Cancer clinical trials occupy a precious space in the health care system, especially with patients. For many, the trials represent the last chance for a cure or, at least, a staving off, of the relentless and deadly disease.

The trials, though, are often bogged down by redundancies and bureaucratic muck from beginning to end, according to a report issued jointly by the American Society of Clinical Oncology (ASCO) and the Association of American Cancer Institutes (AACI).

They’ve become more challenging to conduct, as they must comply with often costly and inefficient federal and state regulatory requirements, according to researchers from several universities and institutions.

When federal and state governments take notice, it can become like the old E.F. Hutton commercial where everybody freezes. That’s because “institutions and sponsors often interpret these requirements conservatively and thereby add to the complexity and perceived (but often highly theoretical) risk of conducting clinical trials,” the report states.

To find a way to break these logjams, ASCO and AACI launched the Best Practices in Cancer Clinical Trials Initiative. The initiative was overseen by a group of hematologists, oncologists, research nurses, administrators, and managers. The FDA and the National Cancer Institute provided input. A survey of 1,200 stakeholders in the fall of 2015 yielded about 310 usable responses.

The responses pointed to two issues: Getting the trials up and running, and then conducting those trials in a smooth fashion. The top three barriers to getting the trials started were contract negotiations with sponsors, contract negotiations with contract research organizations (CROs), and complying with industry requirements.

The three biggest problems in conducting the trials were site-monitoring visits, managing regulatory documents, and reporting of adverse or serious adverse events.

Among the suggestions for improving the launch of trials were developing master agreements between sites and sponsors to cover agreements that do not vary across trials, a centralized repository of templates and tips for negotiating contracts, and working with stakeholders to create worksheets that identify services that aren’t related to oncology for each trial.

Suggestions for making trials run more smoothly included harmonizing training requirements, deployment of cancer-specific electronic data capture systems, and convening stakeholders to examine why FDA guidelines haven’t been adopted.

Clinical trial sites will often do an insurance coverage analysis to identify routine costs that can be billed to insurers. But the coverage analysis can be a mess that includes many redundancies, according to the ASCO–AACI report: “Coverage analyses are completed by a myriad of research team members with various levels of knowledge, skill, and expertise in the arena of clinical trials coding and billing.” The report suggests developing a Turbo Tax–type app that would let sites conduct coverage analyses quickly. It also suggests writing guidelines that would delineate the boundary between routine care and research.

ASCO and AACI plan to expand the effort, focusing on adverse event reporting, site qualification, and insurance coverage analysis.

Managed Care’s Top Ten Articles of 2016

There’s a lot more going on in health care than mergers (Aetna-Humana, Anthem-Cigna) creating huge players. Hundreds of insurers operate in 50 different states. Self-insured employers, ACA public exchanges, Medicare Advantage, and Medicaid managed care plans crowd an increasingly complex market.

Major health care players are determined to make health information exchanges (HIEs) work. The push toward value-based payment alone almost guarantees that HIEs will be tweaked, poked, prodded, and overhauled until they deliver on their promise. The goal: straight talk from and among tech systems.

They bring a different mindset. They’re willing to work in teams and focus on the sort of evidence-based medicine that can guide health care’s transformation into a system based on value. One question: How well will this new generation of data-driven MDs deal with patients?

The surge of new MS treatments have been for the relapsing-remitting form of the disease. There’s hope for sufferers of a different form of MS. By homing in on CD20-positive B cells, ocrelizumab is able to knock them out and other aberrant B cells circulating in the bloodstream.

A flood of tests have insurers ramping up prior authorization and utilization review. Information overload is a problem. As doctors struggle to keep up, health plans need to get ahead of the development of the technology in order to successfully manage genetic testing appropriately.

Having the data is one thing. Knowing how to use it is another. Applying its computational power to the data, a company called RowdMap puts providers into high-, medium-, and low-value buckets compared with peers in their markets, using specific benchmarks to show why outliers differ from the norm.
Competition among manufacturers, industry consolidation, and capitalization on me-too drugs are cranking up generic and branded drug prices. This increase has compelled PBMs, health plan sponsors, and retail pharmacies to find novel ways to turn a profit, often at the expense of the consumer.
The development of recombinant DNA and other technologies has added a new dimension to care. These medications have revolutionized the treatment of rheumatoid arthritis and many of the other 80 or so autoimmune diseases. But they can be budget busters and have a tricky side effect profile.

Shelley Slade
Vogel, Slade & Goldstein

Hub programs have emerged as a profitable new line of business in the sales and distribution side of the pharmaceutical industry that has got more than its fair share of wheeling and dealing. But they spell trouble if they spark collusion, threaten patients, or waste federal dollars.

More companies are self-insuring—and it’s not just large employers that are striking out on their own. The percentage of employers who fully self-insure increased by 44% in 1999 to 63% in 2015. Self-insurance may give employers more control over benefit packages, and stop-loss protects them against uncapped liability.