If the government were to hand out a brochure in your neighborhood, outlining beware the public will soon know what … you received from industry. That statement may seem, just a little Orwellian. That is exactly what a booklet by the Department of Health and Human Services (HHS) Office of the Inspector General (OIG) just included.
In what appears to be a form of guidance for “Avoiding Medicare and Medicaid Fraud and Abuse,” the HHS OIG recently published on its website “A Roadmap for New Physicians.” OIG decided to publish this brochure after conducting a survey of medical school deans and designated institutional officials at institutions that sponsor residencies and fellowships, which found that 92% of deans and 90% of designated institutional officials reported they would like OIG to provide educational materials about Medicare and Medicaid fraud, waste, and abuse that they can use.
In their introduction to the roadmap, OIG states that most “physicians strive to work ethically, render high-quality medical care to their patients, and submit proper claims for payment.” However, they assert that the “presence of some dishonest health care providers who exploit the health care system for illegal personal gain has created the need for laws that combat fraud and abuse and ensure appropriate quality medical care.”
As a result, HHS OIG created this “brochure to assist physicians in understanding how to comply with Federal laws by identifying “red flags” that could lead to potential liability in law enforcement and administrative actions.” The brochure/roadmap is intended for all physicians, regardless of specialty or practice setting, and organizes information around three types of relationships that physicians frequently encounter in their careers:
– Relationships with fellow physicians and other providers; and
Fraud and Abuse Laws
The first part of the roadmap explains the relevant fraud and abuse laws that apply to health care providers concerning Medicare and Medicaid. Government agencies, including the Department of Justice (DOJ), HHS OIG, and the Centers for Medicare & Medicaid Services (CMS), enforce these laws. The five most important Federal fraud and abuse laws that apply to physicians are:
– The False Claims Act (FCA) 31 U.S.C. §§ 3729–3733
– The Anti-Kickback Statute (AKS) 42 U.S.C. § 1320a-7b(b)]
– The Physician Self-Referral Law (Stark law) 42 U.S.C. § 1395nn
– The Exclusion Authorities 42 U.S.C. § 1320a-7
– The Civil Monetary Penalties Law (CMPL)
FCA protects the Government from being overcharged or sold shoddy goods or services. HHS OIG emphasized that “It is illegal to submit claims for payment to Medicare or Medicaid that you know or should know are false or fraudulent.”
The AKS is a criminal law that prohibits the knowing and willful payment of “remuneration” to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs (e.g., drugs, supplies, for CMS patients). Remuneration includes anything of value (i.e. cash, free hotel, meals, etc.) HHS emphasized that in Federal health care programs, paying for referrals is a crime. They also specifically acknowledge, “Taking money or gifts from a drug or device company or a durable medical equipment (DME) supplier is not justified by the argument that you would have prescribed that drug or ordered that wheelchair even without a kickback.”
The Physician Self-Referral Law, commonly referred to as the Stark law, prohibits physicians from referring patients to receive “designated health services” payable by Medicare or Medicaid from entities with which the physician or an immediate family member has a financial relationship, unless an exception applies. Financial relationships include both ownership/investment interests and compensation arrangements.
The Exclusion authorities require OIG to exclude from participation in all Federal health care programs individuals and entities convicted specific criminal offenses (i.e. fraud, patient abuse). Under the CMPL, physicians who pay or accept kickbacks also face penalties of up to $50,000 per kickback plus three times the amount of the remuneration.
Physician Relationships
The first two sections deal with physician relationships with CMS and fellow providers such as other physicians, nurses, hospitals, nursing homes, etc. The third part, discussed below, focuses on physician relationships with vendors.
First, HHS OIG discusses the use of free samples. They explain that it is only legal to give patients free samples, not to charge them for the samples. Then the roadmap discusses relationships with the pharmaceutical and medical device industries.
OIG recognizes that physician-industry collaboration can produce important medical advances. However, they also note that some pharmaceutical and device companies have used sham consulting agreements and other arrangements to buy physician loyalty to their products.” Consequently, in noting that health care providers may work with industry, they recommend that individuals evaluate the link between the services they can provide and the compensation they will receive. OIG tells health care providers to test the propriety of any proposed relationship by asking:
- Does the company really need my particular expertise or input?
- Does the amount of money the company is offering seem fair, appropriate, and commercially reasonable for what it is asking me to do?
- Is it possible the company is paying me for my loyalty so that I will prescribe its drugs or use its devices?
The guidance recommends that if a physician’s contribution will generate useful ideas and the payment received is fair market value, an individual “may legitimately serve as a bona fide consultant.” However, the brochure uses an extreme example to show potential fraud by suggesting that companies would pay to fly a hundred “thought leaders” to attend a conference in the Bahamas. Such a claim is problematic because this kind of abuse has rarely ever existed, and certainly has not occurred in the last several years.
With respect to transparency, the roadmap cites flawed research (as most COI critics do) to suggest that free lunches, subsidized trips, and gifts can influence prescribing practices, justifying transparency measures. While many companies have begun publishing payments to doctors, OIG takes it one-step further. They practically place a warning label on working with industry by noting in bold that “The public will soon know what gifts and payments a physician receives from industry.” While the statement refers to the Sunshine provision of the Affordable Care Act, it strikes as a threat to new physicians not to work with industry.
OIG also explains that academic institutions may impose various restrictions on the interactions their faculty members or affiliated physicians have with industry, including industry-sponsored research, consulting, and grants. They also acknowledge that both PhRMA and AdvaMed have adopted codes of ethics for their respective industries regarding relationships with health care professionals.
Moving to conflicts of interest, OIG focuses on disclosure of such interest, and recognizes that disclosure rules exist from a variety of sources including grant funders, such as States, universities, and the National Institutes of Health, and from FDA when data are submitted to support marketing approval for new drugs, devices, or biologics.
To “manage” conflicts of interest, OIG recommends considering the conflicts policies that affect your professional activities, candidly disclose any industry money subject to these policies, and adhere to restrictions on activities. They also tell doctors to use the “newspaper test” when in doubt and ask whether a person would want the arrangement to appear on the front page of their local newspaper. Ironically, all arrangements with industry are going to end up on the front page, and most already have. Therefore, no matter how small a payment is, how many patients it help or how many doctors it trained, it will still make headlines as a payment arrangement.
On the topic of continuing medical education (CME), OIG notes that drug and device manufacturers sponsor many educational opportunities for physicians, and they specifically emphasize that “It is important to distinguish between CME sessions that are educational in nature and sessions that constitute marketing by a drug or device manufacturer.” OIG goes further by telling physicians they should be “circumspect about a discussion that focuses on a particular brand drug or device, as opposed to all the treatment alternatives for a specific condition,” even if the primary speaker is a physician who is well known in the field. Taking it one-step further, OIG tells individuals that if they are invited to serve as faculty for industry-sponsored CME, to ask the following questions:
- Does the sponsor really need my particular expertise or input?
- Does the amount of money the sponsor is offering seem fair and appropriate for the educational value I will add to the presentation?
- Is it possible the sponsor is paying me for my loyalty so that I will prescribe its drugs or use its devices?
- Does the sponsor prepare a slide deck and speaker notes, or am I free to set the content of the lecture?
The Roadmap also indicates that drug companies cannot promote off label usage of products, and tells physicians to report any misleading advertisements and other promotional materials for drugs, biologics, and medical devices to the FDA through its Bad Ad Program.
Discussion
While the information contained in this brochure/roadmap was created at the request of medical school deans and institutional officers, there are a number of problems with how this information is presented. First, every single page contained in the brochure contains “examples” of cases in which health care providers have violated either a federal fraud and abuse statute or some other institutional policy. Although these may serve as clear examples for students and practitioners unaware of the laws, it also suggests that such incidents are widespread. The brochure does not mention that these violations are in fact extremely rare, and sometimes result in confusion about policies instead of intentional actions. They simply state one sentence that says, “physician-industry collaboration can produce important medical advances.”
Second, the physical and esthetic appearance of the brochure also indicates a negative implication about physician-industry relationships. For example, in numerous places throughout the brochure, OIG highlights in bold, large font language, specific points, such as the “public will soon know what gifts and payments a physician receives from industry.” After reading that kind of statement, what medical student will want to work with industry to develop the newest treatment for diabetes or cancer? Who will help develop new medical devices? There needs to be a neutral understanding about collaboration with industry, examining both the benefits and the risks. In this area as well, OIG uses rare examples of past abuses, but does not discuss the hundreds of breakthroughs in medicine, devices, and treatments created by industry-physician-academia collaboration.
Third, while there is no question that abuses have happened in the past, the brochure does not emphasize the measures and regulations put in place by other institutions, organizations, and accrediting bodies over the past several years.
Additionally, while it is important that individuals evaluate why they choose to work with industry and why a company may approach them, the way OIG frames certain questions they feel providers should ask before working with industry suggests that all interactions are wrong (i.e. guilty until proven innocent). Ultimately, although new physicians may benefit from a concise explanation of the law contained in this brochure, patients, training, and education may suffer if OIG does not clarify the language in the brochure to reflect the balance of benefits physician-industry collaboration provide.
A very interesting and informative article.