WSJ Market Watch: Sterilmed Sponsors US and European CleanMed Conferences for Health Care Sustainability

AMDR Members Selected for Practice Greenhealth’s Environmentally Preferable Purchasing Business Leadership Coalition

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SterilMed and Stryker Sustainability Solutions were recently selected as founding members for Practice Greenhealth’s (PGH) Environmentally Preferable Purchasing (EPP) Business Leadership Coalition, a group of 15 leading businesses in the health care sector that have been brought together by Practice Greenhealth to assist hospitals and others in the sector to promote the purchase of products and processes that are less hazardous to the environment. According to the PGH press release, the 15 founding members pledged in their initial statement of intent to “closely examine their own supply chains in order to identify practices, processes, materials or social considerations that may impact the products offered to the health care sector. They will also share best practices uncovered in their own businesses in “an honest effort to bring about positive change both internally and externally.”” AMDR is proud of both companies for their stewardship to the environment and commends the other 13 members for their commitment to reduce unnecessary waste generated by the health care industry.

Click Here to Read the Full Press Release 

For more information on how a reprocessing program can limit your hospital’s waste production, please visit AMDR on the web, Twitter, or Facebook.

 

AMDR Participating in US International Trade Commission Hearing on Remanufactured Goods

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AMDR President Dan Vukelich will be participating in a public hearing today held by the US International Trade Commission (USITC), entitled “Remanufactured Goods: An Overview of the U.S. and Global Industries, Markets, and Trade.” President Vukelich will be presenting on behalf of the third-party “single-use” device (SUD) reprocessing industry alongside other leaders in the healthcare sector from Siemens, GE Healthcare, and the International Imaging Technology Council. While this procedure is primarily a fact-finding activity for the USITC to determine the size and scope of the remanufacturing industry, AMDR hopes the activity will bring light to the growing remanufacuturing industry and remove unnecessary trade barriers in today’s global economy. Third-party SUD reprocessing has been regulated by the Food & Drug Administration (FDA) since 2000 and is currently used by over 3,000 hospitals in the U.S., Canada, Europe, and other countries throughout the world.

AMDR Statement for US ITC Hearing

Background: As requested by USTR, the Commission will conduct an investigation and prepare a report that provides an overview of the U.S. remanufactured goods industries and markets, estimates U.S. and global trade in remanufactured goods to the extent possible, and examine factors affecting trends in remanufactured goods trade. The Commission’s report will focus on remanufacturing-intensive sectors in the U.S. economy that account for the majority of remanufacturing activity in the United States.  A report based on these findings will be due to the U.S. Trade Representative no later than October 28th, 2012. http://ht.ly/9js6D


					

Protect Our Savings: Are You a Healthy Hospital Award Winner?

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The following was posted by Lars Thording,  Senior Director of Marketing and Public Affairs at Stryker Sustainability Solutions, for the ProtectOurSavings.com blog.

Each year, we recognize our most sustainable hospital partners with Healthy Hospital Awards, showcasing the outstanding progress they’ve made toward reducing their impact on the environment and improving their overall financial viability. In these uncertain economic times, the Healthy Hospital Award is symbolic of the healthcare organization’s transcendence from conventional behavior, to progressive, smarter healthcare delivery…

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Protect Our Savings: Reprocessing Electrophysiology Catheters – What the Studies Show

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The following was written by Gurmeet Singh, Product Director for EP and Cardiology products at Stryker Sustainability Solutions, for the ProtectOurSavings.com blog.

Today, the reprocessing industry is highly evolved. Single-use devices (SUDs) undergo complex and highly technical cleaning, testing, and validation methods. Gaining clearance from FDA to reprocess any SUD, such as an EP catheter, requires proving these devices are as safe and substantially equivalent as they were originally.

In the late 1990’s, reprocessing of diagnostic electrophysiology (EP) catheters became a practice many hospitals conducted in-house to reduce supply expenses. Few incidents of patient injury were reported, if any, but the OEMs began paying more attention. So it came as no surprise when the big manufacturers successfully lobbied Congress to enact legislation to regulate reprocessing. The result? Hospitals were forbidden to reprocess single-use devices in-house, and third-party reprocessors became tightly regulated. The reprocessors that survived were forced to invest fortunes to comply with new FDA guidelines…

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Protect Our Savings: Sustainability in the Healthcare Supply Chain

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The following post, appearing on ProtectOurSavings.com, was authored by Will Probst, Senior Director of Supply Chain Services at Stryker Sustainability Solutions:

2011 was a landmark year in healthcare sustainability. We’ve seen our hospital partners achieve record results, saving tens of millions of dollars in supply costs and avoiding thousands of tons of medical waste from entering landfills in their local communities. But as medical device manufacturers, distributors, and reprocessors continue to bring new products to market, the supply chain has become increasingly complex; leading to a need for more advanced tracking of devices to better safeguard patients…

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Re-post from Millennium Research Group Blog: Major medical device manufacturers embrace reprocessing

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Check out the Millennium Research Group blog post, Major Medical Device Manufacturers Embrace Reprocessing (01/06/12):

…In 2009, Stryker acquired Ascent Healthcare Solutions, the number one reprocessing firm in the US. Ethicon Endo-Surgery later followed suit with its acquisition of SterilMed, the second-largest US reprocessing firm. Together, SterilMed and Ascent Healthcare Solutions are responsible for reprocessing about 95% of devices in the US.

These acquisitions likely reflect the fact that more companies are realizing that reprocessing will be a permanent fixture in the endoscopy device markets—continuing budgetary constraints combined with an unstable economy mean that hospitals are going to continue to look for ways to save money, including by using reprocessed SUDs. These recent acquisitions allow Stryker and Ethicon Endo-Surgery to capitalize on this trend rather than attempting to compete with third-party manufacturers. Furthermore, it gives the companies more control over the resterilization process, allowing them to ensure that the appropriate devices are being resterilized properly. Depending on the success these companies have, more endoscopy device manufacturers may also follow suit in the coming years.

Reprocessing: Going Global

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The following post by AMDR President Dan Vukelich can be found in its entirety on the Protect Our Savings blog:

For more than ten years, America’s hospitals have known that FDA-regulated, reprocessed medical devices are safe, lower-cost and environmentally-responsible. The reprocessing industry has welcomed FDA’s strong oversight because, for customers, it demonstrates every reprocessor’s commitment to providing safe and effective medical equipment. The result is that today, hospital outsourcing to FDA-regulated third-party reprocessors (TPRs) has become the standard of care in America – in fact, of U.S. News & World Report’s “Honor Roll” hospitals (i.e., the top 17 medical institutions in the nation), every single one utilizes reprocessing programs.

In the rest of the world, the reprocessing of so-called “single-use devices” (SUDs) is thought to be quite commonplace, but it is seldom regulated.  Perhaps spurred by the current economic climate, the growth of the U.S. third-party reprocessing (TPR) industry, or both, other nations are now looking to regulate reprocessing as a way to safely and effectively reduce healthcare costs and waste.

For example, the European Union (EU) does not have a comprehensive regulatory framework regarding the reprocessing of medical devices. However, the EU is in the process of revising its Medical Device Directive. The European Parliament identified reprocessing of SUDs as an issue in need of additional clarification, and a European Commission report highlighting the risks of unregulated reprocessing was released in August, 2010…

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Be sure to follow AMDR on the web, Twitter, and Facebook for the latest information surrounding “single-use” medical device reprocessing!

 

Protect Our Savings: ACO Final Rules Released: Medical Device Reprocessing a Natural Cost-Cutter

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Posted on October 31, 2011 by AMDR President Dan Vukelich:

After much anticipation, on October 20, the Centers for Medicare & Medicaid Services (CMS) released its final rules for Accountable Care Organizations (ACOs).  At 696 pages (or 267 pages longer than even the proposed rule), it will take some time for all the details to emerge.  But, in short, as Dr. Donald M. Berwick, CMS Administrator wrote in the New England Journal of Medicine on October 26, ACOs have three specific goals: “better care for individuals, better health for populations and lower cost growth through improvements in care.” Specifically, Dr. Berwick said that

“ACOs are voluntary groups of physicians, hospitals, and other health care providers that are willing to assume responsibility for the care of a clearly defined population of Medicare beneficiaries attributed to them on the basis of patients’ use of primary care services.  If an ACO succeeds in both delivering high-quality care or improving care and reducing the cost of that care below what would otherwise have been expected, it will share in the savings it achieves for Medicare.”

At first glance, this simple concept seems…well, rather simple. So why are hospitals already struggling to strike a balance in the delivery of high-quality care at reduced rates? One cause can be attributed to the fact that most hospitals over the years have enjoyed the luxury of expendable resources, most of which have fallen under the category of “single-use” devices and products. But in today’s environment, hospitals are being forced to evaluate all aspects of their patient care models, including their supply chain practices.

One solution, currently employed by over 3,000 hospitals across the U.S., is the practice of implementing a medical device reprocessing program, which for years has allowed hospitals and surgery centers to optimize allocations of constrained resources.  By employing the services of an FDA-regulated, third party reprocessor, hospitals across the country are able to offer their doctors and clinicians the medical devices they are accustomed to using, at half the cost – and significantly reduce the amount of medical waste they generate (which, incidentally, also saves hospitals money).

With the publication of these final ACO rules, the Association of Medical Device Reprocessors (AMDR) believes reprocessed devices will play an even more instrumental role moving forward.  Yes, many hospitals in the country are already reprocessing on some level – but that’s just the tip of the iceberg.  It is AMDR’s understanding that pursuant to the “shared-savings” (financial incentives) provisions of the ACO rules, doctors could also expect to be rewarded for the savings generated by their affiliated hospitals, which an initial analysis of the rules by Modern Healthcare revealed “CMS also increased the amount of bonuses that providers may earn…once providers clear a savings target, the CMS agreed to share savings earned from the outset.” When you combine that with the fact that today’s third-party reprocessors save America’s hospitals hundreds of millions of dollars per year, – a number that AMDR believes could skyrocket to $2-3 billion per year if reprocessing programs were fully maximized – it can only translate into positive results for the ACOs that choose to utilize reprocessed medical devices in its supply chain.

Additionally, AMDR submitted comments in response to CMS’ proposed ACO rules, which we encourage you to check out HERE.

Still a bit skeptical, or perhaps overwhelmed?  You’re not alone.  But be advised, the world of healthcare is changing and it will require providers to be more accountable for quality and costs.  HealthLeaders reported on October 24 that ACOs may still be a “tough sell” to many hospitals.  Many institutions simply aren’t far enough along with integrating ACO or ACO-like infrastructures to their clinical programs.  But David Spahlinger, MD, an internist and senior associate dean at the University of Michigan, told HealthLeaders that, “My first selling point is there is a non-risk option for you to gain some experience without significant downside….  Yes, you might have to make some significant investments.  But the world is heading in this direction and we are going to be more accountable for the quality and the cost of the care we deliver.”

To see what others are saying about the release of these new ACO rules, check out AMDR’s post on thewww.accountablecareforum.com.  And check back often.  The AMDR/Squire Sanders-sponsored forum will be providing more details and on-going analysis of ACOs http://www.accountablecareforum.com/.  For the latest in reprocessing news, check AMDR at www.amdr.org/news.

Click Here for Original Posting on ProtectOurSavings.com

Be sure to check out www.amdr.org and www.protectoursavings.com for all the latest news surrounding third party reprocessing!

Accountable Care Forum: WHAT OTHERS ARE SAYING: MEDIA ROUND-UP ON FINAL ACO REGS

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The following post was written by Chase Matson (AMDR)  for the Accountable Care Forum blog, appearing October 28, 2011:

 

When we published last week’s blog post, MEDICARE ACO RULES NEAR FINAL HURDLE, we knew it would only be a matter of time before CMS released its final ACO regulations. Sure enough, only two days later, CMS officially published their long-anticipated rules, ending months of speculation surrounding one of the cornerstone provisions of President Obama’s Patient Protection and Affordable Care Act. Here is a sampling of the buzz-worthy articles that best encapsulate these hot new HHS regulations:

“CMS is making several significant changes in its final rule to strengthen the ACO program for providers and beneficiaries alike (see table). Major changes include providing better, and more timely, information to ACOs at the outset of the performance year through preliminary prospective alignment of beneficiaries (while retaining a retrospective reconciliation to ensure that ACOs are measured on the basis of the patients they actually care for during the year); retaining a strong monitoring and quality-measurement mechanism while streamlining the metrics to focus on what matters most, including reducing the total number of quality measures by about half; allowing start-up ACOs to choose a “savings only” track without financial risk during their initial contract period; sharing savings with successful ACOs on a “first dollar” basis when the ACO achieves meaningful savings for the Medicare program and improves care or provides high-quality care; and creating a pathway for full participation of federally qualified health centers and rural health clinics that provide a primary care safety net for Medicare beneficiaries in underserved areas.”

“Today, most hospitals and doctors get paid more by delivering more, not necessarily better, care. ACOs will reward providers for holding down costs and meeting certain quality measures, such as reducing hospital readmissions or emergency room visits. In many ways, ACOs aim to replicate the much touted models of care at the Mayo Clinic in Rochester, Minn., and the Geisinger Health System in Pennsylvania, where hospitals and doctors coordinate their efforts within the same organization.”

  • HealthLeaders Media released an array of initial industry feedback in ACO Final Rule: 10 Healthcare Leaders Sound Off, including one comment by Neil Kirschner, senior associate for regulatory and insurer affairs with the American College of Physicians, that struck a perfect balance of confidence and caution with the final ACO rule:

“CMS went as far as it could to make the ACO as attractive as possible for physician participation. I can’t remember a time when CMS has been so responsive. 

The risk-free track, elimination of the electronic health record requirement, the first dollar payment after the lower cost threshold is reached, “and the change from retrospective to prospective assignment make it easier for ACOs to keep track of how they’re doing and better respond to the needs of their patients.

These changes, will make it more likely providers will consider forming an ACO, and I believe more actually will, but you have to remember that this is not for the faint of heart; There is still a great deal of capital and infrastructure requirement.”

  • Fierce Health Care included the CMS chart comparing proposed vs. final rules inProviders Cheer ACO Final Rule: Reactions to the Revised Cut and included responses from – among many others – the  American Hospital Association, American Medical Association, Association of American Medical Colleges, American Association of Retired Persons, and the following from the Campaign for Better Care:

“We are very pleased that this final rule will require ACOs to adhere to strong patient-centered criteria, use beneficiary experience of care measures to evaluate performance, and ensure full transparency, notification and choice for beneficiaries,” Campaign for Better Care Leader Debra L. Ness said in a statement yesterday. “This new rule is not perfect, but it provides a path away from the broken, dysfunctional health care system we have today toward a system that offers higher quality, better coordinated and more patient-centered care.”

Ann-Marie Lynch, executive vice president of the Advanced Medical Technology Association, said the association was “concerned the rule does not address the very real danger of slowing the development of new treatments and cures. 

“The failure to consider how innovative products play an important role in improving patient care threatens medical progress for current and future patients,” she said. “Without certain design elements, the ACO program may have the effect of limiting treatment options and discouraging physicians from adopting new advancements in care.”

  • And rounding out the list is Modern Healthcare’s optimistic outlook Final ACO Regs Include Bigger Bonuses, which focused on incentives offered under the new rules for ACOs and  affiliated providers:

“As proposed in March, ACOs may choose one of two incentive options under the final rule. However, providers no longer face possible penalties under both options. Previously, providers that failed to achieve quality and savings targets could be at risk for penalties either for one year or three years, depending on the option. The CMS eliminated the possible one-year penalty under the final rules. 

The CMS also increased the amount of bonuses that providers may earn. Now, once providers clear a savings target, the CMS agreed to share savings earned from the outset. Previously, providers were eligible to share savings after the first 2% in cost-reductions.”

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Please visit www.accountablecareforum.com for all the latest news related to ACOs.

Accountable Care Forum: MEDICARE ACO RULES NEAR FINAL HURDLE

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The following post was written by AMDR President Dan Vukelich for the Accountable Care Forum blog, appearing October 18, 2011:

The dog days of summer may officially be behind us, but things are just starting to heat up over at the Centers for Medicare and Medicaid Services (CMS) with signs that a Medicare Shared Savings Program (MSSP) final rule could be released in the near future. This week, Modern Healthcare is reporting that the Office of Management and Budget (OMB) began their review of the final MSSP rule regarding Accountable Care Organizations on October 5th.  The OMB’s review is one of the final hurdles before a regulation is publicly issued.

Thanks to a busy summer by CMS officials, approximately 1,200 comments were reviewed on the initial proposed MSSP rule.  In the meantime, speculation and anticipation has been constantly circulating throughout the healthcare industry on the possible contents of the final rule and what it means for all parties involved. Here are some of the highlights to catch you up on the summer buzz around accountable care organizations (ACOs):

  • MarketWatch reported that interest in ACOs has now spread from healthcare providers to employers, who believe this new health delivery system will help sustain employer-sponsored benefits without compromising affordability or quality of care.  According to MarketWatch: “This survey of 674 U.S. employers reveals that 28 percent are interested or very interested in exploring ACOs, while 37 percent are somewhat interested, 24 percent are unsure and 11 percent are not at all interested. Quality of care delivered is the top ranked factor by 82 percent of employers in evaluating the use of ACOs. This was followed by the ability to manage the total cost of care (81 percent), patient outcomes (66 percent) and plan/provider pricing transparency (47 percent).”
  • For those of us in the medical device industry, Medical Devices & Diagnostics Industry (MDDI) magazine article “Policy Predictions and Planning for Accountable Care” provides an excellent overview of the ACO model and how manufacturers need to prepare for the inevitable market shift that will result when the rule is published.  MDDI outlines a number of predictions and recommendations for manufacturers to take advantage of this new method for healthcare delivery, emphasizing that “competitive advantage will flow to the medical device companies that study the market issues in order to optimally market products in one to three years.”
  • FierceHealthPayer (FHP) published results from one study conducted by America’s Health Insurance Plans that concludes that existing ACOs provide higher quality and lower costs.  According to FHP, data gathered from the study of eight health plans revealed “approximately 10 percent improvements in quality, a 15 percent decrease in readmissions and total patient days in a hospital, as well as annual savings of $336 per patient.”
  • Individual states also took the opportunity to join the ACO discussions by reporting successes with their current accountable care models. One article by Modern Physician features an ACO in Texas that saw their “doctors performing better than other physicians in the area by 6 percentage points.”  Another, by FierceHealthcare, touts a new partnership taking hold in California between UC-San Francisco, two Catholic Healthcare West facilities, California Pacific Medical Center and Blue Shield of California, which is based on a previous care collaborative model that “produced $20M in savings” and “resulted in a 15 percent decrease in 30-day hospital readmissions and a 15 percent decrease in length of stay.”

Regardless of what we have seen in the press leading up to the release of this rule, the one takeaway is that the landscape for delivering healthcare is evolving and will continue to evolve in a way that promotes more accountability for providers (and all related parties) to offer the highest quality care for the lowest cost.  Accountable Care Forum will continue monitoring for the soon-to-be-released rules out of CMS and provide analysis of the rules as they becomes available.

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Please visit www.accountablecareforum.com for all the latest news related to ACOs and the corresponding federal regulations.