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Justin Gallagher, associate publisher of The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network.

Kelly Walsh, PTNN. This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.

Is Novartis being investigated for paying bribes in Turkey? This seems to depend upon who you ask...the drug maker told us that it had concluded an internal investigation and found the accusations were unsubstantiated. The allegations surfaced in March in a report that an anonymous whistleblower accused the drug maker of using a consulting firm to pay bribes so its medicines could be added to formularies (in government-run hospitals)...Novartis also said last week that, while it was cooperating with Turkish authorities, the investigation "really isn’t a confirmed issue." And the drug maker told Reuters that "we are not aware of any government authority investigating Novartis. We now consider this matter closed."...On Wednesday, though, an official at Turkey’s health ministry in Ankara told Reuters that an investigation into Novartis was still "ongoing"…Bribery allegations are, no doubt, a sensitive issue. To what extent Novartis management in Turkey is clearly communicating the facts on the ground to corporate headquarters remains to be seen. But in any event, Novartis would welcome any opportunity to put such charges behind it, especially given a recent spate of embarrassing incidents...

In the latest dust-up over the high cost of hepatitis C drugs, the American Civil Liberties Union is threatening to sue Colorado officials if they refuse to widen access to the medications in the state Medicaid program...The saber rattling came in response to a long-standing policy by the state Medicaid program to restrict coverage only to people with the most advanced stages of liver disease, such as cirrhosis...“Basically, Colorado has been withholding treatment from Medicaid recipients until they have measurable damage to their livers. And we believe that the restrictions violate the Medicaid statute,” Mark Silverstein, the ACLU of Colorado Legal Director...“We hope they’ll do the right thing, but we’re prepared to pursue litigation otherwise.”...Since 2013, the state has spent $26.6 million treating 326 hepatitis C patients, or about $82,000 per person, according to a spokesman for the state Department of Health Care Policy and Financing, which oversees the state Medicaid program. If the state were to cover every Medicaid patient with hepatitis C, regardless of the stage of their disease, it would cost $174 million. “It could be a budget problem,” he said.

...VA has been expanding elsewhere. There's now an East Campus Outpatient clinic on Corporate Boulevard (Reno) , an eye clinic in Franktown Corners and, now open, a dental clinic in the old Smith's Shopping Center near the Atlantis..."A patient can drive up, park right in front of the clinic, walk in and have their dental needs met," says Lisa Howard, Director of VA Sierra Nevada Health System…The idea is to ease the pressure on the main campus, leaving it for in-patient services and bringing the out-patient care into the community, making it more accessible...The new dental clinic occupies what was once a furniture store, lots of room for exams and procedures inside, easy access outside..."Part of what we look at when we're going to situate a new clinic is access to bus service and access to parking," says Howard...More is planned. A north campus offering several outpatient services is in the works, location to be determined. The result, beyond a more efficient operation, should be better care for the vet.

Getting a drug all the way to approval is no easy feat — for pharmaceutical companies or for regulators...in 1992, the Prescription Drug User Fee Act was passed, making it the law for pharmaceutical companies to directly pay the FDA to review their applications for drug approvals. That way the FDA has more resources to conduct rigorous and timely reviews, pharma companies get products through the regulatory pipeline faster, and patients get new drugs more quickly. Win-win-win, right?...That's one way to look at it. But others have argued that PDUFA...puts the FDA in the pockets of the drug industry...In the same way that doctors are accused of subjecting themselves to bias when they receive consulting or speaker fees from a drug company, so has the FDA been accused of kowtowing to the pharmaceutical industry... since PDUFA was passed in 1992, pharma companies have contributed $7.67 billion to the federal agency…User fees are increasingly central to the funding of the drug, biologic and device review programs, and in some cases these fees account for a larger proportion of the FDA budget than congressionally appropriated monies...

A closely watched effort in California to pass a bill that would require drug makers to explain their price hikes has been scuttled. The decision came after amendments were made during an assembly committee hearing last Friday that sources told us "effectively gutted" the legislation...The bill would have required drug makers to report any move to increase the list price of a medicine by more than 10 percent during any 12-month period. And drug makers would also have had to justify price hikes for medicines with a list price of more than $10,000 within 30 days of making such a move..."Unfortunately, recent amendments have made it more difficult for us to accomplish our fundamental goal," said California state Senator Ed Hernandez, who pulled the bill after introducing the legislation and succeeding in getting the state Senate to approve the measure two months ago...Although Hernandez said he hopes to reintroduce the legislation at some point, the withdrawal is a significant victory for the pharmaceutical industry...

FirstMed Health and Wellness Center, a nonprofit providing discounted health care for low-income and underserved patients, opened its second clinic in Las Vegas…The clinic, located at 400 Shadow Lane, Suite 104, will offer preventative and primary care, behavioral health service and care for youth in crisis, including sexual abuse victims...Speakers at the opening included three prominent Nevada Democrats: Sen. Harry Reid, Rep. Dina Titus, and former Attorney General and current U.S. Senate candidate Catherine Cortez Masto...The health center received federal funding through Reid’s work with the Health Resources and Service Administration…

It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare...what’s constraining the dissemination of these small molecule generics...isn’t the Food and Drug Administration and the backlog of abbreviated new drug applications, but a patent and market exclusivity system that can reward pharmaceutical companies long after they’ve recouped their research and development expenses and, at times, hefty profits…Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office...and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA [new drug application] applicant...Exclusivity was designed to promote a balance between new drug innovation and generic drug competition...

Almost half of a special group of drugs, defined as those developed to treat rare diseases, were used for other purposes, according to a new report by America’s Health Insurance Plans. The greatest price increases among this group of drugs — called orphan drugs — were for those used for purposes other than treating the rare diseases they were developed to target...The insurers’ report charged this behavior is yet another example of drug companies potentially gaming the system for profit, the latest development in the rhetorical war between insurers and drug companies over drug costs...Orphan drugs, long thought to be treating so few patients each year that they did not present a reimbursement challenge for payers, are now being more closely scrutinized by public and private payers…study found that of its sample of 46 orphan drugs...47 percent of the drugs’ usage was for non-orphan purposes...