On July 10, 2014, the U.S. House of Representatives overwhelmingly passed legislation intended to speed the approval of drugs and medical devices and increase funding for medical research. The central aim of H.R. 6, the “21st Century Cures Act” (Cures bill), is to accelerate the drug development process by reducing or removing regulatory obstacles. Specifically, … Continue Reading
An Overview of the Medicare Shared Savings Program/Accountable Care Organization Final Rules The Centers for Medicare and Medicaid Services (CMS) recently released a final rule (Final Rule) that makes changes to the Medicare Shared Savings Program (MSSP). The Affordable Care Act (ACA) created the MSSP as one of several delivery system reform initiatives. The goal … Continue Reading
The trade coalition representing pharmacy benefit managers is raising concerns about major bipartisan legislation aimed at streamlining the approval of new medicines and medical devices. However, the Pharmaceutical Care Management Association’s (PCMA) opposition to the legislation is not about the content of the bill but rather how Congress intends to pay for it. The 21st … Continue Reading
The House Energy and Commerce Committee unanimously approved H.R. 6, the “21st Century Cures Act,” on May 21, 2015, after reaching a bipartisan agreement to fund the legislation (Cures bill). Often described as a “landmark medical innovation” bill, key provisions of the Cures bill are intended to speed marketing approval of drugs and medical devices. … Continue Reading
H.R. 2, the Medicare Access and CHIP Reauthorization Act (MACRA), was signed into law by President Obama on April 16, 2015. A broad bipartisan compromise measure, MACRA repeals the much-maligned sustainable growth rate (SGR) formula used to determine physician payment rates and replaces it with a new incentive payment system; extends funding for the Children’s … Continue Reading
This year’s Annual Legislative Seminar, held on May 7, marked the event’s 25th anniversary and featured a distinguished lineup of speakers, including 19 members of the Senate and the House who addressed issues, such as federal tax reform, the federal budget, implementation of the Affordable Care Act and proposed legislation addressing patent reform. The event, … Continue Reading
As we head into the mid-term election cycle, the ongoing implementation of the Patient Protection and Affordable Care Act (ACA) continues to consume the nation’s healthcare industry and political leaders in 2014. On the horizon are several issues likely to dominate congressional time, despite the health policy fatigue felt by most legislators. Below is a … Continue Reading
In this posting: A Look Back at 2013 Antitrust and Competition Policy, Advocacy and Legislative Strategy Development FDA and Life Sciences Privacy and Data Protection Enforcement and Compliance Transactions and Finance Reimbursement, Licensing and Certification Fraud and Abuse Laws Tax-Exempt Organizations Honors and Recognition Was it the number 13? There’s an old superstition about the … Continue Reading