CMS: Innovative treatments call for innovative payment models and arrangements

CMS NEWS FOR IMMEDIATE RELEASE August 30, 2017  Contact: CMS Media Relations (202) 690-6145 | CMS Media Inquiries CMS: Innovative treatments call for innovative payment models and arrangements With today’s U.S. Food and Drug Administration (FDA) approval of Kymriah (tisagenlecleucel) for certain pediatric and young adult patients with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse, the Centers for Medicare & Medicaid Services (CMS) is continuing to explore the development of payment models and arrangements for new and potentially life-saving treatments. “CMS congratulates all of the scientists and researchers involved in the development of Kymriah (tisagenlecleucel),” said CMS Administrator Seema Verma. “Innovations like this reinforce our belief that current healthcare payment systems need to be modernized in order to ensure access to new high-cost therapies, including therapies that have the potential to cure the sickest patients. Improving payment arrangements is a critical step towards fulfilling President Trump’s promise to lower the cost of drugs.” As part of larger efforts to support the President’s priority, CMS is working actively with all stakeholders, including state officials, on innovative payment arrangements. These arrangements may, for example, include outcome-based pricing for medicines in relation to clinical outcomes. CMS will be issuing future guidance to explain how pharmaceutical manufacturers can engage in innovative payment arrangements and will continue to work with states on other options, as well help them manage the cost of new therapies and cures. CMS is committed to further exploring the development of innovative pricing systems that reflect the value delivered to patients. Through the authority provided to the Center for Medicare and Medicaid Innovation (CMMI), CMS will aim to identify and alleviate regulatory barriers in Medicare and Medicaid as may be necessary to test payment and service delivery models that involve value-based payment arrangements. Medicare and Medicaid policies should create incentives for achieving better health results at lower costs. Through flexibility and program simplification, we are working to preserve incentives for innovation while increasing access to high-value and efficiently-provided care. ### Get CMS news at cms.gov/newsroom, sign up for CMS news via email and follow CMS on Twitter @CMSgovPress

Jimmo Corrective Action Plan Completed

Press Release

Jimmo Corrective Action Plan Completed CMS Adds Resources Regarding Medicare Coverage To Help People Who Need Skilled Maintenance Nursing or Therapy For Immediate Release August 28, 2017 As ordered by the federal judge in Jimmo v. Sebelius, the Centers for Medicare and Medicaid Services (CMS) published a new webpage containing important information about the Jimmo Settlement on its CMS.gov website. The Jimmo webpage is the final step in a court-ordered Corrective Action Plan, designed to reinforce the fact that Medicare does cover skilled nursing and skilled therapy services needed to maintain a patient’s function or to prevent or slow decline. Improvement or progress is not necessary as long as skilled care is required. The Jimmo standards apply to home health care, nursing home care, outpatient therapies, and, to a certain extent, for care in Inpatient Rehabilitation Facilities/Hospitals. The Jimmo webpage and other elements of the Correction Action Plan should help ensure that the Jimmo Settlement is implemented correctly and that it opens doors to Medicare coverage and necessary care for beneficiaries who require maintenance care, including people with long-term, progressive, or debilitating conditions. As required by the Court, CMS also provided additional training for Medicare decision-makers. Judith A. Stein, Executive Director of the Center for Medicare Advocacy, which is lead counsel for the nationwide class of Medicare beneficiaries said, “People living with MS, Parkinson’s Alzheimer’s, paralysis and other long-term conditions have waited long enough for this relief. We hope that the new CMS education and information, which can be found at CMS.gov and printed out with the CMS logo, will help convince providers that Medicare really is available for people who need this critical maintenance care.” “After years of fighting over this standard in court, we are hopeful that Medicare has finally acknowledged that beneficiaries with long-standing and chronic problems are entitled to maintenance skilled care to prevent or slow decline in their overall condition,” said Michael Benvenuto, of Vermont Legal Aid, co-counsel for the Jimmo plaintiffs. The new webpage contains an “Important Message About the Jimmo Settlement,” in which court-approved language emphasizes that the Settlement “may reflect a change in practice” for providers and Medicare decision-makers who erroneously believed that the Medicare program covers nursing and therapy services only when a beneficiary is expected to improve.  Indeed, the new education and Jimmo webpage are important because many health care providers still operate under this misconception, leading beneficiaries to be wrongly denied needed services such as physical and occupational therapy. This was the case, for example, for Mrs. B, who was denied necessary on-going physical therapy, needed to maintain her condition after spinal surgery. While she had begun to walk again independently after nursing home care, and out-patient PT, when the PT ended because it was “maintenance only,” Mrs. B declined and was no longer able to ambulate independently. One of the “Frequently Asked Questions” posted on the Jimmo CMS.gov page clarifies that this should not happen: “The Medicare program does not require a patient to decline before covering medically necessary skilled nursing or skilled therapy.” The Jimmo webpage contains fifteen such “Frequently Asked Questions,” which dispel other mistaken beliefs.  One answer, confirms: “Skilled services would be covered where such skilled services are necessary to maintain the patient’s current condition or prevent or slow further deterioration so long as the beneficiary requires skilled care to the services to be safely and effectively provided.” Judge Christina Reiss of the U.S. District Court in Vermont ordered the corrective action plan in February 2017 after finding that CMS was in breach of the original Jimmo settlement agreement, which was reached in 2013. In addition to the webpage, the Corrective Action Plan required CMS to offer additional training about coverage for skilled maintenance care for Medicare’s contractors and adjudicators who decide whether coverage will be granted. Under the original Jimmo Settlement, CMS revised several chapters of its policy manuals (including those for Skilled Nursing Facility, Home Health, Out Therapy and Inpatient Rehabilitation Facility.) CMS also held an educational campaign to clarify that improvement is not required for coverage of skilled care. Lawyers for the Jimmo plaintiff class requested further action from the court when it became clear that too many people were still being wrongfully denied Medicare coverage – in part because many medical providers had not been adequately educated, and in part because many providers were still skeptical that Medicare would alter its coverage practices. The new webpage offers CMS’s official imprimatur on the correct legal standard that improvement is not required when there is a need for skilled care. For more information about Medicare coverage for maintenance care and CMS’s new Jimmo webpage, register for the Center for Medicare Advocacy’s free webinar, to be held September 27, 2017 at 3:00pm EDT/12pm PDT. Contact: Matthew Shepard, Communications Director MShepard@MedicareAdvocacy.org, (860) 456-7790 View as webpage: http://www.medicareadvocacy.org/jimmo-corrective-action-plan-completed ### The Center for Medicare Advocacy, Inc., established in 1986, is a national nonprofit, nonpartisan law organization that provides education, advocacy and legal assistance to help older people and people with disabilities obtain fair access to Medicare and quality health care. The Center is headquartered in Washington, DC and Connecticut, with attorneys throughout the country.

August 29, 2017

ACL Releases First Ever National Data on Adult Maltreatment

Today, at the National Adult Protective Services Association conference, ACL released the first consistently, systematically, and nationally collected data on the abuse of older adults and adults with disabilities.

This report is the first of a series based on data from the first year of the National Adult Maltreatment Reporting System (NAMRS). NAMRS is a voluntary data reporting system collecting data from state and local Adult Protective Services systems.

Fifty-four of 56 states and territories contributed data to NAMRS in its first year. This high level of voluntary participation reflects the value that leaders in the field of adult maltreatment see in this data. 

While NAMRS is still in its infancy, the information it will provide in the years to come will directly inform prevention and intervention practices at all levels of the adult maltreatment field. It will provide a better understanding of the characteristics of those experiencing, and perpetrating, abuse and identify system gaps for responding to maltreatment and preventing repeat maltreatment. As states and territories will continue to improve information systems, add data elements, train staff on new data collection methods, and report additional data, NAMRS data will become an extremely valuable tool.

Data collected by NAMRS includes APS staff and case-load, response and response time, intake and investigation practices, maltreatment type, victim characteristics, and perpetrator characteristics. For example, 44 states and territories reported opening investigations for over 877,000 clients.

Many in the adult maltreatment field, including the federal Elder Justice Coordinating Council, have recognized the need for national data on adult maltreatment. After the passage and funding of the Elder Justice Act, ACL awarded the first-ever federal grants to enhance Adult Protective Services. These grants were used by many states to build data systems and align them with NAMRS.

View the first NAMRS report.

Quote of the Day

"All seem to be able to achieve the high bar of a mid to higher 90% cure rate. Anything short of this efficacy rate will make it hard for the product to compete in the market. By way of safety, all seem to have inherent safety profiles such that patients need to be monitored, but the majority seem to have manageable side effects on the whole."


— Lynn Nishida, area vice president of pharmacy at Solid Benefit Guidance, tells Specialty Pharmacy News about the eight next-generation therapies now available to treat hepatitis C. 

$8,295,681 ...

... was the largest bonus paid to a Blue Cross and Blue Shield CEO in 2016. That bonus went to Daniel Loepp of Blue Cross Blue Shield of Michigan.

Hospitals warn Medicaid DSH cuts could lead to reduced access for low-income patients

By Virgil Dickson  | August 28, 2017

The CMS' plan to cut billions in federal funds meant to help hospitals with uncompensated-care costs could cause hospitals to scale back the number of Medicaid enrollees they see and scrap initiatives aimed at improving care for those patients.

The agency is following through on an Affordable Care Act requirement to cut Medicaid disproportionate-share hospital payments by $43 billion from fiscal 2018 through 2025. According to a CMS rulemaking released last month, the cuts will start on Oct. 1.

In finalized, Texas could lose 14% or $148 million of its DSH funds next year alone. That could be a deal breaker for Doctors Hospital at Renaissance, a 500-bed facility in Edinburg, Texas, where 44% of its patient population is covered by Medicaid.

"Any proposed decrease in Medicaid DSH payments will severely jeopardize the viability of DHR to continue serving such a high proportion of Medicaid and Medicare patients," Dr. Carlos Cardenas, co-founder of the hospital, said in a comment letter sent Monday to the CMS.

The reimbursement cuts could also affect providers' efforts to curb drug abuse among Medicaid beneficiaries, according to staff at Upstate Universal Hospital, one of the few facilities in northern New York that offers addiction treatment.

"Cuts to DSH funds will result in a reduction of and an unnecessary delay in patients receiving essential substance-recovery and mental health services," Raymond Muldoon, a psychiatric-mental health nurse practitioner at Upstate, said in a comment letter.

Upstate is part of the State University of New York system, which has three public hospitals. The system estimates it will lose $320 million from 2018 through 2025 should the cuts be finalized, according to a SUNY system spokesman.

System staffers worry that the DSH cuts could lead to layoffs.

"A cut in federal DSH Medicaid dollars would hurt our hospital, and cause many people in upstate New York to lose jobs," Dr. Daniel Zaccarini, a resident at Upstate Universal Hospital, said in a Aug. 21 comment letter to the CMS. "By cutting these DSH payments you are secondarily hurting our economy."

States with low uninsured rates such as Hawaii, Kentucky and Minnesota are receiving the biggest DSH cuts under the formula outlined in the proposed rule released last month. Residents in these and other states with similar low uninsured rates have made coverage gains thanks to subsidized individual market coverage and Medicaid expansion.

However, the CMS' new DSH formula doesn't take into account the shortfall between Medicaid payment rates and actual costs of care, hospitals say. Medicaid pays 60% of Medicare rates for the same service on average.

"Despite Medicaid expansion, Kentucky hospitals continue to experience millions of dollars in uncompensated care due to growing Medicaid shortfalls," said Nancy Galvagni, senior vice president at the Kentucky Hospital Association.

Her group is pushing the CMS to include this calculation in their formula. Kentucky's federal DSH allotment would be reduced by $120 million by 2024 under the agency's current calculations, leaving only $41 million in federal dollars to help hospitals in the state offset an estimated $135 million in uncompensated-care losses.

If an outright repeal of the rule isn't possible, hospital executives would at least like to see a delay, as it's unclear what data the CMS will use to determine how much a state's hospital population is uninsured, according to the American Hospital Association.

"This lack of transparency significantly hampers state governments' and stakeholder's ability to assess how the (cut) will affect their state DSH allotment," the trade association said.

But the CMS may find its hands largely tied, as the cuts must start on Oct. 1.

America's Essential Hospitals has suggested that Congress could delay the DSH cuts in its legislation to reauthorize the Children's Health Insurance Program. Federal funding for CHIP is set to expire on Sept. 30, and the legislation has wide bipartisan support to pass.

"We continue to work with Congress to further delay or completely eliminate these reductions, which pose a dire threat to the stability of essential hospitals and access to care for their patients," said Dr. Bruce Siegel, CEO of the association, in a comment letter.

Virgil Dickson reports from Washington on the federal regulatory agencies. His experience before joining Modern Healthcare in 2013 includes serving as the Washington-based correspondent for PRWeek and as an editor/reporter for FDA News. Dickson earned a bachelor's degree from DePaul University in 2007.

http://www.modernhealthcare.com/article/20170828/NEWS/170829890?utm_source=modernhealthcare&utm_medium=email&utm_content=20170828-NEWS-170829890&utm_campaign=am

National Medicare Education Week is Sept. 15-21

Posted by Medicare Made Clear

Did you know? According to the 2013 Medicare Made Clear Index survey:

• 1 in 5 Medicare beneficiaries describes Medicare as confusing
• Most adults can’t identify what Medicare Parts A, B, C and D cover
• 70% of baby boomers describe their understanding of Medicare as “fair” or “poor”

National Medicare Education Week (Sept. 15-21) is dedicated to helping people learn more about Medicare. It begins one month before the start of Medicare Open Enrollment, which runs from Oct. 15 to Dec. 7 each year.
During National Medicare Education Week, UnitedHealthcare hosts educational events around the country. Attendees learn about Medicare through an interactive presentation and educational materials that they can take home. They can also speak one-on-one with local Medicare specialists. The events are educational only.
Check out if there are National Medicare Education Week events in your area. Here is a sample of what you’ll learn at these events:

• The different types of Medicare coverage and how to determine what coverage is right for you
• How and when to enroll in Medicare, including tips for people who choose to delay enrolling in Medicare past age 65
• Where to go for more information

Learn more about National Medicare Education Week and how you can take part.
National Medicare Education Week is part of UnitedHealthcare’s Medicare Made Clear initiative. Proud supporters of National Medicare Education Week include AARP, Caregiver Action Network, National Association of Area Agencies on Aging (n4a), Walgreens .

For more information, explore MedicareMadeClear.com or contact the Medicare helpline 24 hours a day, seven days a week at 1-800-MEDICARE (1-800-633-4227), TTY 1-877-486-2048.