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Last week, Republicans in the House of Representatives released a summary of a proposed amendment to the American Health Care Act, which they hope will help the bill garner enough votes to pass. The amendment is intended to appeal to both moderate Republicans and members of the Freedom Caucus. The so-called “MacArthur Amendment,” spearheaded by Representative Tom MacArthur (R-NJ) and Representative Mark Meadows (R-NC), aims to protect individuals with pre-existing conditions by retaining various popular…
Senate confirms Gorsuch On Friday, prior to leaving for its Easter recess, the Senate confirmed Judge Neil M. Gorsuch to be the next Associate Justice of the Supreme Court. The final vote was 54-45 in favor of confirmation. Judge Gorsuch was sworn in today. Of note to the healthcare industry is Justice Gorsuch’s opposition to the Chevron doctrine. In the 1984 case Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., the Supreme Court held…
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the “Cures Act”). We detailed the Cures Act’s provisions affecting hospitals in a prior Health Law Pulse post and will focus on a more in-depth analysis of its impact on the U.S. Food and Drug Administration (the “FDA”) here. The Cures Act authorizes $500 million over 10 years for the FDA to fund the development of new drugs and devices and…
In November 2016, in a departure from its prior position, the US Food and Drug Administration (the “FDA”) announced that it would not develop final guidance to regulate laboratory developed tests (“LDTs”), as we covered previously on Health Law Pulse. In a discussion paper published on January 13, 2017, the FDA instead has proposed a modified regulatory pathway for LDTs. LDTs are in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The…
CMS announced on December 15, 2016 that it will not pursue its plans to finalize a proposed rule that would have created a pilot program to test a new Medicare Part B prescription drug reimbursement model. CMS explained that while the rule garnered some support, numerous stakeholders “expressed strong concerns” about the proposed reimbursement model. Due to “the complexity of the issues and the limited time available,” CMS determined it would “not finalize the rule…
The Food and Drug Administration (“FDA”) released its final guidance on medical device safety on December 14, 2016, titled “Public Notification of Emerging Postmarket Medical Device Signals (Emerging Signals).” The final guidance comes almost a year after FDA issued a similar draft guidance on the topic. As with the draft guidance, industry remains concerned about FDA’s decision to begin issuing warnings about medical devices that may be causing adverse events. Background The final guidance describes…
The US Food and Drug Administration (“FDA”) announced on November 18, 2016 that it will not release a final guidance to regulate laboratory developed tests (“LDTs”), in vitro diagnostic tests designed, manufactured, and used within a single laboratory. The announcement marks a significant reversal from the previous positions of the Obama administration, FDA, and specifically, Dr. Jeffrey Shuren, Director of the FDA Center for Devices and Radiological Health (CDRH). Background LDTs were historically regulated not by…
On October 14, 2016, CMS issued the “Merit-based Incentive Payment System (MIPS) and Alternative Payment Model (APM) Incentive under the Physician Fee Schedule, and Criteria for Physician-Focused Payment Models” final rule with comment period. MIPS and Advanced APMs are the two ways for health care providers to participate in the CMS Quality Payment Program that rewards value and outcomes, as required by the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA). MACRA amended Title…
The Centers for Medicare and Medicaid Services (CMS) has promulgated a proposed rule that makes numerous revisions to the appeals process for Medicare claims. If finalized, this proposed rule will mainly clarify the existing regulations regarding the Medicare appeals process. It will, however, also add two key concepts to help streamline the appeals process.  …