- A new round of cuts to a popular program that provides health care to seniors will touch off a spate of partisan finger-pointing in the coming weeks, handing Republicans a new opportunity to blast the Obama administration.
Posted Mar. 24, 2015 at 8:30 AM
WASHINGTON — A new round of cuts to a popular program that provides health care to seniors will touch off a spate of partisan finger-pointing in the coming weeks, handing Republicans a new opportunity to blast the Obama administration.
The Centers for Medicare and Medicaid Services (CMS) is expected to announce in April how much it will cut from payments in 2016 to health insurers for Medicare Advantage, the popular program that covers seniors through private HMO and PPO plans. CMS in February recommended a 0.9 percent cut, though the agency may cut up to 0.95 percent, which would result in seniors paying higher premiums.
The Affordable Care Act (ACA) requires cuts to the Medicare Advantage program to bring it into alignment with traditional Medicare programs. Those cuts have already been made. In recent years, the Obama administration has cut another 10 percent off the Advantage program.
The program insures more than 15 million seniors nationwide, through either HMOs or PPOs. Projected costs reached $156 billion in 2014.
And Republicans are already preparing to take advantage when CMS’s final decision is announced on April 6 — when lawmakers are home for the Easter recess.
“Your work to protect Medicare Advantage is a topic your boss cannot talk about enough,” a top official at the National Republican Congressional Committee (NRCC) told GOP staffers in an email on Friday. “This would be a great opportunity for your boss to speak directly to seniors in the district about this important issue.”
Both parties have used the other side’s proposals as wedges to appeal to seniors, a vote-rich bloc that is sensitive to benefit cuts. Democrats have routinely attacked Republicans over Wisconsin Rep. Paul Ryan’s budget proposals, which would have cut Medicare spending by $129 billion over a decade, according to the liberal Center on Budget and Policy Priorities. Republicans have fired back, accusing Democrats of cutting $716 billion to Medicare — and $156 billion to Medicare Advantage — under the ACA.
“It was President Obama and Congressional Democrats that cut $152 billion from the popular Medicare Advantage program when they passed ‘Obamacare’ without a single Republican vote,” said Ian Prior, an NRCC spokesman. “Now that those cuts are starting to negatively impact Medicare Advantage and the 15 million seniors covered by the program, it’s important for voters to remember that it is the Democrats that are solely responsible.”
Democrats pointed to the House Republican budget, released last week, which would turn Medicaid into block grants and reduce funding for Medicare.
“Democrats have continually fought to strengthen Medicare while Republicans have been working to weaken it. This contrast comes into sharp focus on a day when the House Republicans released yet another budget that would end Medicare as we know it,” said Matt Thornton, a spokesman for the Democratic Congressional Campaign Committee.
Medicare Advantage’s political clout has grown as reliance on the program has increased. In 1991, 18 percent of all Medicare recipients were enrolled in the Advantage program; today, it’s 30 percent. In states like California and Florida, Advantage enrollees account for 38 percent of all Medicare patients, according to the Kaiser Family Foundation.
An analysis sponsored by America’s Health Insurance Plans, an industry group that opposes the reductions, found the cuts would cost between $40 and $120 per member, per month over a three-year period.
An increase in health care costs is likely to play a role in the battle for the Senate in 2016, where Republicans hold an eight-seat advantage. Republicans will attack Democratic candidates running in GOP-held states like Illinois, Pennsylvania and Wisconsin for voting to implement the steep cuts.
In Florida, one Democratic candidate is already playing proactive offense. Rep. Patrick Murphy, who is likely to formally announce he will run for Senate next week, co-signed a letter last week with Rep. Brett Guthrie, R-Ky., urging CMS to maintain current payment levels. The letter attracted 239 signatures from Democrats and Republicans; a similar letter earned support from 53 senators.
“Further cuts to this important program could limit health care options and deprive beneficiaries of the services they need,” Murphy said in a statement. “The seniors I represent cannot afford higher out-of-pocket costs and slashed benefits.”
But some party strategists wonder if the familiar attacks over cuts to Medicare Advantage, which dominated the airwaves in 2010, 2012 and 2014, still carry the same political sting. While the ACA made up a huge percentage of GOP advertisements in 2010, and the Ryan budget handed Democrats a potent weapon in 2012, some think voters aren’t paying attention anymore.
“I think the dueling Medicare attacks are falling on deaf ears. We need to figure out how to frame this argument in a new way so that voters will actually believe this could affect them,” said one Democratic strategist who was involved in crafting attack ads on Medicare Advantage. “It may be that when voters hear ‘Medicare cuts’ they just tune out.”
Republicans, too, used the ACA less in 2014 than they had in previous years — and that number continued to drop as the campaign progressed. Analysis by Kantar Media’s Campaign Media Analysis Group in 2014 found the number of Republican ads attacking Obamacare declined precipitously throughout the year, while the economy became a more dominant issue.
Equinox Medical is the fastest growing negative pressure wound therapy (NPWT) pump and black foam dressing company in the USA. FDA approved wound dressings are mandatory to use in nursing home and hospitals.
Please join us on March 3rd, 2015 at 10:00 am EST
Hosted by Holly Desimone, RN, BSN, WCC
Location: Online (Webinar)
Subject: Offloading application using the UNI NPWT black foam dressing kit by Equinox Medical
How long is the webinar? Approximately 20 to 30 minutes
How can I join? Please complete the registration form by clicking ont he link below.
Once Registered, you will received an email from EquinoxO2 with all the webinar informations.
You can now download the Halo MINI NPWT quick reference guide for from their website.
But you can click on the link below to make it easier for youself.
I just noticed this website the other day (www.szuomc.com). Its a new distributor that sells the newest Halo MINI Negative Pressure Wound therapy pump system from Equinox Medical. I believe they started carrying this product late last year. They also carry the Halo XT, and Cobaltt NPWT pump system in the US wound care market. Come check this site and see what you think.
FDA’s New Approach to Regulating Medical Device Accessories
The US Food and Drug Administration (FDA) has outlined a new framework for classifying and approving medical device accessories, making clear that device accessories can be brought to market more quickly than their parent devices in certain cases.
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is –
- recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them;
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.”
Medical devices are brought to market, in general, in one of four ways:
- The Premarket Approval (PMA) – This process is intended to evaluate and approve high-risk devices or devices with no known predicate.
- The 510(k)/Premarket Notification – This process expedites the review and approval of devices that are highly similar to an already-marketed predicate device, or that are subject to certain controls on their manufacture.
- The De Novo Process – If a low-risk device is deemed ineligible for the 510(k) process because it lacks a predicate, a manufacturer may petition FDA to review it through the de novo process, which allows FDA to make a risk-based classification of the device.
- 510(k) Exempt — Some low-risk devices, such as bandages, are explicitly exempted from FDA’s premarket review process and can be brought to market almost immediately as long as they conform to established standards (“general controls”).
Medical Device Accessories
That general framework, however, has proven a bit confusing for manufacturers of medical device accessories. Accessories function in tandem with another device, known as a “parent device,” which is often (but not always) cleared or approved as a separate device.
As defined by FDA, a medical device “accessory” is a device “intended to support, supplement, and/or augment the performance of one or more parent devices,” while a parent device is a device “whose performance is supported, supplemented, and/or augmented by one or more accessories.”
At issue is how FDA should evaluate each device accessory. For example, if a parent device was deemed to be “high risk” but a subsequent accessory is inherently low-risk, should the accessory be judged on its own merits, or should it inherit its parent device’s “high-risk” status?
A Nuanced Approach to Risk
FDA’s guidance, Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types, is meant to clarify some of the ambiguity in this space.
As noted by FDA, a key consideration in the agency’s assessment of risk is the accessory’s relationship with its parent device. Some accessories are critical to the proper function of a device, such as a rechargeable battery for an AED. Other accessories allow the parent device to perform new functions, but are not necessary to its core functions. Still other accessories allow a parent device to perform its functions better or more safely.
“FDA intends to determine the risk of accessories and the controls necessary to provide a reasonable assurance of their safety and effectiveness according to their intended use in the same manner that is used to determine such for devices that are not accessories,” the regulator explains in its guidance.
FDA goes on to explain that it plans to access the risk of a device “when used, as intended, with the parent device.” However, it does not plan to simply pass on a parent device’s risk classification to its accessory. “The risk profile of an accessory can differ significantly from that of the parent device, warranting differences in regulatory classification,” FDA wrote.
The regulator also recommended the use of the de novo classification pathway for many device accessories, which it said would help in allowing some manufacturers to get their products to market more quickly.
– See more at: http://www.raps.org/Regulatory-Focus/News/2015/01/19/21106/FDAs-New-Approach-to-Regulating-Medical-Device-Accessories/#sthash.q5WOTR1Q.dpuf
Equinox Medical is offering a free educational training on how to use the black foam dressing for BRIDGING application.
The webinar is hosted by their wound care certified nurse Holly Desimone, RN, BSN, WCC.
When: Tomorrow! January 20,2015
What Time: 10:00 am Eastern Standard Time
How can I join?
Click on the link below and register for free!
Smith & Nephew has slipped back despite analysts continuing to believe there is a chance US rival Stryker could strike.
The medical device company’s shares are down 22p at £11.58 as UBS moved from buy to neutral but raised its target price from £11 to £11.75.
The bank reckoned there could be a takeout bid of £13 or more and said:
As we have argued previously we see a chance that Stryker makes a bid for Smith & Nephew, based on historic multiples including Zimmer Biomet, at a price of £13 or more. We have also examined, in depth, the possibility of a three way deal with Coloplast amongst the bidders for the wound care business.
We have no insight on if or when a deal might be proposed. Our price target is now the midpoint of our upside (a takeout at £13) and downside (standalone valuation of £10.50) scenarios.
At the fourth quarter results on 5 February we expect two areas of focus. (1) Tough fourth quarter Orthopaedic comparisons after a strong final quarter last year, possibly due to patient confusion over the impact of healthcare reform which won’t repeat. (2) Wound care’s continued improvement after a weak first half.