Comments on Proposed Rules: CY 2016 Home Health Prospective Payment System Rate Update; home Health Value-Based Purchasing Model; and Home Health Quality reporting Requirements

September 1, 2015

SUBMITTED ELECTRONICALLY
http://www.regulations.gov

Andrew Slavitt, Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health & Human Services
200 Independence Avenue, SW
Washington, DC 20201

Re: CMS-1625-P

Dear Acting Administrator Slavitt:

The Center for Medicare Advocacy (the Center) is pleased to provide comments on the Centers for Medicare & Medicaid Services (CMS) proposed rule CMS-1625-P published in the Federal Register on July 10, 2015.[1]  The Center is a national, private, non-profit law organization, founded in 1986, that provides education, analysis, advocacy, and legal assistance to people nationwide, primarily older people and people with disabilities, to obtain necessary health care, therapy, and Medicare. Our health policy advocacy is based on our experience assisting thousands of individuals and their families with Medicare coverage and appeals.

The Center’s comments focus on (1) CMS’ analysis of the home health study required by Section 3131(d) Affordable Care Act, (2) CMS’ proposed inappropriate reliance solely on performance measures related to improvement for the Home Health Value-Based Purchasing (HHVBP) Model, and (3) suggested measures in place of or in addition to the current proposed HHVBP Model or for subsequent performance years of the HHVBP Model.

Analysis of the Study of Access to Medicare Home Health Services and Payment for Vulnerable Patient Populations.

Section 3131(d) of the Affordable Care Act directs the Secretary to conduct a study on Home Health Agency (HHA) costs involved with providing ongoing access to care to low-income Medicare beneficiaries or beneficiaries in medically underserved areas, and in treating beneficiaries with high levels of severity of illness. The study analyzed administrative data, as well as survey data collected from physicians and HHAs to examine factors associated with potential access to care issues. The Center objects to CMS’ conclusion from the survey that “much of the variation in access to Medicare home health services is associated with social and personal conditions and therefore CMS’ ability to improve access for certain vulnerable patient populations through payment policy may be limited.”

CMS’ conclusion does not duly take into account the perception and experience of HHAs and physicians that their patients cannot obtain Medicare coverage for home health services.  The admission factor rated as important by the greatest number of HHAs (63.7%) was the inability of patients to qualify for the Medicare home health benefit.[2]  Similarly, medical issues, including the inability of a patient to qualify for the Medicare home health benefit (27.7%) and severity of a patient’s medical condition (26.7%), were among the most important factors reported by physicians. If disparities in access for patients with clinically complex and/or poorly controlled chronic conditions are associated with the providers’ perceptions that Medicare will not cover their patients’ care, CMS could certainly do something about this misunderstanding.  CMS can examine what providers understand of the home health benefit and payment, how they interpret or misinterpret the homebound requirement, and whether providers misconceive that Medicare only covers acute episodes, or won’t cover maintenance therapies and nursing.  By evaluating these issues in greater depth, the agency may discover and then address the factors underlying the disparities in care.

It was likewise very concerning that 9.8% of HHAs and 17.7% of physicians cited the fact that a patient would need “more than 2 episodes of care”[3] as the reason they could not be admit/place the patient in home health. Length of stay should not be a reason to deny home care to a patient who qualifies for benefits. If providers are declining to admit patients on that basis, it raises the question of whether lower payment rates after the second episode make it unprofitable for the HHA to continue services to patients who meet the criteria for coverage. It also suggests that providers and contractors may be misinterpreting Medicare coverage criteria. If coverage or payment policies create disincentives to serving vulnerable patients who have complicated medical profiles or chronic illnesses, who have an ongoing need for skilled nursing, or require total care and are not likely to improve, this is an access problem that CMS can certainly do something about.  The fact that 19.4% of surveyed HHAs cited “severity/complexity of patient’s medical condition” as the reason they would not admit a patient deserves more attention and examination.

Moreover, 12.9% of HHAs cited “language barrier/communication problems” as a factor in being unable to admit Medicare FFS patients. The Center finds that this is also an area where CMS can have an impact on HHAs, through incentives and resources, to promote better access for vulnerable populations. Proprietary and free-standing HHAs were more likely to report language barrier/communication problems as an important factor complicating admissions than government-owned, not-for-profit, and provider-based HHAs. At the very least, this suggests that improvement and achievement can be realized in this area.

With respect to the study’s analysis of payment and cost data, we agree with CMS’ conclusion that modifications to the case-mix system may be needed to address the substantially lower margins for certain vulnerable patients, including those who require parenteral nutrition, have traumatic wounds or ulcers, need substantial assistance in bathing, have poorly-controlled clinical conditions, or are dually eligible for both Medicare and Medicaid. We would support the agency’s exploration of payment methodology to increase financial incentives to select patients in these subgroups. We concur with stakeholders who feel that the current home health payment system methodology is overly complex and does not fully reflect the range of services provided under the home health benefit. As such, we look forward to the results of the follow-up study that will address these problems. Finally, we are heartened by the agency’s analysis of potential payment models that do not include therapy thresholds, and greatly hope that an appropriate model of this kind will eventually be adopted.

Proposed home health value-based purchasing model

CMS is creating incentives to influence the delivery and quality of home health care under the Medicare benefit. “The results of the Demonstration published in a comprehensive report suggest that future models could benefit from ensuring that incentives are reliable enough, of sufficient magnitude, and paid in a timely fashion to encourage HHAs to be fully engaged in the quality of care initiative.”[4] However, changes in the proposed rules are needed to avoid the unintended consequence of pushing HHAs out of areas of skilled care for home health patients – including skilled nursing and therapies to maintain patients’ condition or prevent deterioration.

The Center is concerned that the quality measures place too much emphasis on improvement. The proposed rules virtually guarantee that patients who cannot improve, but still need skilled home care will not get that skilled care because HHAs will have no incentive under the HHVBP Model to provide it. In fact, HHAs risk severe financial penalties of up to 8% if they admit too many patients with conditions that are incapable of improving. This lack of financial incentive combined with risk of severe financial penalties will, based on CMS’ improvement only quality measures, be especially damaging for patients needing complex skilled nursing care. The Center agrees with the comments provided by the Medicare Payment Advisory Commission (MedPAC) that CMS should “…put a declining emphasis on improvement as a factor.”[5]

The Center and Vermont Legal Aid (VTLA) settled a class action lawsuit against the Secretary in the case of Jimmo v. Sebelius (the Jimmo Settlement).[6] Prior to the Jimmo Settlement, Medicare providers would often deny skilled care to people with conditions and diagnoses that meant the patients could not improve or that improvement would happen slowly. The Jimmo Settlement acknowledges that Medicare covers skilled nursing and therapy even if a person may not improve. Medicare coverage of skilled nursing and therapies to maintain a person’s condition or slow deterioration is the whole point of the Jimmo Settlement.

Under the proposed rules, however, HHAs are penalized financially up to 8% for caring for patients who cannot improve based on their condition or diagnoses. How can HHAs take the financial risk of caring for such patients if the proposed rule is enacted as drafted? Why would an HHA ever admit patients with diagnoses of Multiple Sclerosis, ALS (Amyotrophic Lateral Sclerosis), paralysis, stroke, Alzheimer’s disease, etc.? The downside financial risk is significant to HHAs and the quality measures selected by CMS will ensure that only patients who can improve will be admitted by HHAs as patients. Those patients who are unable to improve will intentionally be eliminated as potential patients for home health care.

While improvement can certainly be a measure of quality care, improvement is not the only measurement of quality. CMS should also include quality measures that do not require improvement. Some examples might include: HHA care for slow or non-healing wounds that do not develop infections; appropriate care for a patient with neuromuscular disease that slows deterioration or assists with the transition to increased impairment (e.g., adapted eating utensils, wheelchair use, or a hoyer lift); maintaining a patient with congestive heart failure at home by reducing edema or avoiding pneumonia. All of these examples involve skilled care by the HHA. None of these examples involve improvement of the patients’ underlying condition in cases where that is medically impossible.

Medicare law requires that CMS rely not only on improvement to identify and provide skilled care. CMS must also acknowledge that Medicare law covers skilled care to maintain a patient’s condition or prevent or slow deterioration. The quality measures proposed by CMS would hurt Medicare beneficiaries who need reasonable and necessary complex nursing or therapy provided by an HHA. CMS should revise its quality measures to incorporate quality measures that do not rely solely on improvement as a factor.

Reducing Hospital Readmissions and Emergency Department Visits

Under the HHVBP model, HHAs will be scored based upon the number of home health stays for patients who have a Medicare claim for an unplanned admission to an acute care hospital during the 60 days following the start of care. They will also be scored based upon the number of patients who have Medicare outpatient emergency department claims during the first 60 days of their home health stay.

The Center recognizes that it is a desirable goal, not only from a cost reduction/efficiency standpoint, to reduce readmissions and emergency-room stays. However, we feel it may be unduly harsh to penalize HHAs because their patients may need hospital or emergency room care during their initial episode.  It could create a disincentive to serve very sick patients.

Our healthcare system vitally depends on the availability of HHAs to admit patients directly from acute and post-acute care facilities. Typically when patients are discharged home from a hospital stay, they are weakened and debilitated, and still recovering from infections or surgeries.  They may have just been restarted on their prior medications or they may be adjusting to recently-prescribed medications. They may have new medical restrictions on their activities and diet. Very often, they feel vulnerable and unprepared for the challenge of being at home again.  This initial episode may be the first time the HHA has had contact with the individual and is just learning about the factors that impact his/her health.  While the involvement of the HHA can go a long way to help stabilize the patient, it may be unrealistic to require the HHA to keep the new patient out of the hospital or emergency room during this uncertain period.

The Center thus opposes performance measures that might discourage HHAs from accepting fragile or labile patients. There is immense value in ensuring that HHAs will continue to serve such patients, not only to stabilize their conditions and facilitate their transition to the community, but also to properly identify when they need emergent care. The average home health patient who has just come out of the hospital does not reasonably expect the HHA to resolve their medical issues within 60 days. That patient, however, does probably hope and expect that their visiting nurse or therapist will exercise the professional skill and judgment to send him back to the ER or hospital if his symptoms or condition warrants it.

Discharge to Community

CMS proposes to score HHA performance based upon the number of home health episodes where the patient remained in the community after discharge from home health services. The Center is concerned that this outcome measure will create a bias towards serving patients who are less sick and who may only require a short course of therapy rather than nursing or longer-term maintenance therapy. We are also concerned that it may lead some HHAs to discharge clients from service before it is actually safe to do so from a clinical or practical standpoint.

The proportion of patients remaining at home when discharged from home health services does not necessarily reflect the quality of care they received from the HHA. The feasibility and safety of discharging a patient from home health services often depends on a patient’s cognitive and functional level, as well as the availability of family or other caregivers. This help at home may not exist for many patients.  HHAs should not be financially penalized for serving patients who qualify for coverage of services under the Medicare home health benefit, and who rely upon those continued services to safely remain in the community.

Improvement in Management of Oral Medications

CMS proposes to score HHA performance based upon the number of episodes of care where the patient’s discharge assessment indicates less impairment in taking oral medications correctly at discharge than at the start (or resumption) of care. The Center supports financial incentives in furtherance of helping patients achieve greater compliance with taking medications. However, we are concerned that because improvement is only measured at discharge, the incentive is for HHAs to select less sick and more “able” patients, who are likely to learn, comply, improve and be discharged after a short time.

Conversely, there would be a disincentive for HHAs to serve clients who have functional, cognitive, or psychiatric deficits that may impair their ability to gain greater independence in taking oral medications, and who lack personal support systems to assist them with that task. For patients with these characteristics, an HHA’s immediate and ongoing involvement in keeping track of refilling prescriptions, prepouring medication boxes, and patient education to ensure compliance, often play a critical role in stabilizing patients’ conditions and reducing readmissions. Thus, we would support a performance measure that recognizes the value of promoting patient management of and compliance with medications during all episodes of care, not just at discharge.

Proposed New Measures – Reporting of Adverse Event for Improper Medication Administration and/or Side Effects

CMS will require all Medicare-certified HHAs in the selected states to report the number of home health episodes where the discharge/transfer assessment indicated that the patient required emergency hospital treatment related to an adverse drug event (ADE).  In performance year one (PY1), the HHA’s score on this measure will only be based on whether or not it has submitted this data to the HHVBP web-based platform.

The Center does not dispute the value of collecting and studying data regarding the incidence of an ADE in the home health setting. However, we would oppose any proposal in future performance years to score HHA performance based upon the number of ADEs experienced by their clients.  This would create a disincentive for HHAs to serve clinically complex patients who may have complex medication regimes.

This simple statistic does not adequately portray the circumstances behind ADEs and how the events were addressed. While it is not always within the HHA’s control to prevent an ADE, HHAs can and often do play a significant role in managing these events. Numerous factors, including a patient’s psychiatric status, cognitive impairment, and visual acuity, can increase the risk of an ADE occurring. Not uncommonly, the events occur because one physician has prescribed a drug that adversely interacts with a drug or treatment prescribed by a different physician. Based on our review of thousands of home health claims, it is often the visiting HHA nurse who first identifies and alerts the patient’s physicians to the potential for adverse interaction, and thereby prevents a medical complication or emergency. But, physicians do not always respond, and potential ADEs are not always obvious or preventable. In these situations, and also in instances when a client self-administers or is given the wrong dose or medication, the visiting nurse is frequently the first-responder, evaluating the client and seeking appropriate intervention. This is the type of involvement and the standard of care we expect from HHAs and should try to encourage.

Because ADEs are often beyond the HHA’s power to avoid, simply scoring HHAs on the overall and increased/decreased number of reported incidents may not fairly and accurately measure the quality of the HHA’s performance.

Proposal for Subsequent Model Years – Maintenance Nursing and Maintenance Therapy

Under the proposal, CMS has selected measures in performance year one (PY1) that are “readily available” (primarily through OASIS data) and meet “high impact need.”  In subsequent model years, CMS plans to “augment this starter set with innovative measures that have the potential to be impactful and fill critical measure gap areas.”

The Center strongly supports the inclusion of Maintenance Nursing and Maintenance Therapy as a proposed measure in current and future rulemaking.  This would be an innovative measure because CMS has heretofore has not collected data on skilled maintenance care, which it has recognized as a covered service under the Medicare statute and regulations.  It would also be impactful and fill a critical measure gap area, since so many of the current measures focus on improvement and do not reflect the goals of the many home health patients for whom even modest clinical or functional improvement is not expected. However, these patients still need skilled nursing or skilled therapy services to maintain their condition or to slow deterioration. To this end, adding maintenance care as a measure would help to fulfill CMS’ stated objectives of creating a “broad measure set” that “captures the complexity of HHA services provided,” and developing “second-generation measures of patient outcomes, health and functional status, shared decision making, and patient activation.”

The data-points to measure HHA performance in stabilizing patients and preventing deterioration are already available. It should not be difficult to incorporate maintenance measures into the HHVBP demonstration.  Moreover, skilled maintenance care could be evaluated as an outcome or process measure within the National Quality Strategy Domains of clinical quality of care, patient safety, patient and caregiver-centered experience, or efficiency and cost reduction. For instance, from an efficiency and cost-reduction standpoint, it would be worthwhile to gather data to study whether patients who receive skilled maintenance home care have longer intervals without suffering acute events that require readmission to the hospital, and whether their hospital stays tend to be shorter compared to patients who have the same clinical characteristics but do not receive home care.

Conclusion

In closing, the Center is encouraged by CMS’ interest and efforts in achieving fairer access to home health care for the most clinically complex and vulnerable beneficiaries. We look forward to modifications to the case-mix system that will address the lower margins and financial disincentives associated with serving these patients populations. The Center also hopes that CMS will re-evaluate the proposed outcome and cost-efficiency measures for scoring HHA performance in the HHVBP Model. As discussed above, a number of these measures create financial incentives to select patients who require less care and can demonstrate swift clinical and functional improvement, and disincentives to serve those patients who have the greatest need for care, especially skilled nursing care. Finally, we hope that CMS will view the HHVBP Model as an opportunity to examine and develop quality measures for providing skilled maintenance nursing and therapies in the home health setting.

Sincerely,

Judith A. Stein
Executive Director/Attorney

Margaret M. Murphy
Associate Director/Attorney

Wey-Wey Kwok
Senior Attorney


[1] 80 Fed. Reg. 39840.
[2] Report to Congress Medicare Home Health Study: An Investigation on Access to Care and Payment for Vulnerable Patient Populations. See, http://www.cms.gov/Center/Provider-Type/Home-Health-Agency-HHA-Center.html.
[3] The survey results also revealed that length of stay over two episodes was frequently cited as a factor in being unable to admit a patient for smaller HHAs (13.4%) than for larger HHAs (2.3%).
[4] Id. p. 39867
[5] Page 8 of MedPAC Comments submitted in response to CMS-1625-P in a letter by Francis J. Crosson, M.D., Chairman, dated August 18, 2015 and submitted electronically on http://www. regulations.gov.
[6] Jimmo v. Sebelius, No. 11-cv-17 (D.Vt.); copy of Jimmo Settlement available at http://www.medicareadvocacy.org/wp-content/uploads/2012/12/Jimmo-Settlement-Agreement-00011764.pdf