March 28, 2019

Medicare Reduces Payments to 800 Hospitals Citing Patient Safety Incidences

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

FDA Announces Sweeping Plan To Review Safety Of Surgical Staplers

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

Alabama Blue Cross and Blue Shield (BCBS) Issues a positive coverage policy for Minimally Invasive SI Joint Surgery

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 […]
March 28, 2019

ISASS policy statements highlight evolving evidence and literature in recently published bone graft substitute and vertebral augmentation statements

The International Society for the Advancement of Spine Surgery released two new statements: one focused on bone graft substitutes and the other examining vertebral augmentation. The bone graft substitute statement outlines historical use and U.S. regulatory pathways for bone grafts, including nonstructural allografts, demineralized bone grafts, cellular-based allografts, synthetic bone grafts, autologous cellular grafts and Class III drug-device combination products. “Bone grafting is an essential part of spinal surgery and ever-evolving science,” concluded the recommendation authors. “With each new advance, one needs to understand the characteristics of material, its mechanism of action, the regulatory pathway by which it came to market and the preclinical and human clinical evidence available on which to base a clinical use decision.” The authors found: Nonstructural cancellous allograft […]