Tag Archives: CMS Part B Drug Payment Model proposed rule

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.

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.

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This post was updated on April 26, 2016.