’s practitioner profile. If the physician does not prescribe controlled substances for the treatment of chronic nonmalignant pain, the “Controlled Substance Prescriber” field will indicate “NO,” but as long as the physician holds a DEA prescribing license, he or she is still authorized to prescribe controlled substances.Continue reading

What’s Hot on the OIG’s Workplan for 2013

 It’s that time again, when the OIG publishes its annual Work Plan for the coming year, providing insight and a proverbial “heads up” on the areas where potential concern and program integrity efforts are being focused.  Many of the focus areas are ongoing or have been the subject of previous Work Plans, and come as no surprise.  Nevertheless, it is important for practitioners to familiarize or reacquaint themselves with the 2013 Work Plan projects in order to recognize and prioritize compliance areas currently on the OIG’s radar.

Of particular interest for practitioners are the various OIG review projects involving ancillary services.  For example, the OIG is looking at outpatient therapy services by independent therapists, and will focus on high utilization of physical therapy to determine if claims were reasonable, medically necessary and properly documented.  Similarly, high-cost diagnostic radiological tests ordered by primary care and specialty physicians are being reviewed to determine whether utilization rates match industry practices.  The OIG also will review Part B payments for imaging services with an eye towards determining if utilization rates reflect industry practices and if practice expenses components within payment rates are commensurate with costs incurred.  Electrodiagnostic testing (needle electromyogram and never conduction) is a new area under review, particularly with respect to utilization rates by specialty, the concern being that such services are vulnerable to abuse and inappropriate financial gain.

Errors in billing and claims administration are also the subject of OIG review, with perennially recurring projects directed at incident-to services, place of service coding and E/M services.  A 2009 OIG review of prior claims found that non-physician practitioners often were not properly supervised or that unqualified non-physician practitioners performed services, in each case, resulting in payments that were not compensable.  Since Medicare payment for services in a non-facility setting, like a physician’s office, is often higher than in the rate that applies in other service locations, there is also concern over whether claims for Part B services performed in ASCs and Hospital outpatient departments were coded with the proper place of service.  Another, more recent area of focus involves the documentation supporting E/M services and questions whether Electronic Medical Record documentation processes may result in “cloned” entries (and potentially improper claims) rather than a deliberate process of selecting proper codes based on content of actual service.   Part B payment for chiropractic services are also being reviewed, with this area being the subject of ongoing OIG concern since chiropractic maintenance therapy being considered not medically necessary.

Apparently echoing a series of fairly recent OIG Advisory opinions, the 2013 Work Plan also identifies Polysomnography and Sleep Disorder Clinics as areas of potentially questionable billing patterns and possible overutilization.  High utilization rates have also raised questions regarding whether services are duplicative of diagnostic testing performed previously by attending physicians.  Another ongoing and increasing focus of OIG scrutiny is physician-owned distributors (POD) of high utilization orthopedic implant devices.  The Work Plan for 2013 specifically identifies PODs which provide hospitals with spinal fusion implant devices as being under OIG review to determine if such arrangements are associated with high utilization.

These are just some of the many areas of OIG review with which practitioners and facilities alike should become familiar in order to remain current with the health care regulatory compliance curve.

DME Leads: When is a Lead a Referral?

By: David W. Hirshfeld, Esq.

Durable medical equipment is commonly sold through sales leads generated through telephone and/or internet contact.  These leads often begin with a seemingly innocuous internet survey or an application for something unrelated to DME.  This “raw” lead may be as basic as a person’s name, telephone number or email address, and age.  The lead is then further developed and “qualified” by obtaining more details about the subject; such as: whether and by whom the subject is insured, what (if any) medical issues does the subject suffer from, the name of the subject’s physician.  Ultimately, the lead is sold to a DME vendor who uses the lead to accomplish the sale of medical equipment or supplies.  In the course of a lead’s birth and life, it is handled by a chain of companies, some of whom purchase the lead, add a level of detail to it, and sell it for a higher price.  In the past year or so, several lead generation companies from the “middle of the chain” have come to me asking me whether their business model gives rise to an illegal kickback.  After a bit of research, I gave the lawyerly answer: “It depends.”

The Federal anti-kickback statute provides that it is a felony for a person or entity to knowingly and willfully offer or pay any remuneration to induce a person to refer an individual for the furnishing or arranging for the furnishing of any item for which payment may be made under a Federal health care program, or the purchase or lease or the recommendation of the purchase or lease of any item for which payment may be made under a Federal health care program.[1]  Florida’s corollary to this Federal law is the Florida Patient Brokering Act, but the Florida statute applies to all health care services, regardless of whether paid for by a Federal program.[2]  The Federal law creates criminal liability, and includes a knowledge requirement.  Congress recognized that business models exist that may appear as willfully paying remuneration in exchange for a referral, but which have more innocent motivations, and are less likely to result in abuse to the health care program at issue.  In order to give the health care industry a measure of comfort, Congress created several “safe harbors.”  If a business model fits within a safe harbor, then it is deemed to not be an illegal kickback under Federal and Florida law.

The Department of Health and Human Services Office of the Inspector General (“OIG”) is the agency charged with enforcing the Federal anti-kickback statute.  In November 2008 the OIG considered a situation in which an advertising company created a website that would give prospective patients contact information for a list of chiropractors in their area, in response to a zip code entered by the prospect.  The prospect paid nothing for the service, but the chiropractors paid the advertiser a fee for each call or contact from the website that lasted over thirty seconds, regardless of whether the contact resulted in a prospect becoming a patient.  This scenario is as close as the OIG has come to opining on a typical DME lead generation.

The OIG found that the chiropractors’ advertising service was not a prohibited kickback, and cited four factors as convincing: (i) the advertising company is not a health care provider or supplier, and is only affiliated with the health care industry through the arrangement at issue; (ii) the advertising program did not target Federal health care program beneficiaries; (iii) the fees paid by the health care practitioners did not depend upon whether the prospect actually became a patient; and (iv) the advertising program did not steer patients to a particular chiropractor.

When applied to the DME context, the OIG opinion and the anti-kickback statutes suggest that leads can be sold for a per-lead fee as long as the leads are not priced, and do not contain information so detailed, such that the purchaser can cherry-pick those leads it wants to purchase based on the likelihood that the lead will result in an actual sale of covered DME.  For example, a “raw” lead comprised simply of a prospect’s name, contact information, and interest in speaking with a DME supplier is probably the sort of lead that could be sold for a per-lead fee without running afoul of the anti-kickback prohibitions.  As more and more information is added to the lead, such as the type of DME products of interest to the prospect, information regarding the prospect’s insurer and plan coverage, the purchaser will be better able to determine whether the lead is likely to result in a sale of DME (a “qualified” lead).  At a certain level of detail, a lead morphs from lead that can be sold on a per-lead basis, to a referral that cannot.

A lead generation company can sell highly detailed qualified leads if that sales relationship fits within the safe harbor for “Personal Services and Management Contracts.”[3]  That safe harbor requires that: (a) the aggregate compensation to be paid under the contract must be fixed in advance; (b) the compensation must be consistent with fair market value in an arm’s-length transaction; and (c) the compensation must not be determined in a manner that takes into account the volume or value of any referrals or business otherwise generated between the parties for which payment may be made by a Federal health care program.  The requirement that the compensation be fixed in advance does not tolerate a per-lead fee.   Fixed in advance would be a weekly, hourly, annual fee.

So, if you are in the lead generation business, your liability for buying or selling health care referrals probably depends upon how detailed and “qualified” the lead is at the time of your transaction.  The safe tack is to structure your transactions so that they fit within the safe harbor for Personal Services and Management Contracts so that just in case your leads are qualified enough to constitute “referrals.”

This article focuses on anti-kickback liability associated with DME leads, but there is also liability attached to how the lead is originated, and how the prospect is contacted.  Lead generation companies are often well-served by committing their relationships to written agreements with advice from appropriate counsel.

[1] 42 U.S.C. §1320a-7b(b)

[2] FL Statutes §456.054 and §817.505

[3] 42 C.F.R. §1001.952(d)

Supervisory Requirements for IDTFs

supervisionWe get questions all the time regarding the supervisory requirements for Independent Diagnostic Treatment Facilities (IDTF). Here are some tips in complying with one of the key elements in obtaining and maintaining status as an IDTF and as a Medicare provider.

An IDTF must have one or more supervising physicians who are responsible for the direct and ongoing oversight of the quality of the testing performed, the proper operation and calibration of equipment used to perform tests, and the qualifications of non-physician IDTF personnel who use the equipment. Not every supervising physician has to be responsible for all of these functions. One supervising physician could be responsible for operation and calibration of equipment, while other physicians are responsible for test supervision and the qualifications of non-physician personnel.Continue reading