Why Compliance Plans Make Sense

Clipboard with Checklist and Red PenHas your practice implemented a compliance program or considered improving an existing one?  Is it really necessary?  Prior to the Patient Protection and Affordable Care Act (ACA), the necessity for physician practices to develop compliance plans was merely voluntary.  However, the ACA will now require physician practices to have a fraud and abuse compliance plan in place as a condition of continuing to participate in Medicare or Medicaid programs.  Because the government first published guidelines in the year 2000 for the voluntary use of compliance plans in physician practices and has subsequently enacted a mandate in the ACA for compliance plans, many physician practices are proactively implementing them.  While this compliance plan mandate may be viewed by physicians as yet another administrative burden and expense to the practice, it can have many benefits as well.  Implementing an effective compliance program can have the result of not only reducing liability risks, but can also allow a practice to reap monetary benefits.  In fact, it could be more costly for the practice not to have one!Continue reading

OIG Shoots Down Physician Owned Distributorships (PODS)

Physician owned distributorships (PODs) have been the source of considerable controversy for years.  A couple years ago, they caught the attention of Congress.  Now, the Office of Inspector General of the Department of Health and Human Services (“OIG”) has 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.

PODs distribute various things, most commonly surgical implants and devices, that are reimbursed by insurers.  A patient needs a spinal rod, a surgical implant/device company makes it and a distributor rep distributes it.  Device/implant companies usually contract with distributorships to sell their products.  Distributorships contract with reps who are paid commissions for sales.  Surgeons who actually order the devices sometimes think “Since I’m the one doing the surgery and ordering all this stuff, why can’t I earn something from that?  I’m not ordering anything I don’t need or that I don’t think is good for the patient.”  PODs are one way for physicians to financially benefit from the sales of devices and items their patients need, but they have never been more controversial than now.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.

M.D./Chiropractor Organizations Face Licensure

Beginning January 1, 2013, healthcare organizations owned by both chiropractors and M.D.s (or D.O.s) will have to obtain a Florida Health Care Clinic License (HCCL) in order to take care of patients whose care is compensated by PIP.  These sort of “integrated practices” are clearly on the upswing, especially after the tough new PIP Clinic regulations were passed this year, which makes providing care to patients injured in motor vehicle accidents tricky.Continue reading

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)

The Florida Healthcare Law Firm Goes National

Followers & Friends – BIG Announcement coming out today! If you haven’t seen our new NATIONAL platform, check it out here at www.nationalhealthcarelawfirm.com and stay tuned for our #healthcare #legal news at 2pm EST !!!

The Florida Healthcare Law Firm Announces National Expansion

(Delray Beach, FL) June 21st, 2012 – The Florida Healthcare Law Firm, one of Florida’s leading healthcare law firms, today announced a major increase in their legal practice capabilities with the official launch of the National Healthcare Law Firm, a d/b/a and new portal of the firm. The expansion to a national platform providing healthcare legal services to physicians and healthcare businesses is one that significantly increases resources for clients who lack qualified local healthcare counsel. While the Florida Healthcare Law Firm has for years assisted clients outside the state of Florida*, this new development further cements the firm’s commitment to providing ethical legal counsel in the healthcare industry.

“We are very excited about it. The fact that we serve clients all over the country has been a small secret for a while but we realized there’s a huge demand and decided to just go for it,” said Jeffrey L. Cohen, Esq. Founder and President of Florida Healthcare Law Firm.

According to Cohen, “It’s just a strange area of the law.  Nearly everything in healthcare business is regulated; leases, employment agreements, compensation.  Things you wouldn’t think are regulated are strongly regulated.  And there are large fines and criminal penalties for getting it wrong!  Our clients understand that healthcare business of any kind has serious legal risks and that they need uniquely qualified help.”

To request a service list or for any other firm information, call Autumn Piccolo at 888-455-7702 or visit the firm’s website at www.nationalhealthcarelawfirm.com or www.floridahealthcarelawfirm.com

*     *     *

Acknowledged throughout the country for its service and excellence, Florida Healthcare Law Firm is one of the nation’s leading providers of healthcare legal services. Founded by Jeffrey L. Cohen, Esq and headquartered in South Florida, FHLF provides legal services to physicians and healthcare businesses with the right pricing responsiveness and ethics. From healthcare clinic regulation, home health agency representation and physician contracting to medical practice formation/representation and federal and state compliance matters, the Florida Healthcare Law Firm is committed to bringing knowledge and experience to a diverse group of clients.

OIG SLAMS COMPANY MODEL ANESTHESIA ARRANGEMENTS WITH SURGERY AND ENDO CENTERS

A long awaited opinion from the OIG on relationships between surgery, endoscopy (and other) centers (“Centers”) will doom many arrangements with anesthesiologists.  At the very least, they will have to significantly restructure.

Such “Company Model” arrangements basically involve a way for surgeon investors in Centers to share in the anesthesia services revenue.  These arrangements have always been suspect, but the OIG has been clear that they run afoul of applicable federal law.  In the June 1st OIG Opinion (12-06), two models were proposed, and both were essentially shot down.  The first involved requiring the anesthesiologists who provide services at the Center to engage a management company owned by surgeon owners of the Center to provide management services on a per patient fee basis.  The second, which is far more commonplace, involved establishing a company owned by the surgeons who also own the Center.  The new company would provide the anesthesia services and contract with the anesthesiologists in a way the leaves some of the anesthesia services income to be distributed to the surgeon in the Center, who also happen to generate all the cases for the Center, and hence all of the anesthesia revenue.

Such arrangements are not only “inherently suspect,” as described by the OIG, they have never made much common sense.  How is it not a kickback for the anesthesiologists to make 100% of the anesthesia related profit on Monday, but then have to “share” it with the surgeon owners on Tuesday, once a new management company or separate anesthesia services company (owned by the surgeons) is formed?

At the very least, surgeons looking for a share of anesthesia revenue will have to dig deep into the opinion and into prior opinions to see if there is any legitimate basis available.

OIG Approves Healthcare Coupon Website

The economy has heated up the marketing activity of many healthcare businesses, including physicians. Marketing devices like Groupon have become commonplace, but raise some significant legal issues. So.one such business requested guidance from the Office of the Inspector General of the Department of Health and Human Services and got a nice response.

The requestor operates a website that includes coupons for healthcare items and services and also advertising on behalf of individuals and businesses in the healthcare industry. The healthcare professionals and business people would post coupons on the website, which would give discounts, including discounts on items and services that are covered by Medicare and other state or federal healthcare programs. The website business would have different levels of membership and would charge flat fees for each level of membership. Additionally, the requestor would sell advertising on the website.

The arrangement had certain limitations, including:

1. The providers would not advertise free services, only discounted services; and
2. The providers would be required to give the same discount to any third party payer or insurance carrier, not just to the patient.

The OIG approved the proposal and noted the following key things:

1. The requestor is not a healthcare provider;
2. Payments from providers and advertisers are a set fee, are consistent with fair market value and don’t depend on customers (patients) using coupons or buying services;
3. Advertising would only be received by customers that elected to receive it; and
4. The business structure is not likely to increase utilization.

In short, the OIG thought the requestor was serving only as a conduit of advertising and was not paying anyone to influence any patient’s choice of a provider or supplier.