At 30, Stark Law Chugs Along But It's Overdue for Repairs.

The law is supposed to keep physicians from unduly profiting from referrals. But CMS Administrator Seema Verma thinks that it "may prohibit some relationships that are designed to enhance care coordination, improve quality, and reduce waste," and thereby become an obstacle to ACOs and value-based care.

Under Azar and Boehler, CMMI Gets Its Groove Back.

It seems that under HHS Secretary Alex Azar, the Center for Medicare and Medicaid Innovation-that ACA-enabled office given almost carte-blanche authority to experiment with new payment and care models-may be getting its groove back. Adam Boehler, hired last April as CMMI director, has cranked up output with a flurry of new models.

In Trump, HIV/AIDS Groups Find an Ally Who's Tough To Love.

Adjusting their vision so it looks past the messenger and focuses on President Trump's stated goal to end AIDS by 2030 isn't easy for HIV/AIDS advocates. But they aren't being entirely dismissive, either. They have some faith in, and working relationships with, federal government health officials who will oversee implementation of the plan.

FDA, Gottlieb Get Real About Real-world evidence.

Here we are in early 2019, and how quickly and firmly the FDA and the pharmaceutical industry will embrace RWE and its raw material, real-world data (RWD), remains an open question. If that embrace is ever to get beyond gestures and lip service, the FDA will need to change its rules and culture.

FDA's Gottlieb Aims To End Biosimilars Groundhog Day.

The FDA commissioner has an 11-step "action plan" to get biosimilars out of a repeat mode of unrealized potential. But issues like interchangeability still need clarifying if biosimilars are to have a major effect on drug expenditures.

MA Part B Makes Controversial Jump Into Step Therapy.

Step therapy is common in commercial insurance but new to MA. Insurers defend it as an evidence-based way to put some guardrails on ill-advised, costly prescribing. Practitioners, medical societies, and drugmakers complain, though, that CMS's guidance is vague, and gives plans too much latitude in dictating step edits.

It's Team Trump. But the Players Are From Think Tanks, Many With Koch Brother Roots.

With no experience in elected office, President Trump came into power with a thin bench. Many of the health care officials in his administration have been recruited from think tanks funded by the Koch brothers. And the Kochs and the president don't see eye to eye (to put it mildly).

Guideline Clearinghouse Is Dead. Long Live the Guideline Clearinghouse?

The National Guidelines Clearinghouse might be making a comeback. It's been contracted out to the ECRI Institute, a not-for-profit organization that conducts medical safety research. ECRI plans to have a version of the clearinghouse website up and running anytime soon, with plans for a full relaunch in 2019.

Sessions Leaves the ACA Undefended.

In a last-minute filing, the attorney general elected not to defend the health care law. The legal arguments in Texas v. Azar hinge on severability and legislative intent. While Texas seeks an injunction to block enforcement of the ACA beyond January 1 next year, the Justice Department is seeking a declaratory judgment.

Trying to Sidestep Off-Label Dance-Around.

After years of court challenges, agency-imposed fines, and drugmaker lobbying, those restrictions on off-label marketing are loosening up. The agency is working on revisions to rules that govern how drug companies and their sales representatives can communicate with doctors and payers about off-label use.

Must Sky-High Prices 'Come on Down' Before the Price Is Right?

The pipeline for gene therapies is flush. Clinical-Trials.gov lists 721 gene therapy trials. Last year, the FDA received 106 new drug applications for gene therapies, up 34% from 2016. There is no shortage of diseases for gene therapies to target. But the costs of these therapies will break the bank.

If You Make Them Build It, They Still May Not Come.

State laws that make meaningful price information available-e.g., paid claims, not charges, or prices for episode level bundles, and make these prices broadly available to the public-are an important step in enhancing price transparency. But the jury is still out on whether these efforts will make people buy health care based on quality.

Can Congress Get 'Right to Try' Right?

A federal bill would expand access to experimental treatments to seriously ill patients, but critics say the right to try would take away FDA oversight and create a "Wild West." Proponents counter that the FDA's current process can be onerous for people with just a few months to live. Meanwhile, most states' right-to-try laws have gone unused.

Why Medicaid Managed Care Is Looking Outside the Traditional Coverage Box.

Social determinants of health come into focus to keep beneficiaries out of the hospital.

Medical Tourism: Once Ready for Takeoff, Now Stuck at the Gate.

Consultants predicted it would be a major business. Large employers and insurers were experimenting with it. But medical tourism has not lived up to the heady expectations. The ACA and moderation of increases in health care costs cooled off interest. Besides, who really wants to go to an unfamiliar place for health care?

With Trump Contraception Rules, Parties Trade Places in Courtroom.

The defendants and plaintiffs have changed sides in the latest courtroom drama surrounding the ACA requirement that health plans cover women's contraception. Where once the plaintiffs took exception on religious and moral grounds, it's now states and reproductive rights groups who support the requirements that are bringing the legal challenges.

Parity Could Use Some Fixing, But at Least It Won't Be Dismantled.

Nonquantitative treatment limitations may be why care for mental health and substance abuse disorders isn't keeping up with coverage gains.

Back from the Dead. ACA Exchange Market Looking Healthy, Hale, and Competitive.

The brighter outlook for 2019 is what happens when the learning curve starts to flatten out. Remember, this market has only existed for five years. Margins over the past six months have exceeded even pre-ACA levels, and loss ratios reached new lows in the second quarter of 2018.

Why the politics will continue to favor protections for Americans with pre-existing conditions.

Is it any wonder that Republican office holders are changing their tune regarding pre-existing conditions? Kaiser Family Foundation polling reports that overwhelming majorities say it is "very important" that the ACA's protections for people with pre-existing conditions (75%) remain. Even 58% of Republicans agree.

Why blockchain for health care may be finally turning the corner.

This fall, PricewaterhouseCoopers issued a report on blockchain in health care and outlined six areas where it could have a profound impact: supply chain and inventory management; enrollment and provider data management; back office functions and payments; data management; managing risk and regulatory issues; and research and development.