Health Care

As we previously discussed, in October the Trump Administration issued guidance related to 1332 waivers. This guidance outlines how the Trump Administration interprets the ACA 1332 waiver guardrails. On November 29th, CMS built off that guidance and outlined four concepts that states can utilize in 1332 waivers. Below is a discussion of these concepts and their potential effects. 

On November 26, 2018, FDA Commissioner Scott Gottlieb and device center director Jeff Shuren issued a statement outlining a plan to modernize the 510(k) premarket review program to bolster medical device safety. The 510(k) program relies on a device being compared to a legally marketed predicate device; i.e., a similar device that was already determined to be legally marketable.

In this sixth post in our series on artificial intelligence in health care, Julie Korostoff highlights the importance of securing adequate data rights to commercialize an AI technology. The post addresses the contractual commitments that a developer of a healthcare AI tool should secure in order to have the data rights necessary for development and commercialization.

This week, Congress returns to Washington with 10 working days to prevent a partial government shutdown by December 7th. Reaching an agreement on funding is the highest priority of the Lame Duck, and it could prove contentious given some controversial issues lurking around the corner. Also this week, the Senate will continue to look at health care costs in its ongoing hearing series and, will consider several legislative items.

This week, Congress is on recess for the Thanksgiving holiday. While we can expect action from Congress when they return as it relates to funding aspects of the government, this week our preview looks at the future of the Senate Finance Committee with its new Chairman, Senator Chuck Grassley of Iowa.

In its favorable Advisory Opinion 18-11, the OIG explains how a managed care organization’s proposed incentive program to pay network providers to increase the amount of Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) services provided to Medicaid beneficiaries would not violate the Anti-Kickback Statute (AKS).  What is interesting about this Advisory Opinion is that the OIG finds that the health plan’s proposed arrangement would be protected by the managed care safe harbor for eligible managed care organizations (ECMOs), and there are not many opinions addressing this safe harbor.

Emerging medical imaging technologies being developed for the terahertz spectrum may face regulatory hurdles from an unexpected Federal agency: the Federal Communications Commission (FCC). While the Food and Drug Administration (FDA) has jurisdiction over medical devices with respect to safety and effectiveness – including premarket approval, inspection of manufacturing facilities, and monitoring of post-market adverse events – the FCC has jurisdiction over certain technical and spectrum use requirements for medical devices that operate on radiofrequency (RF) spectrum. Medical device developers need to be aware of the current state of play at the FCC in these areas.

In a three-sentence order issued on October 29th, the Tenth Circuit Court of Appeals declined to grant a Request for Rehearing in the closely watched Polukoff case. One of the questions raised in the Request was whether, by submitting a claim for reimbursement and certifying the medical necessity of the charged service, providers also certify that the claim meets all of the standards set forth in the Medicare Program Integrity Manual (MPIM).

As our use of AI technology becomes more frequent, interconnected, and integral to daily life, the liability exposure to AI product designers and manufacturers continues to escalate. There are more potential liability risks, including product liability risks, in our current environment than ever. With AI technology embedded in interconnected software and hardware products, gone are the days where we can neatly separate data security and privacy from product liability exposure.

This week, Congress returns to Washington for its lame duck session with uncertain expectations for what gets done between now and the next funding deadline of December 7, 2018. There are a number of legislative items that passed one chamber and not the other, and watch to see which bills make it across the finish line.

Last week, HHS unveiled its new Health Security Cybersecurity Coordination Center, known as "HC3."  HC3 will replace the beleaugered Healthcare Cybersecurity and Communications Integration Center (HCCIC) which had lost top officials last fall. The HC3’s role is to work with the sector, including practitioners, organizations, and cybersecurity information sharing organizations to understand the threats it faces, learn the attackers' patterns and trends, and provide information and approaches on how the sector can better defend itself.

On October 19, 2018, a New Mexico district judge rejected a request from HHS to reconsider a February decision that had briefly led to the suspension of the ACA’s risk adjustment program.  In February, District Judge James Browning ruled that HHS’s use of statewide average premium to calculate risk adjustment payments, and the fact that the program was administered as budget-neutral, were arbitrary and capricious.

All eyes are on Tuesday and what the midterm elections mean broadly and in the health care space. The implications are far reaching, from the House to the Senate, and even the gubernatorial races. Read the full post for links to our weekly preview and coverage of the elections.

With the midterms in sight, our lame duck preview takes a look ahead at what the balance of the year will look like in health care. There are several legislative items that must be completed before closing out the 115th Congress, but there are also issues that could receive attention and that stakeholders need to keep on their radar.

The rise of artificial intelligence (AI) developments over the last decade has had profound implications for the health care industry. From IBM’s Watson to lesser known innovations that have flown under the radar, such as clinical decision software and predictive analytics, these changes have infiltrated the field’s daily functions. Congress generally views AI with trepidation and fascination. We expect Congress to keep the subject at arm’s length until provoked to action.

As we discussed last week, the Department of Health and Human Services (HHS) recently published its semi-annual regulatory agenda. In addition to the proposed rules on fraud and abuse, drug pricing, digital health, and devices, the agenda includes topics that could bring significant changes to HIPAA regulations and other health care privacy rules.

On Wednesday, October 25th President Trump, along with HHS Secretary Alex Azar, introduced the administration’s new proposal to lower drug prices through Medicare Part B. The announcement follows ASPE’s morning release of a report comparing U.S. drug prices to international drug prices. The report, which used Medicare Part B payment numbers, stated that the U.S. has about 1.8 times higher ex-manufacturer prices for top drugs than other countries, and the new proposal intends to align U.S. prices with those abroad. The proposal that President Trump discussed will use CMS authority to test three new measures. One will use international pricing as a metric, one will develop a new competitive acquisition program (CAP), and one would alter the average sales price (ASP) model already in effect. Comments on the proposals are due December 31, 2018.

Open Enrollment is fast approaching and the landscape with be notably different than in years past. From the introduction of short-term plans and association health plans to proposals to allow for greater use of health reimbursement arrangements, the strength of the Marketplace will be tested and will inform future policy considerations. We cover this and more in this week's health care preview.

Continuing our coverage of the Federal Circuit’s Applications in Internet Time, LLC v. RPX Corp. (“Internet Time”) decision, on Tuesday, October 23, 2018, the Federal Circuit denied RPX’s request to rehear the case en banc.  Internet Time held that the Patent Trial and Appeal Board (“PTAB”) must use a flexible approach when determining what entities constitute real parties in interest for the purpose of inter partes review (“IPR”). See Applications in Internet Time, LLC v. RPX Corp., 897 F.3d 1336 (July 9, 2018) (“Internet Time”). Petitioners for IPR challenging a patent must identify all real parties in interest in their petition. 35 U.S.C. § 312(a)(2). The Director is not authorized to institute trial on the petition if the petitioner, real party in interest, or privy of the petitioner, was served with an infringement complaint for the patent in question more than one year before the petition’s filing. See 35 U.S.C. § 315(b).