AMCP CEO Praises Enactment of the 21st Century Cures Act, Highlights New Law’s Major Advance Towards Value-Based Health Care System
Alexandria, Va., Dec. 13, 2016 — Academy of Managed Care Pharmacy (AMCP) CEO Susan A. Cantrell, RPh, CAE, issued the following statement on President Obama’s signing today of the 21st Century Cures Act:
“The Academy applauds President Obama for signing the 21st Century Cures Act, and commends both the House and Senate for passing this important bipartisan legislation. The Cures Act includes many provisions that will directly improve the health of Americans, from prompting new cures for cancer to combating opioid addiction.
“One specific provision takes an important step towards creating a value- and outcomes-based health care system that will give patients the medicines they need while ensuring the wise use of health care dollars. Section 3037 modernizes Section 114 of the Food and Drug Administration Modernization Act (FDAMA114) of 1997, which was designed as a safe harbor for manufacturers to share health care economic information with entities that make formulary and coverage decisions. That safe harbor, however, has been little used due to a lack of FDA guidance.
“Section 3037 helps make it possible for health plans and other payers to get the product information they need to determine the value of new and old medicines in improving patient outcomes. This is increasingly crucial with the rapid growth in drug costs, fed by the introduction of expensive and sometimes truly breakthrough medicines. This provision would provide pharmacists, physicians and nurses that must make these decisions with more information to make appropriate coverage determinations for patients and ensure access.
“Section 3037 aligns with recommendations developed during a recent AMCP partnership forum on FDAMA 114 and will aid our members who are responsible for formulary decision making in evaluating the benefits and costs of drugs and health technologies. This is a crucial step in the evolution of our health care system from a fee-for-service model to a value-based system that will foster improved patient care.”