CMS Publishes Final Rule Revising and Expanding Conditions for HHA Participation in Medicare and Medicaid

By Wendy S. Salkin

The Centers for Medicare and Medicaid Services (CMS) finalized a rule concerning home health agencies on January 9th, “Medicare and Medicaid Program: Conditions of Participation for Home Health Agencies.” The rule has been a long time coming, since the proposed rules were set forth on October 9, 2014. This is the first time that CMS has successfully updated the home health agency (HHA) conditions of participation (CoPs) since 1989.

The aim of the final rule, according to CMS, is to “improve the quality of health care services for Medicare and Medicaid patients and strengthen patients’ rights.” The 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.

According to CMS,

[t]hese changes are an integral part of [the Agency’s] 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.

As is likely well known to readers, the use of home health services in the United States is widespread. According to the National Center for Health Statistics, as of 2014, there were 12,400 home health agencies in the United States and, during 2013, 4.9 million patients in the United States received and ended care from home healthcare workers. These numbers have since risen, and today in the United States there are nearly 12,600 Medicare and Medicaid-participating home health agencies and more than 5 million patients. Home health care serves a wide range of purposes. The Medicare website touts it as “usually less expensive, more convenient, and just as effective as care you get in a hospital or skilled nursing facility (SNF).” In addition to serving the aims of treating illness or injury, according to Medicare home health care “helps [patients] get better, regain [their] independence, and become as self-sufficient as possible.” Some examples of what home health care providers do with and for patients, upon doctor’s orders, include: wound care, patient and caregiver education, intravenous or nutrition therapy, injections, monitoring patient health condition, monitoring patient drug and treatment use, teaching patients how to care for themselves, and coordinating care between the patient, their doctor, and any other caregivers.

As CMS reported in its press release, the rule includes amendments to the following areas of the conditions of participation:

Patient rights

 “A comprehensive patient rights condition of participation that clearly enumerates the rights of home health agency patients and the steps that must be taken to assure those rights.”

In particular, at §484.50, CMS “proposed revised patient rights provisions under six standards”:

  1. Notice of rights;
  2. Exercise of rights;
  3. Rights of the patient;
  4. Transfer and discharge;
  5. Investigation of complaints, and
  6. Accessibility.

Among the patient rights enumerated under this CoP are:

  • “a right to have his or her property and person treated with respect” [§484.50(c)(1)];
  • “a right to be free from verbal, mental, sexual and physical abuse, including injuries of unknown source, neglect, and misappropriation of property” [§484.50(c)(2)];
  • “a right to make complaints to the HHA regarding treatment or care that was (or failed to be) furnished which the patient and/or their family believe was inappropriate” [§484.50(c)(3)];
  • “the right to participate in, be informed about, and consent to or refuse care” [§484.50(c)(4)]—this right also applies to patients’ representatives;
  • “the right to participate in and be informed about the patient-specific comprehensive assessment, including an assessment of the patient’s goals and care preferences” [§484.50(c)(4)];
  • “the right to participate in and be informed about the care that the HHA plans to furnish based on the needs identified during the comprehensive assessment, establishing and revising that plan, the disciplines that will furnish care, the frequency of visits, identifying expected outcomes of care, and any factors that could impact treatment effectiveness” [§484.50(c)(4)];
  • “the right to receive a copy of his or her individualized HHA plan of care, including all updated plans of care” [§484.50(c)(4)(iii)]
  • “the right to receive all of the services outlined in the plan of care” [§484.50(c)(5)];
  • “the…right to the confidentiality of his or her clinical records” [§484.50(c)(6)];
  • a requirement that HHAs comply with all home health advance beneficiary notices (ABNs), “including restrictions on who may receive the ABN on the patient’s behalf” [§484.50(c)(7)];
  • “the right to receive proper written notice, in advance of a specified service being furnished, if the HHA believes that the service may be non-covered care; or in advance of the HHA reducing or terminating on-going care” [§484.50(c)(8)];
  • a right to be advised “that the purpose of the [home health] hotline was to receive complaints or questions about local HHAs.” [§484.50(c)(9)];
  • a right to “be advised of the names, addresses, and telephone numbers for relevant federally and state-funded consumer information, consumer protection, and advocacy agencies” ([§484.50(c)(10)];
  • “the right to be free from discrimination or reprisal for exercising their rights, whether by voicing grievances to the HHA or to an outside entity” [§484.50(c)(11)];
  • “the right to be informed of their right to access auxiliary aids and language services, and to be provided instruction on how to access these services” [§484.50(c)(12)];

In addition, CMS proposed to add a new standards “which would mandate that all patients and representatives (if any), have the right to be informed of the HHA’s policies governing admission, transfer, and discharge in advance of the HHA providing care” [§484.50(d)]. The standard includes criteria in accordance with which an HHA can transfer, discharge, or terminate care for a patient. Under the standard, transfer, discharge, or termination of care can only be undertaken for one of the following reasons:

“(1) if the physician responsible for the HHA plan of care and HHA agreed that the HHA could no longer meet the patient’s needs, based on the patient’s acuity; (2) when the patient or payer could no longer pay for the services provided by the HHA; (3) if the physician responsible for the HHA plan of care and HHA agreed that the patient no longer needed HHA services because the patient’s health and safety had improved or stabilized sufficiently; (4) when the patient refused HHA services or otherwise elected to be transferred or discharged (including if the patient elected the Medicare hospice benefit); (5) when there was cause; (6) when a patient died; or (7) when the HHA ceased to operate.”

Comprehensive assessment

In addition to the specific enumeration of the aforementioned patient and patient representative rights, the final rule also includes an expansion of the previous comprehensive patient requirement aimed at considering “all aspects of patient wellbeing”: To the existing requirements found in §484.55, CMS has added a new standard, “Content of the comprehensive assessment,” which requires the satisfaction of “[n]ew content requirements, such as an assessment of psychosocial and cognitive status, which [CMS] believe[s] would provide for a more holistic patient assessment.”

Written instruction

The final rule includes a requirement that the HHA provide written instructions to both patients and their caregivers “outlining visit schedule including frequency of visits, medication schedule/instructions, treatments administered by HHA personnel and personnel acting on the behalf of the HHA, pertinent instructions related to patient care and the name and contact information of the HHA clinical manager.” [§484.60(e)]

Quality assessment and performance improvement

In the final rule, CMS also proposes the replacement of two current HHA CoPs (§484.16, “Group of professional personnel,” and §484.52, “Evaluation of the agency’s program”) with a single new data-driven, Agency-wide quality assessment and performance improvement (QAPI) program aimed at “reduc[ing] medical errors, and improv[ing] the quality of health care in all settings” [§484.65].

Infection prevention and control

At §484.70(a), CMS proposes a new infection prevention and control requirement “that HHAs follow infection prevention and control best practices, which include the use of standard precautions, to curb the spread of disease.”

Coordination of care

In §484.75, CMS proposes “that skilled professionals actively participate in the coordination of all aspects of care where appropriate” and in §484.75(a) defines “skilled professional services” to include physician services, skilled nursing services, physical therapy, speech-language pathology services, occupational therapy, and medical social work services. This CoP is meant to promote coordination among skilled professionals when they are working on an interdisciplinary care team.

At §484.105(c), CMS also proposes a new clinical manager role, who “would be a qualified licensed physician or registered nurse, identified by the HHA, who is responsible for the oversight of all personnel and all patient care services provided by the HHA, whether directly or under arrangement, to meet patient care needs.”

Simplification of HHA organizational structure

Also in §484.105, CMS requires that an “HHA must organize, manage, and administer its resources to attain and maintain the highest practicable functional capacity, including providing optimal care to achieve the goals and outcomes identified in the patient’s plan of care, for each patient’s medical, nursing, and rehabilitative needs,” to which end the HHA (1) “must assure that administrative and supervisory functions are not delegated to another agency or organization,” (2) must assure that “all services not furnished directly are monitored and controlled,” and (3) “must set forth, in writing, its organizational structure, including lines of authority, and services furnished.”

The regulations go into effect on July 13, 2017. This is just over six months after the rule came into effect, which has some HHAs and advocacy organizations worried about the ability to meet the new compliance standards within the timeframe allotted. As reported by Amy Baxter on Home Health Care News, a spokespersons from a number of HHAs and industry organizations are expressing concern about the timeframe. For instance, when the rule was proposed in 2014, both the National Association for Home Care & Hospice (NAHC) and the Visiting Nurse Associations of America (VNAA) “asked for more than a year after publication of the final rule for agencies to comply.” And VNAA also asked that CMS “not sanction home health providers that are not in full compliance” for a one-year period once the regulations came into effect. CMS responds only minimally to this concern over the effective date of the final rule in the section of the final rule entitled “Analysis of and Responses to Public Comments.” There, in response to recommenders’ “recommended implementation time frames rang[ing] from 6 months to 5 years,” CMS responds only:

We agree that it is appropriate to allow additional time to implement the final rule in order to allow HHAs adequate time to prepare for these changes. We believe that requiring HHAs to comply with the requirements of this rule on July 13, 2017 is sufficient to allow for appropriate HHA preparations to implement these changes. Therefore, we are finalizing an effective date of July 13, 2017.

For more on this new rule, see the following sources:

  • Those looking to get a more comprehensive sense of the final rule and who are interested in some light reading can find the rule in its entirety (all 347 pages) here.
  • The official CMS press release is available here.
  • Home Health Care News has nice discussions of the final rule here and here.
  • A brief description of home health care is available from Medicare.gov.