From tobacco to health care and beyond--a critique of lawsuits targeting unpopular industries.

The 1998 settlement between state Medicaid agencies and the five major tobacco companies heralded a new form of litigation in which individual or government plaintiffs allied with private class action attorneys use economic, political and moral leverage to extract huge settlements from entire industries. Beginning with several class action suits filed in late 1999 against managed care companies by aggrieved HMO enrollees, and continuing with government suits against the paint and handgun industries, this new form of litigation has become a powerful vehicle for plaintiffs to punish unpopular--but entirely legal--industries. In this Note, the author demonstrates that the popular appeal of these suits conceals legal theories of recovery that probably could not survive courtroom scrutiny. The author argues that the thin legal merits of these class action claims are often tolerated by courts, who urge settlement in order to clear their dockets, and by the industries, who regard settlement merely as a cost of doing business. The author concludes that the tobacco litigation and its progeny encourage citizens and the executive branches of government to seek restitution and fundamental social change in the courts after losing in the legislative arena, thus forcing the judiciary branches into the unwise and improper role of policymaker.     

Medicaid program; external quality review of Medicaid managed care organizations. Final rule

This final rule establishes requirements and procedures for external quality review (EQR) of Medicaid managed care organizations (MCOs) and prepaid inpatient health plans (PIHPs). It defines who qualifies to conduct EQR and what activities can be conducted as part of EQR. In addition, under certain circumstances, this rule allows State agencies to (1) use findings from particular Medicare or private accreditation review activities to avoid duplicating review activities, or (2) exempt certain Medicare MCOs and PIHPs from all EQR requirements. Also, this rule allows the payment of enhanced Federal financial participation (FFP) at the 75 percent rate for the administrative costs of EQRs or EQR activities that are conducted by approved entities.     

Charter rights & health care funding: a typology of Canadian health rights litigation

Canadian health consumers have increasingly relied on the Charter of Rights and Freedoms to demand certain therapies and reasonably timely access to care. Organizing these cases into a 5-part typology, we examine how a rights-based discourse affects allocation of health care resources. First, successful Charter challenges can, in theory, lead to courts granting and enforcing positive rights to therapies or to timely care. Second, courts may grant a right to certain health services; however, subsequently government fails to deliver on this right. Third, successful litigation may create negative rights, i.e. rights to access care or private health insurance without government interference. Fourth, consumers can fail in their legal pursuit of a right but galvanize public support in the process, ultimately effecting the desired policy changes. Lastly, a failed lawsuit can stifle an entire advocacy campaign for the sought-after therapies. The typology illustrates the need to examine both legal and policy outcomes of health right litigation. This broader analysis reveals that the pursuit of health rights seems to have caused largely a regressive rather than progressive impact on Canadian Medicare.     

Medicare and Medicaid programs; advance directives--HCFA. Final rule

This final rule responds to public comments on the March 6, 1992 interim final rule with comment period that amended the Medicare and Medicaid regulations governing provider agreements and contracts to establish requirements for States, hospitals, nursing facilities, skilled nursing facilities, providers of home health care or personal care services, hospice programs and managed care plans concerning advance directives. An advance directive is a written instruction, such as a living will or durable power of attorney for health care, recognized under State law, relating to the provision of health care when an individual's condition makes him or her unable to express his or her wishes. The intent of the advance directives provisions is to enhance an adult individual's control over medical treatment decisions. This rule confirms the interim final rule with several minor changes based on our review and consideration of public comments.     

Medicaid program; elimination of certain written documentation pertaining to Medicaid long-term care facilities--HCFA. Final rule

This final rule deletes a requirement in Medicaid regulations pertaining to State survey agencies, which certify facilities as meeting the requirements for participation in the Medicaid program. Specifically, we are deleting the requirement that State survey agencies, when certifying facilities with deficiencies, must provide written documentation that the deficiencies do not jeopardize resident health and safety or seriously limit the facility's capacity to furnish adequate care. Because there are already other written requirements for documentation of these deficiencies, this revision eliminates an unnecessary administrative burden, while ensuring resident health and safety.     

Patient confidentiality statutes in Medicare & Medicaid fraud investigations

The Medicare and Medicaid programs have been burdened with health care providers' fraudulent and abusive practices since their implementation in 1965. To help states discover and prevent Medicare and Medicaid fraud, Congress has enacted statutes permitting access to patients' medical records in investigations of fraud. The majority of states have enacted physician-patient and psychotherapist-patient privilege statutes to protect confidential information from disclosure. Thus, the state's need for patient information conflicts with the patient's right of privacy. This Note discusses several court decisions that have wrestled with the tension between these two policies. The courts, after balancing the state interest in eliminating fraud against the patient's privacy interest, have often allowed disclosure of patient medical records. Although some courts have attempted to limit the extent of the information disclosed, few have set forth explicit standards to protect patient records from unwarranted disclosure of confidential information. This Note suggests guidelines for courts, legislatures and health care providers to uniformly limit the extent of this disclosure.     

Medicare and Medicaid programs; mandatory use, collection, encoding, and transmission of Outcome and Assessment Information Set (OASIS) for home health agencies. Health Care Financing Administration (HCFA), HHS. Notice

This notice announces to home health agencies (HHAs), State survey agencies, Medicare and Medicaid beneficiaries, software vendors, and the general public changes to and effective dates for OASIS implementation. This notice announces the effective dates for the mandatory use, collection, encoding, and transmission of OASIS data for all Medicare/Medicaid patients receiving skilled services. For non-Medicare/non-Medicaid patients receiving skilled services, there will be no encoding and transmission until further notice, but HHAs must conduct comprehensive assessments and updates at the required time points. For patients receiving personal care only services, regardless of payor source, we are delaying the requirements regarding OASIS use, collection, encoding, and transmission until further notice. We expect to begin implementation of OASIS for non-Medicare/non-Medicaid patients receiving skilled care and for patients receiving personal care only services in the Spring of 2000. A separate Federal Register notice will be published with instructions at that time. In addition, software changes described at the end of this notice are of interest to software vendors and HHAs. Also, a companion notice concerning the OASIS System of Records (SOR) is published elsewhere in this Federal Register and is available via the HCFA Internet site (http://www.hcfa.gov).     

Medicaid program; Medicaid managed care--HCFA. Proposed rule

This proposed rule would amend the Medicaid regulations to allow the States greater flexibility by giving them the option to require Medicaid recipients to enroll in managed care entities without obtaining waivers. These revisions, which are authorized by the Balanced Budget Act of 1997, would establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services. They would eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. They would also permit State agencies to amend their State plans to require enrollment in managed care organizations subject to certain conditions, including limits on whose enrollment can be mandated, and a requirement for beneficiary choice. In addition, this rule would extend most of these new requirements to prepaid health plans.     

Medicare and Medicaid programs: hospice conditions of participation. Final rule

This final rule revises the existing conditions of participation that hospices must meet to participate in the Medicare and Medicaid programs. The final conditions address the comments that we received on the proposed rule published on May 27, 2005. This final rule focuses on the care delivered to patients and their families by hospices and the outcome of that care. The final requirements continue to reflect the unique interdisciplinary view of patient care and allow hospices flexibility in meeting quality standards. These changes are an integral part of the Administration's efforts to achieve broad based improvements in the quality of health care and our efforts to improve the quality of care furnished through the Medicare and Medicaid programs.     

Public sector primary care and Medicaid: trading accessibility for mainstreaming

Facilities operated by public and nonprofit agencies have become increasingly important sources of primary care for Medicaid patients. These facilities are particularly important sources of care in segregated, competitive urban areas, where they are more geographically accessible than many private physicians and expand the availability of care to Medicaid patients rather than substituting for care provided by private physicians. In rural areas, in contrast, the availability of care from public facilities appears to reduce the level of care Medicaid patients receive from private physicians in the counties where these facilities are located. These findings suggest that policymakers can expand urban Medicaid patients' access to care by spending on public care, but at the cost of increasing the segregation of Medicaid patients into a two-tier system of care.     

Medicaid program; Medicaid managed care: new provisions. Final rule

This final rule amends the Medicaid regulations to implement provisions of the Balanced Budget Act of 1997 (BBA) that allow the States greater flexibility by permitting them to amend their State plan to require certain categories of Medicaid beneficiaries to enroll in managed care entities without obtaining waivers if beneficiary choice is provided; establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services; and eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as, the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing.     

Medicare and Medicaid programs; surety bond and capitalization requirements for home health agencies--HCFA. Final rule with comment period

The Balanced Budget Act of 1997-(BBA '97) requires each home health agency (HHA) to secure a surety bond in order to participate in the Medicare and Medicaid programs. This requirement applies to all participating Medicare and Medicaid HHAs, regardless of the date their participation began. This final rule with comment period requires that each HHA participating in Medicare must obtain from an acceptable authorized Surety a surety bond that is the greater of $50,000 or 15 percent of the annual amount paid to the HHA by the Medicare program, as reflected in the HHA's most recently accepted cost report. The BBA '97 also requires that provider agreements be amended to incorporate the surety bond requirement; this rule deems such agreements to be amended accordingly. The BBA '97 prohibits payment to a State for home health services under Medicaid unless the HHA has furnished the State with a surety bond that meets Medicare requirements. This final rule with comment period requires that, in order to participate in Medicaid, each HHA must obtain from an acceptable authorized Surety, a surety bond that is the greater of $50,000 or 15 percent of the annual Medicaid payments made to the HHA by the Medicaid agency for home health services for which Federal Financial Participation (FFP) is available. In addition to the surety bond requirement, an HHA entering the Medicare or Medicaid program on or after January 1, 1998 must demonstrate that it actually has available sufficient capital to start and operate the HHA for the first 3 months. Undercapitalized providers represent a threat to the quality of patient care.     

State Medicaid managed care enrollment: understanding the political calculus that drives Medicaid managed care reforms

The objective of this article is to understand the political motivations underlying Medicaid managed care reforms by examining the determinants of enrollment of beneficiaries in managed care plans in the fifty states. To highlight the role of the model variables, including measures of the political environment, public interest, and special interests, a distinction is made between capitated and fee-for-service managed care enrollment. The results show that cost containment within the context of the Medicaid program is perceived as strongly favored by voters. Accordingly, the relative cost and tax price of providing Medicaid services are important factors in states' decision to enroll Medicaid beneficiaries in managed care plans, particularly capitated ones. The results also indicate a surprisingly significant influence by labor unions that generally oppose managed care enrollment for fears of lost jobs. The recipient population and provider groups also play an important role in shaping the Medicaid managed care landscape. The influence of variables measuring states' ability and willingness to pay and median voter preferences suggest that, within the context of Medicaid managed care enrollment, the public's interests are being served; however, the results also point toward inequities within the program and implications concerning financing arrangements between states and the federal government.     

EMTALA: dedicating an emergency department near you

Congress enacted the Emergency Medical Treatment and Labor Act (EMTALA) in 1986 to prohibit patient dumping. Subsequent to its passage, however, issues concerning the application of EMTALA have vexed hospitals, patients, regulators, and courts. In an attempt to clarify these issues, the Centers for Medicare & Medicaid Services (CMS) recently promulgated new EMTALA regulations. This Article reviews the basic requirements of EMTALA and highlights the statutory definitions critical to its proper interpretation and application. The article then analyzes the impact of the new regulations, particularly in five major areas: where and when the statute applies, on-call physician requirements, hospital-owned ambulances, managed care, and bioterrorism. It concludes with a discussion of the implications of the new regulations for hospitals and their counsel.     

Cost-effectiveness analysis in the courts: recent trends and future prospects

This article provides an initial look at how managed care organizations (MCOs) might incorporate cost-effectiveness analysis (CEA) into their decision-making process and how the courts might respond. Because so few medical liability cases directly involve CEA, we must look at other areas of the law to assess potential MCO liability for applying CEA. In general negligence cases, courts rely on a risk-benefit test to determine customary practice. Likewise, in product liability cases, courts use a risk-utility calculus to determine liability for product design defects. And in challenges to government regulation, courts examine how agencies use CEA to set regulatory policy. The results have been mixed. In product liability cases, CEA has led to some punitive damage awards against automobile manufacturers. But courts have integrated it in negligence cases without generating juror antipathy, and generally defer to agency expertise in how to incorporate CEA. The article discusses the implications of these cases for MCO use of CEA and outlines various options for setting the standard of care in the managed care era.     

Medicare, Medicaid, and Maternal and Child Health Services Block Grant programs; civil money penalties and assessments for false or improper claims--Department of Health and Human Services. Notice of proposed rulemaking

These proposed regulations are intended to strengthen the Department's ability to protect the health care financing programs against persons and organizations who defraud and abuse those programs. The regulations would specify procedures for implementing the authority provided to the Department by section 2105 of the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), as amended by section 137(b)(26) of the Tax Equity and Fiscal Responsibility Act of 1982 (Pub. L. 97-248), to impose civil money penalties and assessments administratively for the filing of false or certain other improper claims in the Medicare, Medicaid, or Maternal and Child Health Services Block Grant programs. The statute also permits an individual upon whom the Department imposes a civil money penalty or assessment to be suspended from participation in the Medicare and Medicaid programs. Until enactment of the civil money penalties legislation, the federal government had to rely upon litigation under the False Claims Act or criminal proceedings in order to compel restitution of funds falsely or improperly claimed under HHS health care financing programs.     

Medicare and Medicaid programs; recognition of the Joint Commission on Accreditation of Healthcare Organizations standards for home care organizations--HCFA. Final notice

This final notice recognizes accreditation by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) for home health agencies (HHAs) that wish to participate in the Medicare or Medicaid programs. As a result of this recognition, HHAs accredited by JCAHO are deemed to meet the Medicare conditions of participation for HHAs to the extent described in this notice. This final notice sets forth certain specific requirements with which JCAHO must comply to maintain Medicare and Medicaid recognition of its HHA accreditation program.     

Medicaid program; Medicaid managed care. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period amends the Medicaid regulations to implement provisions of the Balanced Budget Act of 1997 (BBA) that allow the States greater flexibility by permitting them to amend their State plan to require certain categories of Medicaid beneficiaries to enroll in managed care entities without obtaining waivers if beneficiary choice is provided; establish new beneficiary protections in areas such as quality assurance, grievance rights, and coverage of emergency services; eliminate certain requirements viewed by State agencies as impediments to the growth of managed care programs, such as the enrollment composition requirement, the right to disenroll without cause at any time, and the prohibition against enrollee cost-sharing. In addition, this final rule expands on regulatory beneficiary protections provided to enrollees of prepaid health plans (PHPs) by requiring that PHPs comply with specified BBA requirements that would not otherwise apply to PHPs.     

Medicaid program and State Children's Health Insurance Program (SCHIP) payment error rate measurement. Interim final rule with comment period

This interim final rule sets forth the State requirements to provide information to us for purposes of estimating improper payments in Medicaid and the State Children's Health Insurance Program (SCHIP), as required under the Improper Payments Information Act (IPIA) of 2002. The IPIA requires heads of Federal agencies to annually estimate and report to the Congress these estimates of improper payments for the programs they oversee and, submit a report on actions the agency is taking to reduce erroneous payments. We published a proposed rule on August 27, 2004 to propose that States measure improper payments in Medicaid and SCHIP and report the State-specific error rates to us for purposes of computing the improper payment estimates for these programs. After extensive analysis of the issues related to having States measure improper payments in Medicaid and SCHIP, including public comments on the provisions in the proposed rule, we are revising our proposed approach. Our new approach incorporates commenters' suggestions to engage a Federal contractor by contracting with that entity to complete the data processing and medical reviews and calculate the State-specific error rates. Based on the States' error rates, the contractor also will calculate the improper payment estimates for these programs which will be reported by the Department of Health and Human Services as required by the IPIA. This interim final rule sets out the types of information that States would need to submit to allow CMS to conduct medical and data processing reviews on claims made in the fee-for-service (FFS) setting. CMS will address estimating improper payments for Medicaid managed care and eligibility and SCHIP FFS, managed care and eligibility at a later time. This rule responds to the public comments on the proposed rule, sets forth the requirements for States to assist us and the contractor to produce State-specific error rates in Medicaid and SCHIP which will be used as the basis for a national error rate, and outlines future plans for measuring eligibility, which may include greater State involvement than the level required for the medical and data processing reviews.     

Medicare and Medicaid programs; surety bond requirements for home health agencies--HCFA. Notice of intent to amend regulations

This document announces our present intent to make technical revisions to the surety bond and capitalization regulations for home health agencies (HHAs) published on January 5, 1998 (63 FR 292-355). These intended revisions include: generally limiting the Surety's liability on the bond to the term when it is determined that funds owed to Medicare and Medicaid have become "unpaid," regardless of when the payment, overpayment or other action causing such funds to be owed took place; establishing that a Surety will remain liable on a bond for an additional two years after the date an HHA leaves the Medicare or Medicaid program; and giving a Surety the right to appeal an overpayment, a civil money penalty, or an assessment if the HHA to which the bond has been issued fails to pursue its rights of appeal. These revisions should help smaller, reputable HHAs, such as non-profit visiting nurse associations, obtain surety bonds without weakening protections to Medicare and Medicaid inherent in the bond requirements.