Home   |   Donate   |   Industry   |   Print Page   |   Your Cart   |   Sign In   |   Join Now
Keyword Search
21st Century Cures Act Signed
Share |

 

               On December 13, 2016, President Obama signed the 21st Century Cures Act. In a memorandum from November 30, the Digestive Disease National Coalition (DDNC), of which Oley is a part, notes that Cures focuses on five key topics: “reducing barriers to collaboration, further incorporating the patient perspective, modernizing clinical trials, developing new pathways to approve treatments and devices, and making new investments to fund the National Institutes of Health (NIH) and the Food and Drug Administration (FDA).” Of further interest to Oley members is that the 21st Century Cures Act includes provisions from the Medicare Home Infusion Site of Care Act, which we encouraged members to support.

 

               DDNC goes on to note that Cures “is a mixed-bag for medical research, patient care, and treatment development. There are many positives created through new opportunities and the potential for enhanced funding. There are also some drawbacks related to relaxing of patient protections in research and regulatory review….NIH and FDA are given a significant number of new mandates and relatively few resources to facilitate the additional responsibilities.”

 

               Among the highlights noted by DDNC are that the Cures Act:

  • Reauthorizes the NIH for FY2018–2020
  • Supports the National Pediatric Research Network (“a consortium of research institutions that… coordinates activities related to pediatric rare diseases and birth defects”)
  • Requires FDA to include patient experience data when a new drug is approved
  • “Establishes a review pathway at FDA for biomarkers and other drug development tools that can be used to help shorten drug development time and reduce the failure rate in drug development
  • “Facilitates drug development for rare diseases by streamlining the regulatory pathway
  • “Reauthorizes the Pediatric Rare Disease Priority Review Voucher (PRV) program until 2010
  • “Requires FDA to evaluate the use of real world evidence to help support the approval of a new indication for a previously approved drug and to help support or satisfy post-approval study requirements
  •  “Requires that pharmaceutical companies have publicly accessible compassionate use policies for drugs treating serious or life-threatening conditions
  • “Allows FDA to grant accelerated approval for regenerative therapeutic products.”

               The National Home Infusion Association (NHIA) has expressed concern over a section of Cures that changes the basis for how infusion companies are reimbursed for Medicare Part B DME infusion drugs from Average Wholesale Price (AWP) reimbursement rates to Average Sales Price (ASP) rates. NHIA notes that the higher AWP rates have “provided a margin which allowed home infusion providers to deliver those drugs in a financially viable manner.”

 

               This will take effect January 1, 2017. The change will be offset by the establishment of a service payment to providers of Part B DME Infusion Drugs, but that payment is not scheduled to begin until 2021.

 

               While this change does not have direct bearing on home enteral or parenteral nutrition (HPEN), it may negatively affect the home care companies that provide HPEN, and the ability for some consumers to infuse certain medications in the home setting.

 

               As we learn more about how the 21st Century Cures Act may affect you, we’ll share those details. Stay tuned.


LifelineLetter, November-December 2016

This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.

 

Updated in 2015 with a generous grant from Shire, Inc. 

 

This website was updated in 2015 with a generous grant from Shire, Inc. This website is an educational resource. It is not intended to provide medical advice or recommend a course of treatment. You should discuss all issues, ideas, suggestions, etc. with your clinician prior to use. Clinicians in a relevant field have reviewed the medical information; however, the Oley Foundation does not guarantee the accuracy of the information presented, and is not liable if information is incorrect or incomplete. If you have questions please contact Oley staff.
Membership Management Software Powered by YourMembership  ::  Legal