ASH Clinical News Focus on Rare Diseases | Page 18

POLICY UPDATES
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 selfadministered 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 .”
16 Focus on Rare Diseases