A Medical Device Daily

With the emphasis on prevention of fraud at the Centers for Medicare & Medicaid Services, industry might not be the least bit surprised to see a large guidance hit the presses on compliance program guidelines, and the Office of Inspector General (OIG) at the Department of Health and Human Services did not disappoint with its April draft supplemental guidance on compliance for nursing homes.

The richly detailed guidance states that neither it nor the 2000 guidance "is a model compliance program," but are instead intended to "offer a set of guidelines nursing facilities should consider when developing and implementing a compliance program or evaluating an existing one."

On the other hand, given the recent bad news about nursing homes, operators might be inclined to see the guidance as almost prescriptive. While OIG says the guidance is not intended as a one-size-fits-all document, the guidance encourages operators to "identify and focus their compliance efforts on those areas of potential concern or risk that are most relevant to their organizations."

Staffing is an area of potential concern, although the guidance points out that "no single staffing model will suit every facility." Staff skills are a vital area of measurement, as are staff-to-resident ratios and turnover of staff. OIG prefers that facilities "ensure that the methods used to assess staffing accurately measure actual 'on-the-floor' staff" rather than raw payroll numbers.

Resident care plans – something OIG says it sees as a continued deficiency for some nursing homes – must include "the involvement of attending physicians in resident care." OIG wants to see nursing homes ensure that physicians visit their patients frequently enough to ensure "a meaningful evaluation of the resident."

The question of appropriate use of psychotropic medications arises in part because of the potential for use "as chemical restraints" and because of a more general need to "avoid unnecessary drug usage." Any use of psychotropics should be deployed with "gradual dose reductions and behavioral interventions aimed at reducing medication use." On the larger question of medical management, OIG says that it would like to see "proper medication management processes" that aim to enhance safety and efficacy while minimizing the risk of "improper kickbacks" from pharmaceutical firms. One mandate in this portion of the guidance is that "the drug regime of each resident must be reviewed at least one a month by a licensed pharmacist, who must report any irregularities ... to the attending physician and the director of nursing."

Nursing homes are also advised to assess residents for "resident abuse committed by fellow residents," but employees must also be screened via "reasonable efforts" involving criminal record checks.

The guidance notes that reporting of case mix is a source of fraudulent activity, and reminds that improper coding for resource utilization groups (RUGs) "requires accurate and comprehensive reporting on a resident's conditions and needs." OIG notes that "both internal and external validation of data may prove useful" to ensure appropriate RUG data.

Medicare may not be allowed to kick out doctors, but it can kick out other entities, and nursing homes are "strongly advised to screen all prospective owners, officers, directors, employees, contractors and agents" involved in the provision of other services.

Referrals are predictably a hot topic, and OIG states that although "liability under the anti-kickback statute ultimately turns on a party's intent," a nursing facility can screen out potential problems by examining whether such referrals are done with an entity that is in a position to "provide anything of value or ... in a position to influence or generate federal health program business."

The same question posed in the opposite direction is also telling as to whether a relationship might be seen as conflicted, OIG indicates, and the possibility of the arrangement to "interfere with or skew clinical decision making" has value in determining whether a relationship runs afoul of anti-kickback laws.

OIG recommends that nursing homes designate a compliance officer and a compliance committee as well as procedures, and states that any reporting of potentially violative activity "should occur within a reasonable period, but not longer than 60 days after determining that there is credible evidence of a violation." OIG reminds that "a facility's good faith and willingness to work with authorities to correct and remedy the problem" will go a long way toward reducing any sanctions (see next article).

OIG eases provider self-disclosure

OIG said it is making it easy for healthcare providers with guilty consciences to come clean. In an April 15 document titled "An Open Letter to Health Care Providers," inspector General Daniel Levinson states that the initiative is a response "to the provider community's suggestions ... for ways to improve" the provider self-disclosure protocol, which OIG published in 1998.

In that time, the program "has returned approximately $120 million to the Medicare Trust Fund ... and has avoided the costs and disruptions often associated the a government-directed investigation." Those providers will, upon successful completion of the process, be able to avoid a corporate integrity agreement or a certificate of compliance agreement with OIG.

Initial submissions to the program will have to include a schedule for completion of the provider's internal investigation and an estimate of the amount overcharged. Providers will have to be able to wrap up any internal investigations "within three months after acceptance" into the program, the letter says.

OIG wants to ensure it won't be swamped with cases of simple accidental overbilling. "Disclosures that are characterized as mere billing errors or overpayments ... should be submitted directly to the appropriate claims-processing entity," Levinson writes.

OIG's willingness to forgo any burdensome agreements with the office is based on the presumption that a provider's willingness to be forthcoming demonstrates "the provider's commitment to integrity and advances our goal of expediting the resolution of self-disclosures."