Health care law newsletter最新文献

In large part due to the foregoing issues, Medicare program officials have focused on respiratory therapy as an area with great potential for abuse, and may well introduce significant reforms in the near future. Accordingly, any contractual arrangements for respiratory therapy programs of the type discussed above should be carefully reviewed for compliance with Medicare requirements and for a realistic assessment of the parties' potential exposure to liability under the anti-kickback statute. At a minimum, these agreements should provide for short "without cause" termination provisions, or include a so-called "jeopardy" provision that permits the parties to renegotiate or terminate their contract if significant changes occur in, or if the current arrangement is found or threatened to be found to violate, applicable law.

The DOJ's latest actions suggest that MFNs in managed care contracts should be evaluated on a case-by-case basis, focusing on the actual or potential impact that the MFNs have on price competition among providers and payors in the relevant marketplace. For health care providers desiring to avoid MFNs, however, the DOJ's heightened activity in this area might furnish an appropriate reason to resist such clauses. To date, the DOJ's focus has been on the market power of payors with MFN status. However, the DOJ's reasoning applies equally to providers that wield buying power in contracting with others. Although the DOJ has yet to take up this latter issue, MFNs imposed by increasingly powerful provider organizations can expect to receive similar scrutiny from the DOJ, especially as their market influence grows.

In any event, the decision to institute a corporate compliance program is a relatively simple one. In view of the ambiguity surrounding certain fraud and abuse provisions, and the corporate "death sentence" that may result from program exclusion, a compliance program is always sound corporate policy. To be sure, if the compliance program is administered improperly, it can actually increase the likelihood of whistleblower actions and create a body of potentially hurtful documentation. But these dangers can be minimized by structuring the program to protect the self-evaluative process through relevant privileges. The risks also pale in comparison to the exposure to criminal or exclusionary sanctions when improper conduct goes undetected by an organization.

The most immediate concern in the development of telemedicine programs, technology, and equipment is the continuation of federal funding. As Congress continues its efforts to balance this year's federal budget, funds for research generally and particularly for the pilot programs discussed above could be cut or eliminated. Federal funding is surprisingly important to the rapid maturation of telemedicine. Without these pilot projects, HCFA believes that it would be unable to assess the effect of Medicare reimbursement for telemedicine consultations. Without such assessment, HCFA may be unwilling to relax the current restrictions on reimbursement for telemedicine outside of pilot programs. HMOs and third-party payors would then be less likely to support telemedicine programs and reimburse providers who participate in them. Similarly, without the promise of federal or private reimbursement, the telecommunications industry will find it harder to justify continuing research and development in new technologies. Nonetheless, even a complete elimination of all federal research monies is likely only to slow the growth of telemedicine, not stop it.

Although S. 308 reportedly has some bipartisan support, its passage is by no means certain. ERISA has for years provided employers with the freedom to design their own benefit plans without state interference, as well as the ability to operate such plans in a uniform manner throughout the country. large employers are thus not likely to cede the advantages of ERISA preemption without a battle. When strong business interests are pitted against the states' equally strong interests in enacting health care reforms, the outcome cannot be predicted.

Increased health care fraud and abuse investigations could result in home health agencies, and other targets, becoming politically acceptable casualties of war in the battle to balance the federal budget. To protect themselves, home health agencies would be well advised to conduct internal fraud and abuse audits on an annual basis and to develop corporate compliance plans (see Newsletter, Vol. 9, No. 7, July 1994, at 16, and next month's issue, which will discuss corporate compliance programs as well as the OIG's new voluntary disclosure program). In addition, purchasers of home health agencies should be especially vigilant of fraud and abuse problems during the due diligence phase of the acquisition and, if problems are discovered, should consider whether voluntary disclosure to the OIG and settlement of any resulting claims is an appropriate condition of closing.

In the long run, the impact of Guernsey will depend on the interpretation and application of the decision by HCFA, the Provider Reimbursement Review Board, and the courts. If HCFA interprets the decision as a signal that the Supreme Court is willing to grant federal agencies broad latitude to avoid the rulemaking requirements of the APA, providers may have fewer opportunities for formal input into payment policy issues under the Medicare program. The impact of the case may well go beyond cost-based reimbursement issues and affect all aspects of the Medicare program.

There is still no general definitive guide for hospitals and other health care providers concerning the extent of their duty to warn third parties of a patient's HIV status. However, even in states like California that have statutorily eliminated any duty to directly inform third parties, the Reisner case clearly indicates that liability to third parties may arise indirectly based on a failure to warn HIV-exposed or -infected patients of their status and the risks of communicating the virus to others. Accordingly, health care providers should take several actions: 1. Ascertain, with the assistance of legal counsel, the precise dictates of applicable state statutes and case law regarding (a) a provider's obligation to warn HIV-exposed or -infected individuals of the potential of communicating the virus to others; (b) additional statutory requirements such as notification of public health authorities; and (c) whether notice to third parties at risk of exposure from the patient is required or even permitted. 2. Develop and implement written policies regarding notification and counseling of exposed or infected patients, including counseling patients on the risks of communicating the virus to third parties; and 3. Develop and implement written policies regarding permissive or mandatory notification and counseling of exposed or infected third parties. In this context, providers should be aware that patient confidentiality and privacy laws may prohibit disclosure of the identity of exposed or infected patients to third parties.