FDA ConneKTion

Timely updates and insights on the latest issues affecting FDA-regulated companies from Kilpatrick Townsend

Archive for July 2015

Posted on Friday, July 31 2015 at 2:39 pm by -

CMS Announces Comprehensive Care for Joint Replacement Model: Agency Includes Waivers for Telehealth

On July 9, 2015, CMS announced the Comprehensive Care for Joint Replacement (“CCJR”) Model. The proposed initiative seeks to hold hospitals accountable for the quality and cost of care provided through the entire hip and knee surgery process. CMS is accepting comments on the proposed model until September 8, 2015.

The proposed two-year model is intended to support better and more efficient care for those patients undergoing hip and knee replacements (also known as lower extremity joint replacements or “LEJR”). The model is designed to test retrospective bundled payment of episodic care for these common surgeries that cost more than $7 billion for hospitalization alone in 2013. Ideally, hospitals, physicians, and post-acute care providers will work together to improve quality and coordination of care throughout the entire surgical and recovery process. Participating hospitals will be held financially accountable for the quality and cost of a beneficiary’s entire episode of care, which continues 90 days after discharge. The hospital will either be financially rewarded or penalized depending on the care provided.
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Posted on Thursday, July 16 2015 at 1:56 pm by -

21st Century Cures Act Passed by the House…Next up, the Senate

On July 10, 2015, the U.S. House of Representatives voted with an overwhelming majority in favor of H.R. 6, the 21st Century Cures Act, after a unanimous vote in the House Energy and Commerce Committee in May. The bill is intended to accelerate the pace of medical cures and to provide support for the leading federal healthcare research agencies to discover, develop, and deliver innovative cures to those suffering from incurable diseases. Federal legislators believe that increased support for these research agencies can help spur the current innovation crisis in the pharmaceutical industry, where fewer drugs are being produced per dollar spent on research and development.
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Posted on Tuesday, July 14 2015 at 9:33 am by -

CMS Issues the CY2016 Proposed Physician Fee Schedule: the First Proposed Adjustments Following the SGR Repeal

On July 8, 2015, the Centers for Medicare & Medicaid Services (“CMS”) released the proposed Medicare Physician Fee Schedule (“PFS”) for CY 2016 (“Proposed Rule”). The Proposed Rule—which is the first released following the repeal of the Sustainable Growth Rate (“SGR”) formula[1]—calls for a 0.5% increase in physician payments starting on January 1, 2016 and, more broadly, begins implementing the new payment system for physicians and other practitioners—the Merit-Based Incentive Payment System (“MIPS”). The Proposed Rule introduces significant policy changes and finalizes others already in the works to shift physician reimbursement to a system that rewards quality over quantity.[2]

As summarized below, the Proposed Rule proposes changes to the Physician Quality Reporting System, the Physician Value-Based Payment Modifier, and Medicare’s Physician Compare website. Additionally, it proposes two (2) new potential exceptions to the Stark Regulations and clarifications to existing exceptions to resolve common trouble areas identified via the Stark Self-Disclosure Protocol.
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Posted on Thursday, July 2 2015 at 7:18 pm by -

The Affordable Care Act Lives On

On June 25, 2014, the U.S. Supreme Court ruled 6-3 to allow millions of Americans to continue to receive subsidies received through federal health insurance exchanges established by the Affordable Care Act (ACA).
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Posted on , July 2 2015 at 12:13 am by -

Down to the Wire: FDA Extends Deadline for Dispenser’s Product Tracing Requirements Less than 24 Hours Before July 1, 2015 Deadline

In response to “concern[s] that electronic systems used to exchange, capture, and maintain product tracing information will not be operational” by the July 1, 2015, deadline, the Food and Drug Administration (“FDA”) issued a new guidance yesterday (“Guidance”) indicating they will not begin to enforce dispenser1 (primarily pharmacy) requirements under section 582(d)(1) of the Food, Drug, and Cosmetic Act until November 1, 2015.2
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