Federal Register. Conditions of Participation for Home Health Agencies.

Start Preamble. Start Printed Page 4. AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Final rule. SUMMARY: This final rule revises the conditions of participation (Co. Ps) that home health agencies (HHAs) must meet in order to participate in the Medicare and Medicaid programs. The requirements focus on the care delivered to patients by HHAs, reflect an interdisciplinary view of patient care, allow HHAs greater flexibility in meeting quality care standards, and eliminate unnecessary procedural requirements. These changes are an integral part of our overall effort to achieve broad- based, measurable improvements in the quality of care furnished through the Medicare and Medicaid programs, while at the same time eliminating unnecessary procedural burdens on providers.

DATES: These regulations are effective on July 1. Start Further Info.

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FOR FURTHER INFORMATION CONTACT: Danielle Shearer (4. Mary Rossi- Coajou (4.

Maria Hammel (4. 10) 7. End Further Info. End Preamble. Start Supplemental Information. SUPPLEMENTARY INFORMATION: I. Background Information.

A. The Home Health Benefit. Home health services are covered for the elderly and disabled under the Hospital Insurance (Part A) and Supplemental Medical Insurance (Part B) benefits of the Medicare program, and are described in section 1.

Social Security Act (the Act). These services, provided under a plan of care that is established and periodically reviewed by a physician, must be furnished by, or under arrangement with, a home health agency (HHA) that participates in the Medicare or Medicaid programs. Services are provided on a visiting basis in the beneficiary's home, and may include the following: Part- time or intermittent skilled nursing care furnished by or under the supervision of a registered professional nurse. Physical therapy, speech- language pathology, and occupational therapy. Medical social services under the direction of a physician.

Part- time or intermittent home health aide services. Medical supplies (other than drugs and biologicals) and durable medical equipment. Services of interns and residents if the HHA is owned by or affiliated with a hospital that has an approved medical residency training program. Services at hospitals, skilled nursing facilities, or rehabilitation centers when the services involve equipment too cumbersome to bring to the home.

Under the authority of sections 1. Act, the Secretary has established in regulations the requirements that an HHA must meet to participate in the Medicare program.

These requirements are set forth in regulations at 4. CFR part 4. 84, Home Health Services. Current regulations at 4. CFR 4. 40. 7. 0(d) specify that HHAs participating in the Medicaid program must also meet the Medicare Conditions of Participation (Co. Ps). Section 1. 86. Act requires that an HHA must meet the Co. Ps specified in section 1.

Act, and other Co. Ps as the Secretary finds necessary in the interest of the health and safety of patients. Section 1. 89. 1(a) of the Act establishes specific requirements for HHAs in several areas, including patient rights, home health aide training and competency, and compliance with applicable federal, state, and local laws. The Co. Ps for HHAs protect all individuals under the HHA's care, unless a requirement is specifically limited to Medicare beneficiaries. Section 1. 86. 1(o) of the Act describes an HHA for purposes of participation in the Medicare program.

All the requirements are stated generally, and are applicable to the HHA's overall activity, not specifically to Medicare patients. This provision, which was reaffirmed by the Congress in the Omnibus Budget Reconciliation Act (OBRA), 1. Act, has been in the law since the inception of the Medicare program, and CMS' interpretation of it has remained the same. Under section 1. 89. Act, the Secretary is responsible for assuring that the Co. Ps, and their enforcement, are adequate to protect the health and safety of individuals under the care of an HHA, and to promote the effective and efficient use of Medicare funds.

To implement this requirement, State Survey Agencies and CMS- approved accrediting organizations conduct surveys of HHAs to determine whether they are complying with the Co. Ps. B. Previous HHA Conditions of Participation Rules. On March 1. 0, 1. FR 1. 10. 04), we published a proposed rule, entitled, “Revision of the Conditions of Participation for Home Health Agencies and Use of the Outcome and Assessment Information Set (OASIS) as Part of the Revised Conditions of Participation for Home Health Agencies,” that would have revised the entire set of HHA Co. Ps. Due to the significant volume of public comments and the rapidly changing nature of the HHA industry at that time, this rule, in its entirety, was never finalized. Rather than finalizing all portions of the March 1.

FR 3. 76. 4, January 2. OASIS regulations. The January 1. 99. HHA a patient- specific, comprehensive assessment that identifies the patient's medical, nursing, rehabilitation, social, and discharge planning needs. We also issued an interim final rule with comment period on the same day (6. FR 3. 74. 8) that required HHAs to use the OASIS data collection instrument that standardizes parts of the assessment and to transmit the data to CMS. That rule implemented sections 1.

C) and 1. 89. 1(d)(1) of the Act, which require the Secretary to establish a standardized assessment instrument for measuring the quality of care and services furnished by HHAs. The OASIS data collection instrument and data transmission rule was finalized on December 2.

FR 7. 61. 99). Although the OASIS requirements were finalized in separate rules, we intended to proceed with another rule to finalize the remainder of the requirements of the March 1. However, section 9. Medicare Prescription Drug, Improvement, and Modernization Act of 2. Star Wars Episode 1 Racer Pod Racers. MMA) added section 1. Act. This section provided that, effective December 8, 2.

Secretary, in consultation with the Director of the Office of Management and Budget (OMB), would have to establish and publish regular timelines for the publication of Medicare proposed regulations based on the previous publication of Medicare proposed or interim final regulations. Section 9. 02 of the MMA further provided that the timeline could vary among different regulations, but could Start Printed Page 4. Pursuant to the MMA, we issued a notice implementing this provision in the Federal Register on December 3.

FR 7. 84. 42). In that notice, we interpreted section 9. Medicare regulations that had been outstanding for 3 years or more as of December 8, 2.

HHA Co. Ps. Therefore, out of an abundance of caution, we decided not to finalize the remaining provisions of the March 1. On October 9, 2. 01. HHAs that choose to participate in Medicare and Medicaid (7. FR 6. 11. 64). We proposed to revise all of the existing Co.

Ps, and to add several new Co. Ps to address aspects of home health care that we believe need attention.

C. Transforming the HHA Conditions of Participation. As the single largest payer for health care services in the United States, the Federal government assumes a critical responsibility for the delivery and quality of care furnished under its programs. Historically, we have adopted a quality assurance approach that has been directed toward identifying health care providers that furnish poor quality care or fail to meet minimum Federal standards. Facilities not meeting requirements would either correct the inappropriate practice(s) or would be terminated from participation in the Medicare or Medicaid programs. We have found that this problem- focused approach has inherent limits.