AMRPA Magazine - August 2019

August 2019 • Vol. 22, No.8

2019 Fall Educational Conference & Expo Loews Coronado Bay Resort San Diego, CA October 14-16, 2019

2020 Fall Educational Conference & Expo Renaissance Dallas Hotel Dallas, TX October 11-14, 2020

2021 Fall Educational Conference & Expo JW Marriott Turnberry Isle Miami, FL October 24-27, 2021

2022 Fall Educational Conference & Expo St. Louis Union Station Hotel St. Louis, MO October 9-12, 2022

August 2019 • Vol. 22, No. 8

The official publication of the American Medical Rehabilitation Providers Association (AMRPA)

Table of Contents Letter from the Chair

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Legislative Update

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U.S. Supreme Court Challenges Validity of CMS “Guidance” Impacting Payment of Rehabilitation Services and Devices

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Improving Physician Documentation for Medical Necessity

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AMRPA Seeking Innovative Burden Reduction Asks as Part of CMS’ New Patients Over Paperwork RFI

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MedPAC’s June Report Examines Three Issues Related to Post-Acute Care and a Unified Prospective Payment System

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AMRPA Submits Comments on the FY 2020 Inpatient Rehabilitation Facility Prospective Payment System Proposed Rule

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AMRPA Weighs In On Medicare Conditions of Participation for Co-Located Hospitals

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Patricia Sullivan AMRPA Senior Editor

Sergeant First Class Cory Remsburg AMRPA’s 2019 Fall Conference & Educational Expo Patient Perspective Speaker

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Brian McGowan Design and Layout

United Hospital Fund Reports Examine Difficult Decisions in Post-Acute Care

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AMRPA Magazine, Volume 22, Number 8

Study Assesses Outcomes of Inpatient or Clinic-based versus Home-based Rehabilitation After Elective Total Knee Arthroplasty

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Study Evaluates Association of Low Vitamin K Levels and Mobility Limitation and Disability in Older Adults

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Richard Kathrins, PhD Chair, AMRPA Board of Directors, President & CEO, Bacharach Institute for Rehabilitation John Ferraro, MS AMRPA Executive Director Kate Beller, JD AMRPA Executive Vice President for Government Relations and Policy Development Carolyn Zollar, MA, JD AMRPA Senior Policy Counsel Mimi Zhang AMRPA Director of Payment Innovation, Quality and Research Catherine Beal AMRPA Government Relations & Policy Coordinator

AMRPA Magazine is published monthly by the American Medical Rehabilitation Providers Association (AMRPA).

AMRPA is the national voluntary trade association representing inpatient rehabilitation hospitals and units, hospital outpatient departments and settings independent of the hospital, such as comprehensive outpatient rehabilitation facilities, rehabilitation agencies and skilled nursing facilities.

SUBSCRIPTION RATES: Member institutions receive the AMRPA magazine as part of their membership dues.

Send subscription requests to AMRPA, 529 14th St., NW, Washington, DC 20045 USA. Make checks payable to AMRPA. ADVERTISING RATES: Full page = $1,500; Half page = $1,000; Third page = $750. Ads may be B&W or full color.

Contact Brian McGowan, bmcgowan@kellencompany.com for additional specs and acceptable submission format.

Advertising Contact: Julia Scott, AMRPA, 529 14th St., NW, Washington, DC 20045 USA, Phone: +1-202-207-1110, Email: jscott@amrpa.org.

Statements of fact and opinion are the responsibility of the authors alone and do not imply an opinion on the part of the officers or the members of AMRPA. All content ©2019

by American Medical Rehabilitation Providers Association.

All rights reserved. Materials may not reproduced in any form without written permission. Design and layout services provided by Kellen Company.

POSTMASTER: Send address changes to Kellen Company, Attn: AMRPA Magazine Circulation 529 14th St., NW, Suite 750, Washington, DC 20045

AMRPA Magazine / August 2019

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Letter from the Chair

Richard Kathrins, PhD, President & CEO, Bacharach Institute for Rehabilitation RKathrins@bacharach.org

Responding to CMS' IRF PPS Proposed Rulemaking AMRPA submitted formal comments to the Centers for Medicare and Medicaid Services (CMS) last month in response to the Inpatient Rehabilitation Facility Prospective Payment System (IRF PPS) Notice of Proposed Rulemaking for Federal Fiscal Year 2020.

I have always been impressed by the amount of interest, support and input from the field in contributing to AMRPA’s comprehensive response. For this year’s submission, we had a number of workgroups addressing many of the pressing issues in this proposed rule, from quality reporting to the rule’s financial impact on IRFs. At one point, I believe we had well over 60 volunteers representing our membership on various workgroups. Still others reviewed our draft statements and even more members listened in to our June 26 membersonly webinar.

The AMRPA’s comment letter and key recommendations are addressed in a separate article in this issue of AMRPA Magazine. In our comments, AMRPA expressed serious concern about a number of issues related to the rulemaking, some of which are listed below:

The lack of data and analyses regarding the development of new case-mix groups (CMGs) and the proposed use of weighted motor score. As a result of the limited information provided in the proposed rule, the field was unable to understand how the proposed removal of some CMGs would affect patient classification in the IRF PPS and the impact of these changes to provider reimbursements.

AMRPA also urged CMS to conduct further analyses about the relationship between cognitive function and resource use and to identify cognitive status items suitable for classifying patients.

AMRPA took the position that a weighted motor score would be more likely to account for patient resource use than an unweighted motor score. However, CMS had not taken the necessary actions in this rulemaking to assure the field that its proposed weighting methodology would adequately and accurately account for rehabilitation hospitals/units’ patients’ complexity and resource use. Because of the lack of clarity, some members of our field justifiably had differing views of the use of the proposed weighted versus non-weighted motor scores.

AMRPA is fortunate to have an engaged, active and diverse membership. We had spirited conversations about a number of issues in preparing AMRPA’s response to CMS. In the end, we were all able to come together with one voice to address the important issues facing the field and ultimately our ability to care for our patients. Given the impact of the IRF PPS rule on our entire membership, AMRPA has continued to request that CMS supply the field with its data and analyses so that we could validate and understand the impact of its proposed policies.

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AMRPA Magazine / August 2019

Find new and exciting opportunities in AMRPA’s Career Center.

Our newly updated Career Center provides services and resources to help the medical rehabilitation field meet their professional goals.

All rehabilitation professionals may browse and apply for jobs at no cost, and AMRPA members will receive discounted rates for posting positions.

Visit our Career Center Here:

careercenter.amrpa.org

Begin by creating your free Career Cast account, which can be found on the top right hand corner of the website.

From there, you can upload and manage multiple resumes, browse through hundreds of job postings, and even research salaries of the positions in question! AMRPA members and affiliates may also purchase Posting Packages at a standard, premium, or platinum level.

AMRPA members will receive a 50% discount on all job postings.

For questions about our Career Center, contact Anna Kruskop, AMRPA Member Services Associate, at akruskop@amrpa.org or 202-207-1120.

AMRPA Magazine / August 2019

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Legislative Update

Pre-August Congressional Recess Wrap-up The July legislative calendar was full of legislative priorities and political debates pressuring Congressional leaders to clear the plate as much as possible before the month-long District Work Period in August.

Martha M. Kendrick, Esq., Partner, Akin Gump Strauss Hauer & Feld LLP

Highlights: »»

»» »» »» »»

ongressional leadership and the Trump C administration continue negotiations on how to raise the Budget Caps, before automatic sequestration spending cuts take effect in January 2020.

Congress moves forward on bipartisan surprise billing legislation, but hurdles remain on a drug pricing package.

The CMS Innovation Center announces two new mandatory payment models.

The federal appeals court case over the future of the Affordable Care Act (ACA) begins.

AMRPA continues to advocate for Members’ key concerns before top Administration officials at CMS and OMB and before Congress.

The Democratic majority in the House made significant progress on fiscal year (FY) 2020 appropriations in June, passing two minibus packages to fund all but two of the appropriations bills. The remaining two bills (Homeland Security and Legislative Branch) are not expected to be considered in the House until September. While Appropriations progress in the House has been steady, the Senate Appropriations Committee has yet to begin markups due to the lack of agreement on the overall spending level for FY 2020, which is currently set for a dramatic reduction thanks to the Budget Control Act of 2011.

Budget Cap negotiations are ongoing, but have largely remained at an impasse. With no sign of a deal on the horizon, Senate Appropriations Committee Chair Richard Shelby (RAL) announced shortly after the July 4 recess that his committee would not begin markups until progress has been made, which may help to jumpstart the talks. At some point this fall, the difference in funding levels will create a critical moment for Congressional leaders and the White House to reach a consensus or find themselves defending large sequester cuts to federal programs prior to an election season that will entrench both parties even further. The Budget Caps deal is also likely to address the debt ceiling, which will need to be suspended again in the coming months, possibly as early as mid-September according to a new analysis from the Bipartisan Policy Center.

The House is also likely to act on a bill to repeal the Cadillac Tax, enacted as part of the Affordable Care Act (ACA), as the bill has crossed the 290 cosponsor threshold for consideration via the new House Consensus Calendar rules. In the Senate, we expect continued confirmation of nominees, possible consideration of several tax treaties approved by the Foreign Relations Committee in June, and, per a statement by Senate Majority Leader Mitch McConnell (R-KY), a vote related to funding for the September 11 Fund. Additional health care legislation is possible in both chambers in July, depending on progress made by relevant committees.

Cost Containment Legislation Advances, Vote Possible Before August The limited July calendar allowed for a narrow window for Congress to move on a number of legislative items before the August recess, including a comprehensive cost containment package that addressed surprise billing and high drug prices.

On June 26, the Senate Health, Education, Labor and Pensions (HELP) Committee marked up its Lower Health Care Costs Act (S. 1895). The package, which addresses health care costs broadly, includes sections on surprise billing, drug pricing and price transparency. The bill adopts a benchmark payment rate approach with respect to determining reimbursement for providers in out-of-network billing scenarios. Specifically,

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AMRPA Magazine / August 2019

providers would be paid the median in-network rate based on their geographic area. It is expected that the HELP legislation will be combined with a Senate Finance Committee health care costs package, which has yet to be released, and a Senate Judiciary Committee package that was reported out just before the July 4 recess to address intellectual property concerns, such as so-called patent thicketing and product hopping, purported to impact drug prices. Senate Finance Committee Democrats with the exception of Sen. Bob Menendez (D-NJ) sent a letter to Chair Chuck Grassley (R-IA) and Ranking Member Ron Wyden (D-OR) urging them to move forward with a drug pricing proposal. Congress will be in session for only a few weeks before the August recess, leaving a small window of time for action on a final Senate package. As we go to print, there is increasing skepticism that the legislation will be considered by the Senate before Congress leaves.

The House Energy and Commerce Committee held a hearing on the issue on June 12, during which members from both sides of the aisle expressed concerns with the No Surprises Act released

by Chair Frank Pallone (D-NJ) and Ranking Member Greg Walden (R-OR). Like the HELP Committee’s legislation, the bill sets a benchmark payment amount based on the median local in-network rate. During the Health Subcommittee’s markup on July 11, physician Rep. Raul Ruiz (D-CA) expressed his ongoing concerns regarding the balance billing provisions of the No Surprises Act, citing the experience to date under California’s law. He asked to continue working with the committee to address these issues before the bill is considered by the full Committee.

In response, Chair Pallone noted that the committee’s approach had bipartisan support, and it also had bipartisan support in the Senate HELP Committee. Subcommittee Chair Anna Eshoo (D-CA) expressed interest in adding an arbitration backstop to surprise billing legislation but Chair Pallone remained non-committal.

Meanwhile, the House Ways and Means Committee has yet to release its own surprise billing proposal, though Health Subcommittee Chair Lloyd Doggett (D-TX) has expressed strong interest in addressing the issue. During the week of July 15, the Ways and Means Committee is expected to mark up health legislation; although, specific bills have not yet been identified.

The House is expected to consider health care cost legislation on the floor during the last week in session before the August recess.

Committees Readies Key Health Care Extenders While Congress continues to debate issues around drug pricing and surprise medical billing, lawmakers are also preparing for action later this year on a number of expiring health care programs and provisions. On June 4, the House Energy and Commerce Committee held a hearing to examine a dozen bills that would extend key programs such as community health centers, the National Health Service Corps, the Certified Community Behavioral Health Clinic demonstration, the Medicare Special Diabetes Program, the Teaching Health Center Graduate Medical Education Program, and the Patient-Centered Outcomes Research Institute Trust Fund. The Health Subcommittee advanced the slew of health care “extenders” on July 11 immediately after the recess; a full committee markup is expected soon with floor consideration before the end of the fiscal year on September 30 when these programs expire.

The subcommittee also advanced legislation to delay scheduled Medicaid Disproportionate Share Hospital (DSH) payment cuts for two years. Senate Finance Committee Chair Chuck Grassley (R-IA) is developing his own legislation that could pair a one-year delay with changes to the DSH allotments and how they are distributed.

On June 26, the House Ways and Means Committee marked up the Beneficiary Education Tools, Telehealth, and Extenders Reauthorization (BETTER) Act (H.R. 3417), which extends several expiring Medicare provisions. The legislation includes a three year extension of the work Geographic Practice Cost Index (GPCI) floor; additional funding for State Health Insurance Assistance Programs; and an extension of funding for quality measure endorsement, input and selection under the Medicare program.

The Senate HELP Committee approved its Lower Health Care Costs Act (S. 1895) on June 26. The legislation includes five year funding extensions for community health centers, the National Health Service Corps and the Teaching Health Center Graduate Medical Education Program.

It is unclear exactly how Congress will address all of the health care extenders, but it is likely these expiring authorities will be incorporated into a larger health care package or other moving legislative vehicle following the August recess.

Nondiscrimination Proposed Rule Faces Criticism The Department of Health and Human Services (HHS) Office of Civil Rights (OCR) on May 24 released proposals to alter regulations pertaining to Section 1557 of the ACA, which prohibits discrimination in certain health programs on the basis of race, color, national origin, age, disability and sex. The proposal would modify regulations to exclude pregnancy termination and gender identity as a basis for sex discrimination. It would also eliminate the requirement that insurers provide foreign language service notifications.

Several Democrats in the Senate, led by Sen. Patty Murray (D-WA), are demanded that HHS immediately withdraw the proposed regulation and respond by July 18 to a series of questions around why the department wants to remove protections for transgender individuals, women who terminate a pregnancy, and people with limited English proficiency.

President Trump Signs Health Care Cost Transparency Executive Order On June 24, President Trump released a new executive order aimed at increasing health care cost transparency. The executive order aims to arm patients with price and quality information to achieve affordability, options and control, and quality health care.

The order contains five “pillars” of how the administration will deliver health care improvements to patients and consumers.

First, the president orders HHS to require hospitals to disclose information about their negotiated rate in a format that is understandable and usable by patients as consumers. Second, the president instructs HHS, as well as the Departments of Labor and Treasury, to work together to require insurance companies to provide patients with information about the cost of care, including out-of-pocket costs, before they receive services rather than

AMRPA Magazine / August 2019

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after, as is the current standard. Third, the president is asking the entirety of the government to come up with a comprehensive quality roadmap for health care to ensure there are consistent, limited consumer-centric quality metrics that can drive quality improvements in the health care system. Fourth, the president seeks to ensure that federal health care data is disclosed in a way that protects patients, privacy, and security while enabling the transformation of the health care marketplace. The fourth pillar will also allow researchers and other entities to develop tools and analytics so that patients can be at the center and in control of their own health care and experience improved costs and quality of care. Finally, the executive order directs the Secretary of the Treasury to open up more health savings accounts (HSA) options by expanding the range of preventive services and products that can be covered during the deductible period as preventive services, allowing HSA money to potentially be used for direct primary care arrangements, and including health care sharing ministries as eligible medical expenses. In addition, the Secretary of the Treasury is directed to issue guidance that can increase the amount of funds that can be carried over.

President Trump Places Focus on Kidney Care with New Executive Order, Mandating New Payment Initiatives On June 10, President Trump announced an executive order, along with five new payment models, aimed at reducing the number of Americans who develop end-stage renal disease (ESRD) by 2030. The executive order focuses on incentivizing prevention of ESRD and late stage chronic kidney disease, improving access to home dialysis, and increasing the number of kidneys available for transplant. The implications for future mandatory CMMI initiatives could be significant so we wanted to share details.

The CMS Innovation Center will test Medicare payment changes that would provide a financial incentive for physicians and clinics to help kidney patients stave off end-stage kidney disease by about six months, and provide a bonus to nephrologists who help prepare patients for early transplant, with steps that can begin even before they need dialysis. The Kidney Care First (KCF) and Comprehensive Kidney Care Contracting (CKCC) Graduated, Professional and Global Models will build upon the existing Comprehensive End Stage Renal Disease (ESRD) Care (CEC) Model structure. The End-Stage Renal Disease (ESRD) Treatment Choices (ETC) Model will offer nephrologists a payment adjustment for helping patients get dialysis at home rather than the large centers that predominate today. The ETC Model is mandatory for chosen participants in order for the Innovation Center to conduct a robust test and evaluation of the models.

CMS also announced the proposed Radiation Oncology (RO) Model that aims to improve the quality of care for cancer patients receiving radiotherapy treatment (RT) by making prospective, episode-based payments in a site-neutral manner for 17 different cancer types. The RO Model would require mandatory participation from providers and suppliers that furnish RT services within randomly selected Core Based Statistical Areas. Comments on the proposed mandatory models are due on September 18, 2019.

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The executive order also called for allowing reimbursement of lost wages and other expenses for living donors, as well as improved ways to measure how well the nation’s 58 organ procurement organizations collect donations from deceased donors.

Future of the Affordable Care Act May Be in Jeopardy The 5th U.S. Circuit Court of Appeals, which is reviewing the Texas vs. United States case that will decide the future of the ACA, requested additional briefs on whether the sixteen states and the District of Columbia have the right to appeal the lower court’s ruling that the ACA is unconstitutional. This raised the ire of ACA supporters as a concerning new threat. The 5th Circuit also asked for both sides to deliberate on whether the House of Representatives has the right to defend the health care law. Oral arguments began on July 9 in New Orleans, and court observers maintain that the case may land back at the Supreme Court, which has upheld the majority of the ACA twice. Severability from the individual mandate, which Congress repealed last year, is a major point of contention between the opposing sides.

CMS Moves Forward with Reforming the Home Health Payment System On July 11, CMS released the CY 2020 Home Health Prospective Payment System Rate Update; Home Health Value-Based Purchasing Model; Home Health Quality Reporting Requirements; and Home Infusion Therapy Requirements Proposed Rule.

The proposed regulation updates payments to home health agencies (HHAs) by 1.3 percent ($250 million) for 2020, which includes reductions to the rural add-on payments mandated by the Bipartisan Budget Act of 2018. The rate also comprises adjustments for changes expected with implementation of the Patient-Driven Groupings Model (PDGM) and the 30-day unit of payment, as well as updates to the home health wage index data and outlier payments determined by the fixed-dollar loss ratio.

As required by the 21st Century Cures Act, CMS outlines its proposal for the home infusion therapy benefit that will be implemented in CY 2021. The benefit offers beneficiaries the option of receiving infusion drug therapies at home, such as chemotherapy or treatment for immune deficiencies, instead of traveling to a hospital or clinic. In a nod to feedback received from the agency’s Patients over Paperwork Initiative, CMS proposes to allow therapist assistants to perform maintenance therapy, instead of just therapists, as way to provide flexibility to HHAs and improve access to home health.

The proposed rule highlights the agency’s concern with an increase in fraud related to a Request for Anticipated Payment (RAP) “perpetrated by existing home health agencies that receive significant upfront payments, [but] never submit final claims and then close for business.” In response, CMS proposes to phase out RAP payments beginning in CY 2020 by reducing the RAP splitpercentage payments for all HHAs in CY 2020, and eliminating all split-percentage payments in CY 2021.

CMS continues to implement PDGM, including the behavioral adjustments finalized in last year’s HH PPS Rule, accompanied by a change in the unit of home health payment from 60-day episodes of care to 30-day periods of care, which will be adjusted for outliers

and partial episodes, as applicable. The PDGM is an alternate case-mix adjustment methodology to adjust payments for home health periods of care beginning on and after January 1, 2020.

CMS proposes that the CY 2020 estimated 30-day budget-neutral payment amount will decrease by 8.01 percent (higher than 2019’s estimate of 6.4 percent). CMS is soliciting comments on concerns stakeholders may have regarding the wage index used to adjust home health payments and suggestions for possible updates and improvements to the geographic adjustment of home health payments.

CMS proposes to adopt two new quality measures for use in the Home Health Quality Reporting Program (HH QRP): 1) Transfer of Health Information to Provider-Post-Acute Care; and 2) Transfer of Health Information to Patient-Post-Acute Care, as well as several standardized patient assessment data elements (SPADEs), as required by the IMPACT Act. CMS has suggested removal of the Improvement in Pain Interfering with Activity Measure (NQF #0177) from the HH QRP and Question 10, regarding pain communication, from the HHCAHPS Survey. CMS proposes to exclude baseline nursing home residents from the Discharge to Community PAC HH QRP measure.

Nine states have been participating in the Home Health ValueBased Purchasing (HHVBP) model since January 2016. CMS proposes to require public reporting of the Total Performance Scores (TPS) and TPS Percentile Ranking from the Performance Year 5 (CY 2020) Annual TPS and Payment Adjustment Report for each HHA participating in the nine model states that qualified for a payment adjustment for CY 2020.

Comments on the Proposed Rule are due on September 9, 2019.

OIG Finds Hospice Care Lacking in Oversight On July 8, the HHS Office of Inspector General (OIG) released two reports that found that from 2012 through 2016, the majority of U.S. hospices that participated in Medicare had one or more deficiencies in the quality of care they provided to their patients.

One report noted that some Medicare beneficiaries were seriously harmed when hospices provided poor care or failed to take action in cases of abuse. OIG made several recommendations in both reports to strengthen safeguards to protect Medicare hospice beneficiaries from harm and to ensure hospices are held accountable for deficiencies in their programs. CMS confirmed

that it will increase its oversight of the hospice program and make Hospice Compare quality information more accessible.

CMS did not agree to place state survey agency data on Hospice Compare, explaining that it would mislead consumers, but OIG urged CMS to reconsider as state survey agency data must already be made public. The second report focused on the beneficiary harm cases by hospices identified via a survey. CMS agreed to OIG’s recommendations, including strengthening the hospice Conditions of Participation to require hospices to develop policies for investigating potential harm and require that hospices report on suspected harm. *** With the month-long August Congressional Recess upon us, now is an opportune time to reach out to your members of Congress to alert and educate them on the negative impact of prior authorization for inpatient rehabilitation services and urge Congress to reform the prior authorization program in Medicare.

Specifically, we need to educate members of Congress about the adverse impact of the use of prior authorization in the Medicare Advantage (MA) program, and the care delays and patient access issues that such policy presents certain types of providers, including inpatient rehabilitation hospitals and units. Among other considerations, you may wish to mention that prior authorization is inappropriate and unnecessary for hospital-level rehabilitation care given the rigorous pre-admission requirements.

This is the most ideal time of year for you to activate grassroots advocacy on behalf of the field! Please reach out and contact your members of Congress during the month-long August recess, which is expected to start on August 5 and runs through September 8.

You can meet at their local district offices or, better yet, invite them to visit your hospitals. Your education and advocacy efforts are greatly needed! Timing is critical and we encourage you to reach out ASAP to your Member of Congress to make the connections, so we can have a timely impact on the legislative and regulatory processes.

We would be happy to provide you with any additional information and assistance you may need in reaching out to your members of Congress. Please be in touch if you need any assistance! We greatly appreciate your time and willingness to help AMRPA build relationships and educate members of Congress about key issues of concern to the field.

AMRPA Magazine / August 2019

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U.S. Supreme Court Challenges Validity of CMS “Guidance” Impacting Payment of Rehabilitation Services and Devices

Peter W. Thomas, JD, Principal, The Powers Law Firm

Leela Baggett, JD, The Powers Law Firm

On June 3, 2019, the United States Supreme Court issued a 7-1 decision in Azar v.

Allina Health Services,1 that will have far-reaching implications for the validity of the Centers for Medicare and Medicaid Services’ (CMS) sub-regulatory guidance governing Medicare payments to providers of rehabilitative services and devices. Although this case concerned a nuanced issue involving the manner in which CMS calculates Medicare disproportionate share hospital (DSH) payments, the case ultimately hinged upon the interpretation of a section of the Medicare statute that requires CMS to engage in noticeand-comment rulemaking. The Court held that CMS must use notice-and-comment rulemaking before issuing guidance that establishes or changes a substantive legal standard governing Medicare payment for services.

The Supreme Court rejected the government’s argument that the Medicare statute’s notice-and-comment rulemaking requirements do not apply to “interpretive” guidance that impacts Medicare payment, which CMS has historically issued through policy manuals and instructions to Medicare contractors. This ruling opens the door to challenging other Medicare sub-regulatory guidance such as the Medicare Benefit Policy Manual (“MBPM”), the Program Integrity Manual (PIM), and other guidance documents, which CMS issued without notice and an opportunity to comment. This memorandum provides an in-depth summary of Azar v. Allina Health Services and its potential impact on Medicare benefits and payments involving rehabilitative care.

Specific Decision in Allina Health Services The Medicare statute provides an additional payment to hospitals that serve a disproportionate share of low-income patients, known as the Medicare DSH payment (pronounced “dish”). The Medicare DSH payment is based on a formula that includes, among other factors, the fraction of a hospital’s patients who have Medicare/ Supplemental Security Income (SSI) or Medicaid coverage. Over the years, there have been numerous court cases concerning whether inpatient days attributable to patients enrolled in Medicare Part C plans should be included in the Medicare/SSI fraction or the Medicaid fraction. Prior to 2004, CMS excluded Medicare Part C days from the Medicare/ SSI fraction but included such days in the Medicaid fraction when determining the amount of DSH payments due to DSH hospitals.

Azar v. Allina Health Servs., 139 S. Ct. 1804 (2019). Justice Stephen Breyer dissented, and Justice Brett Kavanaugh vctook no part in this decision because he authored the lower court’s decision in this case.

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In 2004, CMS issued a final rule purporting to establish a policy to include Part C days in the Medicare/SSI fraction and to exclude such days from the numerator of the Medicaid fraction.2 However, in April 2014, the United States Court of Appeals for the District of Columbia Circuit held that CMS’s 2004 final rule was invalid.3 Despite this ruling, in June 2014, CMS posted on its website the Medicare/SSI fractions for fiscal year 2012, which included Part C days in the Medicare/SSI fractions. Several hospitals subsequently filed suit, which ultimately lead to the Supreme Court’s review of whether CMS violated the Medicare statute when it published its policy to include Medicare Part C days in the Medicare/SSI fractions for fiscal year 2012.

On June 3, 2019, the Supreme Court issued a 7-1 decision, holding that the 2012 Medicare/SSI fractions were invalid because CMS failed to follow notice-and-comment rulemaking procedures required under the Medicare statute when it included Part C days in those fractions. The Medicare statute requires CMS to provide public notice and a 60-day comment period for a “rule, requirement or other statement of policy (other than a national coverage determination) that establishes or changes a substantive legal standard governing the scope of benefits, the payment for services or the eligibility of individuals, entities, or organizations to furnish or receive services or benefits” under Medicare.4 The government argued that the Medicare statute’s noticeand-comment directives are functionally equivalent to the Administrative Procedure Act’s (APA’s) notice-and-comment requirements, which do not apply to “interpretative rules” that merely advise the public of CMS’s interpretation of statutes and rules that it administers.5 The government asserted that because its policy for counting Part C days in the Medicare/SSI fraction for fiscal year 2012 is an interpretive rule, as opposed to a substantive rule, under the APA, it was not required to provide notice and an opportunity to comment before adopting the policy.

The Supreme Court disagreed, determining that the Medicare statute’s notice-and-comment requirements are more expansive than the APA’s requirements. In particular, the Court found that the Medicare statute does not provide an exemption for “interpretive” rules, as under the APA. The Supreme Court determined that the 2012 Medicare/SSI fractions changed a “substantive legal standard” governing Medicare payment and, therefore, implicated the Medicare statue’s notice-and-comment rulemaking 7

MBPM, Pub. 100-02, Ch. 1, § 110.

8

Id. § 110.1.1.

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Id.

requirements. Because CMS merely posted the 2012 Medicare/ SSI fractions on the internet without notice and comment, the Supreme Court vacated the 2012 Medicare/SSI fractions.6 Implications of Azar v. Allina Health Services Although the Supreme Court’s decision only addressed the calculation of Medicare DSH payments, the Supreme Court’s decision will have significant repercussions for other Medicare “interpretive” rules or statements of policy that affect Medicare payment but were not issued in accordance with the Medicare statute’s notice-and-comment requirements. This decision opens the door for providers of rehabilitative care to challenge Medicare sub-regulatory guidance that CMS has historically issued through policy manuals and instructions to Medicare Administrative Contractors. This includes the standards governing coverage of inpatient rehabilitation facility (IRF) care that are stated in the MBPM but not in the statute or Code of Federal Regulations (CFR).

CMS established coverage criteria for IRF care that can be found at 42 C.F.R. § 412.622, a regulation that was subject to notice and comment. These regulations, therefore, are valid under both the APA and the Medicare statute and are unaffected by Allina Health Services.

However, CMS published the MBPM, which contains more specific IRF coverage standards that are not reflected in the Medicare statute or regulation.7 For instance, the MBPM “requires” that the preadmission screening include the patient’s prior level of function (prior to the event or condition that led to the patient’s need for intensive rehabilitation therapy); the patient’s expected level of improvement; the expected length of time necessary for the patient to achieve the expected level of improvement; evaluation of the patient’s risk for clinical complications; the conditions that caused the need for rehabilitation; the treatments needed; the expected frequency and duration of treatment in the IRF; the anticipated discharge destination; and any anticipated postdischarge treatments.8 There are numerous examples of MBPM requirements that impact IRFs’ substantive rights to payment under Medicare that are potentially implicated by this decision.

The MBPM also directs the rehabilitation physician to document concurrence with the preadmission screening prior to the IRF admission.9

Medicare Program; Changes to the Hospital Inpatient Prospective Payment Systems and Fiscal Year 2005 Rates, 69 Fed. Reg. 48,916, 49,099 (Aug. 11, 2004).

2

3

Allina Health Services v. Sebelius, 746 F.3d 1102 (D.C. Cir. 2014).

4

42 U.S.C. § 1395hh(a)(2).

5

5 U.S.C. § 553(b)(A).

The Supreme Court’s decision does not govern the treatment of Part C days for cost reporting periods that are entirely after October 1, 2014, because CMS promulgated a new rule, using notice-and-comment procedures, that provides for inclusion of Part C days in the Medicare/SSI fraction, effective October 1, 2014. Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participating; Payment Policies Related to Patient Status, 78 Fed. Reg. 50,495, 50,620 (Aug. 19, 2013).

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These MBPM “requirements” are not grounded in statutory or regulatory language and were not promulgated in accordance with the Medicare statute’s notice-and-comment requirements.

However, inpatient rehabilitation hospitals and units routinely have IRF claims denied for failure to comply with these additional MBPM standards. (It should be noted that some provisions of the MBPM—such as the brief exceptions policy—are helpful to IRFs and, therefore, the holding in Allina Health Services may cut against IRFs in some instances.)

The Supreme Court’s decision is now the law of the land in this country but it is not the only basis to challenge the MPBM-only IRF standards. In Cumberland County Hospital System, Inc. v. Price, the United States District Court for the Eastern District of North Carolina held that the MBPM “standards” that pertain to IRFs as set forth in Chapter 1, § 110.1 cannot be applied as mandatory.

The district court determined that “the MBPM does not merely clarify or interpret the requirements in the regulation, but creates a new standard by specifying particular items of information not provided for in the regulation.” The MBPM creates substantive requirements that were not properly issued through noticeand-comment rulemaking in accordance with the APA. The Cumberland County decision rested upon the APA and not the Medicare statute’s notice and comment requirements, but the overall holding of the case had the same impact.

IRFs seeking to challenge additional IRF coverage criteria set forth only in the MBPM now have an additional arrow in their quivers as a result of the Supreme Court’s decision. Allina Health Services, however, is not without limitation. It is unclear how courts will interpret this landmark decision, given that the Court did not clearly define what policies affect a “substantive legal standard.”

It is also unclear whether Congress will react to the decision by amending the Medicare statute.

Allina Health Services paves the way for providers of rehabilitative services to challenge Medicare sub-regulatory guidance that has not gone through notice-and-comment rulemaking, assuming that guidance affects a substantive right to payment for services and is not included in the Medicare statute or regulations. We expect that providers of rehabilitative services will challenge several provisions of the MBPM in the coming years, assuming Congress does not act or CMS does not subject the MBPM to notice and comment to bring it into compliance with the Court’s decision in Allina.

Powers Law Firm congratulates its former colleagues, Stephanie Webster, JD, and Christopher Keough, JD, of the Akin Gump Strauss Hauer & Feld, LLP, legal team that argued the Azar v. Allina Health Services case in the federal courts and at the U.S. Supreme Court. Akin Gump’s Martha Kendrick, JD, and Powers’ attorneys Peter Thomas and Ron Connelly, serve as AMRPA’s Washington Counsel.

10 Cumberland Cty. Hosp. Sys., Inc. v. Price, No. 15-CV-319, 2017 WL 1048102, at *13 (E.D.N.C. Mar. 1, 2017), report and recommendation adopted by, No. 5:15-CV-319-D, 2017 WL 1049476 (E.D.N.C. Mar. 17, 2017). This case specifically concerned the requirements for the preadmission screening contained in the MBPM but not in the regulation. However, the court’s reasoning can be applied to other MBPM standards that are not stated in the Medicare regulation.

11

Id.

12 AMRPA Magazine / August 2019

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AMRPA Magazine / August 2019 13

Improving Physician Documentation for Medical Necessity

Lisa Werner, MBA, MS, SLP Director of Consulting Services, Fleming-AOD, Inc.

Thanks to the overabundance of regulatory organizations on the doorsteps of our inpatient hospitals and units, regular audits of patient records have been the norm for a number of years. As I do workshops and audits across the country, I hear that a recurring issue for rehabilitation providers is figuring out a formula for proving medical necessity.

The better we manage the technical components of timely record completion, the more stringent the external auditors become on the topic of medical necessity. Since every reviewer, either internal or external, relies on his/her own interpretation of the regulations, developing a working formula is challenging.

At its most fundamental level, the purpose of documentation is to ensure continuity of care and to secure reimbursement for services rendered. However, this list should also: highlight progress made;

// At its most fundamental level, the purpose of documentation is to ensure continuity of care and to secure reimbursement for services rendered.

focus on deficits; clearly state the barriers to discharge; be written for your audience, who is likely the Medicare or insurance auditor.

We are going to walk through the common elements of physician documentation for inpatient rehabilitation to identify areas where the case can be made for a reasonable and necessary stay.

The pre-admission screening document is the first step in defending your decision to admit a patient to an inpatient rehabilitation facility. That document should demonstrate that the patient would benefit significantly from an intensive inpatient program and show why an inpatient rehabilitation program is necessary. Specifically, the document should provide evidence that the patient has ongoing medical needs that require intervention while in rehab. It is important to list the medical conditions being managed in acute care with a basic plan for those that will require oversight in rehab. A functional assessment is also important. This should include an explanation of why an intensive rehabilitation setting is the only safe environment for this patient or why the patient has the potential to make significant gains as a result of the stay. It should demonstrate deficits that indicate the need for at least two therapy disciplines as well.

In my experience, the two areas of pre-admission screening tools that need the most improvement are the review of medical needs that reflects complex management and a summary to justify the necessity of inpatient rehabilitation level of care. To address the former, it is important to mention the potential consequences of not closely managing a condition. When documenting, think in terms of what the patient is at risk for without close medical supervision. To address the latter, state specifically that the patient

14 AMRPA Magazine / August 2019

requires an inpatient rehabilitation level of care and list the reasons why in medical and functional management terms.

Physician documentation also must show complexity. The plan should reflect active medical management that the physician will direct and the rehabilitation nurse will monitor. Where there are consulting physicians, the physiatrist's role is to lead the rehabilitation team based on his/her unique knowledge of how the medical management impacts the patient's rehabilitation progress and participation. Additionally, the physician should set a plan for the type of nursing care unique to rehabilitation nurses, like education and training for adjustment to the disease, ensuring skin integrity, medication management, pain management, safety awareness, and bowel and bladder management to name a few. Since increased activity will impact medical stability, it is also important for the rehab physician to direct the therapy protocol in the plan established at admission.

A strong plan shows how the patient’s medical conditions and functional issues are interrelated.

Showing ongoing progress and the need for continued intensive rehabilitation services is also a challenge. When we do our jobs well, the patient remains free from complications and gets better.

Throughout the stay, we must justify the continuing need for our program, so this can seem like a Catch-22. What I find when I review physician documentation is that often the decision-making that takes place during regular visits is not recorded in the progress notes. It is very important to state in the progress notes the reasons for ordering new medications, tests, consultations or services. Some physicians list daily changes separate from the assessment plan to indicate a note from each visit. The physician provides the date of the visit and notes changes or observation made. He/she adds to the list each day, so at the end of the stay the medical management that took place over the course of the stay is clear.

Aside from the medical interventions reported in the progress notes, the physician should also indicate progress in therapy at least three times per week, changes to the plan of care, barriers to attaining goals, and collaborative efforts of the team and other consulting physicians. We know that the patient’s medical status can impact their ability to participate in therapy. The physician should document how medical management initiatives are impacting or are likely to impact the therapy outcomes.

The discharge summary is the last opportunity to justify the inpatient rehabilitation admission. Here the physician should review the course of the inpatient rehabilitation stay with emphatic statements demonstrating why inpatient rehabilitation was reasonable and necessary for the patient. Contrasting status at admission and discharge is a good way to show the value of the physical rehabilitation program, while the course of the hospital stay shows the value of the medical management. Of course, we should not forget to document the impact that the rehabilitation nurse plays in both areas of improvement.

In summary, focus physician documentation on the medical management needs of the patient, including those things that will reduce risk and prevent complications related to increased activity. Highlight the need for around-the-clock rehabilitation nursing with emphasis on areas where they impact medical management and the return to independent living. Comment on therapy progress, barriers and the impact of medical conditions on the patient’s functional performance. Audit your records regularly and use the findings to continually improve the quality of your documentation. Don’t wait for a CMS auditor to tell you that you need to do a better job. Prevention is the best medicine.

AMRPA Magazine / August 2019 15

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16 AMRPA Magazine / August 2019

AMRPA Seeking Innovative Burden Reduction Asks as Part of CMS’ New Patients Over Paperwork RFI

Kate A. Beller, JD, AMRPA Executive Vice President for Policy Development and Government Relations

In June 2019, the Centers for Medicare and Medicaid Services (CMS) issued a request for information (RFI) seeking input from stakeholders on how it can continue to advance its Patients over Paperwork initiative. The initiative was launched in fall 2017 and aims to “significantly cut the red tape that weighs down weighs down [the] healthcare system and takes clinicians away from their primary mission—caring for patients.” According to CMS, the regulatory reforms implemented through the Patients over Paperwork initiative will result in an estimated savings of 40 million hours and $5.7 billion through 2021.

Since the launch of Patients over Paperwork, CMS has issued a series of RFIs in various annual payment rules and other stakeholder engagement opportunities seeking ways to streamline various administrative requirements. In the federal fiscal year (FY) 2018 Inpatient Rehabilitation Facility Prospective Payment System (IRF PPS) Proposed Rule, published in the Federal Register on May 3, 2017, CMS specifically solicited recommendations on ways to reduce regulatory burdens and improve efficiencies in the context of the IRF benefit. AMRPA provided a comprehensive response to CMS, urging the agency to address issues including, but not limited to: Revising the IRF classification criteria, particularly vis-à-vis changes to the 60 Percent rule (for example, expanding the conditions covered by the 60 Percent rule); Improving coverage criteria, such as by simplifying the intensity of therapy policy to require that the aggregate amount of therapy over the course of the IRF stay aggregates to at least 15 hours per week; Ensuring new unit parity to allow hospital-based rehabilitation units to be paid under the IRF PPS from the outset (the same as freestanding rehabilitation hospitals), regardless of whether the unit opens on or after the first day of the cost reporting period; Protecting Medicare Advantage (MA) beneficiaries access to IRF services by addressing the use of proprietary guidelines in MA and clarifying the preeminence of Medicare coverage rules; and Implementing a series of proposals to address audits, denials and appeals, such as consolidating the redetermination and reconsideration stages of the appeals process in order to streamline and speed the resolution of appeals

AMRPA Magazine / August 2019 17

Since submitting its response in the FY 2018 IRF PPS RFI, AMRPA has continued to engage extensively with both CMS and Congress regarding the issues raised in our comment letter. AMRPA has also closely analyzed how subsequent legislative and regulatory developments – such as continued implementation of the Improving Medicare Post-Acute Care Transformation (IMPACT) Act and the FY 2019 and FY 2020 IRF PPS proposed rules - affect AMRPA’s burden reduction strategies. For example, AMRPA has closely tracked the Department of Health and Human Services’ (HHS) efforts to implement standardized patient assessment data elements (SPADEs) across post-acute care (PAC) settings and has identified ways for HHS to help minimize SPADE reporting burdens specifically for inpatient rehabilitation hospitals and units.

In this most recent RFI, CMS asserts its continued interest and ongoing efforts to reduce regulatory burdens across the Medicare program. While the RFI does not address any IRF-specific efforts or provisions, the text indicates that CMS remains engaged in its efforts to work with patients, providers, caregivers, payers and other stakeholders to further address issues across PAC settings. CMS notes that it is “especially seeking innovative ideas” in certain areas of the Medicare program, including reporting and documentation requirements, and policies with special impact for rural providers and patients. Of note, CMS requests comments on addressing prior authorization procedures used in the Medicare program, which aligns with one of AMRPA’s top current policy objectives.

Interestingly, CMS states in the RFI that it will use a “humancentered design” approach to identify and respond to regulatory relief requests from stakeholders. CMS explains that, through this approach, the agency is looking to understand the “everyday impact” of burdensome rules and help “build better policies that meet people’s needs.” To this end, AMRPA will look to our full membership for ideas and plans to highlight those areas

18 AMRPA Magazine / August 2019

// Since submitting its response in the FY 2018 IRF PPS RFI, AMRPA has continued to engage extensively with both CMS and Congress regarding the issues raised in our comment letter. AMRPA has also closely analyzed how subsequent legislative and regulatory developments... affect AMRPA’s burden reduction strategies. where CMS can improve the “everyday” impact of IRF coverage, reporting and documentation requirements. We will also continue to zealously advocate for additional regulatory and legislative action on those areas where IRFs already face duplicative or unnecessary compliance requirements. We appreciate all forms of membership input on this critical issue.

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MedPAC’s June Report Examines Three Issues Related to Post-Acute Care and a Unified Prospective Payment System On June 14, the Medicare Payment Advisory Commission (MedPAC) released its June report, “Report to the Congress: Medicare and the Health Care Delivery System – June 2019.” The annual report examines a number of Medicare issues, and this year’s report includes a chapter titled “Payment Issues in Post-Acute Care” which addresses topics relevant to inpatient rehabilitation hospitals and units (IRH/Us), long-term care hospitals (LTCHs), skilled nursing facilities (SNFs) and home health agencies (HHAs).

Carolyn C. Zollar, MA, JD, Senior Policy Counsel, AMRPA

Mimi Zhang, AMRPA Director of Payment Innovation, Quality and Research

Other issues examined in the June report include: beneficiary enrollment in Medicare; restructuring Medicare Part D and specialty drug coverage; payment strategies regarding Part B drugs; beneficiary access to primary care; the Medicare Shared Savings Program and effect on Medicare spending; the accuracy and completeness of the Medicare Advantage encounter date; redesigning the Medicare Advantage quality bonus program; options for slowing emergency department service growth; promoting the integration in dual-eligible Special Needs Plans; and a Congressionally-mandated report on changes in post-acute and hospice care after implementation of the LTCH dual payment-rate structure.

Payment Issues in Post-Acute Care, Chapter 9 In 2016, 43 percent of Medicare fee-for-service (FFS) patients discharged from an acute care hospital were discharged to post-acute care (PAC) providers: IRH/Us, LTCHs, SNFs and HHAs. Total spending in the sector was approximately $60 billion in 2017, with $24.8 billion spent on SNFs and $17.7 billion spent on HHAs. Under the Improving Medicare Post-Acute Care Transformation (IMPACT) Act of 2014, MedPAC was mandated to issue a report on a technical prototype of a post-acute care prospective payment system (PAC PPS) in 2016. Readers will recall that MedPAC met the deadline and suggested that Congress implement the payment system quickly. In each subsequent year, MedPAC has analyzed various issues involved in implementing the unified PAC PPS. In this year’s report the commission examined: The advantages and disadvantages of a stay-based versus an episode-based payment system; The reliability of functional assessment data as recorded by providers; and The current regulatory requirements for PAC providers and approaches for establishing aligned requirements under a PAC PPS. Throughout the report it is interesting to note the repeated theme of anticipation or hypothesizing about provider behavior and generally negative provider behaviors such as

AMRPA Magazine / August 2019 21

stinting on care, “cherry-picking” cases, scoring functional ability to enhance payment and the like. This sentiment is reflected in the most recent commission discussions and staff presentations, much to the dismay of all PAC providers.

Stay-Based versus Episode-Based Payment System In 2016, the commission recommended a PAC PPS model that used stays (either an institutional PAC stay or a home health episode) as the unit of service — that is, a stay-based model would pay for each PAC individual stay. In 2017, the commission sought to improve upon the stay-based model and explore an episodebased model as it believed an episode-based model would further discourage fee-for-service and volume-based incentives. Over the past year, MedPAC has been developing an episode-based PPS model and its findings are summarized in this report. The commission concludes that it is not feasible to proceed with an episode-based model at this time and outlines what it perceives to be the analytical challenges to setting appropriate payment rates in an episodic payment system. Nonetheless, the commission remains interested in revisiting the episode-based model in the future.

The commission conducted an extensive review of an episodebased approach and compared it with a stay-based design. It noted a number of advantages and disadvantages of such an approach. An episode-based stay included only PAC stays, not Part B utilization, intervening acute care hospital stays during the episode, or prior hospital stays. With regard to advantages, an episode-based approach would: dampen incentives to generate unnecessary care with regulatory alignment; allow more flexibility for providers to offer a continuum of services; and “align the unit of service with how PAC providers offering a continuum of services would furnish care.” However, MedPAC determined (based on its analysis of 2017 Medicare data) that an episode-based design would result in untenable differences in profitability across all

episodes with large overpayments for relatively short episodes and underpayments for long ones. The report notes that a high-cost outlier payment policy could be designed to help mitigate these effects, ultimately the variance is so great that outlier payments alone would not be able to correct the significant under- and overpayments.

After evaluating both approaches extensively and the tradeoffs between the two designs, the commission concludes that a staybased design is the better initial strategy for CMS to pursue at this time. It also suggested that once providers have adapted to the new PPS and practice patterns have converged, CMS could consider an episode-based design. Table 9-7 from the report (reproduced below) offered the following comparison of the two approaches.

MedPAC also recommends that a stay-based PAC PPS be implemented in combination with two other strategies to tamp down any volume-driven incentives: Value-based purchasing; and Strengthening incentives for entities that assume risk, such as accountable care organizations (ACOs), and allowing PAC providers to engage in shared savings with ACOs. In reality, simply trying to graft these policies onto a unified PAC PPS may not be appropriate for the PAC sector given its unique attributes and thus requires further examination, as MedPAC recommends.

Reliability of Functional Assessment Data The commission ’s skepticism about provider behavior continues to be reflected in this section of the report. MedPAC addresses its previously stated concerns regarding the validity and accuracy of provider-reported patient function data when such data are used

Table 9-4 from the chapter, duplicated below, summarizes the impact of an episode-based PAC PPS model.

22 AMRPA Magazine / August 2019

to adjust Medicare payments and in quality reporting, stating, “… when payment is tied to patients’ functional status, providers can report this information in ways that raise payments rather than capture patients’ actual clinical care needs.”

To evaluate the quality of provider-reported functional assessment information, MedPAC examined the consistency of reporting for the same beneficiaries discharged from one PAC setting and directly admitted to another, and between the function information recorded for quality reporting and the information used to establish payments. It acknowledges that other administrative data, such as diagnoses included in claims data, are also provider reported and may also be vulnerable to misreporting, yet patient functional status is “more subjective” and may be more difficult to audit. Patient function data is used by Medicare for both payments and quality programs, and MedPAC reviewed the assessment tools used by PAC providers. Specifically, IRH/Us, HHAs and SNFs have reported setting-specific function items for payment but use uniform function items for the settings’ Medicare quality reporting programs.

To evaluate provider-reported function data, MedPAC conducted the following analyses: 1. Compared same-patient functional statuses of beneficiaries who transitioned between PAC settings by examining patient function at IRH/U discharge versus:

a. At HHA admission (using setting-specific function items);

b. At SNF admission (using setting-specific function items); and

c. At SNF admission (using uniform function items).

2. Examined the consistency of IRH/U and SNF assessments by comparing the same-patient functional statuses recorded on items used for payment versus on items used for quality reporting.

3. Compared function level to other beneficiary characteristics such as age and risk scores As a result of this review, MedPAC’s key findings are as follows: When comparing assessments for individual patients, MedPAC found “large inconsistencies’ in the reporting of functional assessment information, especially when patients were discharged from one PAC setting to another. For these beneficiaries, MedPAC notes that functional status recorded at discharge from one setting and at admission to the next were often different and favored reporting functional levels that resulted in higher payments for the admitting PAC provider. Hence MedPAC concludes that levels of function assessed across sequential stays were inconsistently reported with differences that would predominantly raise payments.

A “disproportionate share” of the function levels reported for quality purposes were higher than the function levels reported in the payment-related items.

Recording of data in high margin and low margin IRH/Us suggests problems with the integrity of the IRF-PAI. This criticism has been one of MedPAC’s continuing themes since 2016.

Inconsistencies between HHA-reported function outcomes and claims-based measures raises questions about the validity of provider-reported assessment data.

Given provider responses to changes in payment policies/ incentives historically, MedPAC believes there may be issues if provider-reported patient function data are used for payments.

In comparing function level with other characteristics, MedPAC found, on average, what it expected for patients with the highest and lowest levels of function. Specifically, beneficiaries in the lowest function group had higher severity of illness and beneficiaries with the highest function had lower severity.

The commission concluded that the inconsistencies of the patient functional assessment data “undermines our confidence in and the desirability of using provider-reported function for payment.”

It went on to state that since maintaining and improving function is a key component of beneficiaries’ post-acute care, CMS needs to improve the provider-completed assessment or explore alternative methods to obtain patient function data. The commission suggests four strategies by which the assessment data could be improved.

They include: Improving the monitoring of provider-reported assessments and conducting on-site audits of providers that have submitted aberrant data; Keeping the patient assessment at discharge from the first setting as the assessment for subsequent PAC providers; Requiring acute care hospitals to complete assessments of patient when discharged. However, since a large number of PAC stays are not preceded by a hospital stay this strategy would have limited applicability; and Gathering patient reported outcomes. For patients with cognitive deficits or who are otherwise unable to self-report, proxies may be needed.

Aligning Regulatory Requirements across PAC Finally, MedPAC examines current regulatory requirements for PAC providers and discusses approaches for establishing aligned requirements under a PAC PPS. It started by examining the Conditions of Participation (CoPs) for all PAC providers in five common areas: Services and staffing, including staff credentials; Care planning, including requirements related to care coordination; Patient assessment; admission, transfer and discharge of patients; administration, including administrative staff and activities, such as planning and budgeting; other operational requirements, such as certification; quality and safety; and patients’ rights while under the care of the provider, such as

AMRPA Magazine / August 2019 23

the requirement to be informed of their rights and the right to privacy and confidentiality.

While MedPAC states that the SNF and HHA requirements “set the basic requirements for institutional and in-home PAC” (which is a sobering statement for IRH/Us and LTCHs), it also states that requirements in a unified PAC PPS should not be based on the least restrictive or least burdensome requirement for the existing settings. Rather, they should be based on the minimum conditions needed to ensure patient safety. On this point, the report points to Medicare’s requirements for durable medical equipment (DME) suppliers as an example of a similar tiered approach. Under that system, a general set of requirements applies to all DME suppliers that participate in Medicare, while there are separate requirements for suppliers that offer more sophisticated DME products, such as respiratory devices, manual and power wheelchairs and orthotic and prosthetic devices.

Table 9-14 in the report presents a comparison of selected regulatory requirements across the four PAC settings.

The commission suggests aligning the requirements for PAC providers via a two-tiered system of regulations that establishes patient-centered definitions to link program requirements to the types of patients treated. The new CoPs would include a first tier of criteria would apply to all PAC providers, while a second tier would apply to providers offering specialized services to treat patients with more complex care needs.

Certain requirements under a unified PAC PPS would be different for institutional care and home health care since providing care in a patient’s home differs from providing care in an inpatient or institutional setting. For institutional PAC, MedPAC suggests 24/7 nursing services furnished from a registered nurse (RN), akin to what IRH/U and LTCH already provide as hospitals. MedPAC also suggests that physician requirements could be more frequent than that current SNF standard, but less frequent than the physician visits in IRH/Us and LTCHs currently.

Tier 1 Tier 1 requirements would establish baseline requirements for services that are applicable to most PAC patients. These criteria would define the level of physician supervision, nurse staffing, licensure requirements, and the professional qualifications of nurses, therapists and aides. Because almost every PAC user requires rehabilitation services, a relatively high level of rehabilitation services should be available to patients before referral to more specialized providers. Staffing requirements should address physical therapists, occupational therapists, speech– language pathologists and the supervision of aides. Similar to existing requirements, facilities could be required to have the skill mix and staffing level appropriate for the patients they serve.

As we know, Medicare allows at least IRH/Us and SNFs to provide therapy on an individual, concurrent, or group basis. Under the revised requirements for a unified PAC PPS, MedPAC states that Medicare could establish limits on the mix of individual, group and concurrent therapy minutes a patient receives or sets a cap on the number of patients who can be treated at the same time.

24 AMRPA Magazine / August 2019

Tier 2 Tier 2 requirements would define the capabilities of providers seeking to treat patients with specialized or high-cost needs. It is critical that these requirements protect beneficiaries from receiving substandard care by providers who lack the expertise to truly care for them. The report does not delineate fully all the potential patient categories under a Tier 2 system. Rather, MedPAC states that Medicare, in establishing categories, would have to consider a potential tradeoff between examining utilization patterns (which could reflect responses to financial incentives) with the use of technical expert panels or other processes of clinical consensus.

The report presents several categories of care that would require Tier 2 criteria: Chronically critically ill (CCI) patients; Patient requiring prolonged ventilator services or specialized respiratory care; Patients with serious infections and those receiving chemotherapy; and Patients who require intensive rehabilitation: The intent of this specialized category would be to identify patients with very complex or specialized rehabilitation needs well beyond those that would be available in the first tier of requirements. Patients who require this level of intensive rehabilitation would include patients with severe limitations due to severe stroke, complex joint replacement (such as patients recovering from bilateral joint replacement who are obese), brain and spinal cord injury and major joint trauma.

The rehabilitation care for these patients would often include multiple therapy disciplines (physical therapy, occupational therapy and speech-language pathology services). The expectation would be that these patients would receive the majority of their therapy services in one-on-one care, not in group or concurrent therapy. The requirements could also specify that providers offer the appropriate laboratory and pharmacy services for patients typically requiring this level of rehabilitation.

Patients who require dialysis.

The report also notes that existing PAC regulations would need to be examined. As it has done before, MedPAC suggests eliminating the IRH/U 60 Percent rule and the LTCH 25-day length-of-stay rule under a PAC PPS, as well as revising coverage criteria such as the IRH/Us’ intensity of therapy and certain physician supervision requirements. With regard to the SNF three-day preceding hospitalization requirement, MedPAC believes that requiring all patients to have a prior hospital stay in order receive institutional PAC would “tighten safeguards for appropriate use.” The report suggests that a prior-hospitalization requirement may not need to apply to certain PAC PPS patients, such as those with Tier 2 conditions, or to patients who have two preceding observation days.

The report acknowledges that, realistically, changing such regulations would take a considerable period of time. It suggests an incremental approach and that such alignment should be in

place before the PAC PPS is put in place. An initial set of revisions could implement common requirements for all providers where existing requirements do not vary substantially across all four providers. This step would also include eliminating setting specific requirements that “would no longer make sense” such as the 60 Percent rule. Then a second set of criteria could be implemented at a later date to address Tier 2 requirements and staffing levels.

Next Steps This chapter represented a culmination of the commission ’s work on post-acute care payment over the past year. The commission will start its next cycle of public meetings on September 5-6, 2019, and AMRPA anticipates that MedPAC will continue to evaluate an evolving array of issues with regard to post-acute care. These can include value-based purchasing for the PAC PPS, given the commission s prior public statements on this topic. AMRPA will keep the membership apprised of future updates.

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26 AMRPA Magazine / August 2019

AMRPA Submits Comments on the FY 2020 Inpatient Rehabilitation Facility Prospective Payment System Proposed Rule On June 17, 2019, the American Medical Rehabilitation Providers Association (AMRPA) submitted detailed comments to the Centers for Medicare and Medicaid Services (CMS) regarding the federal fiscal year (FY) 2020 Inpatient Rehabilitation Facility Prospective Payment System (IRF PPS) proposed rule.

In our letter, AMRPA expressed serious concern about the lack of analyses and technical information provided by CMS on the FY 2020 new case-mix groups (CMGs) and the proposed weights for a weighted motor score. AMRPA also urged CMS to conduct further research on the relationship between cognitive function, case-mix and resource use to identify cognitive items that are suitable for classifying rehabilitation hospital patients. With regard to the IRF Quality Reporting Program (IRF QRP), AMRPA voiced its concern about the increased burden associated with the proposed standardized patient assessment data elements (SPADEs) and recommended specific actions CMS should take to minimize and otherwise account for provider burden.

AMRPA supported CMS’ proposals to update the IRF PPS wage index policies to provide parity with acute care hospitals, and urged CMS take further action to ensure equity in the labor market between different types of hospitals. Regarding the proposed FY 2020 market basket update, AMRPA again requested additional information to better understand CMS’ proposed changes. Finally, AMRPA supported CMS' proposal to amend the definition of the rehabilitation physician to provide deference to the inpatient rehabilitation hospital/unit in determining appropriate qualifications.

A summary of the recommendations from AMRPA’s letter is printed below. The complete letter, including Attachment A, is available on the AMRPA website.

As always, AMRPA greatly appreciates those member volunteers who contributed their time and effort to help develop our comments.

AMRPA Magazine / August 2019 27

June 17, 2019 The Honorable Seema Verma Administrator Centers for Medicare and Medicaid Services U.S. Department of Health and Human Services Attention: CMS-1710-P Hubert H. Humphrey Building 200 Independence Avenue, Southwest Washington, D.C. 20201 Delivered Electronically RE: CMS-1710-P "Medicare Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2020 and Updates to the IRF Quality Reporting Program” 84 Fed. Reg. 17244 (April 24, 2019).

Dear Administrator Verma: The American Medical Rehabilitation Providers Association (AMRPA) is pleased to submit our comments regarding the Inpatient Rehabilitation Facility Prospective Payment System (IRF PPS) and Quality Reporting Program Federal Fiscal Year (FY) 2020 Proposed Rule, published in the Federal Register on April 24, 2019. AMRPA is the national trade association representing more than 650 freestanding inpatient rehabilitation hospitals and rehabilitation units of general hospitals (collectively referred to as inpatient rehabilitation facilities (IRFs, hereinafter referred to as IRH/Us) by the Centers for Medicare and Medicaid Services (CMS)), outpatient rehabilitation service providers, long-term care hospitals (LTCHs), and several skilled nursing facilities (SNFs).

The vast majority of our members are Medicare participating providers.

In 2017, IRH/Us served 340,000 Medicare beneficiaries with more than 380,000 IRH/U stays.1 On average, Medicare Part A payments represent approximately 60 percent of IRH/U revenues.2 Any alterations to the Medicare payment system have substantial implications for these medical providers. IRH/Us provide hospital-level care, which is significantly different in intensity, capacity, and outcomes from care provided in nonhospital, post-acute care (PAC) settings. AMRPA members help their patients maximize their health, functional ability, independence, and participation in society so they are able to return to home, work, or an active retirement.

Our substantive comments are found in the attachment to this letter. These comments reflect extensive feedback from the medical rehabilitation industry, including professionals involved in every aspect of the treatment of rehabilitation hospital patients. Over the past two months, AMRPA has convened multiple committees and workgroups with experts from the field to closely analyze aspects of the proposed rule with heightened focus on the impact on IRH/Us and their patients.

Summary of Recommendations AMRPA appreciates the opportunity to comment on this proposed rule and CMS’ careful consideration of the issues raised in this letter. Our primary concerns pertain to: (1) the lack of sufficient data and technical information regarding the proposed IRF PPS case-mix groups (CMGs), including the proposal to use a weighted motor score in FY 2020, and (2) the expansion of the IRF Quality Reporting Program (QRP) to encompass multiple new standardized patient assessment data elements (SPADEs).

Medicare Payment Advisory Commission (MedPAC), “Chapter 10: Inpatient Rehabilitation Facility Services,” Report to the Congress: Medicare Payment Policy, March 2019.

1

2

Id.

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Our complete analysis, comments, and recommendations on the IRF PPS rule are included in Attachment A. A summary of our recommendations follow.

However, AMRPA urges CMS to apply any other applicable changes it makes to the IPPS wage index to the IRF PPS to avoid creating any additional disparities.

PROPOSALS REGARDING THE FY 2020 CASE MIX GROUPS

II. Proposed IRF Market Basket Rebasing and LaborRelated Share for FY 2020 AMRPA supports use of 2016 Medicare cost reports and price inputs as proposed. However, AMRPA recommends CMS not finalize its proposed changes to the Home Office Contract Labor Cost category and labor-related share as proposed. Instead, CMS should finalize use of the previous methodology relating to this category and revisit this potential change with adequate explanation and data in future rulemaking.

I.

roposed Refinements to the CMGs and CMG Relative P Weights Beginning in FY 2020 CMS must provide critical, additional information regarding the proposed CMGs and their potential impact on how patients are classified under the IRF PPS. This information should encompass:

1. How patients in the CMGs removed from RIC 01— Stroke, RIC 02—Traumatic Brain Injury, RIC 05—Nontraumatic spinal cord injury, and RIC 08—Replacement of Lower Extremity Joint will be classified under the proposed new CMGs, and the impact to IRH/U reimbursements as a result of these changes;

2. Any modeling performed to examine whether the proposed CMGs exhibit compression and, if so, how this will impact reimbursement rates for higher-acuity patient conditions;

3. Information and data to explain why there appears to be compression in the proposed CMGs; and

4. Studies or tests that CMS and RTI performed to affirm that the new CMGs will adequately reimburse IRH/Us for treating the most resource-intensive patients.

II. Proposed Use of a Weighted Motor Score Beginning with FY 2020 AMRPA urges CMS to continue to refine the IRF PPS patient classification system (and the sub-components therein, such as motor weights) and to engage stakeholders throughout the process in a comprehensive and timely manner. While AMRPA continues to believe that a weighted motor score is more likely than an unweighted motor score to account for key drivers of patient resource use, CMS has not taken the necessary actions in this rulemaking to assure stakeholders that its proposed weighting methodology will adequately and accurately account for IRH/U patients’ complexity and resource use.

III. Concerns Pertaining to the Exclusion of Cognitive Status Function in the Proposed CMGs

1. AMRPA urges CMS to conduct further study into the relationship between cognitive function and resource use in IRH/Us in future rulemaking. It is imperative a case-mix system for medical rehabilitation patients thoroughly accounts for cognitive impairment by using truly clinically sensitive data items.

2. AMRPA urges CMS to continue to work to identify appropriate cognitive function status items suitable for inpatient rehabilitation patients.

FINANCE AND LABOR PROPOSALS I. Proposed FY 2020 Wage Index Policies AMRPA supports use of the concurrent year’s IPPS wage index to ensure uniformity among different provider types.

III. Proposed FY 2020 Market Basket Update and Productivity Adjustment

1. AMRPA respectfully requests CMS provide access to the analyses done by IGI to calculate the market basket and productivity adjustment.

2. AMRPA recommends that CMS conduct an analysis to determine whether the productivity adjustment appropriately reflects the ability of IRH/Us to improve productivity or whether the nature and requirements of IRH/U services make such changes unlikely.

3. AMRPA respectfully requests that CMS update the market basket and productivity amounts using the latest available data in the IRF PPS final rule.

IV. Proposed Facility-Level Adjustment Factors for FY 2020 AMRPA urges CMS to include more detailed information in the final rule explaining the Agency’s rationale for continuing the freeze of the facility-level adjustments. We continue to recommend a minimum interval for any change in IRH/Us’ provider-level adjustment factors of once every three years.

V. Proposed Update to Payments for High-Cost Outliers Under the IRF PPS for FY 2020 In order to ensure CMS projects outlier payments as accurately as possible, CMS should include historical outlier reconciliation dollars in its outlier threshold projections as it proposes to do for acute-care hospitals.

PROPOSALS FOR THE IRF QUALITY REPORTING PROGRAM (IRF QRP) I.

General Recommendations for IRF QRP 1. AMRPA urges CMS to account for the costs associated with this rule’s IRF QRP proposals by upwardly adjusting the IRF PPS payment update in the FY 2021 rulemaking to reflect higher provider resource use (and therefore costs). This recommendation is consistent with AMRPA’s recommendation for the FY 2018 IRF PPS proposed rule in which CMS first proposed adding new SPADEs to the IRF-PAI. 2. CMS should address in the FY 2020 final rule whether it is still considering a reduced completion threshold for the IRF QRP, as was discussed in the FY 2018 IRF PPS final rule.

AMRPA Magazine / August 2019 29

3. AMRPA urges CMS to propose a reduced IRF QRP threshold percentage that is aligned with other PAC QRPs (i.e., 80 percent) in FY 2021 rulemaking and prior to the October 2020 implementation of the new SPADEs and all-payer IRF-PAI reporting requirement.

4. AMRPA urges CMS to conduct ample provider education, including multiple in-person and virtual IRF QRP training events, well in advance of October 1, 2020.

II. Proposed Method for Applying the Reduction to the FY 2020 IRF Increase Factor for IRFs That Fail To Meet the Quality Reporting Requirements

1. AMRPA continues to ask CMS to provide flexibility in its application of the IRF QRP payment penalty for IRH/ Us that make a good-faith effort to comply and submit quality reporting data.

2. AMRPA requests CMS provide more flexibility in its application of the noncompliance penalty to allow providers an opportunity to correct any errors when a good faith effort to submit data is undertaken and reserve such harsh penalties for egregious offenders who are flouting their responsibilities under the IRF QRP. III. Proposed Standard Patient Assessment Data Elements (SPADEs) Reporting Beginning With the FY 2022 IRF QRP (October 1, 2020)

1. AMRPA recommends CMS consider IRH/Us’ admission assessment for the following SPADEs as also fulfilling the discharge assessment requirement:

a. Patient Health Questionnaire (PHQ)-2/9;

b. Special Services, Treatments, and Intervention SPADEs (with the exception of the Nutritional Approach item, which AMRPA supports for collection at admission and discharge);

c. Pain Interference; and

d. Social Determinant of Health SPADEs.

2. AMRPA recommends collecting the PHQ-2/9 at admission only.

3. AMRPA cautions CMS against relying on BIMS, CAM, and PHQ-2/9 items as cognitive function case-mix indicators/characteristics until CMS is able to determine that these items do not exhibit floor or ceiling effects for IRH/U patients.

4. CMS should explore how it can glean information regarding Special Services, Treatments and Interventions (SSTI) by utilizing Medicare claims data already at its disposal rather than by imposing additional provider reporting requirements. AMRPA recommends that SSTI SPADEs be required for data collection at admission only.

5. AMRPA does not support adopting High-Risk Drug Classes – Use and Indication (Items N0415A-J).

6. AMRPA supports the Pain Interference item, but recommends that it is required only at admission.

7. AMRPA supports adopting the Hearing and Vision items as proposed.

8. AMRPA supports the inclusion of the Social Determinants of Health (SDOH) SPADEs. AMRPA recommends that CMS require these items data be

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assessed at some point during the patient’s stay instead of during the admission assessment time window.

Furthermore, AMRPA does not support requiring any SDOH SPADEs on the discharge assessment; these patient characteristics are not influenced by the IRH/U intervention and therefore would not change over the patient’s stay.

9. AMRPA recommends CMS explore a methodologically sound approach to risk-adjust certain quality outcomes for patient socioeconomic and sociodemographic status factors.

IV. IRF QRP Quality Measure Proposals Beginning With the FY 2022 IRF QRP

1. AMRPA supports adoption of the Transfer of Health Information measures. We also respectfully request CMS address the following issues in the final rule:

a. If the N/A response option will be made available on the HHA version of measure A2121, CMS should make it available as a response option for all PAC settings.

b. CMS should clarify why there is an overlap of “Patients discharged home under care of an organized home health service organization or hospice” in the measures’ inclusion criteria and address how it may affect measure performance.

2. AMRPA appreciates and supports CMS’ proposed modifications to the Discharge to Community measure.

V. Proposed IRF-PAI Data Reporting On All-Payer Patients for the IRF QRP Beginning October 2020

1. AMRPA is unable to support CMS’ proposal to expand the IRF QRP reporting requirements to include IRF-PAI data for all patients, regardless of payer, because CMS has not provided an adequate explanation regarding how this proposal will be operationalized. Specifically, the proposed rule lacks the necessary details regarding how CMS will implement the inclusion of all-payer patient data in determining an IRH/U’s compliance with the IRF QRP requirements.

2. AMRPA recommends CMS develop methods to stratify the display of patient data by payer status prior to any public reporting of all-payer quality measure data.

VI. Proposed Policies Regarding Public Display of Measure Data for the IRF QRP AMRPA supports public display of the Drug Regimen Review measure.

VII. Proposed Migration to the Internet Quality Improvement and Evaluation System (iQIES) AMRPA supports the proposed migration to iQIES. We recommend CMS begin educating and preparing IRH/Us about this transition as soon as possible.

VIII. Proposed Removal of the List of Compliant IRFs AMRPA recommends that CMS make the List of Compliant IRH/Us available to stakeholders upon request.

IX. Request for Information: IRF QRP Quality Measures, Measure Concepts, and Standardized Patient Assessment Data Elements Under Consideration for Future Years

1. While AMRPA supports the agency’s efforts to assess interoperability and identify measure gaps, we oppose the use of mandatory PAC quality reporting programs as the data collection vehicles for this work. CMS should utilize other avenues to research and otherwise inform its understanding of interoperability issues across care settings.

2. AMRPA supports CMS’ commendable efforts currently implemented across its programs that aim to address the opioid crisis.

3. CMS should work with stakeholders to prioritize which patient conditions would benefit from a cognitive complexity assessment, and then engage the research community to identify tests that were designed for and validated in those patient populations.

4. AMRPA continues to encourage CMS to develop a way of capturing for family/caregiver status and/or community supports and accounting for it in discharge disposition outcomes. Our members welcome the opportunity to work with CMS to develop caregiver status data items.

5. Because IRH/Us already communicate continence needs at discharge to the patient caregiver/family or to the next site of care, it would be regulatory duplication to require additional data collection regarding bowel/ bladder SPADEs.

6. AMRPA recommends CMS explore beneficiary-matching methods with its governmental colleagues at the U.S. Department of Veterans Affairs.

PROPOSAL TO CLARIFY THE DEFINITION OF A REHABILITATION PHYSICIAN I. Proposed Amendments to § 412.622 To Clarify the Definition of a Rehabilitation Physician AMRPA supports CMS’ proposal to clarify the definition of a rehabilitation physician as presented.

Conclusion AMRPA welcomes continued opportunities to collaborate with the Department of Health and Human Services (HHS) and CMS to refine and improve the IRF PPS. If you have any questions about AMRPA’s recommendations, please contact us or Kate Beller, J.D., AMRPA Executive Vice President for Policy Development and Government Relations, (kbeller@amrpa.org / 202-207-1132).

Sincerely,

Richard Kathrins, Ph.D. Chair, AMRPA Board of Directors President and CEO Bacharach Institute for Rehabilitation

Mark J. Tarr Chair, AMRPA Regulatory and Legislative Policy Committee President and Chief Executive Officer, Encompass Health

Suzanne Kauserud, FACHE, MBA, PT Chair, AMRPA Quality Committee Vice President, Carolinas Rehabilitation – Atrium Health CC: Jeanette Kranacs Todd Smith Susanne Seagrave Gwendolyn Johnson Hilary Loeffler Mary Pratt Stacey Mandl Tara McMullen Katie Brooks Christine Grose Charles Padgett Attachment A American Medical Rehabilitation Providers Association’s Complete Analysis, Comments, and Recommendations on the Medicare Program; Inpatient Rehabilitation Facility (IRF) Prospective Payment System for Federal Fiscal Year 2020 and Updates to the IRF Quality Reporting Program 84 Fed. Reg. 17244 (April 24, 2019).

AMRPA Magazine / August 2019 31

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AMRPA Weighs in on Medicare Conditions of Participation for Co-Located Hospitals On July 2, AMRPA submitted a formal response to the Centers for Medicare and Medicaid Services (CMS) regarding its draft guidance for compliance with the Medicare Conditions of Participation (CoPs) for co-located hospitals. This draft guidance would apply to hospitals that share a building or campus with another hospital or other separately licensed health care entity. The below is an abbreviated version of the comments submitted to CMS. The full letter is available on the AMRPA webpage in the Advocacy section. The draft guidance can be found on the CMS webpage.

Ms. Karen Tritz Director Quality, Safety & Oversight Group Centers for Medicare and Medicaid Services Department of Health and Human Services 7500 Security Boulevard, Mail Stop C2-21-16 Baltimore, Maryland 21244-1850 Dear Director Tritz, AMRPA member hospitals have long been concerned about the application of the Medicare Conditions of Participation regulations (CoPs) to co-located specialty hospitals such as rehabilitation hospitals. Our hospitals have found that many interpretations of the CoPs have imposed burdensome requirements that bear little connection to patient safety or other goals of the CoPs. Therefore, we welcome CMS’ clarification of its interpretations and wish to establish an ongoing dialogue with CMS regarding the CoPs and their application to co-located rehabilitation hospitals to ensure that regulatory requirements continue to reflect the current state of care delivery.

I.

Distinct and Shared Space

CMS’ interpretation of the CoPs states that co-located hospitals may only share public spaces and public paths of travel, which it defines as non-clinical spaces such as lobbies, waiting rooms and receptions areas, among others. The proposed guidance seems to state that it is not permissible for a patient to travel into a clinical area located in the non-treating hospital for services, as this would be a

AMRPA Magazine / August 2019 33

non-public space. This interpretation presents a serious impediment to the sharing of diagnostic services (i.e., laboratory and imaging) and specialty care (i.e., therapy, dialysis, vision services, etc.). AMRPA questions the reasoning underlying this interpretation. Hospitals often contract for third-party offsite services for patients, and those services are not required to keep separate areas for each hospital. It is unclear why CMS would require such a practice for co-located hospitals. In fact, CMS’ interpretation creates a clear incentive for hospitals to outsource these services to such offsite vendors, which is not in the interest of patient safety or efficiency.

To illustrate why the ban on sharing of any clinical space is problematic, we offer the following example. Under CMS’ draft guidance, a co-located hospital is not permitted to share space where patients are receiving care. This means that if one of the co-located hospitals offers services in a specialized setting, such as a dialysis center or an aquatic therapy pool, the patients at the other hospital would not able to contract to use those services, since patient care is delivered in these areas. This leaves the co-located hospitals with several untenable options: (1) One of the co-located hospitals could not offer that service to patients, while the other does; (2) One hospital could send its patients offsite for these services, despite the service being offered at the significantly more convenient co-located hospital site; (3) The hospital could close the onsite service and send all patients offsite for the service; or (4) The hospital could build a duplicate clinical area. In all of these scenarios, the burden imposed on hospitals is high, with little (if any) apparent benefit to patients, and to the extent the policy encourages stressful patient transfers’ offsite for care, could be detrimental to patients.

AMRPA understands the need for comprehensive infection control plans and protection of patient privacy. However, the Medicare statute allows hospitals to provide services “under arrangements” with other hospitals, under which one hospital provides services to another hospital and the hospital providing the services bills the other hospital for the services. Rather than impeding hospitals from delivering needed services in the most comprehensive and efficient manner possible, and to continue to allow hospitals to provide services “under arrangement,” CMS should instead require hospitals to account for the sharing of specialty space in its infection and privacy protocols. This would ensure that patient safety and privacy, among other concerns, remain addressed while also allowing patient access to the safest and most robust services available onsite at the hospital. In fact, it should be noted that it is common practice for co-located hospitals to adopt or mirror the infection control polices of the host hospital. As both colocated hospitals have matching infection control policies, practices, and training standards, there is little risk to patients accessing contracted services in the other hospital.

As previously stated, hospital already account for comingling of patient or clinical space when patients are

34 AMRPA Magazine / August 2019

sent offsite for services. Creating strict rules barring on-site sharing of space, but not offsite sharing, will only incentivize the use of off-site services, which is not in the interest of patient safety or efficiency. Therefore, CMS should provide for sharing of specialty services in situations in which one hospital is providing services “under arrangement” or otherwise utilizing a service in the co-located hospital. In sum, AMRPA believes there is a way to protect patient privacy and safety and also address other concerns that come with shared space that will be far less burdensome than requiring duplication, denial or elimination of services and would not impede the Medicare statutory “under arrangements” provisions.

AMRPA also has concerns about CMS’ statement in the draft guidance that patients cannot even simply travel through a clinical area to reach a specialty service. Similar to the previously stated concerns regarding shared clinical space, it would be detrimental to patient access to specialty care to impose this unnecessary restriction. For example, by way of necessity, an area like a specialized therapy lab or diagnostic imaging service may need to be located on a ground floor of a building. The CMS draft guidance would exclude the entire co-located hospital’s population from utilizing this contracted service simply because they would briefly pass through a clinical area of the other hospital. Rather than create this needless restriction on patient services, CMS should simply require that passage to be incorporated into both hospital’s protocols for infection, privacy and any other implicated concerns.

CMS should be mindful that co-location has been expressly permitted through regulations like the Hospital-WithinHospital (HwH) rules for decades. Accordingly, there are many co-located hospitals that have invested tremendous capital in their current infrastructure based on these permitted arrangements. It would be cost prohibitive for many hospitals to essentially rebuild their facilities to comply with these policies. Member hospitals report that some infrastructure that currently exists that would run afoul of the draft guidance – like centrally located elevator banks – simply could not be rearranged to ensure patients never traverse or enter the co-located, non-treating hospital. Therefore, if CMS were to nonetheless proceed with finalizing this guidance, it should also create a clear grandfather policy for these pre-existing facilities. These grandfathered facilities would need to incorporate the colocation into their protocols to ensure patient safety, while still being permitted to operate their current facility as they had done previously. This approach would avoid hospital closings and restricting beneficiary access to care, while still ensuring patient safety.

In sum, CMS should take a practical approach to ensuring safety, and allow hospitals to take a robust - but specially tailored - approach to ensuring patient safety. Every hospital is built differently, and hospitals are in the best position to continually monitor and ensure the highest quality care for the patients in their unique buildings. Therefore, CMS

should not create arbitrary and categorical rules, such as blanketly prohibiting any shared clinical space in a hospital.

Instead, each hospital should have its protocols evaluated by surveyors on a case-by-case to ensure the arrangement adequately protects patient safety.

II. Staffing and Staffing Contracts Similar to concerns about shared space, AMRPA finds CMS’ draft guidance pertaining to contracted staffing to be overly burdensome while providing little benefit to patients. AMRPA agrees that all hospitals should be required to provide adequate staffing to ensure patient safety and care needs are met at all times. However, when it comes to delivering specialty and diagnostic services, it is again unclear what patient interest is served by barring the sharing of this staff during the course of one shift – especially among staff that are particularly well-suited to treat patients from the two hospitals during the course of one shift. Hospitals may be staffing well beyond the minimum levels needed to provide the CoP required services, and when hospitals are providing supplemental specialty services, they should be permitted to share such staff.

To provide an example, a co-located hospital may operate a neurological recovery lab that is staffed by personnel that are specially trained to use the neurorehabilitation equipment in the lab. Patients would be served by the lab on an appointment basis, with a limited number of patients being treated in the lab at a given time to ensure adequate supervision. There is no reason that the clinical therapists delivering the treatment in the lab on an appointment basis should not be able to treat patients from both hospitals during the course of one shift. It is unnecessary and unreasonable to require a therapist to clock out from one hospital and into another to provide services to both hospitals. Again, these restrictions appear contrary to the Medicare statutory provision that allows hospitals to provide or obtain services “under arrangement.” Likewise, even in instances where there is not a shared space, specialists such as physical therapists should be able to float from one hospital to the other to deliver their specialized care, as this poses no risk to patient safety or privacy that could not otherwise be accounted for in both hospitals’ protocols.

These unnecessary restrictions proposed by this draft guidance would again discourage co-located hospitals from offering a robust array of specialty services onsite. Under this guidance, it would be more efficient for co-located hospitals to outsource the care to a singular provider (where the patients could be intermingled) than to duplicate services onsite. In addition to adding burden to hospitals, this is potentially stressful and detrimental to patients. Rather than creating this barrier to treating patients in both hospitals, CMS should ensure that shared specialty staff are properly trained by both hospitals and adhere to the policies of both hospitals. This would ensure all of CMS’ interests – such as patient safety and privacy – are satisfied, while not minimizing patients access to needed specialty staff.

AMRPA is especially skeptical of restrictions on the staffing of contracted services that are not patient facing or have minimal interaction with patients, such as diagnostic imaging or laboratory technicians. Offsite laboratories or imaging centers are not required to have staff dedicated solely to each contracted hospital’s patients. This is because there is no clinical or operational reason to divide services in that way. However, under the draft guidance, CMS proposes that these types of staff must be clearly delineated between each hospital simply because of their onsite location. We again encourage CMS to take a practical approach and not require these staff members to be dedicated solely to one hospital or another, so long as adequate staffing for both hospitals is satisfied and patient safety and privacy concerns are addressed in hospital protocols.

During an American Health Lawyers Association (AHLA) webinar and CMS listening session on the draft co-location guidance (June 5 and June 27, respectively), CMS suggested that the restriction on a staff member “floating” between two hospitals applied only if the COPs require that hospital staff a particular position rather than require that the hospital provide a particular service. For example, CMS indicated in the June 5 webinar that a Pharmacy Director could not float because the Medicare COPs require that a hospital have a Director of Pharmacy (42 C.F.R. § 482.25(a)(1)), but that a pharmacist could float. If CMS’ restrictions on whether a staff member may float are tied to requirements in the COPs, CMS should make this clear in its final guidance.

Finally, AMRPA questions the reasoning CMS stated during these listening sessions for imposing these staffing restrictions. CMS stated that the sharing of staff between two co-located hospitals means the staff member would not be immediately available for the hospital because they may be attending to a patient in the other hospital. However, this is no more likely to occur between two co-located hospitals than it is to occur within one hospital. Many co-located hospitals, especially co-located specialty hospitals, may have fewer beds combined than one acute care hospital. It makes little sense that CMS would require one 100-bed acute-care hospital to only have one staff member, but two co-located specialty hospitals with a combined total of 50 beds to have two of that same staff.

III. Emergency Services AMRPA hospitals recognize and appreciate the importance of each hospital having the capability to respond to its own emergencies for initial assessment and treatment of a patient. We agree that each hospital should be fully prepared, with its own independent staff, to engage in such efforts. However, AMRPA is concerned that the wording of CMS’ current guidance could discourage a lifesaving intervention from taking place.

CMS’ guidance states “Hospitals without emergency departments that are co-located with another hospital may not arrange to have that other hospital respond to its

AMRPA Magazine / August 2019 35

emergencies.” AMRPA is worried that this would serve as a complete bar to a co-located hospital’s staff involving themselves in an emergency. This is concerning because some emergencies are unpredictable and require an immediate response. At any given moment, a staff member from a co-located hospital, such as respiratory therapist, may be nearer to the patient experiencing the emergency than the respiratory therapist for the treating hospital.

In situations where immediate lifesaving intervention is needed, there should be no bar on a co-located clinician responding to an emergency. Hospitals should be permitted to allow for the temporary intervention of co-located hospital staff until the treating hospital staff arrives. To be clear, AMRPA does not believe that co-located hospitals should be allowed to meet lesser standards than non-shared hospitals when it comes to adequate response capabilities. Rather, AMRPA recommends that the nearest and most immediate staff member, regardless of which hospital their shift is assigned to, be permitted to intervene when patient safety is at risk.

The draft guidance also states that if a hospital has no emergency department (ED) but has its emergency services provided under contract with an ED of a co-located hospital, the hospital without the ED must also meet the requirements of the Emergency Medical Treatment & Labor Act (EMTALA). AMRPA cannot understand why this would be the case and emphasizes that this is a wholly inappropriate application of EMTALA. Many rehabilitation hospitals are co-located with acute-care hospitals that have EDs and may contract for services from that acute-care hospital. However, rehabilitation hospitals, by CMS’ own regulation, treat patients that are stable. To subject the rehabilitation hospital to EMTALA rules would require this specialized hospital to begin accessing and stabilizing patients that are far outside the hospital’s specialty and expertise. This presents not only patient safety concerns but significant administrative and financial burdens for rehabilitation hospitals. It is beyond AMRPA’s understanding why CMS would require a hospital without an ED to treat emergencies when there is a colocated hospital with an ED on site. It would make far more sense for only the co-located hospital with the ED to be required to be subject to EMTALA. IV. Co-Location and Governing Body Citations AMRPA recognizes that the CoP regulations ultimately place responsibility for compliance with participation requirements on the governing body of the hospital. However, AMRPA finds it unnecessary and redundant to require duplicate citations for singular violations. It is clearly understood that any violation of the CoPs is a serious issue that must be dealt with promptly. It is also understood that responsibility ultimately lies with the governing body. Therefore, a singular citation for the specific violation is more than enough to ensure compliance. Adding a redundant violation of the governing body CoP only serves to confuse the issue at hand, as well as create additional paperwork – in contrast to

36 AMRPA Magazine / August 2019

the goals of the Department. Therefore, CMS should only require a singular citation per violation.

In addition, AMRPA believes the draft guidance should make clear that it is appropriate for the governing body to entrust oversight to compliance officers or other appropriate staff that ultimately report to the governing body. The guidance, as currently written, does not provide for that flexibility, and insinuates the governing body must be involved in the minutiae of day-to-day operations that is nearly always delegated to compliance officials. Therefore, CMS should clarify the governing body’s ability to assign oversight duties to compliance officials who report to the governing body, who bear final responsibility.

CMS also states in the draft guidance that a citation regarding shared space should be considered a violation of the CoPs for both entities, and the other co-located entity will be referred for a separate survey. AMRPA wishes to make CMS aware that many of these co-located arrangements operate through a lease agreement – where one entity owns the property and leases the space to the other entity.

Therefore, many common areas like entryways would only be under the legal control of the lessor, with the lessee unable to make changes to those areas since it does not own or control the property. Therefore, only the owner the colocated space should be held responsible for common areas that the lessee is unable to control due to legal restrictions.

This commonsense clarification would ensure the entity that actually has control is held responsible for compliance.

V. Recommendations on Integrating Sites of Care Last year, CMS reversed a longstanding policy and began permitting hospitals excluded from the Inpatient Prospective Payment System (IPPS) to host IPPS-excluded hospital units.

This meant that a long-term care hospital (LTCH) could begin hosting a rehabilitation unit. Since an LTCH can also incorporate sub-acute facility elements into its hospital, the LTCH is essentially able to incorporate all post-acute care (PAC) facilities in one location as one unified hospital.

Given that transfers through the continuum of care are both administratively burdensome and taxing on (or even directly detrimental to) patients, the ability to consolidate all of these levels of care in one location as one unified hospital is a significant reform that provides notable efficiencies for LTCHs. However, the same opportunity that is newly available to LTCHs has not been afforded to rehabilitation hospitals, which are also IPPS-excluded hospitals. Since there is no LTCH unit under Medicare, like there are rehabilitation and psychiatric units, there is no ability for an existing rehabilitation hospital to incorporate an LTCH unit and thereby operate all levels of care as a unified hospital.

Instead, the only path an existing rehabilitation hospital has to incorporate an LTCH in the same location is to utilize a hospital within hospital (HwH) model, which is one of the colocated entities governed by this draft guidance.

In making the change to IPPS-excluded unit restrictions last year, CMS acknowledged the appropriateness and advantages of an LTCH and IRF operating under the same roof. However, despite rehabilitation hospitals’ tremendous contributions to Medicare beneficiaries and to the entire continuum of post-acute care, an artificial business disadvantage has been created for rehabilitation hospitals as a result of this policy.

Existing rehabilitation hospitals that are co-located with an LTCH as an HwH should be afforded the same flexibilities that an LTCH with an IRF unit are afforded. This should include a significant loosening of the separateness requirements in the context of IRF and LTCH co-location,

such as the shared staffing and shared clinical space requirements. Not only would this help create parity among existing post-acute sites of care, it would open up this efficient arrangement to areas of the country that have IRFs, but face an LTCH shortage. We therefore urge CMS to revise its current policy and to use this guidance as an opportunity to provide IRFs the same flexibility of LTCHs to integrate sites of care at their locations, which would break down administratively burdensome sites of care and allow hospitals to focus more of their resources on patient care.

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EDUCATION , COMMUNICATION, PARTICIPATION & OPERATIONAL ASSISTANCE AMRPA: Working Together to To Preserve Preserve Access To Medical Rehabilitation AMRPA: Working Together Access to Medical Rehabilitation Maggie Ramirez · VP of Membership Services · 347-573-3732 · mramirez@amrpa.org

Anna Kruskop, AMRPA Member Services Associate, akruskop@amrpa.org, 202-207-1120.

AMRPA Magazine / August 2019 37

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Sergeant First Class Cory Remsburg: AMRPA’s 2019 Fall Conference & Educational Expo Patient Perspective Speaker Coming from a long line of family military service, Cory Remsburg knew he wanted to serve his country from a young age. Remsburg enlisted in the U.S. Army in 2001 when he was just 18 years old and chose to become a ranger because he “wanted to be the best.” As an Army Ranger, Sergeant First Class Remsburg was in one of the first troops sent to Iraq in 2003, and by June 2009 he had already been deployed nine times to both Iraq and Afghanistan.

On June 6, 2009, Remsburg was chosen to participate in the parachute jump into Normandy, France, to commemorate the 65th anniversary of D-Day. President Barack Obama gave a speech at the event, and Remsburg was among the soldiers that were able to meet him.

A few months after the commemoration, Remsburg left for Afghanistan for his 10th combat deployment. On October 1, 2009, after completing an operation with his squad, Remsburg was caught in the explosion of an enemy improvised explosive device that nearly took his life. He was propelled into a canal where his fellow rangers found him in critical condition. Remsburg sustained severe injuries, including two collapsed lungs and critical head wounds. He received lifesaving care from members of his squad before being airlifted for further medical treatment.

Remsburg spent nearly four months in a coma before regaining consciousness. His injuries included the paralysis of the left side of his body, severe traumatic brain injury, damaged vocal cords and the loss of sight in his right eye. Remsburg went through dozens of surgeries over the course of his recovery, including the partial removal of his frontal lobe. After receiving some treatment abroad, Resmburg was transferred to the Naval Medical Center in Bethesda, Maryland, for continued care.

Remsburg’s journey for independence did not stop at rehabilitation, he has recently turned his focus to training for competitive activities. In June 2019, he participated in the Valor Games Far West competition in California where he received a gold medal

AMRPA Magazine / August 2019 39

in archery, a silver medal in indoor rowing, and a bronze medal in recumbent cycling.

Remsburg has said that while he faces challenges, competing is his way of trying to live life to the fullest.

June also took Remsburg to the 10th Annual Department of Defense Warrior Games, a multi-sport event for injured, wounded or ill veterans and service personnel. All U.S. military services had a team at the event, which also included teams from a handful of other countries. At the Warrior Games, Remsburg was a part of the U.S. Special Operations Command team and competed in one cycling and two indoor rowing events. He medaled in each event, receiving three bronze medals.

Sergeant First Class Cory Remsburg has made remarkable progress over the years despite the difficulties he has faced, and his journey inspires others to persevere when met with personal challenges. AMRPA is honored to have him speak at the 2019 Fall Conference & Educational Expo. If you’d like to attend and hear more about his inspirational story, visit the AMRPA website to register.

Craig Remsburg, Cory’s father, reports that he plans to participate in even more competitive activities next year.

40 AMRPA Magazine / August 2019

AMRPA would like to express its appreciation to Casa Colina Hospital for introducing us to Cory Remsburg and his inspirational story.

United Hospital Fund Reports Examine Difficult Decisions in Post-Acute Care Highlights: »»

I nadequate information and the pressure to make quick decisions often lead to patients being placed with post-acute care (PAC) providers that are not high quality and/or cannot meet patient needs.

»»

Efficiency pressures, lack of communication and regulatory obstacles disadvantage the ability for patients and families to make well-informed PAC decisions.

A four-part series of reports recently issued by the United Hospital Fund in New York examines the difficulties faced by patients and families when transitioning to post-acute care (PAC). The series, Difficult Decisions About Post-Acute Care and Why They Matter, represents the culmination of a year-long inquiry funded by the New York State Health Foundation to better understand hospital discharge planning practices and the myriad factors that influence the PAC selection process. While the reports focus primarily on skilled nursing facilities and home health agencies, and reference state-specific information, it is important to note that patients transitioning to inpatient rehabilitation hospitals and units (IRH/Us) often face the same challenges, and many of the suggested recommendations are applicable to IRH/Us as well.

The first report of the series discusses the factors that make it challenging for patients and families to make well-informed decisions when arranging the transition to PAC. Specifically, the report mentions external factors that can limit PAC options, such as limited provider capacity and insurance constraints, as well as individual patient factors such as medical and social aspects. This report also points out that while many people are unfamiliar with PAC services and settings, they are forced to make a quick decision due to cost and time pressures at the acute-care hospital discharge, often without the assistance of hospital staff or clinicians. These swift decisions and the lack of information can lead to patients being placed with providers that are not high-quality and/or do not meet the patient’s needs.

The subsequent report dives into the “illusion of choice” when choosing a PAC provider and discusses the experiences and burdens that arise when making that decision. This report touches on what the authors call the “PAC knowledge gap,” how PAC choices were presented to patients/families, and how family members researched those options. While patients and families are told they are able to choose the PAC provider, the provider options, and information on said providers, are often very limited. As a result, the “choice” of provider often becomes a burden of research and decisionmaking, with patients and families frequently choosing a provider based on distance, access to transportation, or where the first bed becomes available as opposed to quality of care.

The third report of the series discusses health care provider perspectives on the hospital discharge planning process. Through a series of interviews, the researchers compiled the following list of factors that affect the PAC discharge planning process: The assessment of medically complex patients for discharge, and the array of consultations necessary while the patient is in the hospital; The change of a patient’s medical status during preparation for discharge;

AMRPA Magazine / August 2019 41

Conflicting opinions between patients and family members about discharge needs;

Enhancing clinicians’ training and experience in different acute and PAC settings.

Limited involvement from family members during the discharge planning process;

Examining how payment models could be used to increase support for facilities that care for the most medically complex patients, expand access, or incentivize improved experiences for patients and families.

Pressure to discharge patients under certain time constraints; Insurance authorization delays; Admission barriers due to social, medical and/or insurance restraints; and Bed availability at the PAC provider settings.

The fourth and final section of the report provides recommendations on how to address the challenges discussed in the previous reports. The authors recommend strategies for the following six issues: 1. Engage patients and families in PAC discharge planning.

Citing disconnect and lack of trust between patients/families and hospital staff, the report recommends various steps providers can take to increase communication, engagement, and trust. Among the recommendations include: Providing relevant information at the patient’s bedside through various means (television, videos, and mobile applications) to assist patients in researching their PAC options.

Educating patients and families about what they can expect from PAC services, including the frequency and level of services, as well as the types of staff that will be providing those services.

2. Improve the discharge planning process.

Essential PAC information is often omitted due to the complexities of the discharge planning process. To improve the process and provide more clarity, the authors recommend: Developing standardized discharge planning procedures for patients with common conditions.

Implementing health literacy resources that are able to provide consumers with important information on PAC services.

3. Bridging silos and removing barriers to facilitate wellinformed decision-making.

The reports underscored the importance of coordinating across care setting silos in order to give patients/caregivers the opportunity and resources for informed decisionmaking during the discharge planning process. These recommendations include: Improving access to electronic health records across PAC settings.

42 AMRPA Magazine / August 2019

Examining how payment silos across federal and private payers can limit access to timely, comprehensive, and coordinated care for vulnerable patients.

4. Address payment policy and regulatory barriers.

Pointing to regulations that influence the information and support hospital staff can provide to patients and family members, the report states that regulations need to be improved so they better prioritize the needs of patients and their families. Among other recommendations, the report suggests the following to address this issue: Streamlining the requirements for state and federal discharge planning.

Reassessing Medicare coverage rules for PAC providers.

Addressing the underlying reasons of insurance authorization delays for PAC services.

Monitoring the impact of preferred PAC networks on the quality of PAC providers to which patients are being discharged.

5. Enhance transparency and public information.

According to the report, the quality information that is currently available to the public, such as on Medicare’s Compare websites, is underutilized by consumers. The report argues that quality information needs to be easier to find and the information should be geared more towards the needs of patients and caregivers. Some of the researchers’ recommendations include: CMS requiring Medicare Advantage plans to be more transparent about the quality of PAC providers in beneficiaries’ networks during enrollment.

CMS requiring PAC providers to start collecting standardized patient experience data.

6. Increase professional and public awareness.

Many individuals are not familiar with PAC services, provider settings, or why provider quality is important. To increase awareness in this area, the report provides a few suggestions, including: Implementing a campaign to raise awareness about what PAC is and why it is important, insurance coverage limits, and how to evaluate PAC provider quality, among other important information.

Encouraging primary care providers and community organizations to start conversations about PAC services and settings with patients who are at risk of hospitalization or are planning to undergo a surgery.

The reports underscore that a collective effort is necessary across numerous levels – from federal/state policymakers to individual providers and all parties in between – to broaden consumers’ understanding of PAC, ease the decision-making burden for

patient and families, and improve access to high-quality PAC. The report notes that while addressing these problems and implementing changes will be challenging, it is essential to creating a better PAC experience for patients and families and improving patient outcomes. The Difficult Decisions About Post-Acute Care and Why They Matter reports can be found on the United Hospital Fund’s website.

AMRPA Magazine / August 2019 43

Study Assesses Outcomes of Inpatient or Clinic-based versus Home-based Rehabilitation After Elective Total Knee Arthroplasty Highlights: »»

A meta-analysis review of elective primary unilateral TKAs did not find inpatient or clinicbased rehabilitation associated with superior function and pain outcomes compared to homebased care.

»»

Inpatient rehabilitation was linked to higher rates of patient-reported satisfaction.

An April 2019 study published in JAMA assessed the patient outcomes associated with inpatient or clinic-based rehabilitation versus home-based rehabilitation after an elective total knee arthroplasty (TKA). According to the report, TKAs were the most frequently performed procedure in inpatient operating rooms in the U.S. in 2012 and as the number of TKA surgeries increased over the years, so too has the cost burden for acute and post-acute care (PAC) providers.

The study was a systematic review and meta-analysis that aimed to investigate the importance of the rehabilitation setting on outcomes for adults after elective primary unilateral TKA. Specifically, the researchers sought to determine whether inpatient or clinicbased rehabilitation is associated with superior function and pain outcomes in comparison to home-based treatment.

The researchers defined superior as “a change considered to be clinically important for each outcome assessed.”

// The study was a systematic review and metaanalysis that aimed to investigate the importance of the rehabilitation setting on outcomes for adults after elective primary unilateral TKA.

Following prescribed methods for reviewing randomized clinical trials, the researchers ultimately selected six published studies that compared the outcomes of inpatient or clinic-based rehabilitation with home-based treatment. The participants in the selected studies were adults who received primary unilateral TKA, and began rehabilitation treatment no more than six weeks post-operation. Excluded from the review were studies of unicompartmental surgery, revision TKA or TKA secondary to trauma.

Of the selected studies, five compared clinic- and home-based care, and one compared inpatient rehabilitation with home-based care. The five studies comparing clinic- and homebased treatment involved 752 participants with a median age of 68.3 years, 40 percent of whom were female. The single study comparing inpatient and home-based care involved 112 participants with a median age of 66.9 years, 68 percent of whom were female. With regard to outcomes, the study focused on mobility and patient-reported pain and function

44 AMRPA Magazine / August 2019

assessed in the 10 to 12 week post-operation period and at 52 weeks post-operation. Mobility was measured through the sixminute walk test, and patient-reported pain and function data was measured based on the Oxford knee score during the subacute period. Secondary outcomes included patient-reported quality of life and knee range of motion at 52 weeks post-operation.

Findings According to the researchers, based on the “low- to moderate evidence� reviewed in this meta-analysis, they did not find superior outcomes to be associated with clinic-based rehabilitation in comparison to home-based treatment for primary unilateral TKAs. The single study that compared inpatient rehabilitation to homebased care also did not find significant difference in outcomes between the settings. However, that study did report that inpatient rehabilitation was linked to higher rates of patient-reported satisfaction.

Conclusions The authors concluded that for primary unilateral, elective TKAs, there were no clinically important differences in patient outcomes when comparing inpatient or clinic-based rehabilitation with homebased programs in the subacute period. The authors state their findings are consistent with several other clinical trials that evaluate the impact of PAC setting on the effectiveness of rehabilitation after these particular surgeries.

For the full study, see Assessment of Outcomes of Inpatient or Clinic-Based vs. Home-Based Rehabilitation After Total Knee Arthroplasty: A Systematic Review and Meta-analysis, JAMA Network Open, April 29, 2019.

AMRPA Magazine / August 2019 45

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Study Evaluates Association of Low Vitamin K Levels and Mobility Limitation and Disability in Older Adults Highlight: »»

tudy suggests older adults with low S levels of circulating vitamin K may be at risk for higher rates of mobility limitation and disability.

A recent study published in the Journal of Gerontology: Medical Sciences evaluated the association between biomarkers of vitamin K status and the mobility limitation and disability of older adults. The study was led by researchers at the Jean Meyer U.S. Department of Agriculture (USDA) Human Nutrition Research Center on Aging at Tufts University. Researchers examined two biomarkers: circulating levels of vitamin K, phylloquinone, and a functional measure of vitamin K, plasma ucMGP. The study used participant data from the Health, Aging and Body Composition (Health ABC) Study, which included 635 men and 688 women all between the ages of 70 and 79 years old, approximately 40 percent of whom were black. The mobility of the participants was evaluated via annual clinic visits and phone interviews every six months for six to 10 years. The Health ABC Study is an interdisciplinary study focused on risk factors for the decline of function in healthier older people, particularly change in body composition with age. Funded by the National Institute on Aging at the National Institutes of Health, it was designed to address differences in onset of functional limitation, disability and longevity in men and women aged 70-79.

For the purposes of this study, the researchers defined mobility limitation as “two consecutive semi-annual reports of having any amount of difficulty either with walking a quarter of a mile or climbing 10 steps without resting.” Mobility disability was defined as “two consecutive semi-annual reports of having a lot of difficulty or inability to walk or climb the same amount.”

Results The results of the study suggest that low levels of circulating vitamin K is associated with an increased risk of mobility limitation and disability among older adults. In comparison to those with sufficient levels, the study found that older adults with low levels of circulating vitamin K were almost 1.5 times more likely to develop mobility limitation, and almost twice as likely to develop mobility disability for both men and women.

Conclusions The researchers concluded that the study suggests a link between low levels of circulating vitamin K and mobility disability. However, further research is necessary to confirm the connection and to develop a better understanding of the relationship between vitamin K biomarkers and mobility, as biomarker levels can also be impacted by additional factors.

For more information, see Vitamin K Status and Mobility Limitation and Disability in Older Adults: The Health, Aging, and Body Composition Study, Journal of Gerontology: Medical Sciences, May 6, 2019.

AMRPA Magazine / August 2019 47

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