Policy Updates

ASH Calls for Payment Innovation in Rare Diseases Such as Sickle Cell Disease

The Center for Medicare and Medicaid Innovation (CMMI), a branch of the Centers for Medicare and Medicaid Services (CMS), was created by the Affordable Care Act in 2010. Since then, CMMI has received $10 billion in funding over 10 years to create more than 50 different payment and delivery models, such as bundled episodes for hospitals and the Oncology Care Model.

As part of their multifaceted initiative to address the burden of sickle cell disease (SCD), the American Society of Hematology (ASH) sent CMMI a letter in April 2016 requesting that it explore new payment models to improve the care of these patients. In the letter, ASH congratulates CMMI on its many endeavors to address payment reform but expresses concern that individuals with rare diseases such as SCD may be left out of this reform.

Many experts believe that the care of people with SCD is in part hampered by a payment system that does not reward ongoing care of individuals with difficult chronic diseases, particularly when they are more likely than not to be covered by Medicaid. The letter also acknowledges that patients who live in areas without specialized sickle cell centers tend to receive “scattered” care from a variety of physicians and hospitals. Most primary-care physicians are not able to adequately care for SCD patients, given the limited time and payment associated with office-based evaluation and management codes.

To address this problem, ASH proposed a risk-based model in which a single organization would be responsible for costs associated with patients with SCD in a given region. This model will be designed so that participants have a strong incentive to improve care for patients who are outside of their existing care network and who have been poorly served by the existing system.

“We hope that the economic realities of practice do not serve as a barrier to ensuring that patients receive state-of-the-art care,” ASH President Charles Abrams, MD, wrote in the letter. “ASH urges CMMI to invest the necessary resources to test payment models to help individuals suffering from this disease.”


Do Major Changes to MACRA Implementation Overlook Rare Diseases?

In late April 2016, CMS released their proposed rule for implementing the Medicare Access and CHIP Reauthorization Act (MACRA). The law, passed in April 2015, eliminated annual planned Medicare payment cuts for physicians and replaced it with a system with small predictable updates that are adjusted based on performance. ASH was strongly supportive of MACRA because it removed the threat of large payment cuts and offered physicians a mechanism for participating in payment models outside of the traditional fee-for-service system.

However, a closer look at MACRA reveals that the proposed programs are largely built around common diseases and may overlook rare diseases, like many of those treated by hematologists.

According to the ASH letter, “That most diseases that hematologists treat are rare can complicate measuring quality and properly accounting for resource use, and it is important that CMS focus on the goal of improving care for all patients.” Hematologists also often practice in large groups, a large percentage of those which belong to multispecialty groups, such as the faculty of an academic medical center.

In the letter to CMS, ASH commented on several areas of the proposed rule to better serve patients with rare diseases treated by hematologists who practice in large groups:

  • Quality measurement: ASH supports CMS’ proposal of flexible quality measurement and reporting under the Merit-Based Incentive Program, including reducing the required number of measures physicians must report (from nine to six) and gradually increasing the required threshold for “successful” reporting (from 50% of eligible patients to 80-90%).
  • Specialty-specific measure sets: CMS proposes to create a series of specialty-specific measure sets, intending to simplify the quality measure selection process for physicians. Since there is no proposed set for hematology/oncology, ASH recommends simply requiring six measures from all physicians, thus requiring everyone to meet the same standards.
  • Resource use: Because hematologists can play different roles for patients with blood diseases (i.e., seeing a patient once to make a diagnosis, taking over care for a long period of time if a patient develops a malignancy, or serving as the long-term primary-care provider for a patient with a chronic condition), their levels of influence on a given patient may differ substantially based on that role. Therefore, ASH recommends that CMS continue to examine and develop these measures to ensure that hematologists and other specialists who treat very ill patients are not inappropriately disadvantaged.
  • Cost of drugs: The new proposed rule continues to exclude Medicare Part D drugs (including self-administered drugs like oral chemotherapy) from resource-use measurement; however, hematologists often use physician-administered drugs that are interchangeable with self-administered drugs due to affordability. ASH suggests that CMS include certain Medicare Part D drug costs, again, to ensure that hematologists are not penalized for the use of appropriate drugs.

For ASH’s full comments on the proposed MACRA rule, visit hematology.org/Advocacy/Testimony.aspx. More details on the changes in MACRA implementation will be detailed in the final rule, which is expected in 2016.


Expanding Hematopoietic Cell Transplantation Coverage to Rare Diseases

Earlier this year, CMS decided to expand the National Coverage Determination (NCD) for allogeneic hematopoietic cell transplantation (alloHCT) to include eligible patients with SCD, myelofibrosis, and multiple myeloma (MM). Patients with the following indications will now be eligible for alloHCT:

  • symptomatic, stage II or III MM
  • intermediate-2 or High Dynamic International Prognostic Scoring System myelofibrosis, plus score in primary or secondary disease
  • severely symptomatic SCD

Prior to the recent NCD, CMS was “silent” on the use of alloHCT for the treatment of SCD and myelofibrosis. That meant coverage decisions were up to local Medicare Administrative Contractors; patients and transplant centers were put in a position of potentially taking on the full financial burden of the procedure if coverage was denied. Beyond that, CMS outright prohibited coverage of alloHCT for MM.

Although this action removes the financial barrier to transplant for a number of patients who would benefit from it, there are caveats to the recent expansion of coverage. First, there are eligibility restrictions within each disease state (based on patients’ risk level and the severity of disease). Second, the new NCD requirement includes a Coverage with Evidence Development component, meaning reimbursement would be provided only if the patient is enrolled in a CMS-approved clinical trial designed to evaluate the benefit of alloHCT in a Medicare population.

For an in-depth take on this expansion of coverage, see our Feature article in our May 2016 issue, “CMS Expands Coverage for Hematopoietic Cell Transplantation: Proceed With Cautious Optimism.”

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