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Doctors and cancer clinics are up in arms about a new Medicare reimbursement scheme that would cut their mark-ups on oncology drugs. But the Centers for Medicare and Medicaid Services has even bigger plans for cancer-drug payments...Pay-for-performance deals and indication-specific reimbursements are on a list of 6 programs CMS plans to try alongside the cuts targeted at physicians and hospitals. It's a rare example of Medicare plucking new ideas from the private sector, even before they've been widely adopted in the biopharma industry...CMS says it looked to private payers for "value-based purchasing tools," and wants to use strategies similar to those used by commercial health plans, pharmacy benefits managers, hospitals and other benefits managers...the agency would experiment with the sort of value-based reimbursement plans that Novartis and Amgen are using on their brand-new heart drugs Entresto and Repatha. CMS says it will be seeking "risk-sharing" deals with drugmakers to link drug payments with patient outcomes...In practice, performance-based deals can be difficult to administer, and that's one reason why U.S. payers have been reluctant to make pay-for-performance arrangements on Entresto...A U.K. government report found that the National Health Service had fallen short on clawing back rebates owed under its cost-sharing deals with drugmakers.

The regulatory system for reporting side effects caused by prescription drugs is producing its own kind of side effect — incomplete information about injuries that patients may have suffered. And the reason for the lack of data is that many drug makers are filing patchy reports...At issue is the Adverse Event Reporting System...The database is the key method for collecting side effect data. Both doctors and consumers can voluntarily report problems to the agency or a drug maker. But drug companies are also required to investigate and report side effects that may be attributable to their products...drug makers generally fail to include key data that the FDA might use to assess future warnings. For this reason...there are still wider implications...With increasing pressure for the FDA to approve drugs fast but with less clinical testing, it is a major concern that postmarket surveillance has major problems that are not being addressed…It is time for the FDA, the medical community, and industry to start work on a badly needed modernization" of this "critical tool" for monitoring safety…reports involving patient deaths offered the least amount of complete information for all of the key data points...the reporting system has not kept pace with changes in pharmaceutical marketing...interactions between patients and physicians, and patients and drug companies, have evolved, partly thanks to the Internet. This means a report may not be based on spontaneous information.

Doctors are more likely to give smokers antibiotics for an infection, a bad habit that may endanger public health by promoting antibiotic resistance...Smokers were 20 percent to 30 percent more likely than non-smokers to get an antibiotic prescription when they were diagnosed with infections...If smokers are being prescribed antibiotics...if not indicated, it’s going to contribute to that antibiotic resistance...and bacteria are going to become more and more resistant...You would think that the number of bacterial infections where antibiotics are clinically indicated should be evenly distributed among smokers and non-smokers...The study can't say why smokers are more likely to get antibiotics for infections...it may be due to an inaccurate belief among doctors that people who smoke are more susceptible to infections.

Big valuations, big investments, and big price tags drove lots of the news in health care in 2015 — and you can bet they’ll do the same in the new year. For signs of where things are headed, keep an eye on these three influencers:

1. Jeffrey Marrazzo, chief executive of Spark Therapeutics - Can gene therapy work — and can the system afford to pay for it?...The idea that a one-time treatment could replace a broken gene has generated plenty of scientific and commercial interest.
2. Deborah DiSanzo, general manager of Watson Health -  IBM’s big bet on health care analytics...use high-powered computing to sift through massive amounts of data to find useful and cost-saving nuggets for medical researchers, doctors, and insurers.
3. Vivek Ramaswamy, chief executive of Axovant Sciences - has recruited some top Alzheimer’s researchers to join his...company...they initiated a late-stage clinical trial testing the GSK reject in combination with another Alzheimer’s drug.

The nation's largest endoscope distributor will pay $623.2 million to resolve civil and criminal allegations that it paid kickbacks to hospitals and doctors in exchange for purchasing its devices, the Justice Department announced...Olympus Corporation of the Americas has agreed to pay a record-setting $310.8 million to settle civil claims that it violated the False Claims Act because its claims were tainted by illegal kickbacks. The sum is the largest ever paid by a medical-device company over violations related to the federal anti-kickback law...Olympus will also pay a $312.4 million criminal penalty over the allegations. The company admitted to paying doctors and hospitals in the form of consulting payments, travel, meals, grants and free endoscopes in exchange for their business...the kickbacks helped the company make more than $600 million in sales and gross profits of more than $230 million...The civil settlement resolves a lawsuit originally brought by whistle-blower John Slowik, a former chief compliance officer for the company. In successful False Claims Act cases, whistle-blowers are entitled to a portion of whatever money the government is able to recover. Slowik will receive $51 million...

With scores of medicines in short supply due to a severe financial squeeze, Venezuela is suffering a "humanitarian crisis" and requires rapid international assistance, according to a major pharmaceutical association...The Venezuelan Pharmaceutical Federation (Federación Farmacéutica Venezolana) listed 150 medicines, from those for hypertension to cancer, as well as basics such as prophylactics and antibiotics, which are scarce in the OPEC nation of 29 million people..."The national government must accept we are in a humanitarian crisis in the health sector, with patients dying across our territory for lack of medicines," said association president...The health ministry did not respond to a request for comment on the pharmaceutical association's statement, but Venezuela's socialist government has bristled at criticism of its health system...It accuses local groups of exaggerating problems and says the widespread shortages in Venezuela - of food as well as medicines - are due to an "economic war" by foes...Long lines form daily outside pharmacies, and doctors and patients constantly complain of lack of medicines and equipment.

...American Medical Association recently called for a ban on advertising prescription drugs and medical devices directly to consumers. The effort is largely symbolic...But doctors resent the increasing pressure the ads place on them to write prescriptions out of concern patients will switch physicians...they argue that many ads aimed at consumers promote more expensive medicines...and pushes patients to ask for products that either they may not need or is not right for them.  This approach is, at best, misguided, and, at worst, ignores the benefits of direct-to-consumer advertising for patients...DTC advertising increases awareness of health problems and leads to a better informed and educated patient who can engage their physician in a dialogue rather than a monologue...So what’s really going on here?...insurers are taking more prescription writing power away from doctors.  They first want patients to try generic medications which now make up 88 percent of all available prescription drugs. Second, higher patient copayments for office visits and insurance mean consumers are “shopping” for health care and health care treatments...This makes doctors very uncomfortable. Even with all these changes, research continually validates the notion that patients view their doctors as the gatekeepers to their prescription medicines...DTC advertising leads patients to their health care providers and, depending on the health condition, does not lead to high-priced unnecessary scripts. The AMA should reach out and work with pharma to improve DTC marketing, not request a ban on all DTC ads.

...for some low-income people, having transportation to a medical facility to receive treatment has been a major obstacle. So Southwest Medical Associates, in partnership with Health Plan of Nevada and Sierra Health and Life, revisited the idea of taking medical professionals to the people..."Medicine on the Move," and it's a 45-foot state-of-the-art mobile medical center built on a custom-designed Peterbilt truck frame. It is scheduled to hit the road sometime in mid-May with the primary objective of serving Medicaid patients at homeless shelters, churches, community centers and some businesses whose employees are enrolled in Health Plan of Nevada or Sierra Health and Life medical benefit plans...The mobile medical center is equipped with seemingly everything, and in many cases, much more than what one would find in his or her own doctor's office. The radiology suite features a digital mammography unit, portable ultrasound machine, X-ray unit and four refrigerators and a freezer for storing vaccines. Patients entering the mobile facility will be able to sit in a comfortable spa-like lobby before being taken to one of two private exam rooms...The onboard staff will consist of two medical assistants, two licensed nurse practitioners and one or two providers/doctors as needed, and a radiology technician...Annual physicals, immunization shots, OB/GYN exams, lab tests, pediatric care and wellness appointments will be offered..."As a native Nevadan, I've witnessed the changes and challenges we've faced over the years with health care in Southern Nevada," McBeath (Dr. Robert McBeath) said. "And I believe that this partnership with Health Plan of Nevada and Sierra Health and Life will help us to close the gap and improve access to quality health care in our community."...

California is set to become one of the first states where women can get birth control from a pharmacist without a prescription with the goal of reducing unwanted pregnancies...Proponents of the new law say it will give younger women easier access...But doctors like gynecologist Kathleen Valenton have concerns...“I think that’s very dangerous,” she said, since pharmacists cannot perform health screenings, including STD checks...Many of the details of the law are still being worked out in Sacramento. It is set to take effect in March.

Pharma can no longer put off the inevitable when it comes to outcome-based models in healthcare. In 2016, drugmakers will begin to engage more not only when it comes to pricing models, but also when it comes to marketing...But what is outcome-based marketing? In mainstream marketing, it usually refers to linking ad campaigns to quantifiable results. Did the ads or marketing draw more customers or an increase in web traffic?...pharma companies are largely already doing that...We're taking a broader view of the outcome model...and looking for outcome marketing that aligns with outcome pricing models. That is, creating advertising, promotions and lifestyle tool communications that clearly relay to patients, caregivers, doctors and healthcare providers exactly what they get for their money...While widespread changes may take years to play out, we think that with some drugmakers already on board, this year could be a bellwether for even more transparent and direct communications, along with the chance for more and better customer connections.