4504 Federal Register /Vol. 82, No. 9/Friday, January 13 ...

1 4504 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Parts 409, 410, 418, 440, 484, 485 and 488 [CMS 3819 F] RIN 0938 AG81 Medicare and Medicaid Program: conditions of participation for Home Health Agencies AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS. ACTION: Final rule. SUMMARY: This final rule revises the conditions of participation (CoPs) 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.

2 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 13, 2017. FOR FURTHER INFORMATION CONTACT: Danielle Shearer (410) 786 6617. Mary Rossi-Coajou (410) 786 6051. Maria Hammel (410) 786 1775. 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 1861(m) of the Social Security Act (the Act).

3 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.

4 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 1861(o) and 1891 of the 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 42 CFR part 484, Home Health Services. Current regulations at 42 CFR (d) specify that HHAs participating in the Medicaid program must also meet the Medicare conditions of participation (CoPs).

5 Section 1861(o)(6) of the Act requires that an HHA must meet the CoPs specified in section 1891(a) of the Act, and other CoPs as the Secretary finds necessary in the interest of the health and safety of patients. Section 1891(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 CoPs for HHAs protect all individuals under the HHA s care, unless a requirement is specifically limited to Medicare beneficiaries. Section 1861(o) of the Act describes an HHA for purposes of participation in the Medicare program.

6 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), 1987 amendments to section 1891(a) of the Act, has been in the law since the inception of the Medicare program, and CMS interpretation of it has remained the same. Under section 1891(b) of the Act, the Secretary is responsible for assuring that the CoPs, 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.

7 To implement this requirement, State Survey Agencies and CMS-approved accrediting organizations conduct surveys of HHAs to determine whether they are complying with the CoPs. B. Previous HHA conditions of participation Rules On March 10, 1997 (62 FR 11004), 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 CoPs. 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.

8 Rather than finalizing all portions of the March 1997 rule, we published a final regulation (64 FR 3764, January 25, 1999) that only finalized the OASIS regulations. The January 1999 final rule required that each patient receive from the 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 (64 FR 3748) 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 1891(c)(2)(C) and 1891(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.

9 The OASIS data collection instrument and data transmission rule was finalized on December 23, 2005 (70 FR 76199). 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 1997 proposed rule. However, section 902 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) added section 1871(a)(3) to the Act. This section provided that, effective December 8, 2003, the 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.

10 Section 902 of the MMA further provided that the timeline could vary among different regulations, but could VerDate Sep<11>2014 20:05 Jan 12, 2017 Jkt 241001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\ 13 JAR2asabaliauskas on DSK3 SPTVN1 PROD with RULES4505 Federal Register / Vol. 82, No. 9 / Friday, January 13, 2017 / Rules and Regulations not be longer than 3 years, except under exceptional circumstances. Pursuant to the MMA, we issued a notice implementing this provision in the Federal Register on December 30, 2004 (69 FR 78442). In that notice, we interpreted section 902 as rendering ineffective any proposed Medicare regulations that had been outstanding for 3 years or more as of December 8, 2003; this included the proposed HHA CoPs.