CMA Comments on Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities

October 14, 2015

Andrew M. Slavitt
Acting Administrator
Centers for Medicare & Medicaid Services
Department of Health and Human Services
Room 445-G, Hubert H. Humphrey Building
200 Independence Ave., S.W.
Washington, D.C.  20201

Medicare and Medicaid Programs; Reform of Requirements for long-Term Care Facilities
CMS-3260-P

Submitted electronically:  http://www.regulations.gov

Dear Mr. Slavitt and CMS Colleagues:

The Center for Medicare Advocacy (Center) is a national, private, non-profit law organization, founded in 1986, that provides education, analysis, advocacy, and legal assistance to assist people nationwide, primarily older people and people with disabilities, to obtain necessary health care, therapy, and Medicare.  The Center focuses on the needs of Medicare beneficiaries, people with chronic conditions, and those in need of long-term care and provides training regarding Medicare and health care rights throughout the country.  We advocate on behalf of beneficiaries in administrative and legislative forums, and serve as legal counsel in litigation of importance to Medicare beneficiaries and others seeking health coverage.  These comments are based on our experiences talking with and representing hundreds of Medicare beneficiaries and their families.  We have worked on enactment and implementation of the Nursing Home Reform Law for 30 years.

Overall comments

The Center for Medicare Advocacy understood three years ago that a guiding principle for CMS in revising the Requirements of Participation (RoPs) was removing regulatory burdens from providers.  Concerned, we sent a letter to Administrator Marilyn Tavenner and Dr. Patrick Conway on June 27, 2012 that proposed three principles for revising the RoPs.  First, we noted that the Nursing Home Reform Law includes many specific mandates that are incorporated, sometimes verbatim, into the regulations, and, accordingly, that regulatory language that repeats statutory language verbatim is not eligible for change.  Second, we urged the Centers for Medicare & Medicaid Services (CMS) to approach any revision of the RoPs through the lens of the Secretary’s statutory “duty and responsibility” under the 1987 Nursing Home Reform Law – “to assure that requirements which govern the provision of care in skilled nursing facilities under this subchapter, and the enforcement of such requirements, are adequate to protect the health, safety, welfare, and rights of residents and to promote the effective and efficient use of public moneys.”[1]  We asked that CMS ensure that any regulatory changes it proposed further its statutory duty and responsibility to “protect the health, safety, welfare, and rights of residents” and to assure that public money is well spent, and to explain how they did so.  Finally, we suggested that CMS incorporate the new guidance that CMS has been publishing in the Interpretive Guidelines since the Clinton Administration so that the Guidelines’ recommendations for improved care practices would become regulations that are enforceable against nursing facilities.  Unfortunately, the proposed rules do not implement these principles.  In addition, the proposed rules miss important areas where improvement could have been made in the RoPs.

The Center has five overriding concerns with the proposed rules.

First, the proposed rules do not address the single most significant cause of poor care in nursing homes – the absence of sufficient numbers of competent, well-trained, well-supervised, and well-compensated professional and paraprofessional nursing staff.  CMS acknowledges that “the need to address staffing levels” was a “consistent theme” in comments it received from the public, 80 Fed. Reg., 42174.  It recognizes that residents have become “more clinically complex” since the RoPs were first written, with “a dramatic increase in the number of residents who are recuperating from an acute episode of an illness or injury and who would have usually been discharged from a hospital to their homes.”  80 Fed. Reg., 42174.  CMS cites the increased number and types of alternative sources of post-acute care, including assisted living and home health care, that have also led to “higher acuity in the nursing home population.”  80 Fed. Reg., 42174.  Nevertheless, CMS explicitly rejects requests to promulgate explicit staffing ratios, which, it says, would conflict with state law and limit flexibility and innovation.[2]  Instead, it proposes a “competency-based approach,” which requires facilities, at least annually, to determine their residents’ needs and meet them.[3]  CMS’s reporting that most facilities already use such an approach belies any serious expectation that this approach will be effective in changing nursing home practices and improving nurse staffing levels going forward.  This approach has clearly failed for decades, as the overwhelming majority of facilities have been, and continue to be, dangerously understaffed. 

Moreover, many improvements set out in the proposed rules – such as antibiotic stewardship and inclusion of a certified nurse assistant who provides care to a resident in that resident’s care interdisciplinary care planning team – as well as the call for decreased hospitalization of residents, cannot be realized without significantly improved nurse staffing levels.  For additional reasons described in more detail below, the Center urges CMS to add meaningful staffing ratios to the final rules and to require a registered nurse in every nursing facility around the clock.

The proposed rules fail to improve staffing levels and staffing credentials across-the-board, making it impossible for facilities to achieve the higher standards that CMS envisions.  The Center is concerned about social services staffing and the need for professional clinical social workers and activities professionals, among others.

Second, the proposed rules diminish quality of life principles and requirements by eliminating quality of life as an independent RoP and creating a single RoP called quality of care and quality of life.

The 1987 Nursing Home Reform Law recognized that nursing homes are homes for many residents, who may stay many months or years, and that they are not only facilities where individuals receive long-term care services.  Indeed, the first section under statutory provision of services was the new statutory recognition of quality of life, the first time quality of life was ever recognized in a federal health care law.  42 U.S.C. §§1395i-3(b)(1)(A), 1396r(b)(1)(A), Medicare and Medicaid, respectively, provide:

(1) Quality of life

(A) In general

A skilled nursing facility must care for its residents in such a manner and in such an environment as will promote maintenance or enhancement of the quality of life of each resident.

Recognizing the importance of the new statutory mandate led the Health Care Financing Administration (CMS’s predecessor agency) to develop a distinct RoP for quality of life, 42 C.F.R. §483.15, with subsections focused on:

1. Dignity
2. Self-determination and participation
3. Participation in resident and family groups
4. Participation in other activities
5. Accommodation of needs
6. Activities
7. Social services
8. Environment

With the proposed consolidation of quality of life requirements into other RoPs, quality of life concerns lose the concentrated focus and attention they now have.  Scattering these specific requirements throughout the RoPs erases any regulatory focus on quality of life.

Moreover, CMS proposes moving all of the specific quality of life requirements, except activities, not to the new combined Quality of Care and Quality of Life RoP, but to a variety of different RoPs (e.g., social services is moved to administration).  These shifts further diminish attention to quality of life needs and principles.

The third overriding concern is that the proposed rules dilute the strength and power of the current quality of care regulations.[4]  For most of the specific care categories identified under quality of care, the current regulations at §483.25 use a similar approach.  They provide that if a resident is admitted to a facility without the problem, the resident should not develop the problem unless it was medically unavoidable for that individual.  The facility must then take steps both to correct the problem and to prevent its recurrence, if possible.  For example, if a resident did not have pressure sores at admission, the resident should “not develop pressure sores unless the individual’s clinical condition demonstrates that they were unavoidable.”[5]  The current regulations then provide that if a resident has pressure sores, the resident must receive “necessary treatment and services to promote healing, prevent infection and prevent new sores from developing.”[6]  This regulatory language brilliantly implements two key provisions of the 1987 Nursing Home Reform Law: the focus on each resident and the recognition that the law creates each resident’s entitlement to care and services “to attain or maintain the highest practicable physical, mental, and psychosocial well-being.”[7]  The current quality of care regulation gives full and enforceable meaning to these key statutory directives.  The language and approach of the current quality of care RoP must be retained in the revised RoP on quality of care.

CMS says that it wants the combined quality of care and quality of life RoP to include “a limited set of concerns that do not clearly fit in other general sections of the regulations.”  80 Fed. Reg. 42196.  This proposal seems both odd and wrong.  The quality of care RoP should be the single location for all specific requirements related to quality of care.  Scattering requirements elsewhere (e.g., moving unnecessary drugs to pharmacy services; moving mental and psychosocial functioning to the new RoP on behavioral health services) disrupts a holistic approach to resident care and is confusing to consumers and providers alike.

The proposed RoP for quality of care revises the pattern and structure of the quality of care subsections; moves specific quality of care subsections elsewhere, making it impossible to find the requirements for care in a single regulatory section; and is difficult to read.  The Center urges CMS to keep totally intact the quality of care regulations as a separate RoP.

A fourth overriding concern with the proposed rules is their likely disruption of administrative and judicial decisions over the past 25 years interpreting the current regulations.  Administrative Law Judges and state and federal court judges will view changes in regulatory language as signaling changes in administrative interpretation of the Nursing Home Reform Law.  They will view prior long-standing interpretations of similar current regulations as no longer legally binding as they interpret new regulatory language, following the legal principle that an agency intends a new interpretation when it changes the language of a regulation.  An agency does not change regulatory language unless it wants to make a change in the prior interpretation of that language.  Indeed, when CMS published the proposed RoPs in 1991, it deliberately changed their title from Conditions of Participation to Requirements of Participation, explicitly signaling substantive change.  56 Fed. Reg. 48825, 48827 (Sep. 26, 1991).  At the very least, a whole new set of administrative and court decisions will need to be developed to interpret the 1987 Nursing Home Reform Law.

Finally, reorganization of existing RoPs into a new set of Requirements inevitably involves unnecessarily long (but avoidable) delay.  CMS needs to draft the final standards in response to public comments, give facilities time to understand and implement the new Requirements, create a new survey protocol, and train state and federal surveyors in the new protocol, at the very least.  As these multiple changes are made, effective enforcement of RoPs, already weak,[8] will be further postponed. 

CMS’s public announcement about the proposed RoPs for nursing facilities stressed that the proposed rules will “modernize” the Requirements, which have not been comprehensively revised since 1991.  The proposed rules use new language (e.g., “behavioral health,” instead of “mental health;” “intellectual disability,” instead of “mental retardation”), refer to new technology (e-mail, internet), reflect changes made by the Affordable Care Act, and substantially revise the internal order of the regulatory standards.  These are not sufficient reasons to create the kind of turmoil and delay that a wholesale revision and reorganization will inevitably cause.  

Moreover, the reorganization itself does not make sense.  As discussed above, all requirements related to care of residents should be retained in a single RoP, the quality of care RoP.  Moving rules about unnecessary medications and medication errors from the quality of care RoP to the pharmacy services RoP is confusing.  The various “service” RoPs (e.g., pharmacy, dietary) should reflect solely requirements that are related to how the department is operated, such as staffing credentials and other requirements.

The chaotic results of the reorganization are further illustrated by the redefinition of substandard quality of care.  The survey rules currently define substandard quality of care at 42 C.F.R. §483.301 as:

one or more deficiencies related to participation requirements under §483.13, Resident behavior and facility practices, §483.15, Quality of life, or §483.25, Quality of care of this chapter, which constitute either immediate jeopardy to resident health or safety; a pattern of or widespread actual harm that is not immediate jeopardy; or a widespread potential for more than minimal harm, but less than immediate jeopardy, with no actual harm.

To maintain the same regulatory standards within the definition of substandard quality of care requires CMS to combine subsections of multiple RoPs.  The proposed definition of substandard quality of care is now:

one or more deficiencies relate to participation requirements under §483.10 “Resident rights”, paragraphs (d) and (e); §483.11 “Facility Responsibilities”, paragraphs (d) and (g); §483.12 “Freedom from abuse, neglect, and exploitation”; §483.25 “Quality of care, and quality of life”; §483.40 “Behavioral health services” , paragraphs (b) ad (d); §483.45 “Pharmacy services”, paragraphs (d), (e), and (f); and §483.80 “Infection control”, paragraph (d) of this chapter, which constitute either immediate jeopardy to resident health or safety; a pattern of or widespread actual harm that is not immediate jeopardy; or a widespread potential for more than minimal harm, but less than immediate jeopardy, with no actual harm.

Instead of reorganizing the regulations, as CMS proposes, the Center urges CMS to retain the current regulatory structure as much as possible and to make all revisions within that existing, familiar structure.  Keeping the current structure will save time and effort on the part of CMS, surveyors, advocates, and providers alike, time and effort that would be better spent on addressing RoPs that actually reflect substantive change and improvement.

In drafting final regulations, the Center encourages CMS to review decisions of Administrative Law Judges and the Appellate Division of the Departmental Appeals Board.  Analysis of these decisions, which usually address significant care issues, could help CMS revise the RoPs to strengthen federal standards of care and to improve quality of life and quality of care outcomes for residents.  This comment letter’s discussion of decisions that are relevant to the Center’s recommendations illustrates the importance of the decisions to understanding how current RoPs are interpreted and enforced as well as to identifying specific regulatory improvements that are needed (for example, strengthening nurse staffing standards).  The decisions also identify record falsification by facility staff as a serious and recurring problem that the RoPs must address.

Additional concerns cutting across the regulations include:

• Concerns about odd terminology.  CMS gives “titles” to activities of daily living, proposed §483.25(b) – e.g., hygiene to refer to bathing, dressing, grooming, and oral care.  The term “hygiene” does not provide further explanation of the requirements and interferes with ease of reading and understanding.
• Inconsistencies in terminology.  Sometimes the proposed regulations use the word “verbal” to mean “oral.”  Verbal means with words and includes both oral and written.  Sometimes the proposed regulations use the correct terminology, oral and in writing.  The end of this comment letter cites the sections that need to be revised and proposes a revision.
• CMS’s need to incorporate the Supreme Court decision in Obergefell v. Hodges, No. 14-556 (U.S. Supreme Court, June 26, 2015),[9] which upholds marriage equality nationwide.  The preamble cites the earlier Supreme Court decision on marriage equality, United States v. Windsor, 570 U.S. 12 (2013).

Although this comment letter will respond on a section-by-section basis to the proposed revisions, in chronological order, the Center wishes to identify the specific changes it most fully supports and those it views as most objectionable.  All of these issues are discussed in detail later in this comment letter.

Revisions CMA supports the most

• Requiring equal access and identical policies and procedures for transfer, discharge, and covered services, regardless of a resident’s source of payment, proposed §483.15(b).  We would add nondiscrimination in admissions as well.
• Requiring facilities to develop (and we would add, “and implement”) a baseline care plan within 48 hours of a resident’s admission, proposed §483.21(a).  Facilities need to have sufficient and sufficiently comprehensive information about a resident in order to be able to provide appropriate care as soon as the resident is admitted.  Too many avoidable bad outcomes occur when facilities have not completed, and implemented, a meaningful assessment and care plan. 
• Expanding the interdisciplinary care planning team to include a certified nurse assistant who provides care to the resident, a social worker, and a member of the food and nutrition services staff, proposed §483.21(b)(2)(ii).

Revisions CMA finds most objectionable

• Moving many current residents’ rights provisions solely to the new RoP on Facility responsibilities.  The list of residents’ rights should be complete and comprehensive and should not require review of other RoPs in order to identify all residents’ rights.
• Limitations on visits to residents by the Secretary, state survey agency, family members, proposed §483.10(d) 483.11(d).  These limitations violate the explicit language of the Nursing Home Reform Law, 42 U.S.C. §§1395i-3(c)(3), 1396r(c)(3), Medicare and Medicaid, respectively.
• Requiring that a physician, physician assistant, nurse practitioner, or clinical nurse specialist conduct an in-person examination of a resident before the resident is transferred to the hospital, except in emergency situations, proposed §483.30(e).  Since these health care professionals are rarely found in facilities, the proposal could prevent the hospitalization of residents who need to be immediately hospitalized.
• Combining antipsychotic drugs into a new category called psychotropic drugs, proposed §483.45(e).  This new category dilutes attention from antipsychotic drugs, which are harmful and deadly when given to most nursing home residents, who have dementia but no psychosis.  There is less evidence that other psychotropic drugs are so frequently prescribed inappropriately, and are so harmful, for nursing home residents. 
• Authorizing binding arbitration agreements, proposed §483.75(n).  These agreements require residents to waive rights involving all aspects of their lives and are inherently coercive and unconscionable in the nursing home context.

The Center endorses the comments on the proposed rules submitted by Consumer Voice and California Advocates for Nursing Home Reform.

Section-by-section comment

Definitions, §483.5. 

1. There is no definition of behavioral health (proposed §483.40, Behavioral health services) or direct access personnel (proposed §483.95(a)). 
2. The definition of composite distinct part prohibits use of composite distinct parts to segregate residents by source of payment.  The Center supports this new language.

CMA Recommendation: Retain the new definition of composite distinct part, proposed §483.5 (that is, retain (2)(v) as part of the definition of composite distinct part).

3. CMS proposes to define the term Adverse event.  The Center supports the revised language proposed by Consumer Voice.

CMA Recommendation: New language (from Consumer Voice) is in bold font.

Adverse event.  An adverse event is an untoward, undesirable, and usually unanticipated event that causes death or serious injury, or the risk thereof.  An adverse event also includes preventable harm due to substandard treatment, inadequate resident monitoring, and failure or delay of necessary care.

4. CMS proposes to define sexual abuse as “non-consensual sexual contact of any type with a resident.”  The Center supports the revision proposed by the National Association of State Long-Term Care Ombudsman Programs and Consumer Voice.  New language is in bold font.

Sexual abuse is non-consensual sexual contact of any type with a resident, including the use of technology, such as a smartphone or webcam, to record or take images of a resident and used for sexual gratification or exploitative purposes.

Residents’ rights, §483.10; facility responsibilities, §483.11, 80 Fed. Reg., 42181-42188

CMS writes that the new “facility responsibility” RoP “parallels many residents’ rights provisions.”  80 Fed. Reg., 42169.  In fact, many of the residents’ rights do not have a counterpart in the facility responsibilities RoP.  All residents’ rights should be reflected in parallel facility responsibilities in order to emphasize that facilities have an obligation to ensure that all of the rights that residents have are fully supported, ensured, and protected by facilities.

Residents’ rights that are missing from the facility responsibilities RoP.  Bold font indicates missing language:

• (a) Exercise of rights.  (1) The resident has the right to exercise his or her rights as a resident of the facility and as a citizen or resident of the United States. 
• §483.10(a)(2). The resident has the right to be free of interference, coercion, discrimination, and reprisal from the facility in exercising his or her rights and to be supported by the facility in the exercise of his or her rights as required under this subpart.
• §483.10(a)(4).  The entire section (about a resident adjudicated incompetent) is missing from §483.11.
• §483.10(a)(5). The entire section (about a resident adjudicated incompetent and about same-sex spouses) is missing from §483.11.
• §483.10(b).  Planning and implementing care.  The resident has the right to be informed of, and participate in, his or her treatment, including:

1. The right to be fully informed in language that he or she can understand of his or her total health status, including but not limited to, his or her medical condition.

Proposed §483.11(b)(1) provides “The facility shall inform the resident of the right to participate in his or her treatment and shall support the resident in this right, consistent with §483.10(b).

These sections are not consistent.  “Total health status” (§483.10(b)(1)) is different from being informed of the right to participate in treatment (§483.11(b)(1)).

The other subsections of §483.10(b)(2)(7) are included only by reference in §483.11(b).

• §483.10(c) Choice of attending physician.  The resident has the right to choose his or her attending physician.
• §483.10(d).  Respect and dignity.  This section is missing from proposed §483.11.
• §483.10(e). Self-determination.  This language is included in proposed §483.15, not in proposed §483.11(e), which is focused solely on residents’ access to various categories of people outside the facility.
• §483.10(g). Privacy and confidentiality.  The resident has a right to personal privacy and confidentiality of his or her personal and medical records.  Proposed §483.11(f) says “privacy in his or her verbal (meaning spoken) written and electronic communications.”  The two sets of rules address privacy and confidentiality in different matters.
• §483.10(h) Communication.  (1) The resident has the right to have reasonable access to the use of a telephone, including TTY and TDD services, and a place in the facility where calls can be made without being overheard.  This includes the right to retain and use a cellular phone at the resident’s own expense.

2. The resident has the right to have reasonable access and privacy in their use of electronic communications such as email and video communications and for internet research,
3. If the access is available to the facility [sic].

• §483.10(j) Grievances.  The resident has the right to voice grievances to the facility or other agency or entity that hears grievances without discrimination or reprisal and without fear of discrimination or reprisal.  Such grievances include those with respect to care and treatment which has been furnished as well as that which has not been furnished.

There are some issues that are moved from the current residents’ rights rules, §483.10, and are addressed in Facility Responsibilities, proposed §483.11, without a counterpart in the new Residents’ Rights, §483.10.  Since residents and their families and advocates look at the residents’ rights language to know what residents’ rights are (and they may be given copies of the federal rights), it is important that the statement of residents’ rights be complete and comprehensive.  Too many specific rights are missing in the proposed rules.

• Current §483.10(b) is titled Notice of Rights and Services and includes notice of rights and services, which is moved solely to Facility Responsibilities, proposed §483.11(e)(9).

CMA Recommendation: Retain the title of Notice of Rights and Services and retain the requirement that residents’ rights include notice of rights and services.

§483.10(b) Notice of rights and services. (1) The facility must inform the resident both orally and in writing in a language that the resident understands his or her rights and all rules and regulations governing resident conduct and responsibilities during the stay in the facility.  The facility must also provide the resident with the notice (if any) of the State developed under section 1919(e)(6) of the Act.  Such notification must be made prior to or upon admission and during the resident’s stay.  Receipt of such information, and any amendments to it, must be acknowledged in writing.

• Current §483.10(b)(5), which addresses information about charges and services for Medicaid residents, is moved solely to Facility Responsibilities, proposed §483.11(e)(10).  Proposed §483.10(f)(2)(iii) (“Information regarding Medicare and Medicaid eligibility and coverage”). 

CMA Recommendation: Restore current §483.10(b)(5) in proposed §483.10(f)(2)(iii):

§483.10(b)(5) — The facility must–

(i) Inform each resident who is entitled to Medicaid benefits, in writing, at the time of admission to the nursing facility or, when the resident becomes eligible for Medicaid of-

(A) The items and services that are included in nursing facility services under the State plan and for which the resident may not be charged;

(B) Those other items and services that the facility offers and for which the resident may be charged, and the amount of charges for those services; and

(ii) Inform each resident when changes are made to the items and services specified in paragraphs (5)(i)(A) and (B) of this section.

• Current §483.10(b)(6) addresses information about charges for services.

CMA Recommendation: Restore current §483.10(b)(6) in proposed §483.10 as a new (f)(3).  Bold font is new language.

§483.10(f)(3). The facility must inform each resident before, or and at the time of admission, and periodically during the resident’s stay, of services available in the facility and of charges for those services, including any charges for services not covered under Medicare or by the facility’s per diem rate.

• Current §483.10(b)(7) requires a facility to provide a written description of legal rights, including requirements and procedures for Medicaid eligibility.  Proposed §483.10(f)(iii) says only “Information regarding Medicare and Medicaid eligibility and coverage.”

CMA Recommendation: Restore the language of current §483.10(b)(7) to proposed §483.10(f).

Current §483.10(b)(8) (advance directive), §483.10(b)(9) (information about contacting the physician), §483.10(b)(10) (information about applying for Medicaid), §483.10(b)(11) (notification of significant changes in condition), §483.10(b)(12) (admission to distinct part), §483.10(c)(2), (3), (4), (5), (6), (7), (8) (protection of residents’ funds), §483.10(h) (work), and §483.10(j) (visitation) are all current residents’ rights whose detailed, substantive content is shifted to Facility responsibilities.  The current rules are either not addressed at all in the proposed new residents’ rights RoP or addressed in only summary fashion.  Some of the specific rights are discussed in greater detail below.

CMA Recommendation: These rights need to be included in detail in the new residents’ rights RoP so that residents and their families and advocates know what rights residents have.  All residents’ rights provisions need to include sufficient detail to ensure that residents and their families and representatives know what specific rights residents have.  Residents should not need to look at regulations for Facility responsibility to learn what their rights are.  Either the current language from residents’ rights must be put back into the proposed residents’ rights RoP verbatim or the proposed RoP needs to be substantially revised to include the necessary substantive detail.

Residents’ rights, §483.10

The residents’ rights RoP includes some odd language (e.g., self-determination, to include access to visitors) and moves some current rights, §483.10, to other RoPs.  Plain language is always best and all residents’ rights should remain in the residents’ rights RoP.

Exercise of rights, proposed §483.10(a).  Consumer Voice cites comments of the American Bar Association about obstacles that prevent residents from voting.  The Center supports the ABA’s recommendation.

CMA Recommendation: Add voting to proposed §483.10(a)(1).  Bold font is proposed language:

1. Exercise of rights.  (1) The resident has the right to exercise his or her rights as a resident of the facility and as a citizen or resident of the United States, including the right to vote in federal, state, and local elections.

Nondiscrimination.  The facility responsibilities RoP, proposed §483.11(a)(2), but not the residents’ rights RoP, requires equal access to quality care with respect to transfer and discharge and covered services.  The Center recommends that the nondiscrimination language be added to the residents’ rights RoP and be expanded to prohibit discrimination in admission, as well as in transfer, discharge, and covered services. 

The Institute of Medicine, whose 1986 report Improving the Quality of Care in Nursing Homes was the legislative history of the 1987 Nursing Home Reform Law, recommended nondiscrimination in admission, transfer and discharge, and covered services.  Report, page 95, Recommendation 3-7C (“A new standard should be written under the administration condition that prohibits facilities that have signed a Medicaid Provider Agreement from having different standards of admission, transfer, discharge, and service for individuals on the basis of sources of payment.”)

In addition, as discussed in comments submitted by the Tennessee Justice Center of these proposed rules,

The proposed rule’s prohibition against discrimination on the basis of source of payment also furthers the national policy expressed in Title VI of the Civil Rights Act of 1964, prohibiting discrimination on the basis of race in federally funded programs, including Medicare and Medicaid.  That is because African-Americans and other minorities are disproportionately poor and are therefore disproportionately dependent upon Medicaid for their coverage.  Over a quarter of African-Americans have Medicaid coverage and African-Americans are nearly 2.5 times more likely to be covered by Medicaid than non-Hispanic white Americans.  See, e.g., Linton v. Carney, 779 F. Supp. 925 (M.D. Tenn. 1990), aff’d on other grounds Linton by Arnold v. Comm’r of Health & Env’t, State of Tenn., 65 F.3d 508 (6^th Cir. 1995), cert. denied, St. Peter Villa, Inc. v. Linton, 517 U.S 1155 (1996).

The Center supports the Tennessee Justice Center’s recommendation to prohibit discrimination in admissions.

CMA Recommendation: Add a new section in the residents’ rights RoP, similar to the provision in proposed §483.11(a)(2), and expand the language to include nondiscrimination in admission.  New language is in bold font.

2. Nondiscrimination.  The resident has the right to equal access to quality care regardless of diagnosis, severity of condition, or payment source. A facility must establish and maintain identical policies and practices regarding admission, transfer, discharge, and the provision of services under the State plan or waiver for all applicants and residents, regardless of payment source.

Planning and implementing care, proposed §483.10(b)

The Center supports Consumer Voice’s recommended changes to the language of this proposed subsection to strengthen residents’ rights to informed consent, to direct the resident’s care planning, and to receive a copy of the care plan written in language that the resident can understand.

CMA Recommendation:  Adopt the language proposed by Consumer Voice.  Language proposed by Consumer Voice is in bold font.

483.10(b) The resident has the right to be informed of give or withhold informed consent, and participate in, his or her treatment, including:

 (5) The right to participate in the development and implementation of his or her person-centered plan of care, including but not limited to:

1. The right to lead the person-centered planning process where possible. The resident’s representative may have a participatory role, as needed and as defined by the resident. In instances where state law confers decision-making authority to the representative, the individual will lead the care planning process to the extent possible.
2. The right to necessary information and support so that the resident directs the process to the maximum extent possible, and is enabled to make informed choices and decisions.

(i)(iii)The right to participate in the planning process, including the right to identify individuals or  and roles to be included in the planning process, the right to request meetings, the right to have meetings at times and locations of their choice within the facility; and the right to request revisions to the person-centered plan of care.

(ii) (iv) The right to participate in establishing the expected goals and outcomes of care, the type, amount, frequency, and duration of care, and any other factors related to the effectiveness of the plan of care.

(iii) (v)The right to be informed, in advance, of changes to the plan of care.

(iv)(vi) The right to receive the services and/or items included in the plan of care.

(vii) The right to have the care plan written in plain language and in a manner that is accessible to individuals with disabilities and persons who are limited English proficient.

Physician credentialing, §483.10(c)(2), (3), 80 Fed. Reg., 42182

CMS proposes to limit residents’ free choice of physician to physicians who meet their facilities credentialing requirements.  It provides neither an explanation of any need for this new requirement (and the Center sees none) nor any standards for credentialing.  The public policy concerns about physicians have always been the lack of appropriate medical care in nursing homes and how few physicians actually provide care to residents.  The new credentialing requirement would not improve the medical care of residents and could further reduce the number of qualified physicians providing care to residents.

CMA Recommendation: Delete subsections (2) and (3) of proposed §483.10(c).

Self-determination, §§ 483.10(e), 483.11(d), 80 Fed. Reg. 42185

CMS proposes to redefine access and visitation rights, currently at §483.10(j), as a subcategory under “self-determination,” both for residents’ rights (§483.10) and facility responsibilities (§483.11).  However, the current language that sets out the details of access for various categories of officials and families is moved only to §483.11.

More disturbing, the proposed rules include an entirely new provision, §483.11(d)(2), allowing facilities to restrict visitation:

(2) The facility must have written policies and procedures regarding the visitation rights of residents, including those setting forth any clinically necessary or reasonable restriction or limitation or safety restriction or limitation that the facility may need to place on such rights and the reasons for the clinical or safety restriction or limitation.

CMS then sets out the requirements for such restrictions or limitations.  Proposed §483.11(d)(2)(i)-(iv).  CMS contends that it is conforming the nursing home rules to rules that apply to hospitals.  80 Fed. Reg., 42185. 

However, restrictions allowing facilities to have written policies restricting visits for “clinically necessary” or “safety restrictions” are inconsistent with specific provisions of the Nursing Home Reform Law, 42 U.S.C. §§1395i-3(c)(3), 1396r(c)(3), Medicare and Medicaid, respectively, which states:

(3) Access and visitation rights

A skilled nursing facility must—

(A) permit immediate access to any resident by any representative of the Secretary, by any representative of the State, by an ombudsman described in paragraph (2)(B)(iii)(II), or by the resident’s individual physician;

(B) permit immediate access to a resident, subject to the resident’s right to deny or withdraw consent at any time, by immediate family or other relatives of the resident;

(C) permit immediate access to a resident, subject to reasonable restrictions and the resident’s right to deny or withdraw consent at any time, by others who are visiting with the consent of the resident;

(D) permit reasonable access to a resident by any entity or individual that provides health, social, legal, or other services to the resident, subject to the resident’s right to deny or withdraw consent at any time; and

(E) permit representatives of the State ombudsman (described in paragraph (2)(B)(iii)(II)), with the permission of the resident (or the resident’s legal representative) and consistent with State law, to examine a resident’s clinical records.

Under federal law, there can be no restrictions on visits by the Secretary, immediate family or other relatives.   Only other individuals who are visiting with the consent of the resident can be subject to “reasonable restrictions.” 

Until now, CMS has understood the immediate access requirements of the Nursing Home Reform Law and that facilities can set reasonable restrictions only on “other visitors,” as set out in the current SOM:

The facility must provide immediate access to any representative of the Secretary of the Department of Health and Human Services, the State, the resident’s individual physician, the State long term care ombudsman, or the agencies responsible for the protection and advocacy of individuals with developmental disabilities or mental illness. The facility cannot refuse to permit residents to talk with surveyors. Representatives of the Department of Health and Human Services, the State, the State long term care ombudsman system, and protection and advocacy agencies for individuals with developmental disabilities or mental illness are not subject to visiting hour limitations.

Immediate family or other relatives are not subject to visiting hour limitations or other restrictions not imposed by the resident. Likewise, facilities must provide 24-hour access to other non-relative visitors who are visiting with the consent of the resident. These other visitors are subject to “reasonable restrictions” according to the regulatory language. “Reasonable restrictions” are those imposed by the facility that protect the security of all the facility’s residents, such as keeping the facility locked at night; denying access or providing limited and supervised access to a visitor if that individual has been found to be abusing, exploiting, or coercing a resident; denying access to a visitor who has been found to have been committing criminal acts such as theft; or denying access to visitors who are inebriated and disruptive. The facility may change the location of visits to assist care giving or protect the privacy of other residents, if these visitation rights infringe upon the rights of other residents in the facility. For example, a resident’s family visits in the late evening, which prevents the resident’s roommate from sleeping.

An individual or representative of an agency that provides health, social, legal, or other services to the resident has the right of “reasonable access” to the resident, which means that the facility may establish guidelines regarding the circumstances of the visit, such as location. If there are problems with the facility’s provision of reasonable privacy for resident to meet with these representatives, refer to §483.10(e), Privacy and Confidentiality, Tag F164.   [bold font supplied]

Procedures: §483.10(j)(1) and (2)

Do residents and family members know that they are able to visit 24-hours a day? Do non-relative visitors know they are also able to visit 24-hours a day, but subject to reasonable restrictions as defined above? If you identify problems during resident, family, or group interviews, determine how the facility ensures 24-hour access to:

• Representatives of the State;
• Representatives of the U.S. Department of Health and Human Services;
• The resident’s individual physician;
• Representatives of the State long-term care ombudsman;
• Representatives of agencies responsible for protecting and advocating rights of persons with mental illness or developmental disabilities;
• Immediate family or other relatives; and
• Other visitors, subject to reasonable restrictions as defined above.

http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf (scroll down to p. 52).

The proposed rules do not recognize the limited permissible bases for restricting visitors’ access to residents and allow facilities to write their own policies, which may not conform to the requirements of the Nursing Home Reform Law.

CMA Recommendation: Restore the full language of current §483.10(j) to proposed §483.10(d)(3).  Delete proposed §483.11(d)(2) in its entirety (as inconsistent with the requirements of the Nursing Home Reform Law).

Right to manage one’s own financial affairs, proposed §483.10(e)(9)

The current regulations set out comprehensive rules for protection of resident funds, §483.10(c), beginning with the statement at §483.10(c)(1), “The resident has the right to manage his or her financial affairs, and the facility may not require residents to deposit their personal funds with the facility.”  The rules address, in detail, a resident’s right to manage his or her own financial affairs; management of funds by the facility, at the resident’s request; and limitations on charges to personal funds.

The proposed rules under residents’ rights are extremely limited, proposed §483.10(e)(9), saying only, as a subcategory of Self-determination, “Manage his or her financial affairs. This includes the right to know, in advance, what charges a facility may impose against a resident’s personal funds as specified in §483.11(d)(6)(ii).”  The other specific current rights at §483.10(c) are shifted solely to the Facility responsibility RoP, proposed §483.11(d)(5).

As noted above, residents’ rights provisions need to include sufficient detail to ensure that residents and their families and representatives know what the rights are.  Residents should not be required to look at regulations for Facility responsibility to learn, for example, about limitations on facility charges to their personal funds.

CMA Recommendation: Restore all of the language at current §483.10(c) to proposed §483.10(e)(9) and restore an independent title “Protection of resident funds.”  Resident funds should not be a subcategory of the term “self-determination.”

Access to medical records, proposed §483.10(f)(3), 80 Fed. Reg., 42138

The proposed rules gives residents access only to their medical records.  Current rules give residents broader access to “all records pertaining to himself or herself including current clinical records.”  Current §483.10(b)(2). 

The proposed rules also allow facilities to charge residents higher amounts for copies of these records.  The new proposed language is a “reasonable, cost-based fee,” which includes labor, supplies, and postage.  The current §483.10(b)(2) allows facilities to charge no more than the “community standard” rate.  The State Operations Manual (SOM) clarifies that if state law does not establish such a rate, facilities may not charge more than the rate charged by an organization such as the public library, Post Office, or commercial copy center.

The SOM provides:

F153

§483.10(b)(2) — The resident or his or her legal representative has the right–

(i) Upon an oral or written request, to access all records pertaining to himself or herself including current clinical records within 24 hours (excluding weekends and holidays); and

(ii) After receipt of his or her records for inspection, to purchase at a cost not to exceed the community standard photocopies of the records or any portions of them upon request and 2 working days advance notice to the facility.

Interpretive Guidelines §483.10(b)(2)

An oral request is sufficient to produce the current record for review.

In addition to clinical records, the term “records” includes all records pertaining to the resident, such as trust fund ledgers pertinent to the resident and contracts between the resident and the facility.

“Purchase” is defined as a charge to the resident for photocopying. If State statute has defined the “community standard” rate, facilities should follow that rate. In the absence of State statute, the “cost not to exceed the community standard” is that rate charged per copy by organizations such as the public library, the Post Office or a commercial copy center, which would be selected by a prudent buyer in addition to the cost of the clerical time needed to photocopy the records. Additional fees for locating the records or typing forms/envelopes may not be assessed.

CMS provides no rationale for restricting residents’ access solely to medical records.   Its only reason for allowing facilities to charge residents higher amounts for this more limited information appears to be its intention to conform the requirements to 45 C.F.R. §164.524(c)(4).   That reason is not sufficient.  CMS should restore prior language.

The large number of residents who use Medicaid are required to contribute most of their income to their care and are left with a small personal needs allowance, a minimum of $25 per month.  They cannot afford these larger amounts to get copies of their records.

CMA Recommendation:  Restore the current regulatory language in full.  Delete the new language at §483.10(f).  New language is in bold font.

§483.10(f)(3) — The resident or his or her legal representative has the right–

(i) Upon an oral or written request, to access all records pertaining to himself or herself including current clinical records within 24 hours (excluding weekends and holidays); and

(ii) After receipt of his or her records for inspection, to purchase at a cost not to exceed the community standard photocopies of the records or any portions of them upon request and 2 working days advance notice to the facility.

Grievances, proposed §483.10(j)

The proposed rules move grievances, current §483.10(f), to §483.10(j) but omit language at current §483.10(f)(2), “including those with respect to the behavior of other residents.”  The language in §483.10(f)(2) is included only in §483.11(h)(2).  As suggested above, the language of residents’ rights and facility responsibilities should be consistent and parallel.

CMA Recommendation: Restore the full language of §483.10(f)(2) to §483.10(j) so that it reads, “Prompt efforts by the facility to resolve grievances the resident may have, including those with respect to the behavior of other residents.” 

Safe environment, proposed §483.11(g)

The proposed rules require facilities to allow residents to use their personal belongings, but do not impose any obligations on facilities to assure the security of residents’ property from loss or theft.  The Center supports the recommendations of Consumer Voice on protection of residents’ belongings and recommends that the new language be included in both the residents’ rights RoP and the facility responsibilities RoP.

CMA Recommendation: Use Consumer Voice’s proposed language, in bold font.

483.11(g)(8) Security of personal possessions.  

(i) The facility shall exercise reasonable care for the protection of the resident's property from loss or theft.

(ii) The administrator or the administrator's designee is responsible for investigating reports of lost or stolen residents' property.

(iii) The facility will have written policies and procedures outlining the steps to be taken in the event an item is reported lost or stolen.

(iv) The policies will include a mechanism to report the results of the investigation to the resident or his or her legal representative in the event the lost or stolen item is not recovered.

(v) If the resident's clothing is laundered by the facility, the facility shall identify the clothing in a suitable manner. The facility is only responsible for marking those items that are recorded on the resident's inventory sheet.

(vi) The facility must:

1. Inventory, upon admission and discharge, the personal effects, money, and valuables declared by the resident; 
2. Review the resident’s inventory at each care plan meeting to determine its accuracy and whether it needs to be updates; and
3. Remind the resident and representative annually in writing of the need to update inventory records.

Transitions of care, proposed §483.15, 80 Fed. Reg., 42189-42191

This reorganization is extremely confusing.  The “current terminology” – transitions of care – may make sense for health care professionals, but for residents and their families, the terminology that makes sense is admission, transfer, and discharge, as described in current §483.12, as well as the concept of “rights.”  The Center endorses the comments of Justice in Aging concerning Transitions of care (transfer and discharge, bed hold).  The Center also strongly supports retention of current “rights” language with respect to the issues addressed in this regulation.

CMS does not clarify what is anticipated by the new requirement at proposed §483.15(a) that a facility “establish and implement an admissions policy.”  Nor does CMS explain what is meant by the new requirement at proposed §483.15(a)(6) that a facility disclose “notice of special characteristics or service limitations.”  The term “service limitations” is not defined.  The preamble suggests that a facility may have a religious affiliation that limits services or may not provide psychiatric care, 80 Fed. Reg., 42189, but the proposed regulatory language contains no limitations at all.  Current rules do not permit facilities to refuse to provide services that a resident might need. 

CMA Recommendation: The regulation on admissions policy, proposed 483.15(a), must explicitly obligate facilities to develop and implement admissions policies that are consistent with federal and state law and regulation.  Facilities should not be permitted to use contract terms that are unenforceable in a court of law.[10] 

The Center proposes deletion of proposed 483.15(a)(6).  If the provision is retained, however, the regulatory language needs to incorporate the very limited “service limitations” that CMS describes in the preamble.  In addition, information about service limitations must be provided prior to admission, not at the time of admission, so that prospective residents and their families and advocates have necessary information about whether the facility can serve the resident’s needs.  Bold font is new language:

483.15(a) Admissions policy. (1) The facility must establish and implement an admissions policy that must be consistent with the requirements of federal, state, and local laws and regulations.  Admissions contracts shall not include provisions that are unconscionable or otherwise unenforceable in a court of law.

            (6) A nursing facility must disclose and provide to a resident or potential resident, at or prior to time of admission, notice of special characteristics (such as religious affiliations that limit food choices) or service limitations of the facility (such as not providing psychiatric care).  A facility shall provide all services required by federal law and regulation and shall not refuse to provide any services that it is required by federal law to provide to residents who need such services.

Equal access to quality care, proposed §483.15(b)(1)

1. This language, currently at §483.12(c), does not make sense in its new location, as a subcategory under transfer and discharge, since it requires equal treatment in transfer, discharge, and covered services. 

CMA Recommendation:  Equal access to quality care needs to be its own subsection, for example, §483.15(b), which would make transfer and discharge §483.15(c).  Alternatively, the language about Equal access to quality care should be moved to an entirely new and independent location, as a resident’s right (new §483.10(b)).  As discussed above, the equal access/

nondiscrimination provision must include equal access in admission, as well as in transfer, discharge, and services.  Bold font is new language.

§483.10(b) Equal access to quality care. (1) A facility must establish, maintain, and implement identical policies and practices regarding admission, transfer, discharge, and the provision of services under the State plan for all applicants and all individuals regardless of source of payment.  A facility’s policies and practices must ensure that each resident has the right to equal access to quality care regardless of diagnosis, severity of condition, or payment source.

2. Proposed §483.15(b)(1)(A) adds the words “and implement” to the current language at §48312(c)(1), “A facility must establish and maintain [and implement] identical policies and practices regarding transfer, discharge, and the provision of services . . . .”  Proposed §483.15(b)(1)(A) also adds new language at the end “for all individuals regardless of source of payment.”

CMA Recommendation:  Retain these two excellent changes. 

3. Proposed §483.15(b)(1)(i)(B) authorizes facilities to charge “any amount for services furnished to non-Medicaid residents unless otherwise limited by state law and consistent with the notice requirement in §483.11(e)(11)(i) and (e)(12) describing the changes.”  Since CMS does not regulate private-pay rates, it should not signal to facilities that they can charge private-pay residents whatever amounts they want.

Moreover, the restriction of “state law” is too limited if it means solely statutory or regulatory law specifically addressing payment by private-pay residents.  There may be case law on the common law principle of unconscionability or interpretation of state consumer protection law that would prohibit exorbitant charges to private-pay residents. 

CMA Recommendation: Delete proposed §483.15(b)(1)(i)(B) in its entirety.

Transfer and discharge, proposed §483.15(b)(2)(ii)(E), 80 Fed. Reg., 42189-42191

1. The proposed language clarifies that non-payment does not occur when a resident has submitted paperwork for third party payment.  This clarification is helpful.  However, the language also needs to clarify that non-payment does not occur when a resident is in the process of submitting the paperwork for third party payment.  It should also state explicitly that conversion from private payment to Medicaid is not non-payment, as provided in the SOM: “Conversion from a private pay rate to payment at the Medicaid rate does not constitute non-payment.”  http://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf, page 59. 

CMA Recommendation:  Modify proposed §483.15(b)(2)(ii)(E) as follows (new language is in bold font):

E. The resident has failed, after reasonable and appropriate notice, to pay for (or to have paid under Medicare or Medicaid) a stay at the facility.  Non-payment does not apply when the resident is in the process of submitting the necessary paperwork for third pay payment, unless the resident does not submit the necessary paperwork for third party payment or until the third party, including Medicare or Medicaid, denies the claim and the resident refuses to pay for his or her stay.  Conversion from a private pay rate to payment at the Medicaid rate does not constitute non-payment.

Transfer and discharge documentation, proposed §483.15(b)(2)(i)(B)

2. New language requires a facility (that is proposing to transfer or discharge a resident on the grounds that the resident’s needs cannot be met in the facility) to document its “attempts to meet the resident needs, and the service available at the receiving facility to meet the need(s).”  This new language is important because, often, a facility claims not to be able to meet a resident’s needs but proposes a transfer to another facility that provides the identical level and type of care.  These two documentation requirements – that a facility made efforts to meet the resident’s needs and that the receiving facility is appropriate to meet the resident’s needs – essentially require the care planning that should have occurred before the facility decided to transfer or discharge the resident.  They may also result in fewer transfer and discharge notices.

CMA Recommendation:  Retain this new language.

Transfer and discharge documentation, proposed §483.15(b)(2)(iii)(A)-(R), 80 Fed. Reg., 4218990-42191

CMS proposes that facilities that are transferring or discharging residents provide comprehensive information to the receiving provider.  Transitions between health care providers are dangerous times for patients and residents when the receiving facility does not have necessary information about the patient or resident to be able to provide appropriate care as soon as the transfer or discharge occurs.

Proposed §483.15(b)(iv) allows the discharge summary at proposed §483.21(c) to meet the requirements if it includes “at a minimum the information specified in paragraph (b)(2)(iii) of this section” (the new detailed language).  The discharge summary language should also include a cross-reference to the requirements at §483.15(b)(2)(iii) in order to ensure that providers understand that the discharge summary is acceptable only if it includes all of the required information.    

CMA Recommendation:  Retain proposed §483.15(b)(2)(iii)(A)-(R); add a cross reference to §483.15(b)(2)(iii) as a new §483.21(c)(v) (new language in bold font):

(v) A discharge plan to another health care provider must meet the requirements of §483.15(b)(2)(iii)(A)-(R).

Bed reserve, proposed §483.15(c), 80 Fed. Reg., 42191

1. CMS repeats current §483.12(b) language, but then proposes new language at §483.15(c)(3)(ii) authorizing facilities to notify a resident “in writing . . . when the facility determines that the resident cannot be readmitted to the facility, the reason the resident cannot be readmitted to the facility, and the information specified in paragraphs (b)(5)(iv) through (vii) of this section.”

This new language undercuts a resident’s right to return to the facility, particularly when it does not specify when such a facility determination may be made.  A facility cannot know when a resident is first transferred to the hospital that it will be unable to continue providing care to the resident when the resident is ready to be discharged from the hospital.  This language also encourages (and essentially supports) the common practice of facility dumping – sending a resident to the hospital for a bogus reason and then refusing the resident admission.

CMA Recommendation: Delete the new language at §483.15(c)(3)(ii).  Alternatively (and a less preferable choice), clarify that the facility can only make this determination when the resident is ready to be discharged from the hospital and to return to the facility.  New language is in bold font.

In writing . . . when the facility determines that the resident cannot be readmitted to the facility when the hospital informs the facility that the resident is ready to be discharged from the hospital and to return to the facility, the reason the resident cannot be readmitted to the facility, . . . .

2. When a state does not pay for bedhold (either under all circumstances or under some circumstances), payment is not a Medicaid-covered service and the facility may ask the resident to pay out-of-pocket to reserve the bed.  Some facilities charge families their private-pay rate, rather than the Medicaid rate, to hold the bed.  There is no justification for allowing this windfall to facilities, which should be limited to charging no more than the Medicaid rate for that individual, as it accepted when Medicaid was the resident’s payment source.  In addition, the resident should not be required to pay more than the Medicaid share of cost that the resident paid for care.

CMA Recommendation:  Add language to proposed §483.15(b)(2):

If a resident requests to reserve a bed during his or her absence and agrees, under §483.11(d) to pay to hold the bed, the facility may charge the resident no more than the resident’s Medicaid share of cost for each day of the resident’s absence, not counting any day that Medicaid pays for the resident’s care.  If charging the resident the full Medicaid rate, rather than the resident’s Medicaid share of cost (as determined by the Medicaid agency), the facility must inform the resident of the incurred medical expense deduction available under 42 C.F.R. §435.832 and it must assist the resident in applying for that deduction.

Comprehensive person-centered care planning, Baseline care plans, proposed §483.21(a), 80 Fed. Reg., 42192-42193

CMS proposes to add a new requirement for a baseline care plan, to be developed within 48 hours of a resident’s admission.  This excellent proposal addresses a serious failing in current care planning requirements – that facilities are not required to develop a comprehensive care plan until 21 days after a resident’s admission.

Admission is an extremely dangerous time for residents, as the HHS Inspector General’s report on adverse events confirmed (finding nearly one-third of Medicare residents experienced an adverse event or other harm within, on average, 15.5 days following admission to the skilled nursing facility).[11]  A new resident does not know the physical layout of the facility; may be confused and disoriented, often having just come from the hospital; and may be depressed or anxious and under considerable stress.  Moreover, the facility may have limited familiarity with physician orders and the resident’s other care and service needs and does not have experience with the resident’s customary routines and patterns.  Having an immediate assessment that is sufficiently comprehensive and implemented is essential to reducing poor outcomes for residents and preventing avoidable rehospitalizations.  The Center endorses the comments of Consumer Voice.

CMA Recommendation: We support the proposal and recommend a few additions to ensure that a baseline care plan is sufficiently comprehensive, and actually implemented, to enable the facility to provide a high level of initial care to a resident.  A baseline care plan must include medication orders, for example.  New language is in bold font:

§483.21 Comprehensive person-centered care planning.

1. Baseline care plans.  (1) The facility must develop and implement a baseline care plan for each resident that includes the instructions needed and is sufficiently comprehensive to provide effective and person-centered care of the resident that meet professional standards of quality care.  The baseline care plan must –

1. Be developed within starting upon a resident’s admissions and over the initial 48 hours of a resident’s stay.  admission.
2. Include the minimum health care information necessary to properly care for a resident including, but not limited to –

1. Initial goals based on admission orders.
2. Physician orders.
3. Dietary orders.
4. Therapy services.
5. Social services.
6. PASARR recommendation, if applicable.
7. Medication orders.
8. Customary routines and preferences.
9. Any other needs or services that must be immediately met for a resident.

Comprehensive person-centered care planning, interdisciplinary team, proposed §483.21(b)(2)(ii), 80 Fed. Reg., 42192-42194

The Center has several points related to the interdisciplinary team in care planning.

1. CMS proposes to require facilities to include “a nurse aide with responsibility for the resident,” “a member of the food and nutrition staff,” and “a social worker” to the interdisciplinary team (IDT).  Proposed §483.21(b)(ii)(C), (D), (E).  These are excellent additions to the IDT.  The nurse aide requirement would work best, of course, with consistent assignment of staff to residents.  A facility using random assignment would have difficulty identifying an aide “with responsibility for the resident.”  Regardless of whether a facility uses consistent assignment or not, however, this requirement will impress on facilities the need to include staff in the IDT who are actively involved in providing care to a specific resident.  The importance of food to residents and the significant social service needs of residents also support the requirements for a member of the food and nutrition staff and a social worker, respectively, to participate in the IDT.

CMA Recommendation: Retain these additions to the IDT.

2. CMS proposes to retain current language at §483.20(k)(2)(ii) in proposed §483.21(b)(2)(F) about the participation of the resident and the resident’s family “to the extent possible.”  New language requires the facility to include an explanation in the medical record if the facility determines that such participation is not practicable.  We support the addition and suggest that the language be made stronger to ensure that the resident and resident representative are encouraged and supported in participating in the care planning.  Facilities need to schedule care planning meetings at times that resident representatives can participate in-person, if possible, and should encourage phone or skype participation by resident representatives, if in-person participation is not possible.

CMA Recommendation: Revised proposed §483.21(b)(2)(F) as follows.  New language is in bold font.

(F) The facility must support and encourage participation by the resident by scheduling care planning meetings at times when the resident is best able to participate.  The facility must support and encourage participation by the resident’s representative by scheduling care planning meetings at times that the representative is able to participate in-person, if possible.  If in-person participation is not feasible, the facility must support and enable participation by other means, such as telephone, skype, or other format that enables participation in real time.

3. In its discussion of “other appropriate staff,” proposed §483.21(b)(2)(ii)(G), the preamble suggests, “a qualified mental health professional should be involved when residents are diagnosed with mental health conditions or prescribed psychotropic drugs.”  80 Fed. Reg. 42193.  This recommendation is not carried out in the proposed regulatory language, however, which says only “other appropriate staff or professionals in disciplines as determined by the resident’s needs or as requested by the resident.”  Proposed §483.21(b)(2)(ii)(G).

If a resident has a diagnosed mental health condition, we agree that a mental health professional should be part of the IDT.  However, if a resident is prescribed psychotropic drugs of any kind, the appropriate health care professional is a pharmacist, who has the professional background to advise the IDT about drug interactions and the inappropriateness of antipsychotic drugs (in particular) for individuals who do not have a diagnosis of psychosis, among other issues.   The rules should mandate participation of these professionals, as appropriate.

CMA Recommendation: Add to §483.21(b)(ii) and new (G) and (H) (and rename the proposed (G) as (I).  New language is in bold font.

(G) A mental health professional, if the resident is diagnosed with a mental health condition.

(H) A pharmacist, if the resident is prescribed any psychotropic medication.

Discharge planning, proposed §483.21(c)(1), 80 Fed. Reg., 42194-42196

1. Discharge planning process, proposed §483.21(c)(1)(1), contains comprehensive new language that recognizes the importance of planning for post nursing home care.  Too often, there is little or no meaningful discharge planning and residents are simply sent home.  The only administrative decision that the Center is aware of involving discharge planning (actually, the complete absence of discharge planning) is Bartley Healthcare Nursing and Rehabilitation v. CMS, Decision No. CR2684 (Jan. 11, 2012), http://www.hhs.gov/dab/decisions/civildecisions/2013/cr2684-compliant.pdf, which sustained the jeopardy-level deficiency when the facility discharged the resident to his home “without confirming that professional care services were in place.”  Decision, page 8.  The facility expected the resident’s family to provide medications to the resident through injections and to safely move him using a sling, but had not provided any training to the family on how to do injections or use a sling.  It failed to provide the resident with medications at the time of his discharge.  It also failed to do any assessment of his home before discharging him home.  In fact, the resident’s wheelchair could not fit through the doorway of his house and he had to remain in the garage for an hour until a new wheelchair was brought. The resident was returned to the facility 22 hours after his discharge.  He had not received insulin or any of his other medications and his clothing and diaper had not been changed.  The Appellate Division affirmed the Administrative Law Judge’s summary judgment decision, Bartley Healthcare Nursing and Rehabilitation, Decision 2539 (Oct. 18, 2013), http://www.hhs.gov/dab/decisions/dabdecisions/dab2539.pdf. 

CMA Recommendation: Retain the new language for discharge planning, proposed §483.21(c)(1), which, if properly implemented, could reduce readmissions and rehospitalizations.

Quality of care and quality of life, proposed §483.25, 80 Fed. Reg., 42196-42199

The Center has four primary concerns about this Requirement.  First, we strongly oppose CMS’s combining the separate quality of care and quality of life RoPs into a single RoP.  As discussed at the beginning of these comments, the Center believes that the combination distorts and erases the new and separate focus on quality of life that Congress intended in the Nursing Home Reform Law.

Second, we strongly disagree with CMS’s proposed reorganization of the quality of care regulations, which limits this RoP to concerns that do not, in CMS’s view, fit elsewhere and moves some of the specific care areas to other RoPs.  We are particularly concerned about moving medications to pharmaceutical services, proposed §483.45.  From the perspective of a resident and his or her family and advocates, it is most useful and meaningful to have all of the requirements related to care in a single location in the regulations.  A resident/family/advocate looking at the proposed §483.25 would not know that medications are addressed elsewhere and would not know where to look.

Third, one of the most brilliant features of the 1991 regulations was their implementation of the highest practicable language of the 1987 Nursing Home Reform Law.  As discussed at the beginning of this comment letter, CMS implemented this overriding standard and principle of the Nursing Home Reform Law by specifying, in the Quality of Care RoP, that a resident who entered a facility without a particular problem should not develop the problem unless it was medically unavoidable for that individual.  That initial point in many of the current quality of care standards is missing in the revision – notably in pressure ulcers.   

Finally, CMS has omitted some critical quality of life requirements that are currently located in §483.15, such as dignity.  The only area taken from the current quality of life RoP is activities; all of the other requirements are moved elsewhere to different RoPs.

CMA Recommendation: Retain all requirements related to resident care in a single RoP called Quality of Care.  Retain current regulatory language that provides, as the first point, that residents who entered a facility without a particular problem should not develop it unless it was medically unavoidable for that individual.

The quality of care RoP should track the current regulation, §483.25, adding new provisions in a way that maintains the current order:

Quality of care

1. Activities of daily living
2. Vision and hearing
3. Pressure sores
4. Urinary incontinence
5. Range of motion
6. Mental and psychosocial functioning
7. Naso-gastric tubes
8. Accidents
9. Nutrition
10. Hydration
11. Pain management [this subsection is new]
12. Special needs

Activities of daily living, proposed §483.25(a), 80 Fed. Reg., 42196

The proposed language is wordier than current §483.25(a) but retains all of the important information and adds oral health, which is extremely important and a good addition.  The new wordiness does add some awkwardness, however.  Most people do not think of dressing as “Hygiene.”  The new modifiers of the activities of daily living are awkward and unnecessary and should be deleted.

CMA Recommendations: Revise proposed §483.25(b).  New language is in bold font.

2. Activities of daily living.

1. Hygiene – bathing, dressing, grooming, and oral care.
2. Mobility – transferring and ambulating
3. Eliminating – toileting
4. Dining – eating, including meals and snacks
5. Communication, including

1. Speech
2. Language
3.  Other functional communication systems.

6. Oral health

Activities, proposed §483.25(b), 80 Fed. Reg., 42197

Moving activities from quality life, §483.15(f), to this new regulation, with its broader language, is not objectionable.  However, listing credentials in this regulation is odd.  All requirements for staff credentials should be located in a single regulation.

CMA Recommendation: Retain §483.25(b)(1), but move §483.25(b)(2) to a new regulation about staff credentials.

Special care issues, proposed §483.25(d), 80 Fed Reg., 42197-42199

CMS has gathered an odd collection of care concerns and labeled them as “special care issues.”  Some of the issues are common to most residents – e.g., vision and hearing, skin integrity, mobility – while other issues are truly “special,” in the sense of less common – e.g., colostomy, parenteral fluids. 

CMA Recommendation: Care requirements common to all or most residents should be separately identified, without the modifier of “special care needs.”  The term “special care issues” should be restricted to issues that are truly special, in the sense of uncommon.  The Center suggests that the subsections under the Quality of Care RoP should be retained in the order that they are in current §483.25.  Language in proposed 483.25(a) should be incorporated into the preliminary language of the regulation so that the current order can be retained.

1. Activities of daily living
2. Vision and hearing
3. Pressure sores
4. Urinary incontinence
5. Range of motion
6. Mental and psychosocial functioning, including dementia care
7. Naso-gastric tubes
8. Accidents
9. Nutrition
10. Hydration
11. Pain management
12. Special needs
    1. Assisted nutrition and hydration
    2. Prostheses
    3. Dialysis
    4. Trauma-informed care

Dementia Care.

CMA Recommendation: CMS has not added any requirements for dementia care, despite its ongoing CMS Partnership to Improve Dementia Care.  New requirements should be added to the Quality of Care RoP on dementia care.  The Center supports the comments on dementia care submitted by California Advocates for Nursing Home Reform.

The State Operations Manual’s Interpretive Guidelines (Appendix PP) contain extensive materials on dementia, https://www.cms.gov/Regulations-and-Guidance/Guidance/Manuals/downloads/som107ap_pp_guidelines_ltcf.pdf (pp. 166 -178) that should be adapted into regulatory language and requirements under the quality of care RoP.

Appendix PP, page 169, sets out important features of providing care to residents who have dementia:

• Arranging staffing to optimize familiarity with the resident (e.g., consistent caregiver assignment);
• Identifying, to the extent possible, factors that may underlie the resident’s expressions of distress, as well as applying knowledge of lifelong patterns, preferences, and interests for daily activities to enhance quality of life and individualize routine care.
• Understanding that the resident with dementia may be responding predictably given the situation or surroundings. For example, being awakened at night in his/her bedroom by staff and not recognizing the staff could elicit an aggressive response; and
• Matching activities for a resident with dementia to his/her individual cognitive and other abilities and the specific behaviors in that individual based on the assessment

Appendix PP, page 172, says that the assessment of a resident with dementia should include an evaluation of

• How the resident typically communicates physical needs such as pain, discomfort, hunger or thirst, as well as emotional and psychological needs such as frustration or boredom; or a desire to do or express something that he/she cannot articulate;
• The resident’s usual and current cognitive patterns, mood and behavior, and whether these present a risk to the resident or others;
• How the resident typically displays personal distress such as anxiety or fatigue.

Appendix PP, pages 173-174, requires facilities to rule out and address, as relevant and appropriate, causes other than dementia for a resident’s behavior:

If medical causes are ruled out, the facility should attempt to establish other root causes of behavior using individualized, holistic knowledge about the person and when possible, information from the resident, family or previous caregivers, and direct care staff. This includes conducting a systematic analysis and consideration of possible causes, including but not limited to:

• Boredom; lack of meaningful activity or stimulation during customary routines and activities;
• Anxiety related to changes in routines such as shift changes, unfamiliar or different caregivers, change of (or relationship with) roommate, inability to communicate;
• Care routines (such as bathing) that are inconsistent with a person’s preferences;
• Personal needs not being met appropriately or sufficiently, such as hunger, thirst, constipation;
• Fatigue, lack of sleep or change in sleep patterns which may make the person more likely to misinterpret environmental cues resulting in anxiety, aggression or confusion.
• Environmental factors, for example noise levels that could be causing or contributing to discomfort or misinterpretation of noises such as over-head pages, alarms, etc. causing delusions and/or hallucinations.
• Mismatch between the activities or routines selected and the resident’s cognitive and other abilities to participate in those activities/routines. For example, a resident who has progressed from mid to later stages of dementia may become frustrated and upset if he/she is trying but unable to do things that she previously enjoyed, or unable to perform tasks such as dressing or grooming.

Here is suggested language.  Bold language is new.  Bold and underlined language indicates language taken from Appendix PP:

Dementia care.  (1) For a resident with dementia, the facility must include in the assessment

• (a) How the resident typically communicates physical needs such as pain, discomfort, hunger or thirst, as well as emotional and psychological needs such as frustration or boredom; or a desire to do or express something that he/she cannot articulate;
• (b) The resident’s usual and current cognitive patterns, mood and behavior, and whether these present a risk to the resident or others;
• (c) How the resident typically displays personal distress such as anxiety or fatigue.
• (d) The physical, functional, psychosocial, environmental, and other potential causes of behavior and related symptoms, including how they interact with each other. 

(2)If the behaviors observed represent a change or worsening from the baseline, the attending physician/practitioner and staff are expected to consider potential underlying medical, physical, psychosocial, or environmental causes of the behaviors.

(3) If medical causes are ruled out, the facility should attempt to establish other root causes of behavior using individualized, holistic knowledge about the person and when possible, information from the resident, family or previous caregivers, and direct care staff. The facility must conduct a systematic analysis and consider possible causes, including but not limited to:

(a) Boredom

(b) Anxiety related to changes in routines such as shift changes, unfamiliar or different caregivers, change of (or relationship with) roommate, inability to communicate;

(c) Care routines (such as bathing) that are inconsistent with a person’s preferences;

(d) Personal needs not being met appropriately or sufficiently, such as hunger, thirst, constipation;

(e) Fatigue, lack of sleep or change in sleep patterns which may make the person more likely to misinterpret environmental cues resulting in anxiety, aggression or confusion.

(f) Environmental factors, for example noise levels that could be causing or contributing to discomfort or misinterpretation of noises such as over-head pages, alarms, etc. causing delusions and/or hallucinations.

(g) Mismatch between the activities or routines selected and the resident’s cognitive and other abilities to participate in those activities/routines. For example, a resident who has progressed from mid to later stages of dementia may become frustrated and upset if he/she is trying but unable to do things that she previously enjoyed, or unable to perform tasks such as dressing or grooming.

(e) The comprehensive person-centered care planning must consider individualized person-centered approaches, utilizing a consistent process to address behaviors that focuses on the resident’s individual needs and tries to understand their behaviors as a form of communication and that uses non-pharmacological interventions.

Restraints, proposed §483.25(d)(1), 80 Fed. Reg., 42197

1. Restraints should be a RoP that is separate from quality of care.  Restraints are not an appropriate method for providing care and do not belong in the quality of care RoP.  The Center endorses the detailed comments on restraints that are submitted by California Advocates for Nursing Home Reform.

CMA Recommendation: There should be a separate RoP called Physical Restraints that addresses restraints and bedrails.

2. The proposed language at §483.25(d)(1) adds a sentence to current §483.13(a) about using the least restrictive alternative for the least amount of time and documenting ongoing evaluation of the need for the physical and chemical restraints.   Although this new language is helpful, the proposed regulation does not provide sufficient detail and protection for residents.  The section does not call for informed consent, as the proposed language on bedrails does (proposed §483.25(d)(2)(iii)).  Considerably more detail is needed, as CMS proposed for bedrails. 

CMA Recommendation: The Center recommends additional language.  New language is in bold font.

1. Restraints.  The facility must ensure that the resident is free from physical or chemical restraints imposed for purposes of discipline or convenience and that are not required to treat the resident’s medical symptoms.  When the use of restraints is indicated, the facility must use the least restrictive alternative for the least amount of time and document ongoing re-evaluation of the need for restraints.   

1. Physical restraints.  The facility must ensure that it

            (i) Attempts to identify and meet the resident’s medical, social, psychosocial needs, including an assessment of the environment to determine whether there is an environmental cause of the resident’s discomfort, before considering use of restraints, except in an emergency, as discussed in ( ).

      (ii) determines that the resident’s physician has conducted an in-person physical examination before ordering the restraint and

1. Has determined that the resident does not have any unaddressed medical condition that could be causing the resident pain or discomfort;
2. Has reviewed the risk and benefits of the physical restraint with the resident and resident’s representative and obtained informed consent prior to the use of the physical restraint.
3. Has included in the order for a physical restraint,
   1. the duration of the restraint (ensuring that the restraint is used for the least amount of time) and
   2. the frequency of staff releasing the restraint (ensuring that the restraint is released no less frequently than every two hours);

(iii) When the use of restraints is indicated, the facility must

1. use the least restrictive restraint for the least amount of time, as specifically ordered by the resident’s physician
2. monitor the resident in a restraint as ordered by the physician, but no less frequently than every two hours

(iv) Emergency use of restraints

(b) Chemical restraints.  The facility shall not use medications, including psychotropic medications, as chemical restraints.

Pressure ulcers, proposed §483.25(d)(4)(i), 80 Fed. Reg., 42198

The current regulation, §483.25(c)(1), begins with the statement that the resident who enters the facility without pressures should not develop them unless the resident’s clinical condition demonstrated that they were unavoidable.  The proposed §483.25(d)(4)(i)(A) omits that language entirely, beginning with the requirement that the facility provide care to prevent development of pressure ulcers.  The current language should be restored as a new (A) with the proposed subsections (A) and (B) moved to (B) and (C), respectively.  New language is in bold font.

CMA Recommendation:

483.25(d)(i)

(A) A resident who enters the facility without pressure ulcers does not develop pressure ulcers unless the individual’s clinical condition demonstrates that they were unavoidable; and

Mobility, proposed §483.25(d)(5), 80 Fed. Reg., 42198

CMA Recommendation: The Center supports the content of the new provision in its entirety, but recommends that the provision be correctly titled – i.e., Range of motion – as it is in the current rule, §483.25(e).

Incontinence, proposed §483.25(d)(6), 80 Fed. Reg., 42198

The Center supports the new provision in its entirety.

Assisted nutrition and hydration, §483.25(d)(8), 80 Fed. Reg., 42198

1. This section is misnamed because it addresses nutrition and hydration generally, as well as assisted nutrition.  It replaces two individual sections under the current quality of care regulations, §483.25(i) and (j), nutrition and hydration, respectively.  The mislabeling and combination minimize the critical importance of nutrition and hydration for residents.

CMA Recommendation: Restore nutrition and hydration to two separate regulatory requirements under Quality of Care, as suggested above.

2. Proposed §483.25(d)(8)(i) repeats current §483.25(i), with the addition of the final clause “or resident preferences indicate otherwise.”  The new phrase is objectionable.  The regulations cannot simply say “resident preference” (or “resident rights”) and absolve the facility from maintaining a resident’s nutritional status.  A facility would need to demonstrate that it served nutritious and appetizing food; identified the resident’s food preferences; offered appropriate alternative foods to the resident; had sufficient numbers of trained staff to assist the resident in eating; maintained a pleasant environment for meals; provided assistive devices, as needed; addressed the resident’s mental health needs; had received a medical determination from the resident’s physician that the resident’s medical condition indicated that weight loss was unavoidable; and took other necessary steps before it could justify not meeting a resident’s nutritional needs.

CMA Recommendation:  Delete from proposed §483.25(d)(8)(i) the final clause (“or resident preferences indicate otherwise”).

3. Proposed §483.25(d)(i)(ii) changes the current language at §483.25(j), from providing sufficient fluids to offering sufficient fluids.

CMA Recommendation: Restore the current language of §483.25(j).  New language is in bold font.

Hydration. The facility must provide each resident with sufficient fluid intake to maintain proper hydration and health.

Pain management, proposed §483.25(d)(13), 80 Fed. Reg., 42198

CMS discusses the importance of pain management at some length in the preamble, but includes no actual regulatory standards for pain management.  With CMS reporting that 45-80% of residents experiencing pain, the issue is common and more direction is required.

CMA Recommendation: As discussed later, CMS needs to require sufficient numbers of nursing staffing and registered nurses around the clock, as well as specific training in pain and pain management, in order to ensure that residents’ pain is adequately addressed.

Bed rails, proposed §483.25(d)(2), 80 Fed. Reg., 42197.

CMS reports in the preamble the “significant safety risks” that bed rails pose for residents.  80 Fed. Reg., 42197.  The new language proposed by CMS is a good first step, but insufficient to protect residents from these known and foreseeable life-threatening risks and dangers.  The Center endorses the analysis and proposed language submitted by California Advocates for Nursing Home Reform and Consumer Voice.  The Center agrees that bed rails should be placed in a separate section under restraints, not included in the Quality of Care RoP; that residents should be free from bed rails used as physical restraints or for purposes of discipline or staff convenience; that informed consent practices are applicable; and that facilities using bed rails must conduct ongoing monitoring and maintenance to ensure that bed rails remain safe for the residents who use them.

Physician services, proposed §483.30, 80 Fed. Reg., 42199

1. Proposed §483.30(e) requires a physician, physician assistant, nurse practitioner, or clinical nurse specialist to conduct an in-person evaluation before a resident is transferred to the hospital, except in emergency situations.  This proposal is highly objectionable.  If facilities were required to have a physician, physician assistant, nurse practitioner, or clinical nurse specialist in each facility, 24 hours per day, seven days per week, the proposal might make some sense.  But these health care professionals are not regularly present in facilities and certainly not on a 24 hour per day basis.  And facilities are already failing to send residents to the hospital who need to be hospitalized.    

I read the administrative appeals filed by nursing facilities for enforcement actions imposed against them by CMS.  In a decade of reading every single Civil Remedies Division and Appellate Division decision, I have never read a single decision involving a deficiency for sending a resident to the hospital who did not need to be hospitalized, but I have read many decisions where the facility was cited for failing to identify a significant change in a resident’s condition; failing to call a physician when a resident experienced a significant change; failing to hospitalize a resident who needed to be hospitalized; and related issues.  For example, in Hillsdale County Medical Care Facility v. CMS, Docket No. C-14-289, Decision No. CR4034, pages 16-20 (July 13, 2015), http://www.hhs.gov/dab/decisions/civildecisions/2015/cr4034.pdf, Administrative Law Judge Joseph Grow sustained the quality of care deficiency, §483.25, when the facility failed to transfer a resident to the hospital when his oxygen levels dropped and he suffered respiratory distress.  Transfer was required by the physician’s standing order and the resident’s advance directive.

Failure to hospitalize a resident who needs hospitalization can in fact be a criminal offense.  In August 2015, the State of California filed criminal charges (involuntary manslaughter) against a nursing facility (owned by the largest nursing home operator in the state) and its Director of Nursing and Supervising Nurse for failing to provide necessary care to a burn victim resident during his 14 months in the facility.  The facility failed to send the resident to the hospital immediately when he experienced a changed level of consciousness and needed to be hospitalized.  He died six days after he was eventually hospitalized.[12] 

CMA Recommendation: Delete the second sentence of proposed §483.30(e) (“The facility must provide or arrange for an in-person evaluation of a resident by a physician, a physician assistant, nurse practitioner, or clinical nurse specialist prior to transferring the resident to a hospital.”)

2. Proposed §483.30(f)(2) authorizes a physician to delegate “the task of writing dietary orders” to a qualified dietician; proposed §483.30(f)(3) authorizes a physician to delegate “the task of writing therapy orders” to a qualified therapist.  With respect to therapy, CMS offers two rationales: more frequent adjustments to therapy will be possible if therapists can change therapy orders directly and “therapists already write therapy orders that are routinely endorsed by a physician without change.”  80 Fed. Reg., 42199.  The first rationale seems focused on reimbursement concerns and does not support eliminating the physician’s role.  The second rationale is no reason at all.  Condoning violation of the current regulation does not necessarily mean condoning good practice.

More significantly, a resident’s need for therapy is not an issue solely within the domain of a therapist.  A physician has detailed knowledge about the medical condition of the resident and the course of recovery from surgery, for example, that could affect what type of therapy a resident could tolerate and benefit from.  Interdisciplinary discussions are appropriate and would improve care and care outcomes for residents, but CMS should not authorize the physician to shift all authority to the therapist.  The absence of appropriate and necessary medical care in nursing homes needs to be reversed, not condoned.  With the increasing acuity of residents, CMS needs to strengthen medical oversight of care, not reduce it.

Moreover, the abuse of therapy by nursing home chains in particular, as evidenced by False Claims Act cases against many chains,[13] would be exacerbated if all authority for therapy services were transferred to therapists employed by nursing facilities.

CMA Recommendation: Delete language authorizing physicians to delegate authority to therapists and the dietician.

Nursing services, proposed §483.35, 80 Fed. Reg., 42199-42203

This is the proposed regulation of greatest concern to the Center.  CMS’s refusal to set nurse staffing ratios and, as the Institute of Medicine recommended in in 1996[14] and again in 2001,[15] to require a registered nurse 24 hours per day, seven days a week will ensure that many residents continue to receive inadequate, life-threatening care.  CMS cites the extensive research literature supporting increasing staffing as well as its own study 15 years ago that documented serious and pervasive understaffing, but then sets out a “competency-based approach” that requires facilities to decide how many staff they need, and with what skill sets and competencies, and to have that complement of staff.  However, by reporting that most facilities already do what CMS is asking them to do – albeit with the new name “competency-based approach” – CMS is signaling to facilities that they do not need to do more than they have been doing.  That signal is a prescription for continuing understaffing.  CMS is fully aware that facilities are understaffed and that understaffing harms and kills residents.  It must do more to strengthen nurse staffing requirements.

CMS defends its refusal to mandate better staffing standards by asserting a need for more accurate payroll-based staffing data.  80 Fed. Reg., 42202.  This position is disingenuous.  In 1987, when it passed the Nursing Home Reform Law, Congress explicitly directed the Department of Health and Human Services to conduct a study of nurse staffing.  The report was not completed until 2001, when the Bush Administration claimed that the four-volume report did not provide sufficient evidence of the need to increase staffing levels.

The absence of professional nurses harms residents.  A recent decision in a facility’s (unsuccessful) administrative appeal of civil money penalties (CMPs) highlights this reality and the need for both sufficient numbers of nursing staff and registered nurses around the clock. 

On October 25, 2012, a woman was admitted to Life Care Center of Columbia to receive therapy following hip replacement surgery.  At the hospital, she had “experienced a significant respiratory incident.”  Life Care Center of Columbia v. CMS, Docket No. C-13-367, Decision No. CR4132, page 2 (Aug. 18, 2015), http://www.hhs.gov/dab/decisions/dabdecisions/cr-4132.pdf.  Accordingly, her hospital discharge instructions “included an order for the [skilled nursing facility] SNF to contact R1’s physician or 911 in the event that [Resident] R1 experienced shortness of breath.”  Decision 2.  Between10:45 p.m. to 10:50 p.m. on October 26, R1 complained to a certified nurse assistant (CNA) that she was short of breath.  The CNA took R1’s vital signs, which showed that her oxygen level had declined to 90%, but she did not inform the licensed practical nurse (LPN) of R1’s oxygen level.  The resident told the CNA that she had had congestive heart failure and would call 911 if she did not receive assistance.  The CNA told the LPN that R1 had congestive heart failure and was gasping breath, but did not inform her that R1 would call 911.  The LPN attended to another resident who appeared to be having a stroke.  At 11:30 p.m., the LPN was still doing the 9:00 p.m. medication passes.  At 11:22 p.m., R1’s roommate called 911.  EMS, which arrived at about 11:30 p.m. and found R1 comatose, took R1 to the hospital, where she died on October 27, 2012.  These incidents are discussed in detail.  Id. 9-14. 

Administrative Law Judge Scott Anderson sustained the five immediate jeopardy deficiencies – (1) physician notification of significant change in resident, 42 C.F.R. §483.10(b)(11)(i), F157; (2) neglect, §483.13(c), F224; (3) professional standards, §483.20(k)(3)(i), F281; (4) quality of care, §483.25, F309; and (5) administration, §483.75, F490 – and per day CMPs totaling $112,250.  One of the facility defenses, rejected by the ALJ, was that the LPN “could not have done a respiratory assessment because she is an LPN and under North Carolina law only a designated nurse can do respiratory assessment.”  Id. 25.  The ALJ faulted the facility with “fail[ing] to have a registered nurse available to do a respiratory assessment, if needed, as there was no registered nurse on duty during the 3:00 p.m. to 11:00 p.m. shift.”  Id.  The resident died two days after her admission for rehabilitation when there were not sufficient nursing staff in the facility to handle two emergencies at the same time and daily care (medication passes) and a registered nurse was not available at all.

The Center endorses the comments and recommendations on staffing that are submitted by the American Nurses Association, the Coalition of Geriatric Nursing Organizations, and Consumer Voice.  These comments cite the extensive research literature documenting that better staffing levels are correlated with better outcomes for residents. 

CMA Recommendation: Nurse staffing levels must be increased to at least 4.1 hours per resident day and CMS must require registered nurses 24 hours per day, seven days per week.  

The Center presents additional arguments in support of improving nurse staffing standards.

The high cost of poor care

The costs of increased nursing staff are found by reducing the Medicare and Medicaid reimbursement that is now spent trying to correct the avoidable poor resident outcomes that inadequate staffing cause – what advocates call the high costs of poor care.  Evidence of the high costs of poor care is overwhelming:

• In this notice of proposed rulemaking, CMS itself recognizes the high (personal and) financial cost of infections in nursing home residents.  In the preamble, CMS reports that there are 1.6-3.8 million infections in nursing homes, leading to 150,000 hospitalizations, 388,000 deaths, and costs of $673 million to $2 billion.  80 Fed. Reg., 42215.  To the extent that many infections are avoidable, CMS’s own data illustrate the high cost of poor care.
• In 2014, the HHS Office of Inspector General (OIG) issued the first-ever analysis of adverse events in skilled nursing facilities, reporting that nearly one in three Medicare beneficiaries who went to a SNF for 35 days or fewer in August 2011 (and who spent an average of 15.5 days in the SNF) experienced an adverse event or other harm, including falls, avoidable infections, pressure sores, improper medication dosing, hospitalizations, and death.[16]  Physician reviewers described 59% of the adverse events and harm incidents as preventable.[17]  Many of the adverse events and instances of temporary harm were caused by staffing failures – “failure by SNF staff to monitor residents or staff delay in providing necessary care.”[18]  The OIG estimated that the cost to Medicare of avoidable hospitalizations, in August 2011 alone, was $208 million.[19]
• Nearly 25 years ago, the Senate Labor and Human Resources Subcommittee on Aging issued a report that addressed, and used the term, “high cost of poor care” – i.e., the costs that are incurred by the health care system when inadequate nurse staffing in nursing homes leads to avoidable medical problems that the health care system spends money to try to correct.  The report described “what happens if we don’t give good care.” 

Explosively expensive care is required to redress the effects of poor nursing care for residents in nursing homes.  Inadequate numbers of nursing assistants, poorly supervised by licensed nurses, lead to breaks in care or inappropriate care.  Basic care, food, fluids, cleanliness, sleep, mobility and toileting, when not carried out, leads to devastating outcomes for residents and additional expense for the government.[20]

The report identified several poor care outcomes, their causes, and their estimated costs:

• "Lack of toileting leads to urinary incontinence," which leads to "skin irritation, decubitus ulcers, urinary tract infections, additional nursing home admission and hospitalization," and is estimated to cost $3.26 billion annually.
• "Poor hydration, nutrition, mobility and cleanliness lead to pressure ulcers," whose treatment costs are estimated to range between $1.2 and $12 billion.
• Use of chemical restraints is a major cause of falls, including hip fractures, which are estimated to cost $746.5 million.
• "Poor care leads to excess hospitalizations," costing nearly $1 million.

These data are now more than a quarter of a century old.  Obviously, the costs for the same avoidable bad outcomes are far higher in 2015 dollars.

The last finding in the Senate report about avoidable hospitalizations was based on a 1989 study about social-cultural (i.e., non-clinical) factors that contribute to the hospitalization of nursing home residents.  The three-year study, conducted between 1985 and 1988 in three nursing facilities, identified various factors that contributed to the hospitalization of nursing home residents.  It found that nearly half of the hospitalizations (48.2%) occurred because of social-structural reasons, rather than clinical reasons, and that 70% of the residents who were hospitalized "could have been treated in the nursing home if the nursing staff had been able to administer IV therapy."[21]  Nursing facilities' "insufficient and inadequately trained nursing staff" could not meet residents' more complex health care needs.  Almost half of hospitalizations were unnecessary and residents could have been cared for in their nursing homes.  The researchers described as the predominant factor causing hospitalization "the insufficient number of adequately trained nursing staff."  Plainly, this 1989 study demonstrates that reducing rehospitalization by increasing staffing in nursing homes is not a new idea.

In 2011, two studies by the Kaiser Family Foundation confirmed the Senate committee’s 1989 findings about the need for RNs in nursing homes as a way of preventing avoidable hospitalizations.[22]

• In April 2011, the National Consumer Voice for Quality Long-Term Care (Consumer Voice) issued a report, The High Cost of Poor Care: The Financial Case for Prevention in American Nursing Homes,[23] which updated its own 20-year old report, The High Cost of Poor Care – The Cost-Effectiveness of Good Care Practices.   The report, once again, provided research-based data on the high, and often avoidable, costs of poor care:
• Falls: Studies indicate that three-quarters of all residents have at least one fall each year, and a quarter of the falls require medical attention. Twenty to thirty percent of the falls are preventable. Falls cost, on average, $19,440 and hip fractures, more than $35,000.
• Pressure ulcers: Pressure ulcers are largely preventable, but nevertheless prevalent in nursing homes. The costs to treat them are high. The total annual cost of treating all pressure ulcers (not just those of nursing facility residents) is $11 billion.
• Urinary incontinence: Two-thirds of residents have urinary incontinence, with direct costs of $5.3 billion per year.
• Malnutrition: Malnourished residents are more likely to have pressure ulcers and fractures and to be hospitalized more frequently.
• Dehydration: Each hospitalization of a dehydrated resident costs, on average, more than $18,000. Dehydration is often avoidable if residents are given more fluids. Insufficient staffing leads to less fluid intake by residents.
• Ambulatory care-sensitive diagnoses and avoidable hospitalizations: Ambulatory care-sensitive diagnoses are diseases for which hospitalization can typically be avoided with adequate primary care. They are often used as a proxy for avoidable hospitalizations. A high percentage of resident hospitalizations are for conditions that fall into this category, such as congestive heart failure, asthma or diabetes. Research found that New York State spent more than $1.2 billion for avoidable hospitalizations over a five-year period.

Reducing hospitalization through better staffing

CMS explains its proposed revisions of the RoPs by discussing, in part, the need to reduce avoidable rehospitalizations of nursing home residents.  80 Fed. Reg., 42175.  While we understand the multiple dangers that hospitalization poses for residents and we support reducing avoidable hospitalizations, we have serious reservations about treating the reduction of hospitalization as a free-standing goal. 

Writing in The New England Journal of Medicine, Joseph G. Ouslander, M.D. and Robert A. Berenson, M.D. recognize the high cost of unnecessary hospitalization of nursing home residents and support the reduction of such hospitalization, but add a cautionary note:

Multifaceted strategies will be needed to address the current incentives for hospitalization if we are to improve nursing home care and prevent unnecessary hospitalizations, with their related complications and costs.  Two caveats are critical.  First, not all hospitalizations for conditions that can theoretically be managed outside an acute care hospital are preventable.  Second, given fiscal constraints and the dearth of health care professionals trained in geriatrics and long-term care, not all nursing homes have the capacity to safely evaluate and manage changes in the condition of the clinically complex nursing home population.  Setting unrealistic expectations and providing incentives to poorly prepared nursing homes to manage such care rather than transferring residents to a hospital could have unintended negative effects on the quality of care and health outcomes.[24]

Dr. Ouslander developed a tool, INTERACT II (Interventions to Reduce Acute Care Transfers), that can carefully and successfully reduce unnecessary hospitalization of nursing home residents.[25]  However, “the goal of INTERACT is to improve care quality, not to prevent all hospital transfers” and INTERACT “can result in more rapid transfer of residents who need hospital care” (bold font and italics in original, slide 16).  INTERACT’s goals are to avoid hospitalization that should be avoided and to support hospitalization that is medically necessary.  These goals should be CMS’s goals as well.

With that caveat, we return to the issue of reducing avoidable rehospitalizations of residents.  In addition to the reports cited above, considerable research demonstrates that unnecessary and inappropriate hospitalizations can be avoided when nursing facilities have more health care professionals in place on a daily basis – physicians, physician assistants, and registered nurses:

• A pilot quality improvement project, funded by CMS in three nursing facilities in Georgia from May 1 to October 31, 2007, reported an average reduction of hospitalizations of 50% over the six-month period. The project's Expert Panel identified as key factors for "preventing avoidable hospitalizations . . . greater on-site availability of physician or nurse practitioner or physician assistants, more registered nurses providing care, availability of lab results within 3 hours, and the capability of the NH to administer intravenous fluids."[26]
• Nursing home chains have also reported that their rates of hospitalizing residents declined when their facilities employed more RNs and other health care professionals.  Genesis HealthCare reported that since employing more RNs, nurse practitioners, and physicians in its nursing facilities, it saw an 11% decline in unplanned hospitalizations since 2004.  Sixty percent of Genesis facilities have a "'transitional care unit,' in which an RN-intensive staff team cares for residents who have been in the hospital within the past 25 days."[27]   The RNs "are intravenous (IV)-certified." The transitional care units also have a nurse practitioner or physician on staff every day.  Similarly, Life Care Centers of America, reports that it reduced rehospitalizations from 40% to 15% in one year in its facilities that employed a full-time physician.[28]  Additional benefits of the employment of physicians in nursing facilities reported by the corporation were reduced use of antipsychotic drugs, "reduced staff turnover, greater resident and family satisfaction, and improved clinical outcomes."

Other costs of insufficient staffing

In addition to avoidable medical and hospitalization costs resulting from insufficient staffing, society pays in additional ways as well when nursing homes are not properly staffed to meet residents’ needs.  Workers compensation is a key example.  Workers compensation claims are made when a staff member is injured at work.  A typical injury for a certified nurse assistant occurs when the aide attempts to move a resident by herself, when the resident’s care plan calls for two aides for all transfers.  The lack of sufficient aides leads aides to attempt a transfer alone.  Often, both the resident and staff member fall and are injured.  Appropriate staffing levels would prevent many of these resident and staff injuries.

CMA Recommendation: Set appropriate nurse staffing ratios, by shift, and require a registered nurse 24 hours per day.

Behavioral health services, proposed §483.40, 80 Fed. Reg., 42202-42203

The Center endorses the comments of the National Association of Social Workers on this RoP.

1. This entirely new Requirement addresses the need for facilities to provide better services for residents with cognitive impairments or behavioral health needs, but CMS nowhere defines the term “behavioral health.” 

CMA Recommendation: Provide a definition for behavioral health.

CMA Recommendation: CMS should include behavioral health services as part of the quality of care RoP, under special services, since CMS appears to intend these services for residents who have mental illness, psychosocial disorders, and trauma or post-traumatic stress disorders (proposed §483.40(a)(1)).   

CMA Recommendation: Reverse the order of proposed §483.40(b)(1) and (2), in line with the current approach of the RoPs, i.e., the first statement is not expecting a resident who does not have behavioral health problem at admission to develop one, unless there is a medical reason specific to that individual that makes the problem unavoidable, followed by a statement requiring a facility to provide appropriate care to a resident who needs the service.

2. CMS places the requirement for medically-related social services, currently included in the quality of life RoP at §483.15(g), in the Behavioral health services RoP.  Many residents in addition to those with behavioral health or mental health issues could benefit from the services of a social worker. 

CMA Recommendation: Requirements for social services should be retained in a freestanding quality of life RoP or moved to the combined proposed Quality of Care and Quality of Life RoP, proposed §483.25.

3. The social services requirements needed to be strengthened considerably.  The current requirement is for a full-time social services worker in facilities with 120 or more beds.  Smaller facilities also need clinical social workers to assist residents and their families with care and rights concerns.  With CMS proposing that a social services person participate in every resident’s interdisciplinary care planning meeting, there is obviously a need for more social services staff.  These staff need clinical credentials.

Non-clinical social services staff are also important for helping arrange for and coordinate services not provided directly by the facility, discharge planning, and identifying ongoing care and services for residents who are moving out of facilities.

CMA Recommendation: The Center supports the comments and recommendations submitted by the National Association of Social Workers on the issue of social services.

CMA Recommendation: Under the authority of §§1395i-3(d)(4)(B), 1396r(d)(4)(B) (“A skilled nursing facility must meet such other requirements relating to the health, safety, and well-being of residents or relating to the physical facilities thereof as the Secretary may find necessary.”),  42 C.F.R. §483.1(a)(1)(ii), CMS should require the nursing homes employ sufficient numbers of social workers who are professionally credentialed to provide clinical services to residents.

Pharmacy services, proposed §483.45, 80 Fed. Reg., 42203-42205

1. CMS proposes to move care requirements involving pharmacy from the quality of care requirement, current §483.25(l), to proposed pharmacy services, §483.45.  The Center strongly opposes this shift.

CMA Recommendation: Requirements related to care of residents should be retained in the quality of care RoP and only requirements related to procedures, staff, credentials, and so forth should be included in the pharmacy services RoP. 

2. CMS proposes to require the pharmacist who is conducting drug regimen review to review the resident’s medical chart at least every six months, on admission, on return to the facility, and whenever the resident is taking a psychotropic medication, antibiotic, or other drug identified by the Quality Assessment and Assurance Committee.  Proposed §483.45(c)(2)(i)-(iii).  This is a good recommendation and we support it.

CMA Recommendation:  Retain this language.

3. CMS proposes to “expand” the regulation of antipsychotics to include all psychotropic medications.  We strongly oppose this revision.  Antipsychotic drugs remain a serious concern when nearly 20% of residents (more than 200,000 individuals) continue to receive them and most of the use is off-label, dangerous, harmful, and life-threatening to the vast majority of residents who take them.  As CMS wrote in 2011, when it proposed that consultant pharmacists be independent of pharmacy providers, “The research and our survey and certification data indicate that the use of unnecessary medications, particularly antipsychotics, is problematic in LTC facilities.”  76 Fed. Reg. 63017, 63039 (Oct. 11, 2014).  CMS cited extensive research documenting the problematic use of antipsychotic drugs in nursing homes, including reports by the Office of Inspector General.  CMS developed a national initiative to address the issue of antipsychotic drug use and, more broadly, dementia care in nursing facilities. 

Other psychotropic medications are also a problem in nursing facilities.  As discussed below, in our recommendation to mandate the independence of consultant pharmacists, non-antipsychotic drugs have been promoted as a way to control residents, without running afoul of current federal requirements limiting the use of antipsychotic drugs.  This misuse of other psychotropic drugs supports the need for specific regulation of all psychotropic medications, but it does not support diverting special attention from the almost always misused antipsychotic drugs.

We support additional attention being paid to all psychotropic medications and a continued, separate focus on antipsychotic drugs.

The Center supports the recommendations of California Advocates for Nursing Home Reform and Consumer Voice on antipsychotic and psychotropic drugs.

CMA Recommendation: Retain current requirements for antipsychotic drugs, §483.25(l)(2)(i)-(ii), as §483.45(e), and retain the new language for other psychotropic drugs, proposed §483.45(e) and §483.45(f).  New language ((i) and (iii) and (1) and (3) are from current §483.25(l)(2)(i)-(ii)) is in bold font.  New language in (ii) and (2) is our own. 

483.45

(e) Antipsychotic drugs.  Based on a comprehensive assessment of a resident, the facility must ensure that –

            (i) Residents who have not used antipsychotic drugs are not given these drugs unless antipsychotic drug therapy is necessary to treat a specific condition as diagnosed and documented in the clinical record;

            (ii) The prescribing physician provides evidence that, prior to ordering the antipsychotic medication, the physician

(A) personally examined the resident 

(B) reviewed the risk and benefits of the particular antipsychotic medication with the resident or resident representative and

(C) obtained informed consent from the resident or resident representative.

(iii) Residents who use antipsychotic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

(f) Psychotropic drugs other than antipsychotic drugs.  Based on a comprehensive assessment of a resident, the facility must ensure that –

            (1) Residents who have not used psychotropic drugs are not given these drugs unless the medication is necessary to treat a specific condition as diagnosed and documented in the clinical record;

(2) The prescribing physician provides evidence that, prior to ordering the medication, the physician

(A) personally examined the resident,

(B) reviewed the risks and benefits of the particular antipsychotic medication with the resident or resident representative, and

(C) obtained informed consent from the resident or resident representative.

            (3) Residents who use psychotropic drugs receive gradual dose reductions, and behavioral interventions, unless clinically contraindicated, in an effort to discontinue these drugs.

Recommendations from study conducted by CMA and Dean Lerner Consulting in cooperation with CMS

In cooperation with CMS and with funding from the Commonwealth Fund, the Center and Dean Lerner Consulting conducted an analysis of antipsychotic drug deficiencies in seven states selected by CMS in 2010 and 2011.[29]  The project also sent a questionnaire to surveyors in 10 states and analyzed the responses from more than 400 surveyors about how to improve RoPs for facilities with respect to antipsychotic drugs (among other issues).  Recommendations from the surveyors and project staff are discussed below and identified as recommendations of the project.

4. CMS proposes to address the issue of PRN psychotropic drugs by limiting their use to 48 hours “unless the resident’s physician or primary care provider documents the rationale for this continuation in the resident’s clinical record.”  Proposed §483.45(e)(4).  This protection is too limited for residents.  The draft language would allow the physician to continue PRN medications without seeing or examining the resident. 

Broader protection is essential.  Before prescribing any psychotropic medication for the resident, the physician should have to conduct an in-person examination of the resident (as CMS proposes for transfers to the hospital) and get informed consent from the resident (as CMS proposes for bed rails).

CMA Recommendation: CMS should prohibit PRN antipsychotic drug orders.  This recommendation was made jointly by surveyors and project staff in the Commonwealth Fund project.  New language is in bold font.

483.45(e)(5).  Facilities shall not dispense antipsychotic drugs to residents on a PRN or as needed basis.

CMA Recommendation: Project Staff recommended that CMS require that nursing facilities draft and complete an Antipsychotic Drug/Dementia Care Compliance Report for each resident taking antipsychotic drug(s).  The facility would be required to identify the resident’s diagnoses, all attempted non-pharmaceutical interventions, consents, and recommendations for, and physician responses to, consultant pharmacists’ recommendations for gradual dose reductions.  The reports would be signed by all members of interdisciplinary team, certifying compliance with all federal Requirements.  As part of the annual survey or any relevant complaint survey, surveyors would review the reports.

483.45(e)(6).  Antipsychotic Drug/Dementia Care Compliance Report.  The facility must draft, complete, and timely update an Antipsychotic Drug/Dementia Care Compliance Report for each resident taking an antipsychotic drug.  The Compliance Report must be made available to surveyors as part of the annual survey and any relevant complaint survey and must identify and include

            (A) the resident’s diagnoses

            (B) all attempted non-pharmaceutical interventions

            (C) signed consent forms

            (D) recommendations from consultant pharmacists and

(E) the physician’s written response to the consultant pharmacist’s recommendations.

CMA Recommendation: Mandate the independence of consultant pharmacists

The Center recommends that CMS mandate the independence of consultant pharmacists, as it proposed in 2011, CMS-4157-P, 76 Fed. Reg. 63017, 63038-63041 (Oct. 11, 2011).  CMS made a compelling case for requiring that consultant pharmacists be independent, but declined to follow through in final regulations, 77 Fed. Reg. 22071, 22100-22107 (Apr. 12, 2012).  In the final rules, CMS acknowledged that “a significant number of commenters who identified themselves as current or former consultant pharmacists acknowledged they had experienced conflict of interest in the past or confirmed our understanding that conflict of interest were an on-going problem.”  77 Fed. Reg., 22101.  CMS described the conflicts and problems at length.  Nevertheless, it declined in the final rules to require the independence of consultant pharmacists, saying such a rule, by itself, would not solve the problem of overprescribing of antipsychotic drugs for nursing home residents.  77 Fed. Reg. 22701, 22101-22107 (April 12, 2012).  CMS contended that a broader approach, addressing facility staff and prescribers as well, would be needed.  That time is now.  As part of a comprehensive review of all RoPs for nursing facilities, CMS should mandate the independence of consultant pharmacists.

Since CMS proposed independent consultant pharmacists four years ago, the evidence of the need for consultant pharmacists to be independent has continued to mount.

In December 2014, when the U.S. Department of Justice intervened in the consolidated whistleblowers’ cases against Omnicare under the False Claims Act, it described Omnicare’s consultant pharmacists’ practice of promoting Depakote “for controlling behavioral disturbances exhibited by dementia patients residing in nursing homes serviced by Omnicare.”[30]  The Government’s complaint explains, in its opening paragraph, the role of consultant pharmacists in this scheme: 

For more than a decade, Defendants Omnicare, Inc. (“Omnicare”) – the nation’s largest provider of pharmacy services to nursing homes – solicited and received kickbacks from drug manufacturer Abbott Laboratories (“Abbott”) to promote the use of the prescription drug Depakote to control the behavior of elderly nursing home residents with dementia.  Through its consultant pharmacists, Omnicare wielded enormous influence over the drugs administered to the residents of Omnicare-serviced nursing homes.  In exchange for millions of dollars in kickbacks disguised as rebates, educational grants, and other corporate financial support, Omnicare used its consultant pharmacists to tout Depakote as a tool to control agitation, aggression, and other behavioral disturbances and to avoid federal regulations designed to prevent the use of chemical restraints on the elderly.  By knowingly and actively soliciting kickbacks to promote Depakote, Omnicare enhanced its profits at the expense of the elderly nursing home residents it purported to protect and caused the Medicaid and Medicare programs to pay hundreds of millions of dollars for claims that should not have been paid. 

United States of America v. Abbott Laboratories, Civil Action No. 1:07-cv-00081 (W.D. Val, filed Dec. 22, 2014).[31]  McKnight’s Long-Term Care News reported in July 2015 Omnicare’s announcement that it will settle two False Claims Act lawsuits with the Department of Justice alleging that Omnicare accepted millions of dollars of bribes for promoting the use of Depakote in nursing homes.[32]  In May 2012, the U.S. Department of Justice announced that Abbott Labs would pay $1.5 billion to resolve criminal civil investigations of its off-label promotion of Depakote for nursing home residents.”[33] 

New language is in bold font.

483.45(b) Service consultation.  The facility must employ or obtain the services of an independent licensed pharmacist who –

(1) Provides independent consultation on all aspects of the provision of pharmacy services in the facility. . . .

(c) Drug regimen review.  (1) The drug regimen of each resident must be reviewed at least once a month by an independent licensed pharmacist.

Food and nutrition services, proposed 483.60, 80 Fed. Reg., 42206-42209

While recognizing that malnutrition affects 35-65% of nursing home residents, 80 Fed. Reg., 42206, CMS proposes to water down current requirements at §483.35 (now called dietary services).  CMS offers no justification for removal of this current requirement.

1. CMS proposes to establish new credentials for qualified dieticians, but delays the effective date for five years, proposed §483.60(a)1)(iii), and in the intervening five years, allows the designated director of food and nutrition services to have woefully inadequate credentials (e.g., proposed §483.60(a)(2)(i)(D) authorizes the director of food and nutrition services to have an associate’s degree in hospitality).

CMA Recommendation:  Retain the current requirement at §483.35(a)(2) defining a qualified dietician as a person “qualified based upon either registration by the Commission on Dietetic Registration of the American Dietetic Association” and add the alternative of meeting state licensure or certification so long as state licensure or certification requirements are at least as stringent as the requirements of the American Dietetic Association. 

2.CMS proposes to allow menus to meet not only established guidelines (current rules specify “recommended dietary allowances of the Food and Nutrition Board of the National Research Council, National Academy of Sciences, 483.35(c)(1)) but now, for the first time, to allow menus to meet an undefined “industry standards” (proposed 483.60(c)(1)).

CMA Recommendation:  The term “industry standards” has no meaning and does not establish any standards whatsoever.  Delete the phrase “or industry standards.”

3. CMS proposes to omit the current requirement, under frequency of meals, that there be no more than 14 hours between a substantial evening meal and breakfast the following morning, 483.35(f)(2), unless the facility offers a nourishing snack at bedtime, in which case there can be a 16-hour lapse between the evening meal and breakfast, 483.35(f)(4).

CMS’s explanation of the deletion – that it is focusing on resident preference for times to eat and on ensuring that food is provided at those times – is neither compelling nor satisfactory.  80 Fed. Reg., 42208.  The preamble language “We do not intend to require a 24-hour-a-day full service food operation or an on-site chef” does not reflect a resident focus to the deletion.  80 Fed. Reg., 42208.  It suggests, instead, that CMS is concerned with limiting the current regulatory requirement that facilities ensure that appropriate food is available and provided to residents at reasonable times.  “Resident choice” is a pretext to delete regulatory standards.

CMA Recommendation: Retain the current requirements at §483.35(f)(2), (4).

4. CMS proposes new language to require that facilities provide appropriate assistance with assistive devices to residents who use the devices.  Proposed §483.60(g).

CMA Recommendation:  Retain the new language.

Specialized Rehabilitative Services, proposed §483.65, 80 Fed. Reg., 42209

1.CMS proposes to add respiratory therapy to the list of rehabilitative services that a nursing facility must provide to residents who need that therapy.  The Center fully supports this addition.  Too often, facilities refuse to provide respiratory therapy, making it impossible for individuals who need respiratory therapy to find a facility nearby that will admit them and provide them with the full range of professional services they need. 

In addition, CMS needs to assure that facilities have sufficient numbers of staff who are trained and competent to provide respiratory therapy to residents.  In addition, paraprofessional nursing staff must be able to recognize situations where professional staff are needed and they must know how to initiate immediate contact with the necessary health care professionals.

CMA Recommendation: Retain the language requiring facilities to provide respiratory therapy to residents who need it.

2. Residents are entitled to professional rehabilitative services if they are necessary to maintain function and to prevent or slow decline or deterioration.  The federal district court in Vermont approved the maintenance standard in Jimmo v. Sebelius, No. 11-cv-17 (D. Vt. Jan. 24, 2013) (settlement approved by court).  CMS needs to confirm the maintenance standard if the RoPs.

CMA Recommendation: New language is in bold font.

483.65(a) Provision of services.  If specialized rehabilitative services such as but not limited to physical therapy, speech-language pathology, occupational therapy, respiratory therapy, and rehabilitative services for mental illness and intellectual disability or services of a lesser intensity as set forth at §483.120(c), are required in the resident’s comprehensive plan of care in order to improve a resident’s function or to maintain a resident’s function or to prevent or slow the resident’s decline or deterioration, the facility must –

Administration, proposed §483.70, 80 Fed. Reg., 42210-42212

Facility assessment, proposed §483.70(e), 80 Fed. Reg., 42210-42211

CMS describes this new requirement as “a central feature” of its revisions to the RoPs, but then writes that the requirement is “similar to existing common business practices for strategic planning and capital budget planning.”  80 Fed. Reg., 42210.   Specifically authorizing what is already common facility practice does not seem to be a significant change at all.  Moreover, the Center does not see how a single process can serve long-range planning needs and, simultaneously, the changing day-to-day needs of a facility for staffing and other services (such as food and nutrition, rehabilitation, and housekeeping).

CMS’s requirement that facilities conduct such an assessment at least annually makes this assessment totally inadequate as a method for determining appropriate staffing levels and competencies, which shift much more frequently than annually. 

It is also not clear which staff members in the facility would participate in a facility assessment.  Different staff members would be appropriate for long-range planning and for day-to-day planning. 

The preamble provides no additional guidance.

CMA Recommendation: One type of facility assessment should be limited to emergency planning, strategic planning, and capital budget planning.  A separate assessment process should be required for determining day-to-day needs of a facility.  Bold font is new language.

§483.70(e) Facility assessment.  (1)Annual strategic planning and capital budget assessment: The LTC facility must conduct and document a facility-wide assessment, at least annually, to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies, for strategic planning and capital budget planning, addressing the requirements at §483.70(e)(1)-(3). 

2. Bi-weekly staffing and day-to-day operations assessment: The LTC facility must also separately conduct and document a facility-wide assessment to determine what resources are necessary to care for its residents competently during both day-to-day operations and emergencies, addressing the requirements at §483.70(e)(1)(i)-(v).  This assessment must be conducted at least bi-weekly by the administrator, director of nursing, medical director, and the heads of each department, including therapy, social services, food and nutrition services, and housekeeping.  The assessment must be documented in writing and signed by all relevant management staff identified above.  The documentation must be

(a) made available to surveyors at the entrance conference and upon request   

(b) posted in a conspicuous location in the facility that is readily visible and accessible to visitors

(c) made available to residents and their families and advocates, upon request, and

(d) retained for at least five years.

5. Proposed §483.70(e)(2)(i) uses the term medical records.  The term in the current §483.75(l) is clinical records, which appears to be a broader term than medical records.  CMS offers no reason for the change.

CMA Recommendation: Retain the current term “clinical records.”

Medical director, proposed §483.70(h)

CMS proposes to incorporate, without change, the current requirements for medical directors, current §483.75(i).  The Center is concerned that, too often, the medical director also serves as the attending physician for most of the facility’s residents.  The dual roles of medical director and attending physician make it impossible for the medical director to perform the medical director’s specific regulatory functions – implementing resident care policies and coordinating medical care in the facility.  The medical director cannot “oversee” the care he or she is providing to residents as attending physician.

CMA Recommendation: The Center encourages CMS to address this issue in final regulations.  Although there may be a need, in some limited instances, for medical directors to serve as residents’ attending physicians, CMS needs to strengthen the regulatory standards for medical direction so that medical directors can, in fact, perform their critical management functions.  For example, CMS could mandate specific minimum numbers of hours per week or per month for medical direction functions; require certification for medical directors; limit medical directors from serving as medical director in more than two facilities; and prohibit medical directors from serving as the residents’ attending physicians (with a limited  exceptions process).

Binding arbitration agreements, proposed §483.70(n), 80 Fed. Reg., 42211

The Center strongly opposes allowing facilities to use binding arbitration agreements. 

CMS forcefully, and correctly, describes problems with use of binding arbitration agreements – the unequal bargaining power of facilities and residents and their families at the time these contracts are signed; the barriers that such agreements create for surveyors and others to obtain information about serious quality of care issues in facilities, 80 Fed. Reg., 42211 – but then authorizes their use.

CMS’s permitting binding arbitration agreements means that nursing home residents would lose access to the courts for virtually every potential dispute they have with their facility.  Long-stay residents, in particular, who spend virtually all of their time in the facility for the remainder of their lives, would lose their rights as United States citizens to have any of their disputes with their facility resolved by courts.  In other contexts, binding arbitration agreements are signed on a transaction-by-transaction basis.  For residents, in contrast, every dispute would be settled by arbitration. 

In a separate provision, the proposed rules prohibit facilities from requesting or requiring residents “to waive potential facility liability for losses of personal property.”  Proposed §483.15(a)(2)(iii).  The rules contain an entire RoP on resident rights, proposed §483.10, confirming residents’ rights to exercise rights as citizens or residents of the United States.  Yet by authorizing binding arbitration agreements, CMS is allowing facilities to require residents to waive potential facility liability for all issues involving health, safety, welfare, and rights. 

Disapproval of binding arbitration agreements in a variety of contexts is growing[34] and one legal scholar has called on the Department of Health and Human Services to declare these agreements by nursing homes unconscionable and to “prohibit federal funding of nursing homes that use them.”[35] 

At the 2009 Midyear Meeting of the American Bar Association, the House of Delegates adopted Resolution 111B, introduced by the ABA Commission on Law and Aging and co-sponsored by the Section of Dispute Resolution.  The Resolution, which became official policy of the ABA, "supports the enactment of federal, state, and territorial legislation and regulations that oppose the use of mandatory, binding, pre-dispute arbitration agreements between a long-term care facility and a resident of such facility or person acting on behalf of such resident." 

In addition, CMS’s proposal to allow pre-dispute arbitration agreements is inconsistent with other initiatives of the Obama Administration.  The Consumer Financial Protection Bureau (CFPB) has initiated rulemaking on arbitration agreements, and, in March 2015, issued a Congressionally-mandated report, which found that arbitration agreements limit consumer relief in disputes.[36]  

On September 23, 2015, 34 Senators sent Administrator Slavitt a letter encouraging him to ban pre-dispute arbitration clauses in facility contracts.

The so-called protections that CMS purports to introduce in the proposed regulations are meaningless and unenforceable.  As long as CMS allows facilities to present binding arbitration agreements to residents and resident representatives for signing at the time of admission, they are inherently coercive and not voluntary.  Regardless of the supposed protections that CMS puts in the regulations – the voluntariness, the neutral arbiter, the prohibition against signing the agreement as a condition of admission – the agreements are not voluntary.  At admission, facilities typically present a collection of papers and ask residents and their representatives to sign.  In such an inherently stressful time, people sign whatever they are asked to sign.  They rarely have, or are given an opportunity, to read the documents. 

Moreover, even if arbitration agreements were explained and their meaning understood, residents and their families would be highly unlikely, at the time of admission, to be anticipating the need for litigation against the facility.  They would be hoping and expecting that care would be excellent.  They would not want to assume or indicate to the facility, at admission, that they were anticipating problems, poor care, and litigation.

We also note that protections identified in the preamble – “any agreement for binding arbitration should not be contained within any other agreement or paperwork addressing any other issues” and “we propose to specify that the guardians or representatives cannot consent to an agreement for binding arbitration on the resident’s behalf unless that individual is allowed to do so under state law, all of the other requirements of this section is [sic] met, and the individual has no interest in the facility” 80 Fed. Reg., 42211 – are not even included in the regulatory language.

The Center supports the comments on binding arbitration agreements that are submitted by California Advocates for Nursing Home Reform, the Center for Justice and Democracy, and the American Association for Justice, Consumer Voice, and 34 Senators.

CMA Recommendation: Either prohibit binding arbitration agreements, as proposed below, (bold font is new language) or delete §483.75(n) in its entirety.

§483.75(n): A facility may not enter into a pre-dispute agreement for binding arbitration with its residents.

Quality assurance and performance improvement, proposed §483.75, 80 Fed. Reg., 42212-42214

The Affordable Care Act requires nursing facilities to establish and implement a Quality assurance and performance improvement (QAPI) program. 

The preamble asks for comment on whether facilities should be required to have a specific number of Performance Improvement Projects (PIPs) and, if so, what that number should be.  80 Fed. Reg., 42213. 

CMA Recommendation: Our answer is yes.  Facilities should be required to have at least three PIPs in place at a time, reflecting different areas of concern.  At least one PIP should reflect residents’ rights and quality of life.

A facility cited with an immediate jeopardy deficiency(ies) should be required to have a PIP in the area where jeopardy was cited.

At end of §483.75(e)(3)

The facility must have at least three performance improvement projects in place at a time, including at least one performance improvement project addressing residents’ rights and quality of life.  A facility that is cited with one or more immediate jeopardy deficiencies must have at least one performance improvement project addressing the subject(s) of the jeopardy deficiency(ies). 

2. CMS also asks for comment on whether facilities should be required to select at least one PIP from a list of mandatory PIPs.  80 Fed. Reg., 42213.  Our response is yes.

CMA Recommendations: CMS should develop, and annually update, a list of a dozen mandatory PIPs, reflecting issues that CMS has identified as significant quality of care and quality of life issues.  This year, for example, the list could include antipsychotic drugs, psychotropic drugs, dementia care, therapy services, and transfer and discharge issues.  The list could reflect CMS’s analysis of deficiencies that are cited (indicating areas of concern) as well as reports from other government agencies or others indicating deficiencies that are often missed in the survey process.  For example, the ombudsman program is a good source of problems that are insufficiently cited and addressed in the regulatory system.  Transfer and discharge are among the most frequent areas of complaints to the ombudsman program, yet these issues are rarely cited as deficiencies.  Each facility must choose a PIP from among the list of mandatory PIPs developed annually by CMS each year.

In addition to CMS’s list of mandatory PIPs, states could develop lists of mandatory PIPs reflecting state concerns that facilities could select in addition to a federally-mandated PIP. 

Add a new (4) to §483.75(e)(4)

The facility must choose at least one performance improvement project from CMS’s list of mandatory performance improvement projects and, if its state develops a list of mandatory performance improvement projects, at least one project from the state list. 

CMA Recommendation: CMS should clarify that documents and reports used or relied on by QAPI are not confidential and must be disclosed to state survey agencies and others, on request, if the documents and reports are required to be produced for reasons other than QAPI. 

In Pinnix v. SSC Silver Stream Operating Company, No. 7:14-CV-00161-FL (E.D. N.C. Aug. 5, 2015),[37] a federal district court in North Carolina held that safety audit forms used, but not written, by the facility’s quality assessment and performance improvement program are not privileged or confidential and are subject to disclosure.

The issue of document confidentiality arose earlier in the context of quality assessment and assurance (QAA) committees, with similar court decisions.  In State of Missouri ex rel. Boone Retirement Center, Inc. v. Honorable Gene Hamilton, Judge, Circuit Court, Boone County, No. 79728 (June 17, 1997), Medicare & Medicaid Guide (CCH) ¶45,430, the Missouri Supreme Court held that the confidentiality of QAA records reflects a narrow privilege covering only the “minutes or internal working papers or statements of conclusions” of the QAA committee and that confidentiality of records does not “extend the statute’s privilege to records and materials generated or created outside the committee and submitted to the committee for its review.” 

In essence, both courts held that facilities cannot hide documents and reports in QAPI or QAA committees.  New language to incorporate this principle into QAPI and QAA is in bold font.

§483.75(h)(2)(i)  Non-disclosure of documents applies solely to minutes or internal working papers or statements of conclusions of QAPI and QAA.  Other documents and reports are not privileged and are disclosable to state survey agencies, and others, upon request, even if they are used by QAPI or QAA.  Documents are not confidential solely because they are used by QAPI or QAA.

Quality assessment and assurance committee, proposed §483.75(g), 80 Fed. Reg., 42214-42215

We reiterate our concern, stated above, about the confidentiality of documents and reports reviews by QAA committee.

Infection control, proposed §483.60, 80 Fed. Reg., 42215-42217

Recognizing the enormous costs of infections in residents, CSM proposes to strengthen the infection control regulations.  Reporting that 40% of drugs used in nursing homes are antibiotics and that 25-75% of the antibiotic use is inappropriate, CMS also includes a new antibiotic stewardship program.  80 Fed. Reg., 42216.

CMA Recommendation: The Center supports the new requirements, but support Consumer Voice’s recommendations that facilities must follow guidance from the Centers for Disease Control and Prevention.

Physical environment, proposed §483.90, 80 Fed. Reg., 42221-42222

1. CMS retains the current requirement, §483.70(d)(1)(i), that resident bedroom accommodate no more than four residents.  This requirement is inadequate.  Although the Center’s preference is private rooms for all residents, there should be no more than two beds per room.  The Center endorses the comments of Consumer Voice.

CMA Recommendation: Revise proposed §483.90(d)(1)(i) as follows.  New language is in bold font.

10. Accommodate no more than two four residents.

2. Residents need accessible outdoor space where they can safely enjoy fresh air and sunshine and move around as independently as possible. 

CMA Recommendation: New language is in bold font.

2. Space and equipment.  The facility must

3. Provide sufficient outdoor space that is accessible to residents and where residents can sit and move around as independently as possible.

Training requirements, proposed §483.95, 80 Fed. Reg., 42222-42225

1. All staff need an orientation to the nursing home and to residents at the beginning of their employment.  While direct care/direct access staff need more intensive training than staff who are not expected, in the ordinary course of their employment, to interact with residents on a daily or regular basis, all staff need orientation in residents’ rights, aging, dementia, abuse reporting requirements, and the policies of their facility.

CMA Recommendation: Add a new subsection to proposed §483.95.  New language is in bold font.

(a)Training and orientation for all staff.  Within the first two weeks of employment, all staff must receive training and orientation on, at least, residents’ rights, aging, dementia, abuse reporting requirements, emergency procedures, and the policies of their facility.

2. Nursing staff need training in specialized rehabilitative therapy, particularly the new requirement for respiratory therapy, and in pain management.  Paraprofessional nursing staff must be able to recognize situations where professional staff are needed and they must know how to initiate immediate contact with the necessary health care professionals.  This critical need is highlighted by the ALJ decision in Life Care Center of Columbia v. CMS, Docket No. C-13-367, Decision No. CR4132, (Aug. 18, 2015), discussed above.

CMA Recommendation: Add a new subsection to proposed §483.95.  New language is in bold font.

(h) Required training for nurse aides.  Nurse aides must be trained to recognize situations where professional nursing staff are needed and they must know how to initiate immediate contact with necessary health care professionals.

Word errors

1. Misuse of word “verbal” to mean “oral.”

In four places, the proposed regulations use the word verbal when the word oral is meant — §§483.10(f)(2), 483.10(g)(1), 483.11(f)(1), and 483.11(h)(3)(i).  When the word “verbal” is misused, the proposed rules say parenthetically “spoken.”  Change the word “verbal” to “oral” and delete the parenthetical explanation of spoken.

2. Use of term “resident representative” when “designated representative” was meant.

Proposed §483.12(c)(4) uses the term resident representative, instead of designated representative.

Thank you for the opportunity to submit these comments.

Sincerely,

Toby S. Edelman
Senior Policy Attorney
Center for Medicare Advocacy
1025 Connecticut Avenue, NW, Suite 709
Washington, DC  20036
(202) 293-5760, ext. 102
tedelman@MedicareAdvocacy.org