Friday, June 28, 2013

CMS Proposes To Cut Home Health Pay 1.5%, Add 2 Quality Measures

CMS Proposes To Cut Home Health Pay 1.5%, Add 2 Quality Measures-insidehealthpolicy: CMS on Thursday (June 27) proposed cutting pay to home health care services in 2014 by 1.5 percent, which would be a reduction of $290 million compared to this year's rate. The proposed pay rule also would add two claims-based quality measures and remove two categories of ICD-9-CM codes from the prospective-pay grouper. The 1.5 percent pay cut is the net result of several adjustments: 2.4 percent home health pay increase ($460 million increase); rebasing the national, standardized 60-day episode pay rate, the national per-visit pay rates, and the non-routine medical supplies (NRS) conversion factor ($650 million decrease); and ICD-9-CM coding adjustments ($100 million decrease).

FDA’s Device Labeling Proposed Rule Misses The Mark, Industry Says

FDA’s Device Labeling Proposed Rule Misses The Mark, Industry Says-graysheet: FDA issued its proposed rule in April on “Use of Certain Symbols in Labeling,” which would allow medical device and biological product makers to include symbols to convey information to users without the previous requirement of including explanatory text next to the symbol. (See "FDA Proposes Rule On Symbols In Device Labeling" — "The Gray Sheet," Apr. 22, 2013.) But to use stand-alone symbols, FDA says firms must explain the symbols in a comprehensive glossary that accompanies the device, a requirement that many in industry say is duplicative and unnecessary.


Hospitals moving to high-tech ways to ensure employees keep their hands clean

Hospitals moving to high-tech ways to ensure employees keep their hands clean-washingtonpost: RICHMOND HEIGHTS, Mo. — Hospitals have fretted for years over how to make sure doctors, nurses and staff keep their hands clean, but with only limited success. Now, some are turning to technology — beepers, buzzers, lights and tracking systems that remind workers to sanitize, and chart those who don’t.

Long-term care commission seeks bipartisan solutions

Long-term care commission seeks bipartisan solutions-politico: The sprint is officially on for the new federal long-term care commission. The 15-member panel met for the first time Thursday afternoon, facing just a three-month window to overcome partisan differences and recommend reforms for long-term care delivery and financing after the highly publicized demise of the CLASS Act.

Monday, June 24, 2013

Industry Says Update To 510(k) Modification Policy Should Emphasize Design Controls, Risk Management

Industry Says Update To 510(k) Modification Policy Should Emphasize Design Controls, Risk Management-thegraysheet:  FDA’s current policy for determining when a modified device needs a new 510(k) works well without major changes, device industry representatives say. But they say it could be improved with more emphasis on the importance of design controls and risk management procedures to guide a company’s decision-making process.

Tuesday, June 18, 2013

Rising healthcare costs not directly tied to medical technology, according to study

Rising healthcare costs not directly tied to medical technology, according to study-massdevice: A recent study by European researchers casts doubt on widespread claims that medical technology is the key driver of rising healthcare expenditures. Some medical technologies do contribute to greater healthcare costs, according to researchers, but others are actually cost-neutral or costs-saving.


Study: More Medicare savings coming

Study: More Medicare savings coming-politico: Medicare savings could be $1.1 trillion more than the Medicare trustees estimated over the next 10 years if current trends continue, according to a study backed by the Federation of American Hospitals. The study, due to be released on Tuesday, also finds that the recent decline in health care spending growth is because of structural changes in health care more than economic factors.

Wednesday, June 12, 2013

CMS Circulates Fact Sheet Calling DME Competitive Bidding Concerns 'Myths'

CMS Circulates Fact Sheet Calling DME Competitive Bidding Concerns 'Myths'-insidehealthpolicyCMS is circulating a fact sheet that rejects as “myths” concerns by stakeholders and a growing chorus of lawmakers that the Medicare durable medical equipment competitive bidding program will lead to less competition in the market, lacks transparency and includes unlicensed suppliers. The agency began distributing the fact sheet Friday, just days before a bipartisan group of 218 House lawmakers wrote to CMS Administrator Marilyn Tavenner this week seeking an administrative delay of the program through the end of the year.

GOP advances a new “doc-fix” to prevent cuts to physician pay

GOP advances a new “doc-fix” to prevent cuts to physician pay-massdevice: On Jan. 1, 2014, Medicare payments to doctors are slated to be slashed by more than 24%, but the doc-fix would temporarily prevent a reduction in payments. The draft legislation would change the payment model from Medicare's controversial "sustainable-growth-rate" formula to a mix of fee-for-service and pay-for-performance.


More than money and lawsuits drive overtesting: study

More than money and lawsuits drive overtesting: study-reuters: (Reuters Health) - Despite reports that financial incentives and fear of lawsuits lead doctors to order too many heart tests, a new study of U.S. Veterans Affairs (VA) doctors suggests overtesting may be the result of more fundamental issues.


Monday, June 10, 2013

Medical device tax: White House doesn't support repeal, Sebelius says

Medical device tax: White House doesn't support repeal, Sebelius says-massdevice: The White House will not support repeal of the medical device tax, Dept. of Health & Human Services Secretary Kathleen Sebelius said during a House hearing this week. House Rep. Larry Bucshon (R-Ind.) asked Sebelius why the Obama administration continues to oppose repeal of the medtech tax despite "overwhelming support" from Congress. He cited the Senate's bipartisan, non-binding 79-20 vote to repeal the medical device tax as well as last year's House vote as evidence of Congress' willingness to strike the levy.

AHRQ Offers Free Software Tool For Public Reporting Of Quality Information

AHRQ Offers Free Software Tool For Public Reporting Of Quality Information-graysheet: The Agency for Healthcare Research and Quality has come up with a solution to help health care providers track and improve health care quality and value while containing costs. MONARHQ – My Own Network Powered by AHRQ – is free software that users can download to create customized websites for internal quality improvement or to report quality information to the public, reducing the cost and effort for organizations working on quality improvement, such as employer coalitions, hospital systems and state agencies.

Monday, June 3, 2013

FDA and device companies butt heads on overseas trial proposal

FDA and device companies butt heads on overseas trial proposal-massdevice: Medtech industry lobbying group AdvaMed commended the FDA and generally lauded the agency's efforts to promote principals of "Good Clinical Practice" in international clinical trials, but warned that certain of the FDA's proposals may butt heads with rules governing medical information in other countries.

Industry Wants Harmonized Good Clinical Practices Before FDA Finalizes OUS Studies Rule

Industry Wants Harmonized Good Clinical Practices Before FDA Finalizes OUS Studies Rule-graysheet: AdvaMed says FDA’s proposed rule on requiring foreign studies to follow good clinical practice guidelines should not be finalized until an international medical device and IVD clinical guideline has been established and adopted.


Compromise Sought On Device Reform Proposal In European Parliament Committee

Compromise Sought On Device Reform Proposal In European Parliament Committee-graysheet: Dagmar Roth-Behrendt, the legislator shepherding medical device reform legislation in the European Parliament, says she wants to work with the European Commission to establish a heightened market-access standard for high-risk devices, even if it falls short of her proposal for a full PMA-like review.


Commentary: Health care’s ‘productivity paradox’ may be short lived

Commentary: Health care’s ‘productivity paradox’ may be short lived-washingtonpost: Spending on health care information technology has risen rapidly over the past decade, but there been little corresponding gain in health care productivity. Instead, the industry’s labor force has been on a growth spurt — creating health care’s version of a productivity paradox.


Heavy summer workload awaits Congress

Heavy summer workload awaits Congress-politico: The House will spend the next two months tackling spending bills and defense policy, possibly even some bite-size immigration measures and changes to education policy. The Senate will continue on the farm bill and likely take up immigration reform. There’s a looming deadline on student loan rates and a desire not to let things drag out into the fall when talk turns to the budget and the debt ceiling.