Comment Letter to CMS on CoPs for Home Health Agencies
January 7, 2015
Centers for Medicare & Medicaid Services
P.O. Box 8011
Baltimore, MD 21244-8013
Re: CMS 3819-P, Medicare and Medicaid Programs; Conditions of Participation for Home Health Agencies; Proposed Rule, October 9, 2014
Dear Ms. Tavenner:
On behalf of The Hospital & Healthsystem Association of Pennsylvania (HAP), which represents approximately 240 member institutions, including 125 stand-alone hospitals and another 120 hospitals that comprise 32 health systems across the state, we appreciate this opportunity to comment about the Centers for Medicare & Medicaid Services’ (CMS) proposed rule to revise the Conditions of Participation (CoP) for home health agencies.
HAP is in agreement with the viewpoints of the American Hospital Association, and we appreciate CMS’ ongoing efforts to update CoPs and supports the proposed rule and the intention of ensuring regulations are current, including the most recent care delivery models, and reinforcing the expectation of quality.
HAP is pleased with the fact that CMS has included ongoing quality assessment and performance improvement and formalized infection control and prevention programs, and that CMS emphasizes patient-centeredness, outcomes, and care coordination as part of the regulatory framework.
CMS does not propose a timeline for implementing the proposed requirements once they are finalized. We ask CMS to adopt an effective date that is one year after the release of the final rule. This timeframe would allow home health agencies sufficient opportunity to effectively incorporate new policies, procedures, and practices. We also understand that many states have modeled their home health agencies’ regulations on the Medicare CoPs. A one-year implementation timeframe would, in theory, give state health departments the time needed to align with federal standards.
A one-year timeline would allow CMS to prepare and pilot test interpretive guidance before the new standards go into effect. HAP urges CMS to consider using an open and transparent process for developing the interpretive guidance for the finalized regulations. CMS could, for example, post the draft guidance electronically for a period of 30 to 60 days and provide an email address for stakeholder comments. We appreciate the fact that CMS provides flexibility with regard to many of the proposed standards and believe that interpretive guidance will be important in terms of defining adequate compliance with those requirements.
HAP supports the proposed rule, however, it is noteworthy that CMS estimates the economic impact of the proposed standards to be $148 million during year one, and $142 million during year two and thereafter. Hospital-based home health agencies will absorb these costs, along with the recent rebasing cut of 14 percent during four years, while experiencing markedly negative margins. According to the March 2014 Medicare Payment Advisory Commission (MedPAC) report, the average Medicare margin for hospital-based home health agencies during 2012 was negative 15 percent. Further, MedPAC’s March 2013 report notes that, in some counties, hospital-based agencies are the sole source of home health services. HAP is concerned that the combined impact of these factors could lead to barriers to access in some areas, particularly rural areas. We ask CMS to address these concerns in the final rule and to outline how CMS will help home health agencies implement the proposals at a lower cost, such as providing the types of tools or resources described on the following pages. We believe this request is aligned with Executive Order 12866, which requires agencies to take into account the costs of cumulative regulations, and Executive Order 13563, which requires our regulatory system to identify and use the best, most innovative, and least burdensome tools for achieving regulatory ends.
Quality Assessment and Performance Improvement (QAPI)
HAP supports the proposal for CMS to develop and implement flexible QAPI programs for home health agencies. Although many hospitals have adopted QAPI activities through hospital engagement network efforts, HAP encourages CMS to continue to develop QAPI programs for home health agencies. This may be done through model QAPI programs and webinars prior to the final rule taking effect. We also encourage CMS to ensure quality improvement organizations that support home health quality initiatives provide home health agencies with education and support.
HAP also would like to see CMS clarify that a home health agency that is owned by a hospital or health system can meet the QAPI requirements by participating in a larger, system-based improvement program while meeting the requirements of proposed § 484.65.
Infection Prevention and Control
HAP supports the proposal for CMS to require home health agencies to have infection prevention and control programs as part of their QAPI programs. We would like to see more examples of infection control activities that CMS would consider best practices. Such an example would be surveillance activities. The proposed rule does not address surveillance in detail, and home health agencies would welcome additional clarification from CMS as to its expectations for surveillance in the home versus surveillance in the community.
HAP supports the proposal for CMS to strengthen and reorganize the patient rights requirement. As proposed, the patient rights are fitting for home health agencies, and it is blatant that CMS understands the importance of patient rights and responsibilities.
HAP agrees with CMS’ proposal to require both written and verbal notice of patient rights. However, we ask CMS to clarify what constitutes adequate verbal notice. As we understand it, verbal notice should cover the content of the notice of rights. CMS estimates that it would take about five minutes per patient for home health agencies to describe the content of the notice of rights and obtain the patient’s signature confirming that he or she received a copy.
HAP asks that CMS provide flexibility to home health agencies to tailor the length of the verbal notice depending on the circumstances and what each patient needs in order to gain an understanding of his or her rights. This type of clarification also would align with The Joint Commission’s standard that each patient has the right to receive information that he or she understands. We also suggest providing user-friendly resources, in multiple languages, for consumers. This will aid in aligning the standards with the end user and their families, and will reduce costs associated with the current method of translation.
Revisions to Patient Care and Discharge Plans
HAP would like clarification regarding the communication of changes in patient care. We agree that home health agencies should provide each patient with a copy of his or her individualized care plan. In the preamble to the proposed rule, CMS explains that a home health agency would need to notify a patient, representative (if any), caregivers, and the physician responsible for the home health agency plan of care when the individualized plan of care is updated due to a significant change in the patient’s health status. However, the text of the proposed regulation does not include the word “significant,” making it appear as if slight changes in patient status that result in tweaks to the plan would require notice to all stakeholders. We ask CMS to include the word “significant” in the final regulation and to allow the home health agency flexibility in how it provides notice to ensure that it is effective in each circumstance.
HAP also would like to see CMS make a revision in the regulatory language related to the individuals who would receive a revised patient care and discharge plan. In the proposed rule, any revision to the plan of care due to a change in patient health status, and any revisions related to the plans for the patient’s discharge, also would need to be communicated to the physician responsible for the home health plan of care. Some home health agencies provide services to veterans who receive care through the Veterans Administration (VA). VA patients may be cared for by a group of physicians, and they do not necessarily have a single physician who is responsible for the plan of care or who signs the revised plan of care. Therefore, we ask CMS to change the wording of the regulation to state that the revised plan of care should be provided to the physician or physician group responsible for the plan of care.
HAP supports the proposed requirement for home health agencies to have a clinical manager to oversee patient care services and personnel. We would like to see CMS provide clarification and rewording of the regulation. We ask CMS to identify in the regulation the functions that it expects the clinical manager to perform without using that title. We recommend changing the title of § 484.105(c) to “Standard: Oversight of Patient Care Services and Personnel” and require that “a designated home health agency staff member” who is a qualified licensed physician or registered nurse fulfill the described oversight duties. The proposed rule also lacks clarity on the definition and interchangeability of the administrator and clinical manager of a home health agency.
HAP encourages CMS to clarify the proposed requirement related to discharge summaries. Under the proposed rule, the clinical record would need to include, among other items, a completed discharge or transfer summary. As required by proposed § 484.110(a), that summary would be sent to the primary care practitioner or other health care professional who will be responsible for providing care and services to the patient after discharge from the home health agency within seven calendar days of the patient’s discharge. Alternatively, if the patient’s care will be continued immediately in a health care facility, a discharge or transfer summary would need to be sent to the facility within two calendar days of the patient’s discharge or transfer. Based on the staffing of many home health agencies, two calendar days may be difficult.
We request that CMS clarify that the summary would be sent after a discharge or transfer by the home health agency for the reasons described under proposed § 484.50(d). We encourage CMS to consider including the requirement to send the discharge or transfer summary in § 484.60(e), Discharge or transfer, in addition to or instead of § 484.110 (a), Contents of the clinical record. This requirement is more aligned with care coordination than clinical records, and moving its placement could make it easier to find for home health agency staff working on discharge policies.
HAP would like to see clarification for the following discrepancies noted in the section of the proposed rule pertaining to personnel qualifications.
Occupational Therapist—In the proposed rule, the qualifications for occupational therapists are almost identical to current regulation. However, the current regulations allow therapists educated abroad to meet part of the necessary criteria by successfully completing a program that is substantially equivalent to occupational therapist entry-level education in the U.S. offered by one of four categories of organizations. In the proposed rule, the therapist must have successfully completed a program that is substantially equivalent to occupational therapist assistant entry-level education in the U.S. by one of the four categories of organizations. Because there is a separate set of qualifications for occupational therapy assistance, HAP would like clarification about the use of the word “assistant.”
Occupational Therapy Assistant—The qualifications outlined in the proposed rule for an occupational therapy assistant are almost exactly the same as those in current regulation. However, the proposed rule states that an occupational therapy assistant is a person who “[a]fter January 1, 2010, meets the requirements in paragraph (b)(6)(i) of this section.” There is no paragraph (b)(6)(i) in the proposed rule text.
Physical Therapist—In current regulation, and in the proposed rule, physical therapists must be licensed, and must meet one of several additional categories of qualifications. In current regulations, the first category requires physical therapists to have successfully completed a physical therapist education program and passed an examination for physical therapists approved by the state. In the proposed rule, the word “and” is dropped, and the text is renumbered in a way that could imply that either education or passage of an exam is acceptable. HAP would like clarification on this wordiness.
Physical Therapy Assistant—Under the proposed rule, a physical therapy assistant is a person licensed, registered, or certified as a physical therapy assistant, if applicable, by the state in which the assistant is practicing, unless licensure does not apply. In addition, the assistant must meet one of two other categories of criteria. In the first category, the assistant must meet the same specified education as listed in current regulations. In the second category, the assistant must have passed a national exam for physical therapist assistants before 2010, and must meet one of the following criteria:
- Is licensed, or otherwise regulated in the state in which practicing.
- In states where licensure or other regulations do not apply, graduated before 2010 from a two-year college-level program approved by the American Physical Therapy Association and after January 1, 2010, meets the requirements of paragraph (b)(8) of this section.
It is unclear what is meant by the reference to (b)(8) of this section, as there is no (b)(8) in the proposed text.
Thank you for consideration of our comments on the proposed rule to revise the CoPs for home health agencies. If you have any questions, please feel free to contact me, or Brian Smith, director, clinical compliance and quality, at (717) 561-5356.
Paula A. Bussard
Senior Vice President, Policy and Regulatory Advocacy