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Hospital clinics and outpatient departments that bill Medicare for unused portions of certain medications recently gained six additional months to meet newly mandated documentation and billing requirements...the Centers for Medicare and Medicaid Services announced that Medicare administrative carriers must delay until January 1, 2017, implementation of a policy requiring the use of the "JW" modifier on Part B claims for appropriately discarded leftovers from single-use vials or packages...CMS introduced the JW modifier—a code that essentially enables itemized billing for the unused portion of certain medication vials—in 2007. But the agency allowed each MAC to decide whether to require the use of this billing mechanism or, instead, reimburse for wasted medication without separately itemizing it...Hospitals aren't required to bill for wasted medications, but those that don't are missing out on full reimbursement for eligible products...The...communication from CMS did not specify the reason for the implementation delay.

The...Food and Drug Administration has enhanced warnings of side effects of a group of strong antibiotics used to treat a variety of respiratory and urinary tract infections and limited their use to patients with no alternatives...fluoroquinolones include Johnson & Johnson's Levaquin, Bayer's Cipro extended-release tablets and Merck Inc's Avelox....FDA added a box warning to the antibiotics in July 2008 to inform users about the increased risk of tendinitis in which the tissue connecting muscle to bone becomes inflamed.

With the vast majority of drugs and drug ingredients being manufactured outside the U.S., the FDA has had to step up its international oversight and often ban products from plants that don’t meet its standards. But the FDA also has found itself increasingly having to walk a tightrope between drug safety and drug availability...Because of the nature of the business, with companies in China or India often being a primary source of essential drugs, the FDA sometimes must exempt products and allow imports from plants that it believes have a poor record. Since 2013 the FDA has allowed 8 plants whose products are otherwise banned from the U.S. to go ahead and import some drugs or ingredients to avoid shortages, according to FDA Import Alert records.

The European Medicines Agency...recommended suspending the sale of dozens of generic medicines — many of which are sold by Novartis and Teva Pharmaceuticals — over concerns about "flawed" studies that were conducted by an Indian clinical research organization...The move comes three months after the US Food and Drug Administration alerted an untold number of drug makers of problems at the Semler Research Center...in Bangalore. An inspection...found "significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples."...the World Health Organization had issued a notice to Semler for the same reasons...regulators in each EU country will have to determine the extent to which specific medicines that were tested by Semler are critically needed before proceeding with suspensions. The EMA noted there is no evidence, to date, that any patients were harmed or that any of the drugs were not effective.

Faced with budgetary constraints, England’s National Health Service took several controversial steps to delay coverage of Gilead Sciences’s pricey hepatitis C treatments, but did so at the expense of patients, according to an investigation by the BMJ (British Medical Journal)...Specifically, the agency’s moves caused delays in providing treatment to many of the estimated 160,000 hepatitis C patients, while others were unable to obtain the medications due to rationing. As a result, some people are now traveling out of the country to receive treatment. Meanwhile, Gilead has been blamed for igniting the problem due to its pricing practices...Gilead has regularly maintained that the high cure rates will eventually lead to lower health care costs by reducing the need for hospitalizations and other treatments for liver cancer and liver transplants. The NICE recommendations acknowledged such calculations. But such savings are only recognized later and, meanwhile, a growing number of payers in various countries complained the drugs were budget busters..."It is truly ironic that NHS England should choose to start rationing drugs that are so effective they cure almost everyone who is treated," The Hepatitis C Trust, a patient group in the UK, told the BMJ. The group is seeking a judicial review of the decision to ration the drugs, which...could have "repercussions for other patients as more new drugs increasingly become available at higher prices."

A safeguard for Medicare beneficiaries has become a way for drugmakers to get paid billions of dollars for pricey medications at taxpayer expense, government numbers show...The cost of Medicare’s “catastrophic” prescription coverage jumped by 85 percent in three years, from $27.7 billion in 2013 to $51.3 billion in 2015...Out of some 2,750 drugs covered by Medicare’s Part D benefit, two pills for hepatitis C infection — Harvoni (ledipasvir/sofosbuvir) and Sovaldi (sofosbuvir)— accounted for nearly $7.5 billion in catastrophic drug costs in 2015...The pharmaceutical industry questions the numbers, saying they overstate costs because they don’t factor in manufacturer rebates. However, rebates are not publicly disclosed...Medicare’s catastrophic coverage was originally designed to protect seniors with multiple chronic conditions from the cumulatively high costs of taking many different pills. Beneficiaries pay 5 percent after they have spent $4,850 of their own money. With some drugs now costing more than $1,000 per pill, that threshold can be crossed quickly...

...AstraZeneca is growing impatient with the U.K. government for not making available the new lung cancer med Tagrisso (osimertinib)...Already available through health programs in France, Germany, Sweden and several other European countries, Tagrisso this week bested chemo in a Phase III trial in advanced EGFR mutation-positive non-small-cell lung cancer. It’s already EU- and FDA-approved, but has so far failed to gain support from NICE (National Institute for Health and Care Excellence), which said on a preliminary basis last month that the drug shouldn’t be included in England’s National Health Service...Anson (AstraZeneca’s U.K. head Lisa Anson) renewed a call for the government to reform NICE, growing the chorus of displeasure among AZ’s pharma peers who have seen effective new drugs turned down on price concerns...

The federal government released its first overall hospital quality rating...slapping average or below average scores on many of the nation's best-known hospitals while awarding top scores to many unheralded ones....The Centers for Medicare & Medicaid Services rated 3,617 hospitals on a one- to five-star scale, angering the hospital industry, which has been pressing the Obama administration and Congress to block the ratings...Hospitals argue that the government's ratings will make teaching hospitals and other institutions that treat many tough cases look bad. They argue that their patients are often poorer and sicker when admitted, and so are more likely to suffer further complications or die, than at institutions where the patients aren't as sick...Rick Pollack, president of the American Hospital Association, called the new ratings confusing for patients and families..."We are especially troubled that the current ratings scheme unfairly penalizes teaching hospitals and those serving higher numbers of the poor."..."Hospitals cannot be rated like movies," Dr. Darrell Kirch, president of the Association of American Medical Colleges..."We are extremely concerned about the potential consequences for patients that could result from portraying an overly simplistic picture of hospital quality with a star-rating system that combines many complex factors and ignores the socio-demographic factors that have a real impact on health."

Last September, U.S. regulators faced a dilemma: whether to allow importation of drug ingredients from a Chinese factory (Zhejiang Hisun Pharmaceutical Co.) with a history of poor quality controls, or face shortages of treatments for American cancer patients...Food and Drug Administration inspectors had uncovered what the agency later called “broad data manipulation” at the factory, located in Taizhou....Information about the potency and purity of some product batches had been deleted, making it difficult to investigate a significant increase in customer complaints...The agency issued an indefinite ban on the factory...one of China’s leading exporters of pharmaceuticals products. Yet to avoid possible shortages of drugs, the FDA allowed the plant continue exporting about 15 ingredients for use in finished drugs in the U.S., including nine key cancer medicine components. Hisun says that it takes quality seriously and has complied with requirements.

The U.S. Food and Drug Administration has become something of a bogeyman for India’s stock market...An inspection blitz on Indian drug factories that supply to the U.S. helped push the broader index of Indian health-care stocks down by as much as 20 percent earlier this year from its all-time high in 2015 after some top firms received warning letters for failing to meet the regulator’s standards...But even as the FDA has increased scrutiny of India, it’s been approving generic drug applications from the country’s firms at a record pace...Everything sounds negative around Indian pharma, but practically it’s just a few companies...India’s growing importance in the U.S. supply of generic medicines -- India Ratings & Research estimates it accounted for 31 percent of all new drug approvals last year -- prompted the FDA to increase its workforce in the country to 19 from 12 in recent years...