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Medicare's Diabetes Testing Supply Program Found Lacking

Posted by dlife on Fri, Jan 31, 14, 02:12 PM 0 Comment

January 29, 2014 (Medscape) -- A new survey from the American Association of Diabetes Educators (AADE) suggests that Medicare's recently introduced national mail-order program for diabetic testing supplies is limiting beneficiaries' access to the brands that work best for them.

The survey, published on the AADE's website last week, was designed to assess implementation of the Centers for Medicare and Medicaid Services (CMS) competitive bidding program for mail-order diabetic testing supplies, which expanded nationwide beginning July 1, 2013. In "secret-shopper" probes conducted in September 2013, 7 diabetes educators called each of the 23 contract suppliers listed with Medicare at the time (the number has since changed), asking which diabetes testing products they supplied. None of them offered products representing more than 50% of the market, and callers received inconsistent answers about which products were available. In addition, the answers often didn't match the information on Medicare's website. Martha L. Rinker, JD, AADE's chief advocacy officer, told Medscape Medical News that despite CMS rules that forbid suppliers from pressuring patients to switch glucose-meter/test-strip brands and that allow physicians to write prescriptions for specific brands, the way the program is being conducted is leading many patients to switch anyway, with potentially negative consequences.
If the patient gets a meter they don't know how to use, it gets unused. That defeats the purpose and is a waste in the long run.
 
"Most Medicare beneficiaries are going to say, 'Whatever you're sending is fine.' There might be a rule, but that doesn't mean it's abided by. And then the problem is if the patient gets a meter they don't know how to use, it gets unused. That defeats the purpose and is a waste in the long run." Ms. Rinker added that there is concern about the accuracy of some of the lower-priced meters and test strips that are increasingly being offered to Medicare beneficiaries. "Most of them are imports that don't go through the vigorous testing that the American-made ones go through. There's a question of accuracy." But both the CMS and a representative of one of the suppliers who spoke with Medscape Medical News dispute the AADE's conclusions. "In my opinion, there's a lot of misinformation being put forth," said David Soblick, vice president of Am-Med Diabetic Supplies. He noted that the AADE is partially funded by some of the manufacturers of brand-name diabetic testing supplies that stand to lose market share with the competitive bidding program, and therefore the survey is "kind of self-serving." For its part, the CMS told Medscape Medical News in a written statement that the agency has in place "comprehensive monitoring…to ensure that the program achieves its goals of quality and savings," including local scrutinizing, a complaint process for all stakeholders to report concerns, a requirement for quarterly reports from suppliers identifying which brands they offer, and real-time claims monitoring data.
[The competitive bidding program] is projected to save $25.8 billion for Medicare over 10 years and save another $17.2 billion for beneficiaries.
 
"We are pleased to inform you that our monitoring data show a smooth implementation to date," the CMS adds. The competitive bidding program "is projected to save $25.8 billion for Medicare over 10 years and save another $17.2 billion for beneficiaries through reduced coinsurance and the downward effect on premiums," it says. "The national mail-order program for diabetic testing supplies is expected to save beneficiaries 72% on included items as compared with the fee schedule." The "50% Rule" No Longer Enforced? To qualify for inclusion in the national competitive bidding program, providers were required to offer a product mix reflecting at least 50% of the market coverage for diabetic testing supplies that had been available prior to the program. However, the CMS did not stipulate ongoing adherence to the so-called "50% rule" once the program was under way. The AADE found in Medicare supplier directory that by the end of the first quarter of the mail-order program, only 5 suppliers were offering more than 50% of the testing systems that had been available prior to the competitive bidding program. On Medicare's website, the majority of suppliers were offering less than 50%, and in the AADE survey, no supplier offered more than 50%. "Although Congress clearly intended the 50% rule to ensure that beneficiaries would have access to the brands offered before the national mail-order program, CMS is failing to ensure that beneficiaries continue to have access to familiar test systems," the AADE report says. In its statement to Medscape Medical News, the CMS said: "All national mail-order program contract suppliers met the 50% compliance rule. As required by law, this rule is applied at the time of bidding." Since that time, the CMS said that "safeguards" have been built into the program "to ensure beneficiary access to necessary items and services during the contract period." Among these is the requirement that suppliers comply with the "physician-authorization process," whereby if a doctor prescribes a particular brand item and documents in the beneficiary's medical record the reason the particular brand is needed, the contract supplier must: furnish the prescribed brand; consult with the physician to find an appropriate alternative brand; or work to obtain and furnish the prescribed brand. If a beneficiary can't obtain a particular brand of preferred test strips from any of the contract suppliers, the beneficiary can get them from a local retail pharmacy rather than through mail order. Contract suppliers are also required to offer the same products to Medicare patients as to non-Medicare patients and are prohibited from pressuring or incentivizing beneficiaries to switch diabetic testing supply brands, the so-called "antiswitching rule." Failure to comply with all of these rules "constitutes a breach of contract and can result in termination of the supplier's contract," the CMS said. Many Have Special Requirements for Testing Supplies Ms. Rinker told Medscape Medical News that many patients require glucose meters with special features, such as large numbers for those with vision problems, test-strip cartridges for those with low manual dexterity from neuropathy, and simple functioning for patients with low educational levels. The AADE doesn't recommend any specific meters, she said. Rather, "The educator works with the person and finds the meter that works best for that person so that that person uses it. That's our ultimate goal. We want them using their meters, we want them testing, and we want them understanding what those numbers mean."
We want them using their meters, we want them testing, and we want them understanding what those numbers mean.
 
She advised physicians to "work closely with your diabetes educators and get to know what your patients need in order to be successful in managing their disease. And be aware that you may have to fight for your patients in order to get them what they need." Mr. Soblick said that "for business reasons" his company's total number of brand offerings dropped from 10 at the time of the survey to just 6 now, but that it had also picked up 2 major brand-name products, from Bayer and Johnson & Johnson. And while he acknowledged that some patients do need specific meters — including those who wear insulin pumps that work with a particular brand — he said that for the majority of patients it's simply a matter of personal preference. "You have to remember all of these products are FDA-approved. If someone has a specific meter they're used to or comfortable with, that's not really sufficient medical reason why they need that product… Medicare does not pay for convenience. It pays for medical necessity."
Medicare does not pay for convenience. It pays for medical necessity.
 
The AADE found that when the 7 "secret-shopper" surveyors called the suppliers to ask whether particular diabetic testing supply brands were available for purchase, they received inconsistent answers. In no case were all 7 given the same answer. Only 3 suppliers gave the same answer to 4 of the 7 callers. "These data suggest that if a beneficiary were to call on different occasions or if multiple beneficiaries were to call the same supplier, they are likely to receive conflicting information about product availability. This is especially disturbing given that beneficiaries must be able to rely on product-related information from the supplier when ordering diabetic testing supplies. Providing inconsistent information to callers should not be considered acceptable," the AADE writes. But Mr. Soblick said the number of calls was too small to provide "a legitimate evaluation of what the provider is willing to give to beneficiaries… Their survey is very, very limited in scope." He told Medscape Medical News, "We have no reason to distort anything about what we're doing and supplying. We're here to serve the Medicare beneficiary. When I see those kinds of things published, and they're using a very biased type of survey…it kind of concerns me." The AADE survey also found that the responses didn't correlate with the information on the online Medicare supplier directory: The information on that site completely matched the information provided in the survey for just 3 suppliers. In the case of 1 supplier (Kohlls Pharmacy & Homecare), the Medicare site indicated that it carried 12 brands, whereas the surveyors found that it carries just 2. (Kohlls did not reply to a request for comment from Medscape Medical News.) Mr. Soblick said that Am-Med informed the CMS when the number of their brand offerings dropped, but that the CMS didn't update the website information right away. But according to the CMS: "Contract suppliers are required to submit a quarterly report indicating the brands they plan to furnish during the next quarter. Each contract supplier's information is posted on the supplier directory. If you have specific examples of inaccuracies, please let us know, as this is supplier-provided information. We will then follow up with the contract supplier." Better Communication May Address Some Issues The AADE report makes a number of recommendations to the CMS, including more frequent communication with beneficiaries, creating standardized language for suppliers to use, requiring the suppliers to maintain their product mixes throughout the program, and regular audits to ensure ongoing compliance. In its statement to Medscape Medical News, the CMS said it is already doing some of those things. "We have already conducted a thorough…education program to ensure beneficiaries have clear, straightforward, and accurate information about their right of choice under the national mail-order program." In addition, an educational publication was mailed to beneficiaries before the program began, and beneficiary information is also available on the national mail-order program website and through 1-800-MEDICARE.

Oral Diabetes Medicine Shows Promise in Study of Oramed Pill

Posted by dlife on Fri, Jan 31, 14, 02:10 PM 0 Comment

January 30, 2014 (Bloomberg) -- Oramed Pharmaceuticals Inc. (ORMP), the Israeli drugmaker seeking to develop the first oral insulin pill, said a trial on type 2 diabetes patients showed that the medicine has promising therapeutic potential. The one-week study of 30 patients also met safety goals, the Jerusalem-based company said in a statement today. The company released no data from the study, and said it expects to present full results at a scientific conference. Oramed plans to follow the mid-stage trial with another this year as it pursues a product that, if approved, would provide relief for millions of people taking daily insulin shots. "The results we announced today give us confidence about the chances of success in a bigger trial going forward," Chief Executive Officer Nadav Kidron said at a press conference today at the Tel Aviv Stock Exchange. "We are also excited about the potential of this drug for type 1 diabetes." The results could bring Oramed, whose stock has more than tripled in the past year, a step closer to doing something no company has ever done: develop oral insulin. The technology has eluded scientists for decades and Novo Nordisk A/S, a Danish developer of diabetes products valued at about $104 billion, has yet to develop a pill to replace daily shots. Oramed fell 4 percent to $24.94 at the close in New York, giving the company a market value of $243 million. The stock dropped as much as 14 percent, the biggest intraday decline since Jan. 15. Prove It "The stock had made a very big move in a really short time with very little data being shared, so perhaps investors are now thinking that the stock is fully valued," said Graig Suvannavejh, an analyst at MLV & Co. who has a buy rating and $27 price estimate on the stock. "This is an early-stage company with a very interesting technology. The data is intriguing, but now they need to demonstrate that it works in larger trials." While Oramed is years away from a potential approval, it's taking advantage of the growing attention to raise money. The company raised $16 million on Dec. 25, five days after it said it had successful results in an early-stage type 1 diabetes study. On Jan. 24, the company filed to raise as much as $100 million. Market Value The market for drugs to treat diabetes is likely to grow to more than $58 billion in 2018 from $35 billion in 2012, Standard & Poor's wrote in an October report. Diabetes afflicted 371 million people and killed 4.8 million worldwide in 2012, according to the International Diabetes Federation. People with type 2 diabetes don't produce enough insulin, a hormone that helps the body use or store blood sugar, or can't use the insulin properly. The illness, the most common form of diabetes, often strikes people over the age of 40, and is tied to obesity and sedentary lifestyles. The drugmaker's Protein Oral Delivery, or POD, technology, is based on research by scientists at Jerusalem's Hadassah Medical Center. The Phase IIa trial detailed today will be followed by a Phase IIb study.

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