Edward Berger's blog
No matter how free communication becomes between the Food & Drug Administration and the Centers for Medicare and Medicaid Services, it's still going to require a lot of post-approval data to drive coverage decisions.
The Food & Drug Administration and the Centers for Medicare and Medicaid Services signed a Memorandum of Understanding June 23 intended to promote data-sharing between the two agencies. Announcement of the MOU came from Center for Devices & Radiological Health director Dr. Jeffrey Shuren at a June 24 public workshop on device innovation. The MOU, Shuren said, "will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions.
The Medicare fee schedule "fix" isn't a fix at all and only postpones the mounting problems with Medicare reimbursement rates.
As reported on this website, the U. S. House of Representatives has signed on to an additional six month "fix" for the unacceptable 21 percent reduction in Medicare physician reimbursements required under current law. So ends yet another sad and frustrating chapter in an extended epic of Congressional dithering on healthcare policy. For years, the perceived political cost has dissuaded Congress from any frontal effort to revise the wrong-headed and obviously ineffective 10-year-old sustainable growth rate (PDF) formula for limiting growth in Medicare spending or physicians' services.
An informal survey of venture capital investors reveals their lack of worry that the healthcare reform act will slow down investment in medical technology.
Readers of this website, and this blog, are likely to have a special interest in the business impacts of healthcare legislative and regulatory initiatives. But when those initiatives are complex, with major societal implications and long implementation timelines, the likely effects on business operations, profitability and/or viability may not be obvious. When that is the case — as it most certainly is with this year's healthcare reform legislation — it is often necessary to evaluate diverse perspectives and attempt to determine which among conflicting projections are more likely to be accurate. My personal prejudice? Be skeptical of those who are directly impacted; follow the people who follow — or supply — the money.
Not psyched to dive into the 1,300-page proposal detailing changes to Medicare reimbursement rules? Ed Berger is here to help.
Medicare's Notice of Proposed Rulemaking for changes to the Hospital Inpatient Prospective Payment System for the year beginning October 1, 2010 (fiscal 2011) will be published in the Federal Register May 4, but was made available for inspection on the CMS website April 19. Masochists who can't wait to digest every detail of the 1,296-page proposal can download it here (PDF). The political fur will fly once stakeholders dig into the mind-numbing details of CMS's assumptions and calculations and analyze the expected direct financial impact of various payment adjustments, during the public comment period (which ends June 18). In the meantime, I can offer a few highly selected observations.
Donald Berwick might be the single best person to enact and enforce meaningful healthcare reform as the head of the Centers for Medicare and Medicaid Services. His appointment, if it passes congressional muster, could also prove to be a boon for the medical device industry.
If you've been studying the contents of the recently passed healthcare reform legislation, and you've looked in vain for the elements that emphatically implement systemic cost control and improvements in quality of care, President Barack Obama's nomination of Dr. Donald Berwick as administrator of the Centers for Medicare and Medicaid Services comes as very good news indeed. With this nomination, the president has demonstrated that he fully understands that insurance reform alone — important as it may be — won't fix the ills besetting U.S.
MedPAC's annual Report to the Congress on Medicare Payment Policy shows that hospitals that depend largely on Medicare provide similar standards of care, at lower costs, than hospitals where most patients are privately insured.
For the most part, annual changes in Medicare payment rates don't directly impact medical device manufacturers. With the exception of the very small number of devices that qualify in any year for the Medicare Inpatient New Technology Add-on or Hospital Outpatient Pass-through (PDF) status, or devices used in the home and classified as "durable medical equipment," demand for devices is influenced more by the overall financial health of hospitals and physician practices than by any particular reimbursement rate decision or trend in payment levels.
Congress has demonstrated that it is incapable of designing policies to reform healthcare reimbursement and it doesn't have the political courage to set standards and allow the incentives created by those standards to force change.
Three health care reimbursement developments of interest in the last few days:
