June 1, 2020
VIA ELECTRONIC SUBMISSION
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Attention: CMS–1744–IFC
P.O. Box 8016
Baltimore, MD 21244-8016
Re: CMS-1744-IFC: Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency
Dear Administrator Verma:
The Center for Medicare Advocacy (the Center) is pleased to submit comments in response to the Interim Final Rule with Comment: Medicare and Medicaid Programs; Policy and Regulatory Revisions in Response to the COVID-19 Public Health Emergency (CMS-1744-IFC).
The Center, founded in 1986, is a national, non-partisan education and advocacy organization that works to ensure fair access to Medicare and to quality healthcare. At the Center, we educate older people and people with disabilities to help secure fair access to necessary health care services. We draw upon our direct experience with thousands of individuals to educate policy makers about how their decisions affect the lives of real people. Additionally, we provide legal assistance to ensure people receive the Medicare coverage to which they are legally entitled, and the quality health care they need.
General Comments
Because of the risks that the COVID-19 pandemic poses to Medicare beneficiaries, particularly older adults, and the need to minimize person-to-person contact, the Center appreciates many of the efforts of the Centers for Medicare & Medicaid Services (CMS) to temporarily waive certain rules in order to streamline Medicare coverage during the public health emergency.
From a beneficiary standpoint, some of these rule changes and waivers have improved eligibility for and access to services (such as waiver of the 3-day inpatient stay and extended coverage allowance re: skilled nursing facilities). We urge CMS to expand such changes after the end of the Public Health Emergency (PHE). Some changes can improve access to care for beneficiaries, such as broadened telehealth coverage, but should not be used as a substitute for necessary in-person visits, nor should they be used to further weaken Medicare Advantage network adequacy standards, as discussed below. Other changes give us great pause, such as those aimed at easing so-called “burdens” on providers – such as suspending certain reporting requirements – and CMS’s suspension of many oversight activities. We urge CMS to reinstate these provisions as soon as possible.
We recognize that several of the waivers and rule changes discussed below did not originate from this specific, above-referenced interim final rule, but rather, through other issuances by CMS, including sub-regulatory guidance. We offer comments on such rule changes here, however, due to the lack of other avenues to do so, and urge CMS to view our feedback in light of its broader COVID-19 response rather than dismissing them as being beyond the scope of the IFR in question.
Telemedicine
We recognize that certain flexibilities given to providers in telehealth and other services provided via technology have increased access to certain types of care during the pandemic and have minimized face-to-face contact between patients and providers, which is necessary to slow the spread of the virus. While some of these flexibilities should be assessed for ongoing viability following the end of the PHE, particularly those that make it easier for individuals who have difficulty leaving their house or otherwise accessing providers, we urge caution before instituting widespread adoption of telehealth without appropriate safeguards in place, include reinstitution of HIPAA privacy protections, which have been largely suspended for the time being.
With respect the current provision of telehealth during the PHE, we appreciate that the HHS Office of Inspector General (OIG) issued a Policy Statement to notify physicians and other practitioners that they will not be subject to administrative sanctions for reducing or waiving any cost-sharing obligations under federal programs, including Medicare. However, beneficiaries are often confused about the application of cost-sharing for telehealth, particularly if it is charged solely at the provider’s discretion. We have already heard about providers trying to collect cost-sharing after failing to disclose at the time services were rendered that they would do so. The second interim final rule issued on May 8, 2020, states that “Practitioners should educate beneficiaries on any applicable costsharing.” 85 Fed Reg 27590 (May 8, 2020); however this permissive request should be a requirement. We urge CMS to mandate that providers disclose any applicable cost-sharing for telehealth at the time of service.
We understand CMS is exploring making many of the telehealth changes permanent, beyond the current Public Health Emergency. We urge great caution, however, before rapidly expanding and increasingly relying on telehealth as a substitution for in-person services in the Medicare program. As noted in a May 2020 article in the Journal of the American Medical Directors Association, despite an increase in research re: the use of telehealth over the last several years, such interactions “are rarely compared to face-to-face delivery and small sample sizes often limits the power and generalisability of these studies.”[1] The authors note that “[u]se of remote interventions therefore needs to facilitate rather than replace contacts with healthcare professionals.” The authors conclude that “whilst these interventions are potentially effective and received positively by some frail older people, those evaluating or providing services should ensure that digitally underserved older people are not left behind through facilitating contact with healthcare professionals and providing both the technology and technical support needed for interventions to be successful.”
Data already shows that the COVID-19 virus has a disproportionate impact on individuals who are low-income and communities of color.[2] The unfettered broadening of telehealth can also further exacerbate health disparities – an outcome that CMS should avoid at all costs. According to Nicol Turner Lee, a research fellow at the Brookings Institution’s Center for Technology Innovation quoted by Politico, “‘Communities without the means to get online will not benefit from telehealth.’”[3] The Politico article goes on to state that “Meanwhile, health systems in wealthier areas over the last two months say they have poured more resources into treating patients over video chat, leading many to believe virtual care will become routine for these communities long after the pandemic. That could create a new divide in the already large gap between the level of health care available to poor and wealthier patients.” The article then quotes Lisa Cooper, founder of the Johns Hopkins Center for Health Equity: “‘People of color and people with low incomes are always the last to get access to any new technology, […] The disparity always gets worse before it gets better.’”
The majority of these telehealth waivers still leave many beneficiaries without reliable and safe access to needed services. Too many people with Medicare lack access to the devices or internet speeds necessary to make telemedicine feasible.
Further, it is essential that, should these additional telehealth flexibilities remain after the end of the PHE, these services are optional, rather than mandatory or functionally mandatory for beneficiaries. Telehealth must not be incentivized in such a way that in-person treatment and consultation is harder to access, and provider compliance with accessibility requirements may not be sidestepped by offering telemedicine. Some health care is simply not best provided via telehealth. Further, beneficiaries vary in their comfort with telemedicine and CMS should not substitute online access for in-person access without express choice.
Finally, the Center strongly objects to using telehealth to further weaken Medicare Advantage (MA) network adequacy requirements. Unfortunately, CMS has already done this through the 2021final rule for Parts C and D rule (to be published in the Federal Register on June 2, 2020). As the Center noted in both comments to the proposed rule[4] and a summary of the final rule[5], allowing MA plans to receive credit towards the percentage of beneficiaries residing within published time and distance standards when they contract with telehealth providers in certain provider specialty types “dilutes access to care by allowing plans to provide less than adequate access to a greater percentage of their enrollees.”
Further, the Center noted that “If an MA plan sponsor cannot contract with an adequate number of providers within reasonable time and distance standards to the maximum number of enrollees it should not be allowed to offer a plan in the area. Offering an MA plan with too few providers, too far away, who are reasonably accessible to too few enrollees does not serve a rural population well […] Existing rules should not be diluted in order to enable more plans to meet such rules; network adequacy should not be graded on a curve.” We fear that a significant expansion of telehealth beyond the PHE will lead to more such weakening of standards.
Skilled Nursing Facilities
Waiver of 3-Day Stay Requirement and Extension of Covered Days
The Center strongly supports CMS’ waiver of the 3-day inpatient hospital stay requirement for skilled nursing facility (SNF) coverage as well as extending the number of covered SNF days for those who have been impacted by the pandemic. With respect to waiver of the 3-day rule, as CMS is aware, Medicare Advantage (MA) plans already have the discretion to waive it, as do certain types of Accountable Care Organizations (ACOs). The 3-day requirement is a relic of the original Medicare Act, and while Congress has not yet chosen to eliminate it altogether, CMS does have the authority and discretion to count all of the time in the hospital – including time spent in observation status – towards this requirement.
As the Center has long-noted, under a 2008 decision of the Second Circuit Court of Appeals, the Secretary of HHS has authority under the Medicare statute to include a hospital patient’s time in observation as part of inpatient time in the hospital for purposes of determining whether the patient qualifies for Part A coverage of a subsequent stay in a skilled nursing facility (SNF). Estate of Landers v. Leavitt, 545 F.3d 98 (2nd Cir. 2008).[6] The Court recognized that neither the statute nor regulations define the word “inpatient” and that the Secretary defined inpatient in the Medicare Benefit Policy Manual as occurring after a formal physician order for admission. Although the Court upheld the Secretary’s position in litigation – that only time in formal inpatient status may be counted toward satisfying the qualifying three-day inpatient requirement – it acknowledged that the Secretary had authority to change his interpretation of inpatient to include time spent in observation. We urge CMS to exercise its authority to so broaden the 3-day inpatient requirement for SNF coverage so that greater access to SNF coverage can be extended beyond the PHE.
With respect to the extension of covered SNF days for individuals who have exhausted their Part A benefits and have been impacted by the PHE, we assert that CMS must do more to enable individuals to effectuate this right. Since CMS has granted this waiver, we have been contacted by individuals who have been denied this opportunity by a SNF but have been unable to exercise their right to appeal the facility’s decision. Both the Quality Improvement Organizations (QIOs) and customer service representatives at 1-800-MEDICARE have disavowed any obligation or ability to effectuate individuals’ appeal rights in this scenario. CMS must ensure that all stakeholders – from facilities, to QIOs and other contractors – are aware of their obligations to provide an opportunity for affected individuals to be heard.
COVID-19 Response and Deficiencies in Oversight and Enforcement
The Center has written extensively over many years about our concerns with deficiencies related to nursing facility oversight and enforcement.[7] Just as COVID-19 began to take hold in nursing facilities across the country, we wrote about how regulations for infection control are ignored and there is, typically, little enforcement when facilities violate them.[8] We have joined other advocacy organizations in urging CMS to require better protections for nursing home residents and better support of residents’ ability to make decisions about their health care and place of residence.[9]
In April, the Center joined other consumer advocacy organizations in making recommendations to the Senate Finance Committee including some legislative ideas that respond to the current crisis and also could be invaluable in future crises; such recommendations included:
Quality of Care
- Require that each facility have a full-time infection preventionist with a specified level of training and experience. Current regulations specify only that a staff member be designated part-time to act as infection preventionist. See 42 C.F.R. § 483.80.
- Require that nursing facilities offer at least two weeks of paid sick leave to each employee.
Transparency about Infection Levels and Staffing Levels (some of our recommendations are included in the interim final rule published May 8, 2020)
- Require nursing facilities to inform residents, families, staff members, the state long term care ombudsman and the public when residents or staff test positive, along with the steps the facility is taking to treat infected residents and to protect other residents.
- Require nursing facilities to post a notice at entrance(s) when residents or staff have tested positive or have an active infection.
- Require nursing facilities as soon as possible, and within 12 hours, to inform the state health department, CMS and the CDC when a resident or staff member tests positive.
- Require states, CMS and the CDC to release the identities of nursing facilities that have a resident or staff member with a positive test result.
- Require facilities each day to post staffing levels before the beginning of each shift inside the facility (already required) and on the door at the facility entrance. Also require facilities to report these staffing levels to the state survey agency, the state long term care ombudsman, and CMS on a daily basis. Require state survey agency to publish these staffing levels on its website for access by the public who cannot physically access the facility.
Emergency Complaint System
- Require states to implement an emergency complaint intake system for infection-related complaints, and to dedicate adequate surveyor resources to immediately investigating those complaints.
Reinstitution of Pre-Pandemic Rules
- Require CMS to establish criteria for re-instituting Requirements of Participation that have been waived during the pandemic as soon as possible after the infection is contained and the danger of new infections has ceased.
Requiring Per Day Civil Money Penalties for Infection Control Violations
- Require per day Civil Money Penalties (CMPs) for violations of infection control or emergency preparedness regulations that result in positive tests for infection or active infection of any kind.
- Date imposition of daily CMPs from the date the infection was detected and the facility failed to implement all required infection control methodologies to halt its transmission to other residents, staff or visitors.
The current pandemic has exacerbated pre-existing conditions in nursing facilities that endanger residents. CMS must do more during the current crisis, and, once it subsides, it cannot let there be a reversion to the status quo.
Home Health
We appreciate some of the flexibilities that CMS has instituted during the PHE with respect to home health services, such as expanding the types of provider who can initiate home health services. This will particularly help Medicare beneficiaries in rural and less accessible areas, and we urge CMS to make these waivers permanent.
We are concerned, however, about the manner in which some home health agencies are implementing waivers regarding the provision of telehealth services as part of a home health episode of care. While we appreciate that CMS is trying to strike a balance between the provision of in-person vs. an option for telehealth services, an appropriate balance has not yet been struck. The needs of a given individual should be paramount rather than a payment model that is contingent upon a minimum threshold of in-person visits. For instance, if an individual who is eligible for home health services is fearful of home health workers entering the home during the current pandemic, such individuals are told by the agencies, in our experience, “either you let us in or you will be discharged” from services since providers cannot be paid solely for telehealth visits. CMS must allow for greater flexibility during the PHE concerning an appropriate mix of in-person v. telehealth visits, based on the individual’s needs, while ensuring that once the PHE subsides, telehealth does not substitute for visits that should be in-person.
Reinstate Oversight and Reporting Requirements
While we recognize that the PHE can warrant temporary waivers of certain reporting requirements, we are concerned that providers, Medicare Advantage and Part D plans, and other industry stakeholders will push to permanently ease some of these “burdens.” Many of these requirements were imposed for a reason. CMS must reestablish its oversight and enforcement of those requirements for supervision, assessment, and timeliness that are necessary to ensure people with Medicare have appropriate care delivered professionally and competently.
Conclusion
We appreciate the opportunity to submit these comments. For additional information, please contact David Lipschutz, Senior Policy Attorney, dlipschutz@MedicareAdvocacy.org at 202-293-5760.
David Lipschutz
Associate Director/Senior Policy Attorney
Licensed in CA and CT
_______________________
[1] Frost R, Nimmons D, Davies N, Using remote interventions in promoting the health of frail older persons following the COVID-19 lockdown: challenges and solutions, Journal of the American Medical Directors Association (2020), doi: https://doi.org/10.1016/j.jamda.2020.05.038.
[2] See, e.g., Center for Medicare Advocacy Weekly Alert “Research: Low-Income and Communities of Color at Increased Risk From COVID-19” (May 21, 2020) and citations therein, available at: https://medicareadvocacy.org/research-low-income-and-communities-of-color-at-increased-increased-risk-from-covid-19/.
[3] “What if telehealth widens health care disparities?” by Mohana Ravindranath, Politico (5/07/2020).
[4] Center for Medicare Advocacy, Comments to Proposed C & D Rule (April 6, 2020) available at: https://medicareadvocacy.org/wp-content/uploads/2020/04/CMA-CD-Comments-2020.pdf.
[5] Center for Medicare Advocacy, Weekly Alert, “Final Rule for Medicare Parts C and D Includes Weakened Standards for Medicare Advantage Networks” (May 28, 2020), available at: https://medicareadvocacy.org/final-rule-for-medicare-parts-c-and-d-includes-weakened-standards-for-medicare-advantage-networks/.
[6] See, e.g., Center Weekly Alert “CMS has Authority Under Existing Law to Define Inpatient Care” (July 2014), available at: https://medicareadvocacy.org/cms-has-authority-under-existing-law-to-define-inpatient-care/.
[7] See, generally, Center for Medicare Advocacy website at: https://medicareadvocacy.org/medicare-info/skilled-nursing-facility-snf-services/.
[8] Joint Statement by Center for Medicare Advocacy and Long Term Care Community Coalition: “The Coronavirus and Nursing Home Residents” (March 19, 2020), available at: https://medicareadvocacy.org/the-coronavirus-and-nursing-home-residents/.
[9] Letter to CMS – Request for CMS Action to Better Protect Nursing Facility Residents (April 28, 2020), available at: https://www.justiceinaging.org/wp-content/uploads/2020/04/letter-to-CMS-re-NF-COVID-guidance-FINAL.pdf