Hospitals' Acceptance Of CMS Appeals Offer Hinges On RACs Not Getting Full Fees

Hospitals' Acceptance Of CMS Appeals Offer Hinges On RACs Not Getting Full Fees-insidehealthpolicy: The American Hospital Association is asking CMS to clarify whether Medicare Recovery Audit Contractors will be required to forfeit any of their fees on claims partly paid by the agency under its hospitals appeals settlement offer, warning hospitals may not be willing to accept the settlement if RACs are paid in full. The AHA says that, as a matter of fairness, the RACs should not receive their full fee for claims in situations where CMS partially pays the hospitals. AHA says it has raised the issue with CMS staff numerous times and has not received a definitive answer. “Hospitals have informed us that they consider the decision on RAC fees to be one of fundamental fairness that will impact their evaluation of the terms of CMS's offer,” AHA warns CMS in a Sept. 24 letter.

CDRH Funding Levels Frozen For Next Several Months

CDRH Funding Levels Frozen For Next Several Months-thegraysheet: The bill, which the House approved 319-108 on Sept. 17, and the president signed after the Senate agreed to add short term funding for training and equipping Syrian rebels to support ongoing military actions, will expire on Dec. 11. A lame duck Congress fresh from the November elections will have to work out a new deal to fund the government for the rest of the fiscal year. The bill also provides emergency funding to deal with the Ebola outbreak in West Africa.

UDI Milestone: Unique Identifiers Now Required For Class III Devices – But Are Some Firms Lagging Behind?

UDI Milestone: Unique Identifiers Now Required For Class III Devices – But Are Some Firms Lagging Behind?-thegraysheet: FDA’s Unique Device Identification system finally passed arguably one of its most important milestones on Wednesday: Makers of high-risk medical devices are now required to add distinctive barcodes to product labels. Manufacturers were also expected to enter product identifiers into a global UDI database by FDA’s Sept. 24 compliance deadline – a task that some firms are still struggling to complete, industry insiders say.

First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance

First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance-thegraysheet: The clearance does not necessarily resolve the broader debate about regulatory standards for hospital glucose meters going forward. Lias stressed that the January document is draft guidance and that it did not play a role in FDA’s review of Nova’s submission. “It was not a factor at all in this clearance,” the FDA official told “The Gray Sheet.” An assessment based on the standards described in the draft guidance “was not even done because it is draft guidance,” she said. “It is not something that is applied or used.”

Tavenner Says She's 'Not Interested' In Second Look At Part D Policies

Tavenner Says She's 'Not Interested' In Second Look At Part D Policies-insidehealthpolicy: CMS Administrator Marilyn Tavenner said during a congressional hearing that the agency has no interest in re-introducing a series of controversial Part D policies it had proposed and then rescinded earlier this year. Her comments on Thursday (Sept. 18), the same day CMS released details on the Part D landscape for 2015. CMS in March put on hold policies from a proposed regulation that would have reduced the number of Medicare protected drug classes, opened up preferred pharmacy networks, limited the number of Part D plans insurers could offer and clarified the “non-interference” clause, which blocks the government from negotiating drug prices with manufacturers.

More PMAs Would Results From FDA’s Classification Proposal, AdvaMed Warns

More PMAs Would Results From FDA’s Classification Proposal, AdvaMed Warns-thegraysheet: The FDA’s proposal to amend and clarify its regulations on classification and re-classification of medical devices could fundamentally change the classification process and result in more devices having to undergo the more stringent PMA review, warns medtech industry association AdvaMed. In particular, the propose rule, if implemented in its current form, would substantially rewrite the definition of high risk, class III devices and move more products from 510(k) to PMA standards, AdvaMed argues.

Reps. Burgess, Schwartz Bill Would Exempt Indirect Payments For CME From Reporting

Reps. Burgess, Schwartz Bill Would Exempt Indirect Payments For CME From Reporting-insidehealthpolicy: Reps. Michael Burgess (R-TX) and Allyson Schwartz (D-PA) introduced bipartisan legislation Friday (Sept. 19) that would exempt indirect payments that drug and device manufacturers offer to continuing medical education providers from sunshine reporting requirements, legislation that if enacted would reverse CMS' plan to do away with the exemption.

Clinton to women: Remember the midterms

Clinton to women: Remember the midterms-politico: Former Secretary of State Hillary Clinton on Friday urged Democratic women to prioritize the midterms for the sake of advancing women’s rights — and also in defense of a larger progressive agenda. “We’re here because there’s a movement stirring in America,” Clinton said, citing issues such as paid sick leave, equal pay, affordable child care and a living wage for fast-food workers. “This is a movement that is not waiting for Washington with its gridlock and grandstanding. This movement won’t wait, and neither will we.

American Attitudes Toward Lobbying Improve -- Public Affairs Council

IRB, HIPAA Changes To Be Folded Into 21st Century Cures Bill Next Year

IRB, HIPAA Changes To Be Folded Into 21st Century Cures Bill Next Year-thegraysheet: Two key lawmakers said they intend to incorporate ideas that would hasten device development into legislation expected out early next year under the 21st Century Cures initiative. Among the ideas are centralization of Institutional Review Board approvals and removal of Health Insurance Portability and Accountability Act (HIPAA) privacy provisions that stand in the way of medical researchers sharing data from large trials and registries. The information-gathering phase of the House Energy and Commerce Committee’s 21st Century Cures project is coming to an end and draft legislation incorporating ideas from the months of hearings is expected out by January, Committee Chairman Fred Upton, R-Mich., signaled during a Sept. 10 roundtable on Capitol Hill.

CMS Gives RACs Green Light To Start Automated Audits As Program Re-Starts

CMS Gives RACs Green Light To Start Automated Audits As Program Re-Starts-insidehealthpolicy: CMS says Recovery Audit Contractors can begin some reviews now that updates to the contracts are finished, and at least one RAC says providers should expect to start seeing reviews soon if they haven't already. The program re-start will continue until new RAC contracts are awarded and a smooth transition can occur, according to CMS. Contract modifications to allow the auditors to re-start after the agency put the RAC program on hiatus in June were finished at the end of August, according to the agency's website. CMS originally said it paused the program in order to wind down and prepare for the transition to new RAC contractors, but the agency moved earlier last month to re-boot the program because the contracting process was taking longer than expected

Kimberly-Clark Set To Spin-Off Medical Biz With Device, Infection-Prevention Focus

Kimberly-Clark Set To Spin-Off Medical Biz With Device, Infection-Prevention Focus-thegraysheet: Kimberly-Clark Corp. is set to spin off its health care business by Nov. 1 as Halyard Health, a stand-alone, publicly traded company making infection prevention products for hospitals, as well as devices for pain and hospital respiratory and feeding technologies. Executives hope the move will allow the health care unit to pursue a strategy more focused on growing a medical device business, and, in particular, to better capitalize on hospitals’ and insurers’ increasing focus on preventing patient infections.

U.S. healthcare spending growth to slow further: government report

U.S. healthcare spending growth to slow further: government report-reuters:(Reuters) - U.S. healthcare spending is expected to grow more slowly in the coming decade as a sluggish economic recovery and higher cost sharing in private insurance plans limit demand for services, a government report released on Wednesday said. The Centers for Medicare and Medicaid said it expects average annual healthcare spending to grow by 5.7 percent from 2013 to 2023, compared to 5.8 percent in last year's projections, which covered the years 2012 to 2022.

Court Blocks CMS From Moving Forward With New RAC Contracts

Court Blocks CMS From Moving Forward With New RAC Contracts-insidehealthpolicy: A federal claims court has stopped CMS from moving forward with new contracts for Recovery Auditors pending CGI Federal, Inc.'s appeal of an earlier decision that sided with CMS over the contractor's protest.The agency had previously said it hoped the new contracts would be awarded this year, but one lobbyist following the issue says the appeal adds more uncertainty to the contracting process. If CGI wins, the agency must start the contracting process for the RACs over again, which the lobbyist said is not ideal. One industry expert said the court's decision could push back the contracting process by another year.

Rural hospitals pressured to close as healthcare system changes

Rural hospitals pressured to close as healthcare system changes-reuters: Now the Affordable Care Act, better known as Obamacare, is bringing additional pressure. Obamacare is designed to fold the poor and uninsured into the healthcare system, but changes in how the federal government pays for the disadvantaged are already pressuring the hospitals that cater to them, such as rural ones.

What Makes The Ideal Registry? Focus, Transparency, Versatility, Groups Say

What Makes The Ideal Registry? Focus, Transparency, Versatility, Groups Say-thegraysheet: Registries are not for every device, but when they are warranted, they should be tightly focused and very transparent, according to Sept. 3 recommendations from groups closely engaged in FDA’s efforts to upgrade the U.S. postmarket device surveillance system. The report from the Pew Charitable Trusts, the Blue Cross Blue Shield Association and Cornell University researchers, argues that the U.S. needs a stronger system of registries to answer safety and effectiveness questions that can’t be addressed by size-limited premarket studies. But it also readily acknowledges the limits of registries and that they can be very resource intensive.

Communication and the patient experience: On being present, not perfect

Communication and the patient experience: On being present, not perfect-massdevice: Clinical excellence is the foundation of patient care. But at a recent TEDx Longwood event, Elaine C. Meyer, PhD, RN, co-founder and director of theInstitute for Professionalism and Ethical Practice at Boston Children's Hospital and an Associate Professor of Psychology at Harvard Medical School, offered insight on the other half of the health care equation: the human connection and the power of conversation.