All-Payor Kickback Statute Included in the Recently Passed Opioid Legislation Applies Broadly to Laboratories
November 12, 2018 | Blog | By Karen Lovitch, Laurence Freedman, Benjamin Zegarelli
The Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (the “SUPPORT for Patients and Communities Act”) – which is intended to combat the spread and pernicious effects of opioid abuse – contains an all-payor kickback prohibition that applies to laboratories, recovery homes, and clinical treatment facilities.
November 8, 2018 | Blog
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.
November 6, 2018 | Blog | By Xavier Hardy
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.
November 5, 2018 | Blog | By Eli Greenspan
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.
November 2, 2018 | Blog
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.
November 2, 2018 | Blog | By Eli Greenspan
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.
October 30, 2018 | Blog | By Sarah Beth Kuyers
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.
October 29, 2018 | Blog | By Eli Greenspan
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.
October 29, 2018 | Blog
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.
October 26, 2018 | Blog | By Daryl Berke
October 26, 2018 | Blog | By Peter Snell, Daniel Weinger
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).
October 25, 2018 | Blog | By Dianne Bourque
Software developers are racing to develop health care products that leverage artificial intelligence (AI), including machine learning and deep learning. Examples include software that analyzes radiology images and pathology slides to help physicians diagnose disease, electronic health records software that automates routine tasks, and software that analyzes genetic information to support targeted treatment. The one thing that all of these products have in common is a need to interact, in some way, with real world medical data. However, this real world data can be protected by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as well as a patchwork of federal and state laws and regulations. Below we discuss the contexts in which developers may encounter these laws, as well as strategies to navigate related legal issues.
October 25, 2018 | Blog | By David Chorney
Recently, the Department of Health and Human Services (“HHS”) and the Department of Treasury (“Treasury”) released new guidelines (the “Guidance”) on the application and approval process for states seeking waivers through Section 1332 of the Patient Protection and Affordable Care Act (“ACA”) from certain requirements for health plans issued under the ACA. The Guidance replaces guidelines issued under the Obama Administration and previously published on December 16, 2015. This post highlights how the Guidance differs from the Obama Administration guidelines and what those differences will mean for states seeking Section 1332 waivers.
October 24, 2018 | Blog | By Daria Niewenhous, Caitlin Beresin, Rachel Irving Pitts, Cassandra Paolillo
The Massachusetts Health Policy Commission (“HPC”) held its annual Health Care Cost Trends Hearing on October 16-17, 2018. The hearing covered a wide range of topics affecting the health care industry here in the Commonwealth and across the country. Here are some key takeaways and a legislative outlook.
October 24, 2018 | Blog | By Aaron Josephson
On October 17th, the Administration released its semiannual forecast of the rules that the Department of Health and Human Services (HHS) will be churning out over the next year. The list includes nearly 200 rules, 23 of which are already posted on the Office of Information and Regulatory Affairs (OIRA) dashboard. The bulk of the rules on the Agency Rule List for Fall are under the purview of CMS or the FDA (63 and 77 rules, respectively). Also, earlier in October, FDA’s device center released a list of draft and final guidance documents it plans to publish in FY 2019. Many of these rules or guidance documents touch on issues top of mind and we expect that the administration will be moving forward with many of these priorities in the coming months.
October 23, 2018 | Blog | By Ellyn Sternfield
For much of the past 18 months, the Trump Administration, and in particular CMS, have talked a good game regarding reducing pharmaceutical prices. On October 16, 2018, a key component of the Administration’s strategy was revealed in the form of CMS’ Proposed Rule requiring manufactures to include the “list price” for prescription drugs reimbursable by Medicaid or Medicare in television advertisements. While I do think that there will be new initiatives to address drug pricing, I believe most will come through the state and not the federal level. This post addresses six potential initiatives from a recently released report of the National Governors' Association.
October 22, 2018 | Blog | By Benjamin Zegarelli
On October 18, 2018, FDA released a new draft guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, which describes the Agency’s current thinking and recommendations on designing medical device software with adequate cybersecurity controls. Once finalized, the draft guidance will supersede a final guidance of the same name issued in 2014.
October 22, 2018 | Blog | By Eli Greenspan
While Congress is in full campaign-mode, the Administration is continuing its regulatory push in the health space. On Monday, the Administration put forth new guidance on Section 1332 waivers. These waivers were created by the Affordable Care Act as a way for states to seek additional flexibility to pursue avenues for providing high quality and affordable health coverage. Today's guidance will put the Administration out front on interpreting state proposal's to drive innovation. We cover this and more in this week's health care preview.
Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation
October 18, 2018 | Blog | By Aaron Josephson
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.
October 17, 2018 | Blog | By Joanne Hawana
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.
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