There has been a lot of buzz in the healthcare world lately about “specialty pharmacy” as an opportunity for rapid growth, financial opportunity, and expansive change, however there is some debate as to what exactly constitutes a specialty pharmacy.     Here we will examine that questions and look at some of the definitions that have been recently emerging by focusing on three key questions: What is a Specialty Drug? Specialty Pharmacies are most often focused on the dispensation of specialty drugs.  While there is no standardized definition of what constitutes a specialty drug, most often the meet the following criteria: the drug is a specialized, high cost product (typically more than $500 per dose or $6000 or more per year) the drug is utilized as a complex therapy for a complex disease the drug requires special handling or administering, shipping, or storage (such as an injectable) the drug may have a Food and Drug Administration (FDA) Risk Evalaution and Mitigation Strategy (REMS) in place specifying that there is required training, certifications, or other requirements that must be met in order for the drug to be administered. The drug has the potential for significant waste due to high cost Specialty drugs are used to treat a variety of complex and chronic conditions including but not limited to: anemia, cancer, infertility, multiple sclerosis, HIV and hepatitis.  Some categorize specialty drugs as meeting all of the three H’s: High Cost, High Complexity, High Touch. Because of the specialized way in which these drugs need to be administered, specialty pharmacies come into play with a specific focus on this group of drugs and the required comprehensive and coordinated delivery and support required to effectively deliver these drugs to patients.  Leading us to the question “What is a Specialty Pharmacy?” What is a Specialty Pharmacy? Now that we have identified what a specialty drug is, we can begin to touch on what constitutes a specialty pharmacy.  In broad terms, a specialty pharmacy is a specific type of pharmaceutical delivery system which coordinates delivery and offers comprehensive support in the distribution of drugs which are high cost or complex and utilized to treat complex conditions. The Academy of Managed Care Pharmacy (AMCP) in a recent publication entitled Format for Formulary Submission, version 3.1 defined specialty pharmacy as the following: “Specialty pharmacies are distinct from traditional pharmacies in coordinating many aspects of patient care and disease management.  They are designed to efficiently deliver medications with specialized handling, storage, and distribution requirements with standardized processes that permit economies of scale.  Specialty pharmacies are also designed to improve clinical and economic outcomes for patients with complex, often chronic and rare conditions, with close contact and management by clinicians.  health care professionals employed by specialty pharmacies provide patient education, help ensure appropriate medication use, promote adherence, and attempt to avoid unnecessary costs.  Other support systems coordinate sharing of information among clinicians treating patients and help patients locate resources to provide financial assistance with out of pocket expenditures.”  What we are essentially…

Medicine is getting cheaper. That may come as a surprise amid hand-wringing about the spiraling cost of health care, but two new studies, one from research company IMS Health and one from pharmacy benefit manager Express Scripts, show that the amount of money Americans spend on prescription drugs went down in 2012 for the first time in decades. The reason for this welcome development is an influx of generic medications. Recently, the patents on a slew of blockbuster drugs — like Lipitor, which fights cholesterol, and Plavix, which prevents blood clots — have expired, paving the way for less expensive versions. The research behind a new drug is protected for a fixed number of years, after which competing firms can begin manufacturing generic forms. In 2012, 84 percent of all prescriptions were dispensed as generics, the highest rate in history. It’s a boon for consumers. These new studies also found the prices of specialty medicines are rising. These new drugs involve cutting edge technologies and can, therefore, be expensive, priced as they are to help inventors recoup their investments. Fearful of what the newest medicines may cost patients and insurers, some politicians have proposed measures aimed at forcing these prices down. We shouldn’t fear the price tag of these new medicines. Expensive medicine may be a bitter pill, but these advanced therapies offer hope to millions of patients, keeping them healthier for longer. Lawmakers must continue to promote smart policies that encourage the research investments critical to invention. We’re living in a golden age of drug development. New treatments for everything from cancer to rare genetic diseases are entering the market all the time, many of which are cutting-edge biologic medicines derived from living cells. Biologics offer amazing promise. Consider their potential impact on cancer. Conventional cancer treatments often generate significant collateral damage to the patient. In contrast, the biologic approach injects a genetically engineered protein designed to knock out a tumor’s ability to produce new blood vessels, thereby cutting off its capacity to grow. No innocent tissue is harmed in the process. Such a biologic has already been approved for treating colorectal cancer. Or consider a vaccine that, when injected directly into a tumor, would not only destroy the malignant cells but also stimulate the body’s immune system to go after similar tumor cells. That therapy for treating melanoma is already in the development pipeline, along with 906 other biologics targeting over 100 diseases from autoimmune disorders to viruses. There are currently 176 biologics in development to treat infectious diseases alone. But the most specialized and complex drugs can come at an astronomical price. According to an exclusive Forbes’ survey of the most expensive medications, four biopharmaceuticals approved in 2012 cost more than $200,000 per year, per patient. That’s because it costs on average, $1.2 billion dollars to bring a new drug to market — from the time it is a twinkle in a scientist’s eye, through a decade or more of lab research, to clinical trials and finally…

Elizabeth Rosenthal’s eye-opening article about health care costs in The New York Times on Sunday was a reminder of how much more Americans pay for given procedures than citizens in health systems abroad. What was probably more surprising to most readers was the huge price differentials for identical procedures — not only across the United States, but even within American cities, where prices for a given procedure can vary tenfold. These price differentials, it should be noted, have never been shown to be related either to the cost of producing health care procedures or to their quality. The question, not addressed in the article, is who bears the blame for this chaotic, private-sector price system. The only fair answer is: American employers. Who else could it be? I have been critical of employment-based health insurance in this country for more than two decades. In the early 1990s, for example, at the annual gathering of the Business Council, I bluntly told the top chief executives assembled there, “If you want to find the culprit behind the health care cost explosion in the U.S., go to the bathroom and look in the mirror.” After years of further study, I stand by that remark. I can imagine that some would look instead to the usual suspects – Medicare, Medicaid and possibly even the Tricare program for the military – but that would be a stretch. The argument would be that the public programs shift costs to the private sector, causing the chaos there. Few economists buy that theory. Most health-policy analysts I know regret that employers appointed themselves their employees’ agents in the markets for health insurance and health care, developing in the process the ephemeral insurance coverage that is lost to the family when its breadwinner loses his or her job. Employers were able to capture that agency role during World War II when they successfully walked around the prevailing wage controls simply by having Congress exempt fringe benefits from the wage cap. Employers were able to retain their agency even after the wage controls ended by having Congress exempt employer-paid fringe benefits from the taxable income of employees, a tax preference not granted Americans who purchased health insurance on their own. Retaining their tax-preferred agency role has been of great help to employers in the labor market. Alas, in their self-appointed role as purchasing agents in health care, American employers have arguably become the sloppiest purchasers of health care anywhere in the world. The chaotic price system for health care is one manifestation of that sloppiness. For more than half a century, employers have passively paid just about every health care bill that has been put before them, with few questions asked. And all along they have been party to a deal to keep the chaotic price system they helped create opaque from the public and even from their own employees. Only very recently and very timidly have a few of them dared to lift the veil a little. Employers may protest…

Spending in the U.S. on specialty drugs used to treat serious diseases is projected to increase 67 percent by the end of 2015, according to a forecast  by pharmacy benefit management firm Express Scripts. Specialty medicines are those used to treat chronic, complex diseases such as cancer, multiple sclerosis and rheumatoid arthritis. They are prescription drugs that require special handling, distribution and administration. Many specialty medicines are biologics that are delivered via an injection or an infusion and are used to treat chronic, complex diseases. Prescription drug spending on eight of the top 10 specialty therapy classes will continue to increase over the next three years, according to the report. This is due to both the introduction of new biologics and physicians delaying treatment of patients until the new drugs are on the market. According to the forecast, overall spending on traditional prescription drugs – mostly pills used to treat common conditions such as high cholesterol and depression – will decline four percent by the end of 2015, largely because of the availability of generic medications. Only two of the top 10 traditional drugs — for diabetes and attention disorders — are likely to have spending increases over the next three years, but those increases will be significant. Express Scripts said it expects that cancer, multiple sclerosis and inflammatory conditions such as rheumatoid arthritis — all specialty conditions — each will command higher drug spending than any other therapy class except diabetes by the end of 2015. Hepatitis C drug spending likely will quadruple over the next three years, the largest percentage increase by far among therapy classes.  This increase will be caused in part by new interferon-free medications expected to gain FDA-approval in 2014. “As we see what’s on the horizon, it’s time for employers and health plans to act so they can continue to offer an affordable pharmacy benefit for their members,” said Glen Stettin, M.D., senior vice president, Clinical, Research and New Solutions at Express Scripts. “New specialty treatments are making a real difference in the lives of patients, but the very high cost of these drugs creates difficult decisions for plan sponsors on which medicines to cover.” Biosimilars, which are  less-costly alternatives to biologics, could become available once the patents expire on currently marketed biologics, a development that could help mitigate the rising cost of specialty medications.. Express Scripts recently projected that the country would save $250 billion between 2014 and 2024 if the 11 most likely biosimilar candidates were launched in the U.S. Diabetes became the costliest prescription drug therapy class in 2011, and according to the new projections, it will continue to hold that distinction at least through 2015. Over the next three years, Express Scripts expects spending on diabetes medications to rise an additional 24 percent because of high prevalence and a robust pipeline of new therapies. Despite the availability of generic equivalents for many attention disorder therapies, the data projects spending in the category to increase approximately 25 percent over the next…

Deirdre Yapalater’s recent colonoscopy at a surgical center near her home here on Long Island went smoothly: she was whisked from pre-op to an operating room where a gastroenterologist, assisted by an anesthesiologist and a nurse, performed the routine cancer screening procedure in less than an hour. The test, which found nothing worrisome, racked up what is likely her most expensive medical bill of the year: $6,385. That is fairly typical: in Keene, N.H., Matt Meyer’s colonoscopy was billed at $7,563.56. Maggie Christ of Chappaqua, N.Y., received $9,142.84 in bills for the procedure. In Durham, N.C., the charges for Curtiss Devereux came to $19,438, which included a polyp removal. While their insurers negotiated down the price, the final tab for each test was more than $3,500. “Could that be right?” said Ms. Yapalater, stunned by charges on the statement on her dining room table. Although her insurer covered the procedure and she paid nothing, her health care costs still bite: Her premium payments jumped 10 percent last year, and rising co-payments and deductibles are straining the finances of her middle-class family, with its mission-style house in the suburbs and two S.U.V.’s parked outside. “You keep thinking it’s free,” she said. “We call it free, but of course it’s not.” In many other developed countries, a basic colonoscopy costs just a few hundred dollars and certainly well under $1,000. That chasm in price helps explain why the United States is far and away the world leader in medical spending, even though numerous studies have concluded that Americans do not get better care. Whether directly from their wallets or through insurance policies, Americans pay more for almost every interaction with the medical system. They are typically prescribed more expensive procedures and tests than people in other countries, no matter if those nations operate a private or national health system. A list of drug, scan and procedure prices compiled by the International Federation of Health Plans, a global network of health insurers, found that the United States came out the most costly in all 21 categories — and often by a huge margin. Matthew Ryan Williams for The New York Times A poster illustrating diseases of the digestive system at a doctor's office. Americans pay, on average, about four times as much for a hip replacement as patients in Switzerland or France and more than three times as much for a Caesarean section as those in New Zealand or Britain. The average price for Nasonex, a common nasal spray for allergies, is $108 in the United States compared with $21 in Spain. The costs of hospital stays here are about triple those in other developed countries, even though they last no longer, according to a recent report by the Commonwealth Fund, a foundation that studies health policy. While the United States medical system is famous for drugs costing hundreds of thousands of dollars and heroic care at the end of life, it turns out that a more significant factor in the nation’s $2.7…

Few big moves expected...   Days after the Centers for Medicare & Medicaid Services released hospital chargemaster data for dozens of the most common procedures performed, providers are mulling whether to cut their prices or do nothing at all.   Bruce Lamoureux, chief executive officer of Providence Alaska Medical Center, told Kaiser Health News he was reconsidering the prices his facility charges. "There are some instances where our charges for a particular procedure are, in one case, half of a different provider's, and in a different case, twice a different provider," he told Kaiser. Lamoureux added that listing prices gives consumers more bargaining power. By contrast, Rick Davis, CEO of Central Peninsula Hospital in Soldotna, Alaska, told Kaiser he believes his prices are fair and doesn't expect them to change.   C. Duane Dauner, president of the California Hospital Association, observed in a statement that since Medicare is paid based on DRGs and the state's Medicaid program is paid on negotiated contracts, the chargemaster data release by CMS is "less relevant and may confuse patients as well as the public."   And on a national level, hospitals indicate it would be a gargantuan effort to change their prices so they're in line with Medicare payments.   "I can promise you that if you got into the weeds here, you would immediately discover that it ain't as easy as it sounds," Chip Kahn, CEO of the Federation of American Hospitals, the lobby for for-profit facilities, told the Huffington Post. "If someone decided tomorrow to do it, everybody could do it. But I'm telling you, it would cost billions of dollars--probably small billions, not big billions--because it's not a minor task."   May 13, 2013 | By Ron Shinkman

The Centers for Medicare & Medicaid Services, the largest purchaser of prescription pharmaceuticals, is eliminating or at least leveling the playing for itself and patients.  CMS is collecting wholesale invoices from pharmacies across the country (see below).     CMS will use a combination of calculus, statistics and probability to determine a national average acquisition cost for every prescription medication on its formulary.  It will then send out an RFP stating these are the prices (based upon the calculated acquisition costs) we're willing to pay for prescription drugs listed on our formulary - take it or leave it!     If you're a self-insured employer or a broker this is exactly what you should be doing for clients and employees alike.  It doesn't matter the size of your organization.  If you pay for PBM services accept nothing less than full transparency.     In this case, that means paying only true acquisition costs for all prescription drugs and not a penny more.  If you need help in calculating and/or verifying acquisition costs get off your butt and send me an e-mail I'll be happy to help.  In the meantime, read the letter sent to us by CMS.  Information asymmetry occurs when one party has significantly more information than another.  More important, the party with more information takes advantage of its position.  In business, this often leads to a lack of transparency and abhorrent price disadvantages for purchasers.     It's quite simple, don't do business with any PBM that isn't willing to: (1) share all their price lists/wholesale invoices and (2) provide full audit rights.  If you would like a copy of the original letter simply send me an e-mail and we'll get one out to you. Click here to register for: "How To Slash the Cost of Your PBM Service, up to 50%, Without Changing Providers or Employee Benefit Levels."

Federal and state policymakers should avoid enacting laws that undermine payers' ability to use mail-service pharmacies, preferred pharmacy networks, and other innovative pharmacy benefit management (PBM) tools, the National Center for Policy Analysis (NCPA) asserts in a new report,"Unnecessary Regulations that Increase Prescription Drug Costs." "This report shows policymakers that appeasing the drugstore lobby means higher prescription drug costs for small businesses, consumers, and government programs," said Pharmaceutical Care Management Association (PCMA) President and CEO Mark Merritt. Click here to read the NCPA report which highlights a number of regulations and laws that could increase prescription drug costs, including: Barriers to Competition: State Boards of Pharmacy Conflict of Interest Background: The report highlights how some states are seeking to transfer regulatory authority of drug plans from the state's insurance commissioner to the state's Board of Pharmacy. NCPA: "Because state pharmacy boards are controlled by pharmacists, giving them authority over drug plans creates conflicts of interest that could undermine drug plans' ability to negotiate lower prices with pharmacy networks." Barriers to Lower Cost Mail-Service Pharmacies Background: Employers and payers use a variety of incentives to encourage patients to use efficient mail-service pharmacies to address chronic illnesses, such as diabetes. Mail-service pharmacies will save Medicare seniors, employers, unions, government employee plans, consumers, and other commercial-sector payers $46.6 billion in prescription drug costs over the next ten years. NCPA: "Unfortunately, some states are enacting laws that interfere with the ability of drug plans to reward enrollees that use the plan's mail order option by barring drug plans from offering lower prices for mail-order dispensing. This unnecessarily raises costs for consumers, insurers and employers. Obviously, these laws mostly aim to benefit local community pharmacies rather than consumers." Barriers to Competitive Pharmacy Networks Background: A new study finds that the extraordinary number of pharmacies in the United States offers an opportunity to save $115 billion over the next decade through the greater use of preferred and limited pharmacy networks. However, some states have in place so-called "any willing pharmacy" laws and regulations that force plans to contract with pharmacies that don't meet their quality standards or geographic access needs. NCPA: "These any-willing-pharmacy laws are costly to taxpayers, employers and patients alike. The Federal Trade Commission notes that these laws reduce the drug plans' bargaining power, leading to higher drug prices and higher premiums for consumers." Barriers to Efforts to Combat Fraud Background: Health care fraud is a problem that increases overall health costs and is especially burdensome in Medicare and Medicaid. Billions of claims are submitted to millions of providers, making fraudulent claims easy to disguise. PBMs and companies processing electronic payments are effective at discovering irregularities that lead to fraud. NCPA: "Regulations requiring Medicare drug plan administrators to pay claims within 14 days make it difficult to detect fraud before a claim has been paid. At the very least, drug plans need the authority to delay paying questionable claims to providers suspected of fraud. Plans also need greater authority to exclude or suspend suspected…