April 26, 2016 Healthcare alliance calls for action to lower prescription-drug costs A broad coalition including healthcare providers, insurers and seniors is proposing major changes designed to rein in prescription-drug costs, including a shorter exclusivity period for biotech medications and a requirement that manufacturers disclose more information about pricing. The Campaign for Sustainable Rx Pricing, whose members include AARP, Walmart and several health plans, is trying to stoke interest in the fall elections with an eye toward winning policy changes in 2017. Many of the proposals would require congressional or administrative action and have little chance this year. “We have worked pretty hard to raise this at the presidential campaign level, and each of the candidates has acknowledged this is an issue,” said John Rother, president and chief executive of the National Coalition on Health Care and head of the drug-pricing coalition. “We are now going to expand our efforts to other races.” To promote competition, the coalition is calling for a reduction in the 12-year exclusivity period for biological drugs and is pressing for more resources for the Food and Drug Administration to allow quicker processing of generic-drug applications. Currently, the agency faces a backlog of thousands of such applications. Rother described the initiatives as “market-based” and said they would lead to “a functioning market that would better balance innovation with affordability.” In some ways, the proposals are fairly cautious, reflecting reluctance by some members of the coalition to push for more-aggressive government intervention. For example, the group does not call for giving Medicare the authority to negotiate prices with pharmaceutical companies — an idea that has been endorsed by Hillary Clinton, Bernie Sanders and Donald Trump but is staunchly opposed by Republicans in Congress. But Lori Reilly, executive vice president for policy and research at the Pharmaceutical Research and Manufacturers of America, the drug industry’s main trade group, sharply disagreed. She said the coalition’s ideas were neither market based nor consumer friendly and would result in new government requirements that would themselves increase costs. Moreover, she said, the proposals were an attempt by the insurance industry “to try to deflect the conversation about a lot of things going on in the marketplace.” She pointed to studies showing that some health plans have been increasing out-of-pocket costs for consumers and have placed expensive drugs for serious or chronic illnesses, such as HIV, on “tiers” requiring the highest level of cost sharing. She added that drug-price increases slowed in 2015 after rising more rapidly in 2014. On the presidential campaign trail, Clinton and Sanders have issued detailed position papers on how they would rein in drug costs. Besides allowing Medicare to negotiate over drug prices, they back permitting Americans to re-import drugs from other countries, where they are often much cheaper. In addition, Clinton, in a proposal disliked by insurers, would cap out-of-pocket drug costs at $250 a month for people with chronic or serious health problems. Ted Cruz, meanwhile, has said he wants to make significant changes in the FDA drug approval process. John Kasich has said he wants to take a close look at who is actually footing the bill — the taxpayers or the drug companies — for research and development involving pharmaceuticals. The coalition issuing the proposals would require manufacturers to disclose how much they spend on research and development, and how much is paid for by other entities, such as the National Institutes of Health. The group also would require drug companies to release details about their products’ estimated prices and the impact on federal spending before the FDA gives final approval. Visit the Washington Post for the story. More exchange plans ease access to some expensive drugs: Report Some people with cancer, HIV, and multiple sclerosis have better access to high-cost specialty drugs in marketplace plans this year, yet a significant proportion of these plans still place many expensive drugs in cost-sharing categories that require the highest patient out-of-pocket costs, according to a new analysis. The report by Avalere Health examined how silver-level plans handled 20 classes of medications that are used to treat complex and expensive diseases such as HIV, cancer, hepatitis C, and bipolar disorder. Health plans generally place covered drugs into tiers. Generics and preferred brand-name drugs are in lower tiers with lower cost sharing, while higher-priced drugs are often placed in tiers that require patients to pay a percentage of the cost of the drug rather than a flat copayment. The study found that for five classes of drugs -- two used to treat cancer, two that treat HIV, and one class of multiple sclerosis drugs -- fewer plans in 2016 placed all the drugs in the class in the top specialty drug tier with the highest patient cost-sharing requirements or charged patients more than 40% of the cost for every covered drug in the class. For example, in 2015, 57% of silver marketplace plans put all cancer drugs called "antiangiogenic agents" in the top specialty tier. In 2016, that dropped to 50%. Last year, a quarter of silver plans charged patients more than 40% coinsurance for every drug in that class. In 2016, 15% of such plans did so. Likewise, 14% of 2015 silver plans placed "protease inhibitors," a class of HIV drugs, in the top tier, compared with 10% in 2016. The percentage of plans charging more than 40% coinsurance for those drugs dropped to 6% in 2016 from 9% the previous year. The changes are likely driven by protests and legal challenges from patient groups and from increased regulatory oversight, said Caroline Pearson, a senior vice president at Avalere. For example, California next year will prohibit insurers from placing most or all of the drugs for a specific condition in the highest-cost tier. In addition, the federal Department of Health and Human Services has signaled in guidance to insurers that placing all or most of the drugs in a high-cost tier may be discriminatory. (Kaiser Health News) Visit MedPage Today for the article. Problems finding your way around may be earliest sign of Alzheimer's disease Long before Alzheimer's disease can be diagnosed clinically, increasing difficulties building cognitive maps of new surroundings may herald the eventual clinical onset of the disorder, finds new research from Washington University in St. Louis. "These findings suggest that navigational tasks designed to assess a cognitive mapping strategy could represent a powerful new tool for detecting the very earliest Alzheimer's disease-related changes in cognition," said senior author Denise Head, associate professor of psychological and brain sciences in Arts & Sciences. "The spatial navigation task used in this study to assess cognitive map skills was more sensitive at detecting preclinical Alzheimer's disease than the standard psychometric task of episodic memory," she said. Preclinical Alzheimer's disease denotes the presence of Alzheimer-related changes in the brain that occur prior to the development of symptoms that lead to the diagnosis. The cognitive findings from this study, published in the Journal of Alzheimer's Disease, are consistent with where in the brain the ill effects of Alzheimer's disease first surface, as well as with the progression of the disease to other brain regions. Previous research has shown that navigation problems crop up early in individuals with Alzheimer's disease. These deficits may be associated with the buildup of amyloid plaques and tau tangles and other signs of deterioration and shrinkage in the brain's prefrontal cortex, hippocampus and caudate. While these deficits are well documented in patients with early stage Alzheimer's disease, they have not been well studied in seemingly normal patients who may be progressing toward identifiable early stages of the disease, a status known as preclinical Alzheimer's disease. "People with cerebrospinal markers for preclinical Alzheimer's disease demonstrated significant difficulties only when they had to form a cognitive map of the environment—an allocentric, place-learning navigation process associated with hippocampal function," Head said. "This same preclinical Alzheimer's disease group showed little or no impairment on route learning tasks—an egocentric navigation process more closely associated with caudate function." When compared with cognitively normal study participants who lacked the cerebrospinal fluid markers of Alzheimer's, those with preclinical Alzheimer's disease scored lower on their ability to learn the locations of objects in the environment in relation to each other during the initial study phase. Visit Medical Express for the study. MLB players voice Zika fears for games scheduled in Puerto Rico Players from the Miami Marlins and Pittsburgh Pirates have expressed concerns about playing their two-game series next month in Puerto Rico because of the Zika virus. Officials with Major League Baseball, the Marlins and Pirates expect the games to be played as scheduled May 30-31, they said. But the teams, MLB and the players union are continuing discussions about the trip. "We recognize the importance of the trip," Marlins pitcher Craig Breslow said. "But at the same time, our health and the health of our families is paramount." Major League Baseball commissioner Rob Manfred said the league is in contact with the union about the issue. Since the virus lasts longer in semen than it does in blood, the CDC advises abstaining or using condoms if a man is exposed while his partner is pregnant. It also can be tough to know if someone has contracted Zika, because some infected people do not show any symptoms. CDC guidelines recommend that couples trying to get pregnant should wait six months if the man was diagnosed with Zika and was in an outbreak area. "There are guys who are uncomfortable engaging in the lifestyle changes being recommended by the CDC," he said. "I'm not sure that's fair to ask of 20- to 30-year-old men who are potentially looking to start families or expand families." U.S. health officials say Puerto Rico is the front lines of the nation's battle with Zika. While there has been no mosquito transmission of the virus in the continental United States, there have been hundreds of cases in the island territory. As of last week, Puerto Rico had nearly 450 confirmed Zika illnesses, almost all of them infections that people got on the island. In comparison, there were 358 cases in the 50 states, and all of them were tied to travel abroad to Zika outbreak countries. (Associated Press) Visit ESPN for the story. Pharmakon Pharmaceuticals, Inc. issues voluntary nationwide recall of all sterile compounded products Pharmakon Pharmaceuticals, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by Pharmakon Pharmaceuticals, Inc. that remain within expiry due to the Food and Drug Administration’s (FDA) concern over a lack of sterility assurance and other quality issues. Administration of a sterile drug product intended to be sterile that is compromised may result in serious and potentially life-threatening infections or death. To date, Pharmakon Pharmaceuticals, Inc. has not received any reports of adverse effects or injuries. These compounded sterile products are used for a variety of indications and are packaged in bags, syringes and cad cassettes. All recalled products have a label that includes the Pharmakon Pharmaceuticals, Inc. name, address and expiration date. The sterile products were distributed nationwide to hospitals between March 4, 2016 and April 15, 2016. As Pharmakon Pharmaceuticals, Inc. takes the utmost care to ensure patient safety and out of an abundance of caution, then, Pharmakon Pharmaceuticals, Inc. is notifying its customers that received sterile compounded products via email and is arranging for return of all recalled products. All hospitals that received sterile compounded products from Pharmakon Pharmaceuticals, Inc. between March 4, 2016 and April 15, 2106 and that remain within expiry, to take the following actions: Discontinue use of the products, and Quarantine any unused product. Visit FDA for the recall notice. Join HPN at the 2016 Critical Care Exposition for SCM discussions on critical supplies Supply Chain/Materials/Purchasing Managers and their staff are cordially invited to attend the 2016 Critical Care Exposition at the New Orleans Memorial Convention Center in New Orleans, LA, May 17-19, 2016 on a complimentary (fee-waived) admission basis. The Critical Care Exposition is the largest tradeshow featuring healthcare equipment and supplies for acute and critical care nurses in the U.S. The three-day show features more than 200 exhibitors of products, devices, technology and pharmaceuticals used or administered by nurses who care for critically ill patients. The Critical Care Exposition is produced by the American Association of Critical-Care Nurses (AACN) as part of their annual conference, which attracts more than 6,000 nurses each year. Healthcare Purchasing News, in conjunction with AACN, hosts its 12th annual pair of panel discussions that explore how supply chain professionals collaborate with critical care nurses to facilitate buying decisions, inventory levels, customer service and patient care. Critical care nursing and supply chain management panelists discuss black, white and gray areas in ordering and using the right products when and where they needed them. They will also examine some of the challenges critical care nurses and supply chain professionals face when communications break down between the two areas, demand for products spike and supplies run low, if not out. From those discussions and an active question-and-answer time, attendees learn tips and tricks for success, as well as what went right during the successes and what went wrong during the failures. Listening to "real world" case studies help you apply the lessons learned to your own situations. The session will be held at the Healthcare Purchasing News exhibit space on Tuesday and Wednesday, May 17 and 18 in Booth 1601. To request the "HPN Registration Special" (fee-waived registration information) send an email with your name, title and employer's name to [email protected] or call the AACN Exhibits Director Randy Bauler at (800) 394-5995, ext. 366. When you request the "HPN Registration Special" by email or phone, you'll receive a complimentary registration certificate (good for free admission), plus a list of the participating exhibitors and access to the NTI 2016 exhibits floor plan. You and your staff may visit the show May 17-19, using the show's generic "Exhibits Only" badges on the show floor. We look forward to seeing you in New Orleans. For more information about the conference visit www.aacn.org/nti. For NTI 2016 exhibits information, including a complete list of exhibitors, your readers can visit www.aacn.org/exhibits. To view the electronic floor plan, visit www.aacn.org/ntifloorplan. 2016 International Association of Healthcare Central Service Material Management (IAHCSMM) Annual Conference and Expo, April 24-27, San Antonio, TX Aesculap, Inc. showcases CS solutions at IAHCSMM annual conference Aesculap, Inc., is showing their customer solutions to the sterile processing department at the IAHCSMM 2016 annual conference in San Antonio, TX at the Henry B. Gonzalez Convention Center at booth 1000 on April 25-26, 2016. The booth’s theme, “Confidence in our Products. Trust in our Expertise”, revolves around how Aesculap’s services and products can help the customer drive efficiency in the OR, maximizing patient care. Aesculap’s comprehensive solutions help provide its customers with the tools needed to optimize its processes, reduce costs, and increase quality and safety. Help reduce your operating expenses and case delays with the SterilContainer System. Optimize your sets with Aesculap quality surgical instruments. Support your OR and SPD staff in optimizing your entire reprocessing cycle with service and educational programs from knowledgeable Aesculap team members. Protect valuable instruments and containers with repairs and preventative maintenance by Aesculap Skilled Craftsmen. Visitors to the booth will also be eligible to be entered into a raffle to win an IAHCSMM gift card. In addition to booth participation, Aesculap will be part of the conference’s educational poster gallery, featuring the titles "Maximize SPD Resources with Surgical Asset Management” and “Containerizing Preconfigured Sets”. Visit booth 1000 at IAHCSMM. If you are unable to attend, visit www.aesculapusa.com. 2016 IAHCSMM Award of Honor given to Ray Taurasi It is with IAHCSMM’s sincere appreciation and admiration that Ray Taurasi is the recipient of the 2016 IAHCSMM Award of Honor. Here in San Antonio, in 1967, Ray Taurasi found himself at the Brooke Army Hospital, just starting his service in the U.S. Army Medical Corp. It was the beginning of a professional journey that would eventually lead to a thriving career in Central Service, notable involvement within IAHCSMM and many other organizations, and numerous opportunities to educate, consult and serve CS professionals around the world. From 1969 to 1998, he served in the hospital sector as director of CS and supply distribution. From there, he entered the vendor segment and today serves as Eastern Regional Director of Clinical Sales and Services for Healthmark Industries. His rich history with IAHCSMM includes serving as President in 1992, as well as an IAHCSMM Executive Board for 11 consecutive years. During that time, he proved instrumental in laying the foundation for the Association’s growth and helping IAHCSMM become the successful organization it is today. Aside from his many CS-related credentials, which include CRCST, CHL, FCS and ACE, he also holds a BS degree in management and counseling, and a Master’s degree in business administration. He was an advanced member of ASHCSP, a past president of the Massachusetts Association of Surgical Technologists, past president and education director for the Massachusetts Association of Central Service Materials Management, and active member and contributor to AORN, AAMI, AHA and SGNA. He served as a faculty member for numerous colleges; authored numerous articles, columns and textbook chapters; and served as an international speaker. For many years, he also served as an elected political official on the Board of Health in the metro Boston area. Ray has earned many awards over the years, such as the Beth Israel Deaconess Medical Center Harvard Chair Distinguished Service Award, and was also named by Healthcare Purchasing News as one of the “Most Influential People in Healthcare Sterile Processing” over the last 30 years. Ray’s many contributions led to a Mayoral proclamation of “Ray Taurasi Day” – June 11 -- in the city of Boston. Ray also has answered thousands of sterile processing questions in his CS Questions – CS Answers monthly popular column in HPN, and contributed as a valued editorial board member for HPN. Advisor. Service provider. Advocate. Educator. Leader. Each of these words aptly describes Ray Taurasi; however, anyone who has had the privilege of knowing him can agree that “loyal friend,” “respected mentor” and “trusted colleague” are equally befitting. His vast knowledge, love for the CS profession, and commitment to customer service and education are equally matched by his warm personality and giving spirit. Congratulations Ray! Visit IAHCSMM for the article. Jewish Hospital awarded Healthcare Purchasing News 2016 SPD of the Year Award Jewish Hospital had a large audience of IAHCSMM attendees as they received their award at the HPN booth. Hank Balch, System Director KentuckyOne, Bobby Parker, SPD Manager, Jewish Hospital receive the HPN annual CS/SPD Award from Kristine Russell, Executive Editor and HPN Publisher at IAHCSMM 2016, with Karen Owens formerly with Jewish Hospital, now with STERIS. Healthcare Purchasing News (HPN) named the Sterile Processing Department (SPD) team at Jewish Hospital in Louisville, KY this year’s Central Service/Sterile Processing and Distribution Department of the Year Award recipient. HPN presented Jewish Health with this year’s award on Monday, April 25, during the International Association of Healthcare Central Service Materiel Management (IAHCSMM) 2016 Annual Conference & Expo in San Antonio, TX. Part of the statewide regional integrated delivery network KentuckyOne Health, Jewish Hospital is a 462-bed acute-care center with a state-of-the-art SPD department that reprocesses surgical instruments for the facility’s four surgical centers, including Main Surgery, the Rudd Heart & Lung Surgery, and the Hand and Outpatient Surgery Center. Jewish Hospital SPD also reprocesses and delivers instruments to the Emergency Department, Cath Lab, Endoscopy and Vascular Radiology. Beyond sterilizing surgical instruments, SPD houses the majority of sterile storage for the hospital in its department and manages the distribution of instruments for surgery case carts. Under the leadership of Weston “Hank” Balch, CRCST, CIS, CHL, System Director, Sterile Processing Operations for KentuckyOne (Louisville campus), SPD Manager Robert “Bobby” Parker, CRCST, CIS, CHL and the 32-member team has consistently demonstrated unwavering commitment to improving its performance with creative solutions and best practices in sterile processing. The impressive outcomes achieved at Jewish Hospital prove once again how vital SPD departments are to the healthcare delivery system for improving patient safety and making operations across the board more efficient and cost effective. Visit HPN to read the full story in the May 2016 issue.
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