Reining in agency action: the rejected proposal rule and Section 1011 of the 2003 Medicare Act

Section 1011 of the 2003 Medicare Act authorized the disbursement of over one billion dollars to healthcare providers that provide uncompensated emergency medical care to undocumented immigrants. In 2005, the Centers for Medicare and Medicaid Services (CMS) issued its final interpretation of the statute. Despite previous statementsto the contrary, CMS conditioned eligibilityfor Section 1011 funds on the collection of certain immigration status-related information from patients seeking emergency care. Prior to the issuance of CMS' final guidance, the House defeated House Resolution 3722, which was substantially similar to the CMS final guidance. This Article argues that the House's rejection of H.R. 3722 renders CMS's final guidance invalid under the analysis set forth in Chevron, U.S.A. Inc. v. National Resources Defense Council, Inc.     

Stark II and physician compensation models: integrating business and legal issues

In March of 2004, the Centers for Medicare & Medicaid Services released new regulations that interpreted the Federal Physician Self Referral Act, otherwise known as Stark II. The new regulations, commonly referred to as the Phase II regulations, must be carefully considered when structuring physician compensation models. Stark II generally holds that physicians may not make a referral for designated health services to an entity with which they have a direct or indirect financial relationship. This Article outlines the provisions of Stark II that are applicable to physician compensation methodologies. In addition, the authors evaluate hypothetical transactions involving physician groups seeking viable compensation schemes and explore the validity and risks of each.     

TRICARE senior demonstration of military managed care--DOD. Notice of demonstration project

This notice is to advise interested parties of a demonstration project in which the Department of Defense (DoD) will provide health care services to Medicare-eligible military retirees in a managed care program, called TRICARE Senior, and receive reimbursement for such care from the Medicare Trust Fund. The program is authorized by section 1896 of the Social Security Act, amended by section 4015 of the Balanced Budget Act of 1997 (P.L. 105-33). The statue authorizes DoD and the Department of Health and Human Services (HHS) to conduct at six sites during January 1998 through December 2000, a three-year demonstration under which dual-eligible beneficiaries will be offered enrollment in a DoD-operated managed care plan, called TRICARE Senior Prime. The legislation also authorizes Medicare HMOs to make payments to DoD for care provided to HMO enrollees by military treatment facilities (MTFs) participating in the demonstration. This part of the demonstration, to be called Medicare Partners, will allow DoD to enter into contracts with Medicare HMOs to provide specialty and impatient care to dual-eligible beneficiaries currently provided on a space-available basis. Additional legal authority pertinent to this demonstration project is 10 U.S.C. section 1092. Under TRICARE Senior Prime, Medicare-eligible military retirees who enroll in the program will be assigned primary care manager (PCMs) at the MTF. Enrollees will be referred to specialty care providers at the MTF and to participating members of the existing TRICARE Prime network. TRICARE Senior Prime enrollees will be afforded the same priority access to MTF care as military retiree and retiree family member enrollees in TRICARE Prime. DoD will receive reimbursement from HCFA on a capitated basis at a rate which is 95 percent of the rate HCFA currently pays to Medicare-risk HMOs, less costs such as capital and graduate medical education, disproportionate share hospital payments, and some capital costs, which are already covered by DoD's annual appropriation. However, under the authorizing statute, DoD must meet its current level of effort for its Medicare-eligible beneficiaries before receiving payments from the Medicare Trust Fund. That is, DoD must continue to fund health care at a certain expenditure level for its Medicare-eligible population before it may be reimbursed by HCFA for care provided to TRICARE Senior Prime enrollees. The Balanced Budget Act of 1997 required DoD and HHS to complete a memorandum of agreement (MOA) specifying the operational requirements of the demonstration project. That MOA was completed on February 13, 1998, and is published below. Except as provided in the MOA, TRICARE Senior Prime will be implemented consistent with applicable provisions of the CHAMPUS/TRICARE regulation, particularly 32 CFR sections 199.17 and 199.18.     

Pharma on the hot seat

The pharmaceutical industry has been receiving greater scrutiny lately due in large part to the many public and private legal enforcement actions taken against pharmaceutical manufacturers. These enforcement actions, along with legal developments such as the OIG Compliance Guidance for Pharmaceutical Manufacturers, the Sarbanes-Oxley Act's statutory guidelines for public corporations, the HIPAA privacy regulations, and the Medicare Modernization Act, have the potential to encourage the pharmaceutical industry to self-regulate beyond the bounds currently required by the law. After a brief overview of enforcement actions and compliance programs directed toward the pharmaceutical industry, this Article reviews a similar situation the hospital industry faced when Medicare promulgated major reimbursement modifications. The Article proposes that the pharmaceutical industry, in the face of such intense scrutiny and uncertainty, should implement more rigorous self-regulation. Without more stringent self-regulation, this intense interest in the pharmaceutical industry may result in a regulatory push that establishes unanticipated and cumbersome measures for the industry.     

Medicare and State health care programs: fraud and abuse; OIG anti-kickback provisions--HHS. Final rule

This final rule implements section 14 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, by specifying various payment practices which, although potentially capable of inducing referrals of business under Medicare or a State health care program, will be protected from criminal prosecution or civil sanctions under the anti-kickback provisions of the statute.     

Medicare program; availability of Medicare data for performance measurement. Final rule

This final rule implements Section 10332 of the Affordable Care Act regarding the release and use of standardized extracts of Medicare claims data for qualified entities to measure the performance of providers of services (referred to as providers) and suppliers. This rule explains how entities can become qualified by CMS to receive standardized extracts of claims data under Medicare Parts A, B, and D for the purpose of evaluation of the performance of providers and suppliers. This rule also lays out the criteria qualified entities must follow to protect the privacy of Medicare beneficiaries.     

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.     

Medicare program; appeals of CMS or CMS contractor determinations when a provider or supplier fails to meet the requirements for Medicare billing privileges. Final rule

This final rule implements a number of regulatory provisions that are applicable to all providers and suppliers, including durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) suppliers. This final rule establishes appeals processes for all providers and suppliers whose enrollment, reenrollment or revalidation application for Medicare billing privileges is denied and whose Medicare billing privileges are revoked. It also establishes timeframes for deciding enrollment appeals by an Administrative Law Judge (ALJ) within the Department of Health and Human Services (DHHS) or the Departmental Appeals Board (DAB), or Board, within the DHHS; and processing timeframes for CMS' Medicare fee-for-service (FFS) contractors. In addition, this final rule allows Medicare FFS contractors to revoke Medicare billing privileges when a provider or supplier submits a claim or claims for services that could not have been furnished to a beneficiary. This final rule also specifies that a Medicare contractor may establish a Medicare enrollment bar for any provider or supplier whose billing privileges have been revoked. Lastly, the final rule requires that all providers and suppliers receive Medicare payments by electronic funds transfer (EFT) if the provider or supplier, is submitting an initial enrollment application to Medicare, changing their enrollment information, revalidating or re-enrolling in the Medicare program.     

Medicare program; suggestion program on methods to improve Medicare efficiency. Health Care Financing Administration (HCFA), HHS. Final rule with comment period

This final rule with comment period establishes a program to encourage individuals to submit suggestions that could improve the efficiency of the Medicare program. The rule implements section 203(c) of the Health Insurance Portability and Accountability Act of 1996. The intent of this rule is to encourage suggestions and to award, if we deem appropriate, monetary payments to individuals for suggestions that improve efficiency and produce monetary savings to the Medicare program.     

Payment method for health care services under the Supplemental Health Care Program for Active Duty Members of the Uniformed Services; adoption of CHAMPUS procedures--DoD. Final rule

This final rule partially implements 10 U.S.C. 1074(c), as amended by section 729 of the National Defense Authorization Act for Fiscal Years 1990 and 1991, Public Law 101-189. The recent amendment authorizes the Department of Defense to establish for the active duty supplemental care program payment rules similar to those used under the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). The supplemental care program is the program which provides for the payment to civilian (non federal-governmental) health care providers for care provided to active duty members of the uniformed services. This final rule would adopt CHAMPUS payment amounts for the supplemental care program.     

Health care programs: fraud and abuse; amendments to OIG exclusion and CMP authorities resulting from Public Law 100-93--HHS. Final rule; correction

This document corrects technical errors that appeared in the final rule, published on January 29, 1992, that is designed to implement section 2 of Public Law 100-93, the Medicare and Medicaid Patient and Program Protection Act of 1987, along with other conforming amendments.     

The national residency exchange: a proposal to restore primary care in an age of microspecialization

Healthcare deficiencies in the United States have long been perpetuated by a shortage of primary care providers. A core purpose of the Patient Protection and Affordable Care Act (PPACA) is to provide health insurance for America's approximately fifty million uninsured. Implementation of universal health insurance, however, does not mean sufficient healthcare access for all, since the supply of physicians does not and will not meet demand. For reasons reviewed in this Article, the current physician shortage mainly impacts primary care providers. This shortage is particularly troubling because increased provision of primary care relative to specialty care has been associated with improvement in health outcomes, disease prevention, cost effectiveness, and coordination of care. This Article highlights provisions in the PPACA that impact primary care physicians. Finally, this Article proposes the creation of a universal primary care loan repayment program and a national residency exchange designed to alleviate the U.S. primary care crisis by facilitating optimal distribution of resident physicians in each medical specialty based on community need.     

Privacy Act of 1974; matching program--HCFA. Notice of a matching program--the Internal Revenue Service (IRS), the Social Security Administration (SSA), and HCFA--disclosure of IRS taxpayer identity and filing status information to be matched with SSA earned income information for Medicare beneficiaries and their spouses

As required by Section 6202 of the Omnibus Budget Reconciliation Act of 1989 (OBRA 1989), Public Law 101-239, the Department of Health and Human Services is providing public notice that the IRS and the SSA will disclose certain information regarding the taxpayer identification and filing status and the earned income of Medicare beneficiaries and their spouses for HCFA's use in identifying Medicare secondary payer (MSP) situations. This will enable HCFA to seek recovery of identified mistaken payments that were the liability of another primary insurer or other type of payer. The matching report set forth below is in compliance with the Computer Matching and Privacy Protection Act of 1988 (Pub. L. No. 100-503).     

Medicare Program; establishment of the Medicare+Choice Program--HCFA. Interim final rule with comment period

The Balanced Budget Act of 1997 (BBA) establishes a new Medicare+Choice (M+C) program that significantly expands the health care options available to Medicare beneficiaries. Under this program, eligible individuals may elect to receive Medicare benefits through enrollment in one of an array of private health plan choices beyond the original Medicare program or the plans now available through managed care organizations under section 1876 of the Social Security Act. Among the alternatives that will be available to Medicare beneficiaries are M+C coordinated care plans (including plans offered by health maintenance organizations, preferred provider organizations, and provider-sponsored organizations), M+C "MSA" plans, that is, a combination of a high deductible M+C health insurance plan and a contribution to an M+C medical savings account (MSA), and M+C private fee-for-service plans. The introduction of the M+C program will have a profound effect on Medicare beneficiaries and on the health plans and providers that furnish care. The new provisions of the Medicare statute, set forth as Part C of title XVIII of the Social Security Act, address a wide range of areas, including eligibility and enrollment, benefits and beneficiary protections, quality assurance, participating providers, payments to M+C organizations, premiums, appeals and grievances, and contracting rules. This interim final rule explains and implements these provisions. In addition, we are soliciting letters of intent from organizations that intend to offer M+C MSA plans to Medicare beneficiaries and/or to serve as M+C MSA trustees.     

Medicare program; end-stage renal disease quality incentive program. Final rule

This final rule will implement a quality incentive program (QIP) for Medicare outpatient end-stage renal disease (ESRD) dialysis providers and facilities with payment consequences beginning January 1, 2012, in accordance with section 1881(h) of the Act (added on July 15, 2008 by section 153(c) of the Medicare Improvements for Patients and Providers Act (MIPPA)). Under the ESRD QIP, ESRD payments made to dialysis providers and facilities under section 1881(b)(14) of the Social Security Act will be reduced by up to two percent if the providers/facilities fail to meet or exceed a total performance score with respect to performance standards established with respect to certain specified measures.     

Law Enforcement Officers in Schools: An Analysis of Ethical Issues

The use of law enforcement officers in American schools has rapidly expanded since its inception in the 1950s. This growth can in part be attributed to the Safe Schools Act of 1994, the establishment of the Community Oriented Policing Services (COPS) Office, and tragic events that have occurred in our nation's schools. Law enforcement officers in the school environment traditionally have primary roles of protection and enforcement, although many have ancillary roles of educating and mentoring students. However, the use of police in schools has also been associated with the formalization of student discipline and the criminalization of minor misconduct. Specifically, an increase in the number of officers in schools has mirrored an increase in the number of arrests and citations for relatively minor offenses. We argue that officers' socialization and training create role conflict in that the duty to enforce the law competes with other duties to mentor and nurture students. We present several hypothetical dilemmas and then illustrate how the “right thing to do” is determined by the perceived duties of the school safety officer. We conclude by presenting some modest suggestions on how to address the potential role conflict experienced by law enforcement officers working in schools.     

TRICARE; sub-acute care program; uniform skilled nursing facility benefit; home health care benefit; adopting Medicare payment methods for skilled nursing facilities and home health care providers. Final rule

This rule partially implements the TRICARE "sub-acute and long-term care program reform" enacted by Congress in the National Defense Authorization Act for Fiscal Year 2002, specifically: Establishment of "an effective, efficient, and integrated sub-acute care benefits program," with skilled nursing facility (SNF) and home health care benefits modeled after those of the Medicare program; adoption of Medicare payment methods for skilled nursing facility, home health care, and certain other institutional health care providers; adoption of Medicare rules on balance billing of beneficiaries, prohibiting it by institutional providers and limiting it by non-institutional providers; and change in the statutory exclusion of coverage for custodial and domiciliary care.