The next few years will elucidate if the U.S. federal government’s participation in healthcare reform this week will prove Tacitus, a First Century Roman senator, correct. Was enough time spent to enact meaningful change within the provider setting? Will the health insurance industry undergo the necessary reforms? Also, is the U.S. federal regulatory agency taking the proper amount of inspection time to assess new therapies for cardiovascular patients?

Late Sunday evening, the U.S. House of Representatives approved the Senate version of healthcare reform legislation, and sent its package of amendments to the Senate. Since that time, President Obama has signed the Senate version into law and as of last evening, the Senate is returning the Reconciliation Act back to the House with some minor alterations.

Of course, the reaction to the first healthcare reform bill has been immense, even leading 14 state attorneys general to file lawsuits against HHS, and the treasury and the labor departments, over the legislation’s individual mandate that all U.S. citizens and legal residents have health insurance or pay a tax penalty.

Of note, the American College of Cardiology issued a mixed reaction, calling the bill a “start,” but faulting the creation of an ‘independent payment advisory board’ and prohibitions on physician-owned hospitals.” The college also said that the bill should have included delivery and payment system reforms, as well as tort reform.

While the Physician Hospitals of America said the bill would have a “devastating impact” on physician-owned hospitals, the American Medical Association referred to the passage of the bill as “historic.” Thinking of Tacitus’ words, the true benefits or faults of the legislation will reveal themselves through time.

Meanwhile, the FDA has been equally as busy as federal legislators in enacting change for cardiovascular care options. The Circulatory System Devices Panel, which advises the FDA on device approval, unanimously recommended the clearance of two devices that could impact clinical practice—Medtronic’s Revo MRI SureScan pacing system for safe use in MRI systems and an expanded indication for Boston Scientific’s Cognis cardiac resynchronization therapy defibrillators, based on the results of the MADIT-CRT trial.

Not to be outdone by the flurry of activity in the legislature, the FDA issued a warning about the link between myopathy and simvastatin, extended the recall for The Medicines Company’s hypertension drug Cleviprex, and asked for further studies on the much-anticipated Watchman device, designed to prevent strokes in patients with atrial fibrillation.

Regardless of the results of all these decisions, Tacitus also encapsulates the excitement that surrounds great change, and will hopefully transmit into reform: All enterprises that are entered into with indiscreet zeal may be pursued with great vigor.

On these topics, or any others, please feel free to contact me.

Justine Cadet, Managing Editor
jcadet@cardiovascularbusiness.com