Health Care

Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers? This post, the second in our blog series about AI in health care, explores FDA’s proposed regulatory model that is supposed to be better suited for AI (and similar technologies) while still protecting patients.

In the first new guidance document from FDA in several years specific to the subject of direct-to-consumer (DTC) promotion of prescription drugs and biological products, the Agency is recommending that companies take additional steps to ensure that quantitative efficacy or risk information does not convey inaccurate information and does not have the potential to confuse consumers. The draft guidance defines quantitative efficacy and risk information as “information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks.” FDA’s advice on how to most clearly share this type of information should be considered by companies when developing any form of DTC promotional media, whether they are digital, broadcast, in traditional print format, or otherwise.

The Department of Health and Human Services Office of the Inspector General (“OIG”) has issued an Advisory Opinion regarding a surgical device and wound care product manufacturer’s proposal to offer its hospital customers who purchase a suite of three joint replacement products a warranty program covering the Product Suite.

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed rule that would require pharmaceutical manufacturers to disclose the list price of their pharmaceutical products in direct-to-consumer (“DTC”) television ads (the “Proposed Rule”).

Congress has left town until after the midterm elections, but the Administration is continuing to advance its priorities in the regulatory arena. This week, the Administration is expected to publish the proposed rule, "Medicare and Medicaid Programs; Regulation to Require Drug Pricing Transparency." We cover this and the political implications in this week's health care preview.

The Journal of the American Medical Association in its September 18, 2018, issue included four articles on deep learning and Artificial Intelligence (AI). In one of several viewpoint pieces, On the Prospects for a (Deep) Learning Health Care System, the author’s conclusions aptly describes why health care providers, entrepreneurs, investors and even regulators are so enthusiastic about the use of AI in health care.

As in any technology area, it is important to consider patent protection early in the development of an AI-related invention. However, AI inventions raise a number of particular issues that, if not addressed fully or at the right time, could be fatal to securing U.S. patent protection that would otherwise be available to prevent others from making, using, selling, or importing the invention. This article identifies common pitfalls in getting a patent for AI inventions and provides insights on how to avoid them. These principles apply not only to AI-related inventions, but also to digital health inventions more broadly.

Drug and device manufacturers will need to update their reporting systems and provide new training to their sales staff in the coming years based on changes to the Physician Payment Sunshine Act included in the final opioid package passed last week. Beginning with data reported in 2022, the Sunshine Act will cover payments made to advanced practice nurses and physician assistants. The change will also impact state laws requiring the reporting of payments made to these provider types, which will be preempted by federal law.

This October 3rd marked the 10-year anniversary of the passage of the Mental Health Parity and Addiction Equity Act (MHPAEA). Now, 10 years later, the question is whether the law has changed the playing field to ensure greater access to care and more equitable financial parameters. Although the passage of this legislation created a pathway for change, there are still challenges to address. Hopefully our path forward will continue address these issues of implementation, so we approach the day when those living with mental health and substance use disorders will be seen as having a condition or disease that deserves prevention strategies, supports and treatment services, and civil rights protections similar to all other medical conditions.

While the House is out on recess, the Senate continues to be in session. This week the Senate has some non-health care related hearings scheduled as well as nomination hearings. We are looking for signals for a deal to finish work and send vulnerable Senators home to campaign. However, while legislative action may begin to cool down, regulatory activity at OIRA could be heating up.

The final bipartisan opioid package, which passed in the Senate this week and is expected to be signed into law, includes a significant revision from the original House bill that could lead to an increase in treatment options for Medicaid beneficiaries suffering from substance use disorder (“SUD”). The final version of the “SUPPORT for Patients and Communities Act” will provide state Medicaid programs with the option to cover SUD treatment in certain Institutions for Mental Diseases (“IMD”) for Medicaid beneficiaries between the ages of 21 and 64.

On September 25, 2018, House and Senate negotiators agreed on a final legislative package to address the opioid crisis. Following this agreement, the House passed the opioid package on September 28, 2018. The Senate is expected to pass the package in the weeks ahead, and the President is expected to sign the package into law. ML Strategies has created a chart tracking the provision of the final opioid package.

You might have missed it but Congress averted a government shutdown last week. While several appropriations bills passed on time for the first time in years, several agencies, including the FDA, were funded on a continuing resolution (CR). The CR provides funding until December 7th and will need to be addressed again by that time. However, the House is now in recess and won’t be back in town until after the midterm elections. So the lame duck session will have a few ‘must dos’ on the list.

On August 27, 2018 the Office of the Inspector General (OIG) of the Department of Health and Human Services (HHS) issued a request for information (RFI) seeking comment on the anti-kickback statute (AKS) and the beneficiary inducement prohibition to the civil monetary penalties (CMP) as potential barriers to coordinated and value-based care. The August 27 RFI was the second RFI issued as part of HHS’s “Regulatory Sprint to Coordinated Care,” an ongoing effort to accelerate the transition from fee for-service to a value-based system that emphasizes care coordination.

Medicare Advantage Organizations (MAOs) have been hailing a federal judge’s recent ruling to vacate the 2014 Overpayment Rule. But, how did we get here? And what does it really mean for MAOs?

The Massachusetts Department of Public Health (DPH) Determination of Need (DoN) Program has proposed a number of changes to the DoN Regulations (105 CMR 100.000, et. seq.). Program Director Nora Mann presented the proposed revisions, together with an informational briefing memorandum, to the Massachusetts Public Health Council at its September 12, 2018 meeting. The proposal reflects administrative lessons learned in implementing the regulations, which, as reported in a previous post, DPH redrafted and promulgated in January 2017.

This week, Congress and the White House need to finalize a government spending bill in order to avoid a shutdown. While all signs point to a deal being reached, it is widely expected that several agencies will be operating on a continuing resolution for the first couple months of fiscal year 2019. While the Departments of Labor, HHS, and Education are expected to receive a full appropriation prior to September 30th, the FDA, which is funded through the Department of Agriculture, is expected to be funded through the continuing resolution, which will go through December 7th.

This week, Congress is off and running with two emerging priorities to complete before members head off to campaign. With the midterms just 50 days away, the longer issues like opioids and appropriations remain unsolved the more likely they are to get punted until after the midterms.

Over the past couple of years, FDA has introduced multiple programs allowing faster review of medical devices in order to get them to market more quickly. Some of the FDA’s efforts have been highly visible, such as the Breakthrough Devices program in the 21st Century Cures Act and the Software Precertification pilot program in the FDA’s Digital Health Innovation Action Plan. Others have been less trumpeted but are still significant developments for device manufacturers.

ACA plans scored a major victory last week when a federal court held that health plans participating on the ACA exchanges are entitled to unpaid cost sharing reduction (CSR) payments from the federal government.