Getting ready for MACRA

Providing meaningful real-world evidence (RWE) to providers—to enable them to better manage healthcare services—will be a growing part of the life sciences industry’s marketing activity in coming years, according to stakeholders convened by the Network for Excellence in Health Innovation, a nonprofit group. That’s one of the key recommendations of a just-released consensus of stakeholder views, put together by NEHI and the Deloitte Center for Health Solutions.

While there have been every-day headlines about Obamacare’s repeal and the fate of Trumpcare (the American Health Care Act, passed by the House and currently in Senate deliberations), another Obama-era law—the Medicare Access and CHIP Reauthorization Act (MACRA) is steadily progressing toward implementation. While the Congressional actions address the insurance aspects of healthcare, MACRA addresses the reimbursement side—specifically, how CMS pays providers for services under Medicare and children’s healthcare. With carrot-and-stick financial incentives, CMS will move healthcare providers from current fee-for-service financial models to a variety of “alternative payment models,” beginning in 2019 and extending to 2022. (All this presupposes, of course, that the Trump administration will allow CMS to continue the effort, and will provide the necessary funding; NEHI and other noted that MACRA was passed with strong bipartisan support.)

In simplified version, the report says that MACRA will give healthcare providers incentives to adopt reimbursement models based on improved outcomes, coordinated care, episodic care and other models, all trying to get away from the complexities and cost of paying a fee for each step in patient care. A key intermediate step is interoperable health information systems, so that diverse care providers can share data and outcomes with each other, and this is moving forward in fits and starts under the direction of the Office of the National Coordinator of Health Information Technology. Life sciences companies will be called on to provide RWE of their products’ effectiveness, so that providers can reliably forecast the results of their actions. And an obstacle to overcome in that regard is the difficulty for life sciences companies to provide such data without being in violation of CMS rules on kickbacks (since such information has economic value), as well as FDA rules on off-label marketing. Medical device companies, especially those involved in mobile health (mHealth) technology, have a significant value in collecting and recording patient data to verify outcomes.

Bill Copeland, vice chair and US Life Sciences & Health Care Industry Leader at Deloitte, notes that parts of the healthcare delivery system—such as provider-based insurance programs—are already gaining experience in these alternative payment models, but even so, it’s going to be a multi-year rollout nationally. Life sciences companies, too, are taking initial steps to a variety of value-based contracts for drug pricing, and that experience will have value, too. The important action is to get involved now.