Métodos de regularización en el problema inverso

In addition to laws — such as the Stark and Anti- Kickback Laws — aimed at addressing the potential overutilization of covered items and services, certain federal health care laws are intended to address the opposite issue: the underutilization of such items and services. For example, the federal civil money penalty (CMP) laws provide that if a “hospital . . . knowingly makes a payment, directly or indirectly, to a physician as an inducement to reduce or limit services provided with respect to individuals” who are (1) entitled to Medicare or Medicaid benefits and (2) “under the direct care of the physician,” then the hospital and physician are subject to a CMP of $2,000 for each individual with respect to whom the payment is made.65 _{For purposes of} this publication, will refer to this as the “Services Reduction CMP.”

Potential Application to ACO Arrangements

Payments By Hospitals to Physicians

As a threshold matter, the Services Reduction CMP only applies to payments from hospitals to physicians. Thus, to the extent that shared savings or similar payments under an ACO are not being provided by a hospital (e.g., they are being furnished by a payer) or are not being paid to a physician (e.g., they are being furnished to any other provider or supplier), the Services Reduction CMP will not be implicated by the arrangement.

Reduce or Limit Services

If the payments are made by a “hospital” to a “physician,” however, the CMP will be implicated if they serve as an inducement to “reduce or limit” the services provided to Medicare or Medicaid beneficiaries “under the direct care of the physician.” The OIG has interpreted this element of the Services Reduction CMP quite broadly. For example, in 1999, the OIG issued a Special Advisory Bulletin entitled, “Gainsharing Arrangements and CMPs for Hospital Payments to Physicians to Reduce or Limit Services to Beneficiaries.” As its title suggests, the Bulletin interprets the Services Reduction CMP in the context of so-called “gainsharing” arrangements. According to the Bulletin, and as discussed above, these arrangements typically involve a hospital giving “physicians a percentage share of any reduction in the hospital’s costs for patient care attributable in part to the physicians’ efforts.” These arrangements, the OIG continued:

seek to align physician incentives with those of hospitals by offering physicians a share of the hospital’s variable cost savings attributable to Medicare and Medicaid reimbursement. Since the institution of the Medicare Part A DRG system of hospital reimbursement and with the growth of managed care, hospitals have experienced significant financial pressures to reduce costs. However, because physicians are paid separately under Medicare Part B and Medicaid, physicians do not have the same incentive to save hospital costs. Gainsharing arrangements are designed to bridge this gap by offering physicians a portion of the hospital’s cost savings in exchange for identifying and implementing cost saving strategies.

The OIG recognized that “hospitals have a legitimate interest in enlisting physicians in their efforts to eliminate unnecessary costs.”

Savings that do not affect the quality of patient care may be generated in many ways, including substituting lower cost but equally effective medical supplies, items or devices; re-engineering hospital surgical and medical procedures; reducing utilization of medically unnecessary ancillary services; and reducing unnecessary lengths of stay. Achieving these savings may require substantial effort on the part of the participating physicians. Obviously, a reduction in health care costs that does not adversely affect the quality of the health care provided to patients is in the best interest of the nation’s health care system.

“Nonetheless,” the OIG concluded, “the plain language of [the CMP] prohibits tying the physicians’ compensation for such services to reductions or limitations in items or services provided to patients under the physicians’ clinical care.” The OIG emphasized that the Services Reduction CMP “is very broad.” For example, “[t] he payment need not be tied to an actual diminution in care, so long as the hospital knows that the payment may influence the physician to reduce or limit services to his or her patients.” Further, “[t] here is no requirement that the prohibited payment be tied to a specific patient or to a reduction in medically necessary care.” In short, “any hospital incentive plan that encourages physicians through payments to reduce or limit clinical services directly or indirectly violates the statute.”

Since issuing the Bulletin in 1999, the OIG has addressed the Services Reduction CMP in connection with a number of advisory opinions. For example, in addition to considering the Anti-Kickback Law in Advisory Opinion 08-21 (summarized above), the OIG also analyzed the arrangement under the Services Reduction CMP. As a threshold matter, the OIG concluded that “all of the recommendations implicated the CMP.”

Simply put, with respect to the

recommendations under the [a]rrangement regarding standardization of devices and supplies, limiting use of specific vascular closure devices and cutting balloons, and substitution of contrast agent[s] and anti- thrombotic medication, the [a]rrangement might induce physicians to reduce or limit the then-current medical practice at the [h]ospital. We recognize that the then-current medical practice may have involved care that exceeded the requirements of medical necessity.

However, whether the current medical practice reflects necessity or prudence is irrelevant for purposes of the CMP.

Risk Management

Unfortunately, the Services Reduction CMP (unlike the Stark and Anti-Kickback Laws) does not have any statutory exceptions or regulatory safe harbors. (Note once again, however, that the §3022 waiver authority under the ACA does extend to the Services Reduction CMP.) Thus, where an arrangement implicates the Services Reduction CMP, affected providers have three choices: (1) refrain from undertaking the arrangement at issue; (2) refrain from undertaking the arrangement until and unless a favorable advisory opinion is obtained from the OIG; or (3) undertake the arrangement subject to safeguards that are consistent with the guidance issued by the OIG over the past 10 years, thereby lowering — but not eliminating — the overall risk of the arrangement under the Services Reduction CMP.

Once again, many of the risk factors and safeguards associated with ACO-like arrangements can be gleaned from OIG advisory opinions. In Advisory Opinion 08-21, for example, the OIG concluded that notwithstanding the fact that the arrangement at issue implicated the Services Reduction CMP, it also incorporated “several features that, in combination, provide sufficient safeguards so that we would not seek sanctions against the [r]equestors.”

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First, the “specific cost saving actions and resulting savings were clearly and separately identified.” This “transparency” allows for “public scrutiny and individual physician accountability for any adverse effects” of the arrangement, “including any difference in treatment among patients based on non-clinical indicators.” The “transparency of the incentives for specific actions and specific procedures also facilitates accountability through the medical- legal professional liability system.”

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Second, there is “credible medical support for the position that implementation of the recommendations did not adversely affect patient care.”

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Third, the amounts to be paid under the arrangement “have been calculated based on all procedures performed, regardless of the patients’ insurance coverage, subject to the cap on payment for federal health care program procedures.” In addition, the “procedures to which the [a]rrangement applied were not disproportionately performed on federal health care program beneficiaries.” Further, “the cost savings have been calculated on the [h]ospital’s actual out-of-pocket acquisition costs, not an accounting convention.”

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Fourth, the arrangement “protected against inappropriate reductions in services by utilizing objective historical and clinical measures to establish baseline thresholds beyond which no savings accrued to the [g]roups.” The requestors “have certified that these baseline measures were reasonably related to the [h] ospital’s or comparable hospitals’ practices and patient populations.” In addition, these safeguards were “action-specific and not simply based on isolated patient outcome data unrelated to the specific changes in cardiac catheterization practices.”

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Fifth, the “product standardization portion of the [a]rrangement further protected against inappropriate reductions in services by ensuring that individual physicians still had available the same selection of devices and supplies after

implementation of the [a]rrangement as before.” The arrangement “was designed to produce savings through inherent clinical and fiscal value and not from restricting the availability of devices and supplies.”

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Sixth, the hospital and groups “provided written disclosures of their involvement in the [a]rrangement to patients whose care might have been affected by the [a]rrangement” and “provided patients an opportunity to review the cost savings recommendations prior to admission to the [h]ospital (or, where pre-admission consent was impracticable, prior to consenting to the procedure).” While “we do not believe that, standing alone, such disclosures offer sufficient protection from program or patient abuse, effective and meaningful disclosure offers some protection against possible abuses of patient trust.”

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Seventh, the “financial incentives under the [a]rrangement were reasonably limited in duration and amount.”

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Eighth, because “each of the [g]roups distributes profits to its members on a per capita basis, any incentive for an individual physician to generate disproportionate cost savings was mitigated.”

In sum, the OIG noted, the arrangement is “markedly different from ‘gainsharing’ plans that purport to pay physicians a percentage of generalized cost savings not tied to specific, identifiable cost-lowering activities.” Rather, the arrangement “set out the specific actions to be taken and tied the remuneration to the actual, verifiable cost savings attributable to those actions.” This transparency, in turn, “allowed an assessment of the likely effect of the [a]rrangement on quality of care and ensures that the identified actions are the cause of any savings.” In short, “[g]iven the limited duration and scope of the [a]rrangement, the safeguards provided sufficient protections against patient and program abuse.” “Other arrangements,” however, “including those that are

longer in duration or more expansive in scope than the [a]rrangement, are likely to require additional or different safeguards.”

In document Técnicas geodésicas y riesgos naturales: el problema inverso de la gravimetría (página 31-36)