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May 29, 2019
Published by Nikki Golden at May 29, 2019
Categories
At a meeting on May 2, at the Medical Device Manufacturers Association (MDMA) Annual Meeting, Centers for Medicare & Medicaid Services (CMS) Administrator Seema Verma publicly announced the agency’s comprehensive strategy to improve patients’ access to emerging technologies. Administrator Verma’s remark build on recently released CMS policies designed to promote innovation in the U.S. healthcare system. The Administration hopes that encouraging a competitive and innovative market will lead to lower overall healthcare costs for patient and the government and to increases in the quality of and access to healthcare for all Americans, including Medicare and Medicaid patients. Verma highlighted two specific actions in the address. First, CMS has recently announced changes to the process of updates and issuing Healthcare Common […]
March 28, 2019
Published by Nikki Golden at March 28, 2019
Categories
Medicare announced on March 1, 2019, that 800 hospitals will be paid less by Medicare this year because of high rates of infections and patient injuries. The number is the highest since the federal government five years ago launched the Hospital Acquired Conditions (HAC) Reduction Program, created by the Affordable Care Act. This year, 110 hospitals are being punished for the fifth straight time. The penalties pit hospitals against one another in a race to prevent the most infections, blood clots, cases of sepsis, bedsores, hip fractures and other complications. Each year, the quarter of general hospitals with the highest rates are punished, even if their records have improved from the previous year. Under the announced sanctions, each hospital will lose 1 […]
March 28, 2019
Published by Nikki Golden at March 28, 2019
The FDA Food and Drug Administration announced a sweeping plan on March 8, 2019, to review and address the safety of surgical staplers. In a letter sent to health-care providers Friday, the FDA said it will convene an advisory meeting on the safety of the devices and signaled that it might reclassify surgical staplers to put them under tighter control. The agency also said it plans to issue proposed recommendations to companies that make the devices, which are used in countless surgeries. The FDA also acknowledged in its letter that “we are aware that many more device malfunction reports during this time frame” were submitted as “summary reports,” which go to the FDA but are not included in the public database known […]
March 28, 2019
Published by Nikki Golden at March 28, 2019
Categories
A recent convening of Alabama BCBS’ Medical Policy Group proposed a positive change to their policy on Minimally Invasive SI Joint Surgery to establish MIS SIJ fusion as medically necessary using an FDA-approved device (not specific to any one device type) when all of the following criteria are met: Pain is at least 5 on a 0 to 10 rating scale that impacts quality of life or limits activities of daily living; AND There is an absence of generalized pain behavior (e.g., somatoform disorder) or generalized pain disorders (e.g., fibromyalgia); AND Patients have undergone and failed a minimum six months of intensive non-operative treatment that must include medication optimization, activity modification, bracing, and active therapeutic exercise targeted at the lumbar spine, pelvis, sacroiliac joint, and […]