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Date: June 1995
Contact:  HCFA Press Office (202) 690-6145

Nursing Home Reform: Flexible Enforcement Rules
to Ensure High Quality Care


Overview

As of July 1, 1995, HHS is implementing the last major phase of nursing home reform. On that day, new enforcement regulations take effect to assure high quality care in nursing homes.

Nursing home reform has been put into effect in phases by HHS' Health Care Financing Administration, working in cooperation with nursing home providers as well as organizations representing Medicare and Medicaid beneficiaries.

To date, reform has included a residents' "bill of rights" and requirements for individual resident assessments and plans of care, as well as nurse aide training and competency requirements and the establishment of a nurse aide registry. Now, with the new enforcement regulations, a wider range of sanctions will be available, tailored to different kinds of quality problems.

The new enforcement rules provide a variety of remedies that can be applied for deficiencies of varying severity. Adopting "substantial compliance" as the acceptable standard, the new rules are meant to ensure reasonable regulation, while at the same time they require nursing homes to fix problems quickly and on a long-term basis. An important goal of the new enforcement plan is to ensure that continuous internal quality control and improvement is performed by nursing homes themselves. HCFA is working closely with states, providers and beneficiary groups as the new enforcement regulations are implemented.

                   Nursing Homes at a Glance

   Number of nursing home residents . . . . . . . . . . 1.5 million

   Number of nursing homes. . . . . . . . . . . . . . . . . .16,700

   Annual nursing home spending*. . . . . . . . . . . . $40 billion

   (*FY95 estimate, Medicare/Medicaid-federal & state)

Background

Nursing home reform was the result of the Institute of Medicine's (IoM) study of the regulation of nursing homes, entitled, "Improving the Quality of Care in Nursing Homes," published in 1986. The study culminated in the passage of reform legislation in the Omnibus Budget Reconciliation Act of 1987. Nursing home reform resulted in a new set of outcome-based requirements which have been in effect since 1990.

A primary focus of the IoM study was the chronic problem of nursing homes that fail to comply with federal requirements and the manner in which "borderline" nursing homes were in and out of compliance with Medicare and Medicaid health and safety participation requirements. The IoM found that many of these facilities could avoid termination of participation if they came into compliance long enough to be recertified, but that these facilities had no commitment to sustained compliance. Therefore, the study recommended that HCFA implement a range of intermediate remedies to deter violations.

HCFA's new long term care enforcement regulation implements the nursing facility reform legislation passed by Congress. The legislation mandated the abandonment of HCFA's traditional methodology of responding to deficiencies, which relied primarily on a single severe sanction: termination of payment for Medicare and Medicaid patients. The new variety of remedies allows HCFA or the state to tailor the particular remedy to the seriousness of the violation.

The proposed enforcement rule was published in the Federal Register on August 28, 1992. HCFA considered 28,000 comments received during the comment period, including all concerns raised by industry, advocates, and beneficiaries, in the creation of improved measurements of compliance. The final regulation was published in the Federal Register on November 10, 1994.

The regulation provides for the imposition of civil money penalties and other alternative remedies, such as denial of payment for new admissions, state monitoring, temporary management, directed plans of correction, and directed in-service training. At the same time, the enforcement regulation requires that all violations be addressed, employing a remedy that is appropriate to the severity of the problem.

To implement the law and regulations, a workgroup comprised of state, regional, and central office representatives created the State Operations Manual instructions for the new enforcement system. The manual instructions were then circulated for comment. HCFA has addressed and incorporated comments and suggestions received from industry representatives, consumer advocates, and internal partners such as states and regions.

The final enforcement regulation is effective July 1, 1995.

Goals

The enforcement regulation establishes attainable compliance standards for Medicare/Medicaid providers. Perfect compliance is not a realistic expectation. Facilities are, however, expected to achieve substantial, continued compliance and take an active stance in quality assurance and improvement, with ongoing efforts at internal quality control. The enforcement process, including definitions of scope and severity, was developed in partnership with provider and beneficiary groups.

HCFA recognizes that one enforcement response is not appropriate for all deficiencies. The new regulation provides alternatives to termination and denial of payment for addressing noncompliance. Sanctions are commensurate with the level and pervasiveness of harm.

HCFA has four goals in implementing the final rule. These goals are key to the success of the overarching objective -- continuous improvement in the quality of nursing home care.

  1. Motivate facilities to remain in compliance. Enforcement process can result in remedies for noncompliance. A facility cannot wait for a state to act as its quality assurance program by identifying deficiencies on the survey, then fix it without a remedy.

  2. Promote survey and enforcement consistency. Requires that studies be conducted, education programs be provided, and mandatory surveyor training and testing be completed. An enforcement model to assess deficiencies and select remedies is used to guide decision making.

  3. Link enforcement responses to deficiencies. Puts enforcement remedies into three remedy categories, and each remedy category is associated with specific levels of noncompliance. Makes a correlation between the seriousness of noncompliance and the enforcement response.

  4. Create no unnecessary processes. Informal dispute resolution process should reduce burden of formal mechanism and will not delay enforcement remedies. The existing enforcement remedies are blended into the new enforcement model.

What the Regulation Does

Expands the menu of remedies that can be imposed instead of, or in addition to, termination.

Uses substantial compliance as the standard of compliance. Substantial compliance means that a provider's deficiencies pose no more than a potential for minimal harm. Providers in substantial compliance are certified in compliance and are not subject to enforcement remedies.

Uses severity and pervasiveness to determine appropriate remedies.

Discourages "yo-yo compliance" by providing for the imposition of a civil money penalty upon identification of current noncompliance as well as periods of noncompliance between two certifications of compliance. Poor performers who come into compliance only long enough to be recertified, but who don't sustain compliance, can be sanctioned quickly.

Codifies informal dispute resolution. Providers have an opportunity to dispute survey findings to the State or regional office. This informal review will not delay enforcement actions.

Partnership: Training and Assistance

An intense and wide-ranging training initiative has been carried out to prepare for implementation of the new enforcement regulations. HCFA has worked with states and with private industry to assure preparedness.

HCFA is also establishing unprecedented procedures, including early alert systems, to monitor implementation and ensure that the new rules work as intended to ensure high quality care.

The actual requirements that nursing homes must meet (the nursing home certification rules) have been in effect nearly five years, and during this time providers have received extensive training on those requirements.

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