United States: CMS Proposes Major Update Of Home Health Agency Conditions Of Participation Focusing On Care And Quality Standards

Proposed Revisions to HHA Conditions of Participation

The Centers for Medicare & Medicaid Services (CMS) published its proposed update to the home health agency (HHA) Conditions of Participation (CoPs) in the October 9, 2014, Federal Register.  The CoPs are the requirements that an HHA must meet in order to participate in the Medicare program.  Comments on the proposed rule are due by 5:00 pm on December 8, 2014.

CMS has provided that the core of its proposal is an HHA-wide, data-driven quality assessment and performance improvement (QAPI) program.  Finding that a problem-focused approach of identifying providers that furnish poor quality care or fail to meet minimum federal standards has resulted in CMS expending resources on dealing with marginal providers, rather than on stimulating broad-based improvements in quality of care to all patients, the focus of the new CoPs is on a patient-centered, data-driven, outcome-oriented process brought together under the QAPI.  The requirements encompass patient rights, comprehensive patient assessments, patient care planning and coordination of care by an interdisciplinary team.  The proposed new CoPs would apply the approach similar to that which CMS has implemented for hospitals, end-stage renal disease suppliers, hospices, transplant centers and organ procurement organizations to HHAs.

The proposal adds four new CoPs (including the CoP for QAPI), revises other CoPs and would, if adopted, remove certain process details from the current COPs (e.g., requirement for a 60-day summary to the physician, the "group of professionals" and quarterly record review).

This update would represent the first major revisions since 1989.  Notably, CMS pulled back from proposed revisions in 1997, citing the volume of public comments and the changing nature of the HHA industry at the time.  The rule was finalized in December 2005 only as to OASIS provisions for data collection and transmission.  The OASIS provisions, requiring that each patient receive a patient-specific, comprehensive assessment that identifies the patient's medical, nursing, rehabilitation, social and discharge planning needs, became a condition of participation in Medicare.  The proposed new CoPs build on OASIS data, as part of the functioning of the new QAPI program.  CMS observes that the OASIS data set provides empirical data to measure the quality of care a Medicare patient receives from an HHA, including care delivery, patient outcomes and potentially avoidable events.  According to CMS, the OASIS data and the measures calculated from that data are indicators of quality that can be used for internal quality improvement efforts, in the survey process and in the consumer decision-making process. 

For OASIS data, CMS proposes to replace the current requirement that an HHA transmit data using electronic communications software that provides a direct telephone connection with a requirement that the OASIS data be transmitted using electronic communications software that complies with the Federal Information Processing Standard issued May 25, 2001.  Because, according to CMS in its Regulatory Impact Analysis, the "presence of the OASIS data set and quality reporting measures has been in place for several years and the concepts of each are fully integrated into standard HHA practice," CMS does not believe that it would be a burden for HHAs to incorporate new data gathered for dual patient care planning and QAPI purposes into their current systems and processes.  However, there are real questions as to whether these proposed CoPs will unduly burden HHAs while they are feverishly exploring new ways to deliver efficient care in light of the ongoing economic pressures from year two of the multiyear reimbursement cuts mandated by the Affordable Care Act.

New CoPs and CoP Revisions

CMS would group together all CoPs directly related to patient care and place them near the beginning of the CoP regulations.  Regulations concerning the organization and administration of an HHA follow in a separate subpart titled "Organizational Environment."  CMS states that this format would be better in keeping with the patient-centered orientation of the regulations and CMS's view that "patient assessment, care planning, and quality assessment and performance improvement efforts are central to the delivery of high quality care."

QAPI program

The new CoP for QAPI appears to be the core CoP of CMS's proposal, bringing together the multiple facets of the comprehensive new update.  Each HHA must develop, implement, evaluate and maintain an effective, ongoing, HHA-wide, data-driven QAPI program.  The HHA's governing body is responsible for the HHA's QAPI program and for ensuring it reflects the complexity of its organization and services, and involves all HHA services, including services provided under contract or arrangement.  The board of the HHA is also tasked with ensuring the QAPI program focuses on indicators related to improved outcomes, including hospital admissions and re-admissions, and takes actions that address the spectrum of care, including the prevention and reduction of medical errors.  The HHA must maintain documentary evidence of its QAPI program and be able to demonstrate its operation to CMS.  Given the extensive and comprehensive nature of the QAPI requirements, HHAs and their boards will need to familiarize themselves with the extensive new, data-driven process requirements, and, after the proposal is adopted in final form, turn attention to developing a QAPI program specific to their agency as a condition of Medicare participation. 

Elimination of "group of professional personnel"

Showing the weight that CMS proposes to place upon the QAPI program, CMS would remove the existing CoP for a "group of professional personnel" requiring at least one physician and one registered nurse, and with representation from other professional disciplines.  The professional group was charged with establishing and annually reviewing the HHA's policies, program and operation, advising the HHA on the same and meeting "frequently" to do so.  These responsibilities would be integrated into the overall operation and functions of the QAPI program as part of CMS's change in its regulatory approach based upon principles of continuous and ongoing quality assessment and performance improvement.  CMS would also remove the requirement that the HHA send a summary of care to the attending physician at least once every 60 days because the need for this would be subsumed under the QAPI program.

Care planning, coordination of services and quality of care

A new condition of participation for "care planning, coordination of services and quality of care" would combine existing HHA care standards and would specify that the HHA would have to provide the patient a plan of care that sets out the care and services necessary to meet the patient-specific needs identified in the comprehensive patient assessment, as well as the outcomes the HHA anticipates will occur as a result of developing the individualized plan of care and subsequently implementing its elements.  While many CoP requirements remain, the proposal expands patient rights, emphasizes integration and interdisciplinary care, and increases the involvement, responsibility and accountability of the HHA's governing body.   Among specific care planning and coordination of services requirements, and of interest in light of CMS's continuing and significant focus on hospital readmissions, is the requirement that if HHA services are initiated following the patient's discharge from a hospital, the individualized plan of care must include a description of the patient's risk for emergency department visits and hospital re-admissions (classified low, medium or high), and all necessary interventions to address the underlying risk factors.

Infection control  

A CoP on "infection prevention and control" would require HHAs to follow accepted standards of practice to prevent and control the transmission of infectious diseases and to educate staff, patients and family members or other caregivers on these accepted standards.  The HHA would be required to incorporate an infection control component into its QAPI program.

Skilled professional services

A new proposed CoP for "skilled professional services" would consolidate and revise current conditions on skilled nursing services, therapy services and physician and medical social services, and set forth the requirements for skilled professional services.  Instead of identifying tasks, CMS would broadly describe the expectation of the skilled professionals who participate in the interdisciplinary team approach to home health care delivery, shifting the focus to outcomes of care.  Skilled professionals would provide services to HHA patients directly as employees of the HHA (or under contractual arrangements) and actively participate in the coordination of all care where appropriate for their professional discipline.  Stressing interdisciplinary assessment of the patient, skilled professionals must assume, among multiple other responsibilities, responsibility for participation in the HHA's QAPI program and in HHA-sponsored in-service training.

New CoP for home health aide services

A new CoP on home health aide services, reflecting CMS's emphasis on the QAPI program and an interdisciplinary approach, will incorporate current provisions concerning the qualification requirements for becoming a home health aide, including standards for home health aide training programs, expand upon those training requirements and include extensive competency evaluation.  For example, the current HHA requires that "communication skills" be part of the training for home health aides because they are members of the interdisciplinary team and often visit a patient multiple times each week.  Thus, under the new CoP, CMS would require that communication skills include the aide's ability to read, write and verbally report clinical information to patients, representatives and caregivers, as well as to other HHA staff.  Moreover, only after an individual has successfully completed a competency evaluation program would that individual be considered qualified to provide home health services.

No more subunits of an HHA

In a definitional change potentially affecting provider enrollment and administration of HHA locations, CMS proposes to delete the term "subunit" because the distinction between the requirements that the parent HHA and a subunit must meet are minor.  A subunit may share the same governing body, administrator and group of professional personnel with its parent HHA.  CMS indicates that, in practice, the requirement that a "subunit" must independently meet the CoPs renders this distinction moot, such that CMS believes that an entity operating for all intents and purposes as a distinct HHA should be treated as such.  If the rule is finalized, existing subunits, which already operate under their own provider numbers, would be considered distinct HHAs and would be required to independently meet all CoPs without sharing a governing body or administrator.  Because CMS proposes to delete the requirements for the group of professional personnel as a CoP, it would no longer matter if this group was shared among HHAs.  Thus, CMS reasons, this regulatory change would permit a subunit to apply to become a branch of its existing parent HHA if the parent provided "direct support and administrative control" of the branch.  No new subunits would be approved, only "branch offices," subject to CMS's survey and approval of the branch office under the CoPs and under direct supervision and administrative control of the parent agency.  The sense of this, at least from CMS's viewpoint, is to assure the importance of the role of an HHA's QAPI program in HHA services and programs in all locations.

Surveys under the revised CoPs: the QAPI program

The status of QAPI as core to CMS's proposal is crystalized in the survey process.  In the preamble to the regulations, CMS states that, through the survey process, it intends to assess whether HHAs have all of the components of a QAPI program in place.  Surveyors would expect HHAs to demonstrate, with the objective data from the OASIS data set and other sources available to the HHA, that improvements had taken place with respect to actual care outcomes, processes of care, patient satisfaction levels and/or other quality indicators.  Additionally, surveyors would expect the HHA to demonstrate that all disciplines are involved in its QAPI program, consistent with the requirements of the regulations.  This would then apply equally to existing HHA subunits with their own Medicare number that seek CMS approval as a branch office of a parent HHA.

In view of the extensive nature and complexity of CMS's proposal, it would seem that CMS may again receive voluminous commentary, not unlike its experience with its March 1997 proposal.  While the proposal contains the mandated Regulatory Impact Analysis, there is a sense that CMS has not adequately considered the actual financial impact and burden that the proposal places in practice upon the daily operation of a HHA.

Stakeholders are encouraged to review this rule and consider comment strategy.  CMS is accepting comments on the proposed rule until 5:00 pm on December 8, 2014.

CMS Proposes Major Update of Home Health Agency Conditions of Participation Focusing on Care and Quality Standards

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