Gifts to referring doctors and/or their family members may violate OIG regulations

Though it may not be at the top of your to-do list when you’re starting to build a practice, it’s a good idea to review federal and state laws pertaining to gift-giving. Gifts may create a financial relationship and violate the Ethics in Patient Referral Act (aka Stark law) or the Anti-Kickback Statute (AKS). Gifts may prohibit a doctor and their family members from referring Medicare patients or for you to receive these referrals. ‘Intent’ does not matter when considering the Stark law. This rule is a strict liability statute. No matter how altruistic your intent, a violation will stand if the letter of the statute is not followed. Some states and medical boards prohibit this gift-giving even if the Stark or AKS rules do not apply. Always check with your licensing board prior to giving or receiving gifts.

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Gifts to patients may constitute a felony if in violation of the OIG rules

When giving gifts to Medicare-age patients, use caution and check with the OIG for all rules that apply. Gifts that are perceived to be an inducement to patients to choose your clinic over other providers, may be in violation of HIPAA regulations.. Beyond civil monetary penalties, a provider could be excluded from all plans or face felony conviction. Review this information from the OIG to see how this law is interpreted.

Section 1128A(a)(5) of the Act (the “CMP”) provides for the imposition of civil monetary penalties against any person who offers or transfers remuneration to a Medicare or State health care program (including Medicaid) beneficiary that the benefactor knows or should know is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of any item or service for which payment may be made, in whole or in part, by Medicare or a State health care program (including Medicaid). The OIG may also initiate administrative proceedings to exclude such party from the Federal health care programs. Section 1128A(i)(6) of the Act defines “remuneration” for purposes of the CMP as including “transfers of items or services for free or for other than fair market value.” The OIG has previously taken the position that “incentives that are only nominal in value are not prohibited by the statute,” and has interpreted “nominal in value” to mean “no more than $10 per item, or $50 in the aggregate on an annual basis.” 65 Fed. Reg. 24,400, 24,410–11 (Apr. 26, 2000) (preamble to the final rule on Civil Money Penalties).

OIG rules in favor of grocery store gift cards for non-covered preventive care to Medicare patients

Can a provider offer appropriate gifts to Medicare-age patients without running afoul of HIPAA gift regulations discussed in last week’s post? In an OIG (Office of the Inspector General) opinion dated December 27, 2012, the OIG ruled to allow a specific Health Center the right to offer grocery store gift cards to Medicare age patients. However, it was done on a specific case inquiry made by this one particular Health Center. All exceptions to the rule must petition the OIG or there may be legal ramifications. Below is the legal rationale. If you wish to offer such gifts to Medicare-age patients, contact the OIG with specific inquiries.

The CMP (Civil Monetary Penalty) contains an exception for incentives given to individuals to promote the delivery of preventive care. See section 1128A(i)(6)(D) of the Act. The applicable regulations exclude from the definition of “remuneration” incentives “given to individuals to promote the delivery of preventive care services where the delivery of such services is not tied (directly or indirectly) to the provision of other services reimbursed in whole or in part by Medicare or an applicable State health care program.” See 42 C.F.R. § 1003.101. The regulations define “preventive care” to mean any service that “(1) [i]s a prenatal service or post-natal well-baby visit or is a specific clinical service described in the current U.S. Preventive Services Task Force’s Guide to Clinical Preventive Services [(the “Guide”)], and (2) [i]s reimbursable in whole or in part by Medicare or an applicable State health care program.” Id.

See also

Use caution with gifts to Medicare patients

An August 2002 “Special Advisory Bulletin” by the Office of the Inspector General (OIG) at the US Department of Health and Human Services, notes that HIPAA rules prohibit providers from offering valuable gifts to Medicare patients as an inducement to choose a provider. Offering ‘giveaways’ to attract business favors providers with larger businesses who may have greater financial resources while producing a disadvantage to the smaller business providers. There is broad language with a number of marketing practices potentially affected by this rule (Section 1128(a)(5)). The following are some, but not all of the rule language:

  • The OIG has interpreted the prohibition to permit Medicare or Medicaid providers to offer beneficiaries inexpensive gifts (other than cash or cash equivalents) or services without violating the statute. For enforcement purposes, inexpensive gifts or services are those that have a retail value of no more than $10 individually, and no more than $50 in the aggregate annually per patient.
  • Providers may offer beneficiaries more expensive items or services that fit within one of the five statutory exceptions: waivers of cost-sharing amounts based on financial need; properly disclosed copayment differentials in health plans; incentives to promote the delivery of certain preventive care services; any practice permitted under the federal anti-kickback statute pursuant to 42 CFR 1001.952; or waivers of hospital outpatient co-payments in excess of the minimum co-payment amounts.
  • The OIG is considering several additional regulatory exceptions. The OIG may solicit public comments on additional exceptions for complimentary local transportation and for free goods in connection with participation in certain clinical studies.
  • In sum, unless a provider’s practices fit within an exception (as implemented by regulations) or are the subject of a favorable advisory opinion covering a provider’s own activity, any gifts or free services to beneficiaries should not exceed the $10 per item and $50 annual limits.

More information can be found in the OIG bulletin posted at Next week, we’ll consider a OIG decision that allow grocery store gift cards to be offered to Medicare-age patients.

New anatomy discovery “glymphatic system” – Key to treating Alzheimer’s and more?

A 2013 study published in the journal Science entitled “Sleep Drives Metabolite Clearance from the Adult Brain,” was honored at the American Association for the Advancement of Science (AAAS) with the 2014 Newcomb Cleveland Prize.

This study revealed new anatomic considerations that demonstrate a newly named “glympahtic system”. This system is responsible for brain metabolite health and has given doctors new ways to treat brain-lymph system diseases. Implications of this discovery are labeled ‘monumental’ because so few treatment options serve this population. Treatments for Alzheimer’s, MS, and other neurological disorders of the glymphatic system may be alleviated surgically by restoring circulatory function or with techniques that restore mechanical impingement-venous problems. This article contains links to other research that may help when treating MS, Alzheimer’s, Arnold Chiari, Parkinson’s disease, dementia and other neuro-degenerative diseases.

Drug resistant gonorrhea “may be antibiotic resistant and untreatable”

Gonorrhea is the 2nd most common sexually transmitted disease in England and there’s been a 20% increase in cases from 2013 to 2014. In the US the CDC reports that there are approximately 820,000 new infections each year with less than half of them detected and reported. Now, doctors from both continents are concerned that this form of STD (sexually transmitted disease) will soon be untreatable with current drug regimens due to patients either not receiving appropriate treatment or not following through with their medication protocol. As the bacteria becomes more resistant to treatment, fewer alternatives to treat this drug-resistant form of the infection are available. Patients at risk should be informed and infected patients should be closely monitored for adherence to treatment regimens.

Increase caffeine triggers higher teen diabetes risk

It’s a good idea to gather information via intake forms, asking how much sugary, energy drinks, your teen patients are using. A Canadian study where teens were given sugar-free, 5- hour caffeinated drinks with 208 mg of caffeine, could not metabolize sugar as easily as when they drank the same caffeine-free drink. The subjects given glucose tolerance tests showed a 25% increase in glucose and insulin levels compared to those subjects using the decaf version of the drink. Jane Shearer, assistant professor and diabetes researcher stated: “…elevated caffeine content in (sugar free) energy drinks is what causes this response.” Although findings are preliminary, the results are troubling, especially because the blood sugar did not reduce even after insulin was being produced. These findings could signal another link to the increasing diabetes problems now being found in teens as well as adults.

To improve glucose metabolim, get up, stand up!

Post-prandial glucose metabolism was shown to improve when sedentary workers stood up for five minutes of every 30 for 7.5 hours. Adding 5 minutes of walking every 30 minutes, produced an even better result. Although the results were not lasting, and required continuation of movement to sustain, this study was well-crafted and has statistically significant results. Many chronically sedentary patients resistant to initiating exercise programs may be willing to ‘get up and stand up’ when you show them this type of study. Suggesting simple standing during commercials while watching TV may help normally sedentary patients to improve glucose metabolism.

FDA ups warning on NSAIDs for heart, stroke risks

The FDA is now requiring a stronger warning on over-the-counter NSAIDs (non-steroidal anti-inflammatory drugs) to inform users of the increased risk of stroke and heart complications. There is increasing evidence that this family of medications greatly increases risk, especially in patients who already have identifiable stoke, high blood pressure, and other heart-associated illness. Adding a question to your intake forms for NSAID use and associated risk disease states can protect patients.

Navy deep-sixes the sit-up

Testing our servicemen and women for physical fitness has long included the sit-up as a measuring stick for core strength. This despite the fact that the evidence indicates the forward-bending or flexion movement of the lower back performed in the process of the sit-up is potentially harmful to the lower back. There are better exercises to measure core strength, e.g. planks, and other fitness tests that can better measure the capacity to perform their jobs. This approach has been adopted, in part, by the Marines where testing includes more functional measures that better mimic the actual requirements of their job, such as a 50-yard loaded carry to test their capacity to carry an injured person out of harm’s way. The Navy is now moving in this direction; read more about these changes in the Navy Times.