Category Archives: In and Around Washington, DC

Key Takeaways from Congressional Hearing on “Medicare Drug Experiment”

By Brittney Fairman, Policy Analyst, ACCC

Capitol BuildingOn Tuesday, May 17, the U.S. House Energy and Commerce Committee Subcommittee on Health held a hearing titled “The Obama Administration’s Medicare Drug Experiment: The Patient and Doctor Perspective,” which focused on CMS’ proposed Medicare Part B Drug Payment Model. The Subcommittee heard from witnesses representing the provider and patient communities, including:

  • Debra Patt, MD, MPH, MBA, Vice President of Texas Oncology and Medical Director of The US Oncology Network;
  • Marcia Boyle, President and Founder of the Immune Deficiency Foundation;
  • Michael Schweitz, MD, FACP, MACR, National Advocacy Chair of the Coalition of State Rheumatology Organizations;
  • Heather Block, a patient advocate; and
  • Joe Baker, President of the Medicare Rights Center.

Notably, the hearing echoed many of the concerns ACCC and fellow stakeholders have been voicing since CMS released the proposal in early March. Key takeaways include:

CMS is operating under a false premise that there are always less costly therapeutic equivalents available to treat patients. In the case of oncology, treatment situations where there are true clinical substitutes are “few and far between,” Dr. Patt pointed out. When a therapeutically equivalent drug does exist, those drugs are not always available to every clinician nor are they always most conducive to a patient’s specific treatment plan.

The proposed demonstration will create barriers to patient access and have a disproportionate impact on rural areas. With a lack of appropriate safeguards, healthcare providers fear the demonstration program would create additional financial pressures that would push rural or small physician practices out of business.  For patients in rural areas – or patients that require more expensive therapies – this may cause difficulty in accessing oncology care.

CMS’ proposal is akin to an involuntary clinical trial. Witnesses and Committee members pointed out that CMS’ experiment is not unlike a clinical trial, requiring participation of providers and their patients for the purposes of data collection. However, unlike a clinical trial, participation is involuntary and the proposal lacks critical patient safeguards – patients may never know if their provider is operating under a control or experimental arm of CMS’ demonstration. This randomized trial will, unknowingly and unwillingly, limit patient access to needed care.

Average Sales Price (ASP), by definition, is an average. Many community oncologists – often smaller practices – are not able to gain price advantages and are currently paying well above ASP for Part B drugs. Any further reductions to reimbursement will make it impossible for providers to cover the acquisition cost of many, if not most, cancer treatments.

Witnesses also addressed a series of “carve-outs” that have been discussed by policymakers, including for oncology providers, the Oncology Care Model (OCM) participating practices, or rural providers. Dr. Patt, however, pointed out that “there’s no right way to do the wrong thing.” Most witnesses called for a full withdraw of CMS’ proposal.

These points and more can be found in ACCC’s comments, submitted to CMS in early May. ACCC is continuing to monitor Congressional efforts on the CMS proposal.

ACCC Voices Part B Demo Concerns on Capitol Hill & at CMS

By Amanda Patton, ACCC, Communications

ACCC-PartB-Demo-Meeting-Capitol Hill-crop2With the Medicare Part B Drug Payment Model comment deadline fast approaching (Monday, May 9 at 5:00 pm EDT), ACCC continued its push to educate policymakers on the detrimental impact this ill-conceived proposal will have on community cancer care, providers, and patients.

This morning ACCC President Jennie R. Crews, MD, MMM, FACP;  ACCC Past President Ernest Anderson Jr., MS, RPh, FASHP; and Leah Ralph, Director of Health Policy, ACCC; together with representatives from the Hematology/Oncology Pharmacy Association (HOPA) and the Oncology Nursing Society (ONS), traveled to Capitol Hill to meet with Senate Finance Committee staff and discuss concerns about the Part B proposal’s impact on cancer care. During the meeting, ACCC shared information from a data analysis that reveals the significant financial impact the proposal would have on providers and patients.

In a meeting with CMS Center for Medicare and Medicaid Innovation (CMMI) staff on Monday afternoon, ACCC leadership, along with representatives from HOPA, and ONS—reflected the voice of multidisciplinary cancer care providers.  ACCC shared results from the Part B proposal data analysis and reiterated ACCC’s strong concerns that are reflected in our comment letter to the agency.  Read our comment letter.

Stay tuned for advocacy updates from ACCC.

 

ACCC Supports H.R. 5122, Legislation to Prohibit Medicare Part B Drug Demo

By Leah Ralph, Director of Health Policy, ACCC

Capitol BuildingThe Association of Community Cancer Centers (ACCC) thanks Representative Larry Bucshon (R-IN) for introducing H.R. 5122, legislation to prohibit further action on the Centers for Medicare & Medicaid Services (CMS) proposed rule for the Medicare Part B Drug Demo. ACCC urges prompt passage of H.R. 5122 in the U.S. House of Representatives.

ACCC remains strongly opposed to the Part B Drug Demo and is deeply concerned about the potential impact of this misguided proposal on both providers and the patients they serve.

Our membership, comprising approximately 2,000 practices and hospitals across the country, is committed to implementing value-based reforms and to continuing to work with CMS on meaningful payment reform—our members will be participating in the CMMI Oncology Care Model and investing in the infrastructure needed to comply with MACRA. However, CMS’ Part B Drug Model proposal is a nearsighted approach to Medicare reform.

ACCC supports H.R. 5122, and a full withdraw of the program, to provide the oncology community and CMS time to fully understand the impact of this policy and to work with CMS on meaningful reform.

For more on ACCC advocacy efforts on this issue, visit accc-cancer.org.

ACCC Asked: Congress Listened

By Leah Ralph, Director of Health Policy, ACCC

time for actionToday 242 members of Congress joined in a bipartisan letter to CMS Acting Administrator Andy Slavitt urging the agency to withdraw its proposed Medicare Part B Drug Payment Model.  The effort was spearheaded by House Ways and Means Committee Member and Budget Committee Chairman Tom Price, MD (R-GA), House Energy and Commerce Committee Member John Shimkus (R-IL), and House Ways and Means Committee Charles Boustany Jr., MD (R-LA).

You asked and Congress listened.  Last week, hundreds of ACCC members reached out to their legislators asking that they sign on to the Congressional letter to CMS.  ACCC thanks its membership from 2,000 cancer programs and practices across the country for speaking up and telling their legislators about the detrimental impact this proposed rule would have on their patients and providers.

But the question remains: Will CMS listen?

May 9 is the deadline for comments to CMS on this misguided proposal. ACCC will be submitting comments to the agency and urges its members to send comments as well.

Learn more about ACCC advocacy efforts on this issue here.

A Misguided Experiment?

By Leah Ralph, Director of Health Policy, ACCC

Centers_for_Medicare_and_Medicaid_Services_logoThe noise around drug costs seems to have gotten louder in recent months, with policymakers clamoring for controls on drug pricing, Congressional hearings calling on pharmaceutical executives to testify, and recommendations from the Medicare Payment Advisory Commission (MedPAC) focused on containing Medicare spending in the context of ever-increasing prescription drug costs.

In early March, the Centers for Medicare and Medicaid Services (CMS) issued a proposal to implement a national demonstration program that would target provider reimbursement and fundamentally change the way Medicare pays physicians and hospitals for Part B drugs. The scope of what CMS is proposing is sweeping. If finalized, it represents a significant departure from the methodology and philosophy underlying Medicare’s current reimbursement system, leading to bigger questions about the most appropriate—and effective—way to curb drug spending.

Mandatory Participation

 CMS has broad authority under the Center for Medicare & Medicaid Innovation (CMMI), created by the ACA, to test different models that would improve quality and lower costs in the Medicare program. However, the agency seems to be pushing the scope of its authority, breaking from past demonstration programs to propose a mandatory model in which all Part B providers–hospital outpatient departments, physician offices, and pharmacies–would be required to participate.

The proposed Part B Drug Payment Model would consist of two phases in which providers would be divided into four groups: three experimental groups and one control group over a five-year period. Phase I would be implemented as early as August 2016 and would mandate that approximately half of all Part B providers would have their reimbursement rates reduced to ASP+2.5% plus a flat fee of $16.80 per drug per day. Importantly, Congressionally-mandated sequestration will continue to apply to payments made under the model. As a result, under the proposal, the experimental group’s actual payment rate will be ASP+0.86% plus $16.53 per drug per day. The remaining half, the control group, would continue to be reimbursed for Part B drugs at ASP+6%. The goal, which policymakers have discussed for sometime, is to eliminate financial incentives for providers to prescribe more expensive drugs.

Ambitious Timeline

The agency’s ambitious timeline calls for Phase II to begin as early as January 2017. Phase II would further divide the control and test groups—creating a four-arm control trial—and overlay a requirement to use value-based pricing (VBP) reimbursement strategies and clinical decision support (CDS) tools to produce Medicare savings. One (unlucky) group of providers will be subject to both the reduced ASP rate and the requirement to utilize VBP tools. These tools might include:

  • Reference pricing: Medicare would set a standard payment for therapeutically similar products.
  • Indications-based pricing: Payment would vary for a drug based on its clinical effectiveness for different indications.
  • Voluntary-risk sharing agreements: CMS would enter into voluntary agreements with manufacturers to link health outcomes with payment.
  • Discounting or eliminating patient coinsurance to encourage beneficiary use of high-value drugs.

Unanswered Questions

Despite a preliminary list of potential tools, CMS failed to describe these VBP approaches in any meaningful detail, leaving many questions about how CMS will develop this methodology and how the agency will make determinations about high-value treatments.

Perhaps most unnerving, providers would be assigned to arms of the trial at random based on their geographic location in Primary Care Services Areas (PCSAs), which are clusters of ZIP codes that reflect primary care service delivery. Although CMS has structured Phase I to be budget-neutral for the Medicare program, among providers, there will be winners and losers: the program is designed to redistribute drug spending by increasing payments to provider specialties, such as primary care, that use relatively inexpensive drugs and decrease payments to hospitals and physician specialties, such as oncology and ophthalmology, that often use more costly drugs. Specifically, under the proposed model, the tipping point is $480–drugs that cost providers more than $480 per day on average would result in lower reimbursement, whereas products costing less than $480 per day would produce higher payments than what is reimbursed today.

The majority of drugs–7 of 10–that would make up the largest reduction in reimbursement are used to treat cancer. Moreover, many of these drugs do not have a lower cost alternative.1

ACCC Takes Action

 On both policy and process, ACCC remains deeply concerned. Rather than working with cancer care professionals to build the infrastructure needed to define quality and value in their cancer programs, CMS has responded to a call for reigning in drug costs with a myopic focus on reimbursement. Our members have partnered with CMS on meaningful payment reform – including the most recent Oncology Care Model – and will soon be dedicating extensive resources to navigating a new, and complex, reformed physician payment system under MACRA.

Oncologists are ready for change, but CMS’ proposal reaches too far, too fast, with seemingly little understanding of the devastating impact this approach will have on community cancer care and patient access.

Early on, ACCC joined with 60 oncology stakeholder groups in a letter to CMS asking the agency to withdraw its proposal. On March 17 ACCC, together with more than 300 state and national organizations, sent a letter to Congress asking policymakers not to move forward with the CMS Part B Drug Payment Model proposal. We recently partnered with the Hematology/Oncology Pharmacy Association (HOPA), the Oncology Nursing Society (ONS), and the Association of Oncology Social Work (AOSW) to caution Vice President Biden about how the proposal would impede the goals of the Administration’s cancer Moonshot initiative.

CMS will accept comments on the proposal until May 9, 2016. ACCC will be submitting a comment letter and urges members to express their concerns to the agency.

Access ACCC resources related to this issue and learn more about our advocacy efforts here.

_________________________________________

This post was updated on April 26, 2016.

ACCC Annual Meeting: Five Key Takeaways

by Amanda Patton, ACCC Communications

ACCC 42nd Annual MeetingNearly 500 oncology professionals gathered in Washington, D.C., last week for the 42nd ACCC Annual Meeting, CANCERSCAPE. Throughout sessions centered on policy, value, and quality, attendees heard a recurrent message: Your experience, perspective, and input on the issues of value-based care, quality measures, and outcomes are essential as the healthcare system and oncology transition to the new world of alternative payment models and value-based care.

From ACCC Capitol Hill Day last Wednesday throughout the meeting sessions, attendees were urged to educate policymakers and payers about the real-world processes involved in delivering quality cancer care.

In the meeting’s opening session, Congressman Rick Nolan (MN-D)  called out the vital role ACCC members can play in helping educate legislators and policymakers, “No one can articulate need, challenges, potential to ultimately cure cancer [better] than the people in this room today,” he said.

Can precision medicine be reconciled with value-based care? “Absolutely” said Kavita Patel, MD, MS, of the Brookings Institution.  Oncology already delivers personalized (or precision) medicine through targeted therapies for some cancers, she pointed out. Communicating about the oncology care process so that policymakers understand real-world cancer care delivery is imperative, Patel said. Part of that conversation should aim to help policymakers understand the demanding intuitive thought process that is part of today’s oncology care, along with the tremendous amount of information cancer care providers must keep up with given the pace and variety of emerging therapies. “It’s not writing prescriptions,” she said.

Five Key CANCERSCAPE Takeaways

High-level meeting takeaways that interconnect value, policy, and quality include:

  1. Alignment. For value and quality measures to work in oncology, alignment among payers, providers, and patients is essential.
  2. Put your data to work. Cancer programs and practices are finding ways to harness their data to improve quality patient-centered care and reduce costs. In a presentation on Collaboration Across Specialties to Improve Care and Curb Costs, Matthew Manning, MD,  from Cone Health demonstrated how his program used data to identify “hotspotters,” assess gaps in care, improve outcomes, and reduce costs.
  3. Communicate. Support conversations across silos and among stakeholders. Engage with patients to understand their goals of care and to define value and quality. While value frameworks are generic, “all patients are different” agreed panelists in a Town Hall discussion on Value Framework Tools.
  4. Be proactive. Don’t wait until USP Chapter 800 goes into effect to assess your facilities readiness. Don’t wait until HRSA issues its final 340B mega-regulation. Take steps today to assess your program’s compliance. “Be prepared” was also the message in a Biosimilars Update from Nisha Pherwani, PharmD, BCOP, clinical director of Oncology, Cardinal Health. She urged attendees to:
    • Understand the FDA approval process for biosimilars
    • Provide a concise review to your P&T committee
    • Review the FDA guidances on biosimilars
    • Stay tuned for more on how interchangeability will impact regulations.
  5. Speak up. Oncology providers can best articulate the care they provide and the issues impacting care delivery. Leadership in oncology has to step forward to help define quality and value and inform policy. Work with ACCC to make your voice heard.

This week’s CMS release of a proposed rule designed to test new Medicare Part B drug payment models makes clear the critical need for the oncology community stay on top of what is happening among policymakers in Washington, D.C.  ACCC has voiced strong opposition to CMS’s proposal. Among other concerns, ACCC points to the lack of opportunity for stakeholder input on the development of this proposal.

ACCC urges its members speak up and ask Congress to stop the CMS Medicare Part B Drug Payment Model.  Click here to contact your legislators.

Annual Meeting Highlight: Medicare Update & What to Expect in 2016

By Amanda Patton, ACCC Communications

ACCC 42nd Annual Meeting-ConwayAt the ACCC 42nd Annual Meeting last week, Lindsay Conway of The Advisory Board Company updated attendees on Medicare payments and what to expect in 2016.  Not surprisingly, her presentation touched on issues related to the meeting’s central themes of policy, quality, and value.

Two examples of the forward momentum in quality this year will be “testing” new oncology quality measures through PCHQR Quality Reporting Measures and CAHPS for Cancer Care.  Field testing for the CAHPS for Cancer Care is wrapping up, Conway said, and we can expect to see the CAHPS trademark on three oncology-specific surveys this summer.  Specifically, we will see a survey for surgical oncology, a survey for radiation oncology, and a medical oncology survey. Each survey will consist of about 85 questions and will likely reflect five CAPHS domains, including:

  1. Effective Communication
  2. Shared Decision Making
  3. Enabling Patient Self-Management
  4. Technical Communication
  5. Access

Looking ahead, Conway noted that new policies are supporting population health goals while also slowly moving forward with payment for value. As examples, she cited recent Medicare policies related to biosimilars, advance care planning, and lung cancer screening.

As cancer programs plan strategically for the future, Conway suggests keeping an eye on the following:

  • Payment equalization—which is gaining momentum
  • Progression of site-neutral payment policies
  • Physician practice acquisition—the equation is becoming increasingly complex from both the hospital and the physician practice perspectives
  • Alternative payment models (APMs), in particular the Center for Medicare and Medicaid Innovation (CMMI) Oncology Care Model.

The CMS OCM initiative, which will pilot a value-based reimbursement model in oncology, is on everyone’s radar screen, as the oncology community awaits the agency’s announcement of practices selected for participation. Conway acknowledged that the OCM model is complex and that many questions remain about how CMMI will implement the model.

The ultimate benefit for those participating in the OCM will not be financial, according to Conway. The benefits for participants will be strategic, e.g., new data sets, benchmarks, more data about the patients being served, the opportunity to develop competencies in operating in a risk-based environment, and having a voice in the development of new risk-based models in oncology.

Rep. Nolan Praises Advocacy Efforts of ACCC Members

by Amanda Patton, ACCC Communications

Rep. Richard Nolan opens ACCC 42nd Annual Meeting

Rep. Richard Nolan opens ACCC 42nd Annual Meeting

Congressman Richard “Rick” Nolan (MN-D) opened the ACCC 42nd Annual Meeting on Thursday paying tribute to ACCC membership. “I want to thank you for all that you do,” he said.

“You are part of the team that comes together to be there for people at the most challenging and emotionally difficult and troubling times in their lives. . . Thanks to the dedication and hard work of people like you so much progress is being made in [the fight] against cancer.”

In an ideal transition from ACCC Capitol Hill Day to CANCERSCAPE Annual Meeting sessions focused on policy and key drivers of change, Representative Nolan told attendees coming to Washington is critical, “I know it’s not easy, but it is so important because as a practical matter lending your voices, your knowledge, your perspective is unbelievably important.”

He spoke movingly about the impact of cancer in his own family. Congressman Nolan lost his father to cancer, and an aunt—who was an inspiration for his political career—also died from cancer at age 54.

Last January, he announced that his youngest daughter had been diagnosed with stage 4 non-smoking lung cancer. She is “a high spirited, very determined, and very, very health conscious young woman,” Nolan said. “Thanks to people’s prayers and advances in medical science she’s doing better. She is still with us fighting the good fight.”

His daughter’s struggle inspired Nolan to establish the Congressional Lung Cancer Caucus, along with co-founders Lois Capps (CA-D) and Frank LoBiondo (NJ-R).

Because nearly everyone has someone in their lives who has been touched by cancer, Congressman Nolan is optimistic that “we can find nonpartisan almost unanimous agreement to find better funding for the research needed to end this terrible scourge.”

Advocacy efforts such as ACCC Capitol Hill Day are critical he said. It’s important to tell your story because “no one can articulate need, challenges, potential to ultimately cure cancer [better] than the people in this room today.”

___________________________

Stay tuned for Annual Meeting key takeaways.

Navigation Metrics and Value-Based Care

By Tricia Strusowski, MS, RN

Ms. Strusowski recently co-authored an article on “Patient Navigation Metrics” for Oncology Issues, the journal of the Association of Community Cancer Centers. In this guest blog post, she explores this topic in the context of value-based care.

ThinkstockPhotos-467463476Value-based care is a highly coordinated, patient-centered solution to address rising costs, duplication of services, barriers to care, and to help patients receive the care they need. Over the decades, patient navigation standards and core competencies have been established through national organizations. These guidelines and standards have provided an excellent foundation for oncology navigation programs. Metrics are exceedingly important for measuring the success of your patient navigation program. Value-based care (which drives improvements to the delivery of care by requiring improved care at a lower cost) encompasses more than metrics and has the potential to skyrocket your program to a new level.

As we advance present navigation programs, value-based care will be essential; it will incorporate all the key categories from the Institute of Medicine (IOM) report, “Delivering High-Quality Cancer Care: Charting a New Course for a System in Crisis.”

The conceptual framework from the IOM report includes:

  • Engaged patients
  • Adequately staffed, trained, and coordinated workforce
  • Evidence-based cancer care
  • A learning healthcare IT system for cancer
  • Translation of evidence into clinical practice, quality measurement, and performance improvement
  • Accessible, affordable cancer care

The goal of value-based care is to empower patients to actively participate in their care, which will enhance the patient experience and drive patient-centered outcomes.

How can we support our patients to participate in their care discussions? Some examples include:

  • Provide decision aides including questions to prompt discussion with the patient and his or her healthcare provider
  • Provide patients with educational information that incorporates their preferred learning style, i.e., written, visual, or verbal
  • Mandate health literacy and cultural competency training for our staff
  • Utilize evidence-based tools to identify barriers for patients and their families
  • Create a patient appointment checklist to explain the reason for tests and procedures

The result of value-based care is a patient-centered process in which patients and their families are educated and able to participate in their treatment discussion from time of diagnosis through to survivorship or end-of-life services. By having our patients actively participate in these treatment discussions, value-based outcomes will prevail and advance the level of our patient navigation programs.

Next week, the ACCC 42nd Annual Meeting, CANCERSCAPE, in Washington, D.C., will feature sessions that focus on various facets of value-based care, including a special Town Hall discussion: Value Framework Tools: The Provider Perspective, which will be live-streamed on Thursday, March 3, 2016, from 12:50 pm — 1:35 pm EST. Learn more here.  

Oral Parity: When Modern Medicine Outpaces Policy

By Leah Ralph, Director of Health Policy, ACCC

PillsACCC has been a longtime champion of oral parity, the legislative effort to equalize patient cost sharing for intravenous (IV) and oral chemotherapy drugs.

Oral oncolytics can offer a better quality of life for patients undergoing chemotherapy treatment, including less travel time, fewer work absences, often fewer side effects, and the convenience and comfort of at-home administration. For some cancer patients, an oral anti-cancer medication is the only option for treatment. Yet insurance coverage has not kept pace with medical innovation. Outdated insurance benefit designs continue to cover oral medications under the pharmacy benefit, which often means high, burdensome out-of-pocket costs for patients. (Traditional IV chemotherapy is covered under a plan’s medical benefit, resulting in minimal co-pays or no cost for patients.) This coverage disparity creates financial burdens for patients prescribed an oral anti-cancer medicine, leaving them less likely to adhere to treatment and often unable to fill their prescription. The number one reason a patient does not take his or her medication appropriately is cost. According to a 2011 study published in the Journal of Oncology Practice and the American Journal of Managed Care, 10 percent of cancer patients failed to fill their initial prescriptions for oral anticancer medications due to high out-of-pocket costs.

Progress at the State Level

We’ve come a long way in terms of state law. To date, 40 states plus the District of Columbia have passed oral parity legislation. These laws are not a mandate to cover oral chemotherapy, but rather require that if an insurance plan covers chemotherapy treatment, a patient’s out-of-pocket costs must be the same, regardless of how the therapy is administered. As a member of the State Patients Equal Access Coalition (SPEAC), ACCC has partnered with several state oncology societies—including Virginia, West Virginia, and Arizona in recent years—to pass oral parity laws, and this year we’re focusing our efforts on Tennessee and South Carolina. (If you are a provider in either of these states, and you’d like to be an advocate, email ACCC Director of Health Policy, Leah Ralph. ACCC participated in this new SPEAC video that helps to tell the oral parity story from the patient’s perspective.

Why Federal Legislation is Necessary

And even though a majority of states have now passed state-level oral parity legislation, federal legislation is still needed. A federal law would ensure that new cost-sharing restrictions are implemented consistently across the country, and that plans that fall outside state regulation, such as those covered under the federal ERISA law (usually large, multi-state health plans), must comply with the same equitable coverage requirements. In September, an ACCC member spoke at a Congressional briefing on the Cancer Drug Coverage Parity Act of 2015 (S.1566/H.R.2739), helping gain critical momentum to move the bill forward.

In a few weeks, at ACCC 2016 Capitol Hill Day on March 2, ACCC members will be walking the halls of Congress to talk with legislators about the importance of this bill to cancer patients and the providers who care for them.

ACCC encourages members to join our efforts, and continue to monitor opportunities to weigh in with your state and federal legislators. For more on this issue, look for an upcoming article to be published in the March/April Oncology Issues, “Exploring the Issue of Cancer Drug Parity.”