August 24, 2020
Centers for Medicare & Medicaid Services
Department of Health and Human Services
P.O. Box 8013
Baltimore, Maryland 21244-8013
Submitted electronically to: http://www.regulations.gov
Re: File Code CMS-1730-P; Federal Register, Volume 85, No. 126 (June 30, 2020)
Medicare and Medicaid Programs; CY 2021 Home Health Prospective Payment System Rate Update; Home Health Quality Reporting Requirements; and Home Infusion Therapy Service Requirements – Proposed Rule
The Center for Medicare Advocacy (the Center) provides these comments regarding CMS-1730-P and the impact of the proposed rule on access to home health care for vulnerable older and disabled people.
The Center, founded in 1986, is a national, non-profit law organization that works to ensure access to Medicare and quality healthcare. The organization provides education, legal assistance, research and analysis on behalf of older people and people with disabilities, particularly those with long-term conditions. The Center’s policy positions are based on its experience assisting thousands of individuals and their families with Medicare coverage and appeal issues. Additionally, the Center provides individual legal representation and, when necessary, challenges patterns and practices that inappropriately deny access to Medicare and necessary care. The Center also participated on a Technical Expert Panel to discuss issues related to the impact of the Patient Driven Groupings Model (PDGM) which serves as the new reimbursement system for home health agency providers.
Congress authorizes access to an array of home health services to help individuals stay healthy and safe at home. Beneficiaries who qualify for Medicare home health care have: 1. No limit on the duration of time an individual can qualify for home health care. 2. No prior-institutional stay requirement or limit on covered visits (both repealed in 1980); and, 3. No cost-sharing in traditional Medicare.
Regrettably, many beneficiaries are denied access to necessary care for which they qualify under the law. In the Medicare Payment Advisory Commission’s (MedPAC) 2020 report to Congress, MedPAC stated, “Ensuring that Medicare beneficiaries have access to needed care will continue to be a priority, and the Commission will monitor these changes to understand their impact on access for beneficiaries and the quality of care.” MedPAC further reported, “Access to home health care is adequate: Over 98 percent of beneficiaries lived in a ZIP code where at least one Medicare HHA operated in 2018, and 83 percent lived in a ZIP code with five or more HHAs.” Unfortunately, while MedPACs statement on access adequacy may be true in theory, in reality, agencies are not required to take all beneficiaries who qualify for Medicare-covered care and, due to incentives and disincentives in the Medicare payment system, many agencies reject patients who most need care.
The following comments to the proposed rule will address PDGM, Quality Measures, Telecommunication Technology, Home Infusion Benefits, and Frequently Heard Access Issues Described to the Center by Patients and Home Health Agencies.
- PDGM – The Current Medicare Payment System
Medicare home health qualifying criteria and coverage laws have remained largely unchanged over the past 20 years, although various payment systems and quality measurements have influenced the delivery of care. The PPS (Prospective Payment System) incentivized the use of therapy services, reduced the emphasis on nursing care, and diminished the delivery of covered home health aide services that are often the key to beneficiaries remaining safely at home. These changes are starkly noted in the chart (rounded to the nearest whole number) below.
|Average Visits Per Home Health Episode (60 days)||1998||2018|
Changes in access to home care services were not all attributable to PPS; other factors also play a part, including: agency ownership changes, mergers/acquisitions, an increase in for-profit agencies from <50% to >90%, and Medicare Advantage (MA) plan participation growth (coupled with relatively low MA plan payments that undercut total agency profits). Incentive payment models, quality measures, and CMS compliance/audit practices also influence agency behavior.
Currently, PDGM purports “to shift the focus from volume of services to a more patient-driven model that relies on patient characteristics.” (FR 39409, 39412). Unfortunately, beneficiaries who are most in need, people with complex, longer-term and chronic conditions who were already facing access barriers to care, are faced with even greater barriers under PDGM. Simply put, PDGM is not appropriately guided by the needs of all patients but instead creates strong incentives to primarily serve short-term, post-acute care patient needs.
As an economic model, PDGM may make sense in the aggregate. But, it falls far short in practical application because agencies are allowed to cherry-pick the beneficiaries they serve. Many agencies reduce services, or refuse to provide services when beneficiaries “are less profitable”. Under PDGM, the amount of therapy patients receive is dropping precipitously. This gap in therapy is not being filled by different care modalities; it has simply led to less available care.
As lead counsel in Jimmo v. Sebelius, the case that confirmed Medicare determinations should turn on the need for skilled care, not on an individual’s ability to improve, the Center continues to strenuously object to PDGM and the limitations on care it poses for people with longer-term conditions. The following example illustrates some of the provisions of PDGM that result in access to care problems.
Consider two Medicare beneficiaries, Ms. A and Mr. B. In the case of Ms. A, from Jacksonville, Florida, her home health case would have generated a PDGM payment of $600/hour for the agency, while in the case of Mr. B, also from Jacksonville, his home health case would have generated a PDGM payment of $12/hour (his case is not outlier qualifying). The resulting disparity in payment, and the inevitable denial of care for Mr. B after only a short time, while an agency profits handsomely on Ms. A, is all too real. People with needs similar to Mr. B are left out of necessary care or forced by agencies to accept greatly reduced services in a system that overpays for some patients (Ms. A) while leaving the most vulnerable patients (Mr. B) unable to access care.
Ms. A is a healthy, active beneficiary who lives in Jacksonville, FL. She was discharged home from the hospital with a home health care order for 4 nursing visits over 30 days to evaluate & manage a surgical site and provide wound care. Medicare will pay $2,400 for 30 days or $600 per hourly visit.
Case mix and wage adjusted 30 day period payment calculation:
1.4269(2CA11 (HHGM)(Wound, low functional impairment, early institutional, no comorbidities, LUPA threshold 4)) x $1,864.03 (national base rate, agency reporting quality information). $2,660 x 76.1% x .8703 (Jacksonville) = $1,761 (wage component) plus $2,660 x 23.9% (non wage) = $2,397 for 4 nursing visits
Mr. B has severe COPD, multiple co-morbidities, and needs assistance with all his daily activities. 2 months ago, to keep him home in Jacksonville, his doctor ordered reasonable and necessary weekly care: 2 nurse visits, 2 PT visits, an OT visit, and 28 aide hours. Medicare will pay $1,600 for 30 days or $12 per hourly visit averaged over all service disciplines.
Case mix and wage adjusted 30 day period payment calculation:
.9502(3LC31 (HHGM)(MMTA respiratory, high functional impairment, late community, multiple comorbidities)) x $1,864.03 (national base rate, agency reporting quality information). $1,771.20 x 76.1% x .8703 (Jacksonville) = $1,173 (wage component) plus $1,771.20 x 23.9% (non wage) = $1,596 for 132 hourly visits (not in 2.5% statutory outlier limit).
As can be seen from the example with Ms. A and Mr. B, PDGM payments to agencies for services have little correlation to the amount of care a beneficiary actually needs. Further, patient medical characteristics (functional level and comorbidities) represent a significantly smaller percentage of PDGM payments than episode timing and admission source. The average PDGM payment adjustment impact, after analyzing multiple home health resource groupings, is approximately as follows, for the 12 clinical categories:
- Episode timing (32%)
- Referral source (13%)
- Functional level (16%)
- Presence of comorbidities (10%)
The allowances for patient health and function characteristics cannot compare with the larger allowances for admission source and timing. The result of PDGM: Medicare beneficiaries with the most health care needs have the least access to Medicare-covered home health care.
Inequities in delivery of service under PDGM should be examined, not ignored. CMS cannot analyze data that does not exist for patients who are denied services under PDGM. MedPAC’s simplified approach to access that examines only home health agencies that “offer” services by zip code cannot account for agencies that systematically cherry-pick patients and deny services to high-need, high-cost qualified patients, who are penalized for their health conditions.
Regrettably, PDGM rewards waste and abuse in the Medicare program, by paying home health agencies prospectively, allowing agencies to steer the delivery of services to certain beneficiaries and to inappropriately discharge other patients with few repercussions or oversight. The Office of Inspector General (OIG) does not audit to protect the program or beneficiaries by investigating agencies that underserve patients. Instead, the OIG only focuses on agencies “overserving” patients, although agencies would often get the same payment even if they provided far less services. Agency profit margins bear this out, year after year. As MedPAC reports, home health agencies post approximately 16% profits every year. This represents millions of dollars going to profits that should be going to patient care.
In the proposed rule, CMS states “[b]ased on our analysis, we conclude that the policies proposed in this rule would not result in an estimated total impact of 3-5 percent or more on Medicare revenue for greater than 5 percent of HHAs.” (FR 39447). This statement flies in the face of historical experience that consistently shows a 16% profit margin, as stated by MedPAC. PDGM will continue to increase profits while care is reduced for the most vulnerable patients. An explanation for this is one we hear from home health agencies – traditional Medicare profits are subsidizing private insurer Medicare Advantage (MA) plan loses. Agencies make a 16% profit from traditional Medicare and use it to offset losses in their contracts with private MA plans; perhaps as a loss leader to obtain those companies more lucrative commercial insurance contracts. Allowing this system to continue abuses the Medicare Trust Fund, while patients go without Medicare-covered care for which they are eligible under the law.
- Quality Reporting Measurements (QRM)
CMS’ decision not to provide quality updates or proposals (FR 39430) in this proposed rule is disappointing because they are necessary. Table 28 (FR 39429) lists 5 of 14 OASIS-based HH QRM measures (36% of measures) that require a patient to improve in order for an agency to get “credit” for “quality service”.
CMS should not continue to ignore quality care for people for whom improvement is not a reasonable goal. CMS should propose measures to encourage agencies to help maintain the health of patients, or slow decline. Because CMS does not reward quality care to maintain patients’ conditions, home care agencies have yet another disincentive to admit such patients or to continue to their needed care. In the example outlined above, for instance, an agency serving Ms. A would be further rewarded, with greater profits and higher quality star ratings, while an agency serving Mr. B would not be paid sufficiently under PDGM and would be further penalized because of lower quality measurement results.
Thus access to quality “maintenance care” is eroded and undermined by quality measures that do not include maintenance patients and clearly discriminate against them, through existing quality measures that reward care to patients who can improve. This conflicts with the Jimmo Settlement. This problem is further exacerbated when CMS penalizes agencies by 2% if agencies do not report their quality data (FR 39421). Quality matters for every patient, not just some. CMS should develop standards to measure quality care to maintain an individual’s condition or slow decline – not just to improve. Quality measurements should consider, and encourage the provision of necessary care to, all Medicare beneficiaries.
Value Based Purchasing (VBP) was also not mentioned in the proposed rule. Although CMS considers VBP to be a separate consideration from quality measurements, agencies are further rewarded under VBP (in an annual increasing percentage through 2022), by criteria that mimics quality measurements, including improvement. VBP also rewards agencies that largely ignore maintenance patients, and penalizes agencies that help people maintain their conditions. CMS’ QRM and VBP policies should be rectified immediately to properly include and measure quality care for patient who qualify and require home health services to maintain their conditions.
- Telecommunications Technology (Telehealth) (FR 39427-39428)
- Patient Choice
The Center strongly agrees with the following CMS statement in the proposed rule:
If there is a service that cannot be provided through telecommunications technology (for example, wound care which requires in-person, hands on care), the HHA must make an in-person visit to furnish such services. Furthermore, a HHA cannot discriminate against any individual who is unable or unwilling to receive home health services that could be provided via telehealth communications technology. In those circumstances, the HHA must provide such services through in-person visits as the intent of the Medicare home health benefit as defined in section 1861(m) of the Act is to provide items and services on a visiting basis in the individual’s home. (FR 39428. Emphasis added.)
The Center urges CMS to develop policies and education efforts to clearly communicate this directive to agencies, patients, and health care practitioners.
Too often we hear from beneficiaries who are given misinformation about coverage laws, policies, or other protections afforded them through the home health conditions of participation. Too often patients are essentially told by agencies, about receiving services, to “take it or leave it – this is what we’ll provide you and if you don’t take it, we won’t admit you.” With regard to telecommunications technology, the Center is concerned that agencies will offer in-person services to just over the LUPA threshold and designate the remainder of services to telecommunications, again telling patients to “take it or leave it”. Practitioners who order services may also have little to no alternative but to “take it or leave it” for their patients, since other agencies say the same.
CMS must prohibit agencies from refusing to care for patients who are “unwilling or unable” to accept services through telecommunications. The Center raises this caution because we are aware that many agencies ignore a CMS policy that requires agencies to provide qualifying home health aides when family members are “unwilling or unable” to provide care for their loved one. However, CMS oversight of this issue is lacking. We hear from beneficiaries who are told by agencies they cannot have aide services because they have a family caregiver who should provide the care. Rarely does the agency find out if the caregiver is willing and able to provide the care and the patient is willing to accept it. We fear that a similar lack of oversight will apply to telecommunications technology if patients are “unwilling or unable” to use it. In order to protect beneficiaries, CMS should develop and articulate clear guidelines and an effective oversight and enforcement mechanism to assure telecommunications technology is not the default means of providing care, and that patients don’t lose access to in-person care.
- Patient Inclusivity
The Center urges CMS to continue to “remind stakeholders” that access to all Medicare home health services, not just telecommunications technology, must be inclusive. The Center agrees with the following:
We remind stakeholders that access to telecommunications technology must be inclusive, especially for those patients who may have disabilities where the use of technology may be more challenging. Section 504 of the Rehabilitation Act and the Americans with Disabilities Act protect qualified individuals from discrimination on the basis of disability in the provision of benefits and services. Concerns related to potential discrimination issues under 504 should be referred to the Office of Civil Rights for further review. Likewise, we remind HHAs that the home health CoPs at 484.50(f)(1) require that information must be provided to persons with disabilities in plain language and in a manner that is accessible and timely, including accessible websites and the provision of auxiliary aids and services at no cost to the individual in accordance with the Americans with Disabilities Act and section 504 of the Rehabilitation Act. This means that the HHA must meet these requirements to ensure access to and use of telecommunications required by law. (FR 39428)
- Telehealth Policies for Further Consideration
The Center, and the Medicare Rights Center (MRC), have published joint principles to address the needs of patients in policy conversations including for telecommunications technology, a number of which CMS has included in the proposed rule. The following principles are intended to aid such a process. When making decisions about whether and how to expand Medicare coverage for telehealth, we urge policymakers to:
- Ensure any covered telehealth services are clinically appropriate;
- Ensure that telehealth options supplement, rather than replace, in-person care—and ensure that payment incentives align with this goal;
- Promote behavioral health parity to help address the unmet needs of current and future beneficiaries in both urban and rural settings;
- Ensure that any expansion of telehealth does not exacerbate health, racial, or income disparities, and that actions and expenditures are authorized to meaningfully address the digital divide many Medicare beneficiaries face—including lack of or limited access to digital literacy training, reliable broadband, and remote technologies;
- Ensure equitable access to telehealth for underserved communities, including Black Americans and people of color, individuals with disabilities, and people with limited English proficiency; purposefully collect data on such access; and ensure compliance with all existing civil rights laws, including rules requiring the use of interpreters and the provision of materials in alternative formats and non-English languages;
- Require providers to accurately disclose beneficiary cost-sharing obligations prior to service, and to fully document such disclosures; connect beneficiaries and providers with the resources they need to understand their financial responsibilities; and carefully monitor to ensure that any waivers of cost-sharing are not happening in a discriminatory or otherwise problematic way;
- Ensure that any expansion of telehealth protects patient privacy and data security for personal health information. HIPAA privacy protections must apply to telehealth interactions between the patient and provider and personal health data must also be kept secure;
- Ensure any expansion of telehealth is identical in traditional Medicare and private Medicare Advantage, and that the services and necessary equipment to access telehealth are equally available to all beneficiaries, regardless of the coverage pathway they choose;
- Ensure that telehealth does not weaken Medicare Advantage network adequacy standards, including by prohibiting telehealth providers from satisfying network adequacy requirements;
- Require public release of data concerning Medicare-covered telehealth, including the type of services provided, beneficiary experience and preferences, programmatic and beneficiary spending, health outcomes, and quality measurements.
- Ensure continuing, on-going monitoring, oversight, data collection, and evaluation in order to best inform future telehealth policymaking;
- Provide an extended phase-out period for the temporary COVID telehealth waivers and rules in order to minimize interruptions in care and prevent rushed policy development.
Too often home health agencies discriminate against the most vulnerable patients by reducing or denying access to care for which they patients qualify under Medicare law. Telecommunications technology, although intended to be additive, creates more concerns for this population. Telecommunications technology can be a positive way to reach patients when that is the best form of access. But, this technology could also become a slippery slope, degrading quality home health care and access to in-person, hands-on care.
If CMS finalizes this proposed rule, the Center urges CMS to develop and implement a robust program of careful implementation and oversight so that access to in-person, quality home health care is ensured for all patients.
- Home Infusion
For patients who hear that home infusion services will be covered by Medicare in 2021, it will be confusing and frustrating to navigate through the convoluted definition of what is covered, what is not, and why. Relatively speaking, the benefit is extremely limited as to the number of possible drugs and biologicals that are covered for home infusion. As the transitional home infusion drug (in effect 2019-2020) is broader than the permanent home infusion drug definition effective January 1, 2021 (FR 39432, 39437), beneficiaries who are currently covered for Hizentra, Ziconotide, Floxuridine, Morphine and any other drugs only available for temporary transitional payments should be appropriately informed home infusion coverage will not be available after December 31, 2020. Further, consideration should be given to “grandfathering in” patients who have been receiving these infusions and continue to have medical necessity for the infusions.
The Center understands that CMS is following the definition set out in section 1861(iii)(3)(C) of the Act, defining a home infusion drug as a parenteral drug or biological administered intravenously or subcutaneously for an administration period of 15 minutes or more, in the home of an individual through a pump that is an item of DME. Such term does not include the following: (1) Insulin pump systems; and (2) a self-administered drug or biological on a self-administered drug exclusion list.
It is, disappointing, however, to see home infusion coverage narrowing, rather than expanding. Once the infrastructure to certify and enroll home infusion suppliers is in place, Congress should expand the definition of home infusion drugs to allow CMS to cover additional drugs and biologicals. We hear from beneficiaries enrolling into Medicare whose previous commercial insurance covered home infusion services but who are now heavily burdened by having to leave their homes for covered services. For example, ALS patients who receive Radicava infusions must typically get infusions 10 days in a row every month. For Medicare coverage, ALS patients undergo a grueling, quality-of-life draining process to leave their homes every day to get Radicava, rather than to be allowed to receive it at home.
The limited home infusion coverage is a covered Medicare benefit, in addition to home health care. Under the home infusion benefit, a beneficiary is not required to be homebound. For non-homebound beneficiaries who could not qualify for home infusion services prior to this rule, it will be a welcome addition. However, this will create an extra burden for beneficiaries who previously received home infusion therapy through their home health benefit. The proposed amendment to 42 C.F.R. 409.49, to exclude home infusion from the definition of services covered under the home health benefit for covered drugs and biologicals, will force beneficiaries to continue to pay the Part B co-insurance for the physician (or other authorized practitioner) order/plan of care and for the DME order but, in addition, co-insurance will now apply for the infusion supplier, which would have been covered without cost-sharing under the home health benefit. CMS should consider the impact of this additional co-insurance to ensure it does not adversely impact access to this benefit for beneficiaries in need. CMS should also work with Congress and advocates to expand applicable coverage for Medicare home infusion benefits.
- Frequently Heard Access Issues Described to the Center by Patients and Home Health Agencies
The Center hears continuously from beneficiaries and agencies. We believe it is important for CMS to consider this information as well as comments CMS receives directly from beneficiaries. These are the most common home health access issues raised:
- I can’t find an agency to provide me care; my care is being reduced; I’m being discharged.
- My agency says: I’m not homebound (when they do meet the homebound criteria);
- I’m told I have to be able to improve to get care;
- I’m told I don’t need skilled care (even when they need a service specifically considered skilled and covered by federal regulations);
- I can only get home health aides 1-3 times a week; I can only get home health aides for a bath; a bath a week; Medicare doesn’t pay for aides, but I can get them if I private pay.
- We don’t have enough staff; Medicare doesn’t pay enough; MA plans pay worse; compliance is challenging; audits are intimidating; value-based and quality programs only measure improvement.
The Center is eager to continue to work with CMS and Congress to address home health access problems. We urge CMS to uphold Medicare home health coverage law so that home health care is available to everyone who qualifies. CMS should also ensure that home health agencies that seek to maximize profit while minimizing care are not rewarded with the highest profits under PDGM, QRM and VBP.
The Center for Medicare Advocacy urges CMS to place the interests of all Medicare beneficiaries at the heart of its payment models, quality measures, telecommunication technology, and home infusion rules. How providers get paid and measured drives who gets access to care. Thus, these rules must carefully reflect Medicare coverage laws, and advance Congressional intent. The payment rules – past, present, and proposed, fall short of this standard. We urge CMS to consider the collective impact of all home health payment rules, quality measures, and conditions of participation requirements on actual access to necessary care for homebound beneficiaries.
New rules should be proposed that encourage agencies to provide care for all people who qualify under the law, for all services covered under the law. A study of traditional Medicare and Medicare Advantage home health payments should be undertaken to ensure traditional Medicare is not subsidizing Medicare Advantage. Telecommunication Technology should be advanced with caution and oversight; patients should be fully informed of their right to choose, or not to choose, telecommunication technology; and providers should be educated about when it is appropriate to offer it. Home infusion rules should be carefully monitored to determine if the additional co-pays for homebound beneficiaries creates a barrier to necessary care. Further, the infusion benefit should be expanded to include drugs and biologicals not currently included in the program.
We appreciate the opportunity to submit these comments on behalf of all those who have the legal right, and urgent need, to obtain Medicare-covered home health services.
Judith Stein, J.D.
Kathleen Holt, M.B.A, J.D.
 MedPAC March 2020 Report to Congress, page 257. http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0
 MedPAC March 2020 Report to Congress, page 251. http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0
 MedPAC March 2020 Report to Congress, page 255. http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0
 MedPAC March 2020 Report to Congress, page 257-258. http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0
 MedPAC March 2020 Report to Congress, page 257. http://www.medpac.gov/docs/default-source/reports/mar20_entirereport_sec.pdf?sfvrsn=0
 Medicare Benefit Policy Manual, Chapter 7, Section 20.2, page 21. https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/Downloads/bp102c07.pdf
 12 Principles to aid in telehealth policy processes. https://medicareadvocacy.org/joint-principles-from-center-for-medicare-advocacy-and-medicare-rights-center-medicare-expansion-of-telehealth-helps-beneficiaries-access-care-during-the-pandemic-but-caution-is-needed-bef/