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Paradigm Shift: Regulating Software as a Medical Device in the U.S.

December 19, 2018 | Blog | By Aaron Josephson

The U.S. Food and Drug Administration (FDA) is exploring the development of a new regulatory approach for software as a medical device (SaMD) that the agency believes will promote innovation while still assuring device safety and effectiveness. SaMD is software used for a medical purpose that is not part of a hardware medical device. The new approach is known familiarly as Pre-Cert and relies on a company being certified by FDA as having a culture of quality and organizational excellence.
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ML Strategies Weekly Preview - December 17, 2018

December 17, 2018 | Blog | By Eli Greenspan

This week, Congress is in session for what should be the last week of the 115th Congress. However, the spending fight that has been raging since the last continuing resolution is no closer to being wrapped up than it was a month ago. Additionally, we watch to see if the IMPROVE Act can be finalized this week.
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On Friday, December 14th, Judge O’Connor, a Texas Federal District Court Judge, ruled on the case Texas vs. Azar. As background, Texas vs. Azar was filed by 20 Republican state attorneys general and governors. The plaintiffs challenge the constitutionality of the individual mandate in the Affordable Care Act (ACA) and argue that since the individual mandate has been repealed, or more technically zeroed out, the rest of the ACA must be struck down. They argue that the individual mandate cannot be severed from the ACA given its key structural role in the law. The Department of Justice agreed with some, but not all parts, of this argument, and sixteen states and DC are defending the ACA.
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Summary of the IMPROVE Act

December 14, 2018 | Blog

On December 11, 2018, the House of Representatives passed the IMPROVE Act in a vote of 400-11. The bill is currently moving to the Senate. Our summary of the major provisions of the IMPROVE Act can be found...
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In his typical forceful style on December 11, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced several big pieces of policy news affecting the nascent biosimilar market. The Commissioner’s statement broadly relates to FDA’s “actions to advance the biosimilars policy framework” and is a well-articulated hodgepodge of FDA regulatory, drug pricing, industry competition, and patent thicket complaints, which Dr. Gottlieb is becoming famous for in his written and oral presentations. 
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As of December 2018, 37 states (including D.C.) have adopted Medicaid expansion. Of the remaining 14 states, some are considering expanding Medicaid. States with recent activity relating to Medicaid expansion include: Florida, Idaho, Maine, Missouri, Nebraska, New Hampshire, North Carolina, and Utah. States continue to explore different opportunities as it relates to Medicaid expansion. 
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HIPAA Penalties For Failure to Cut Off Access To Former Employee

December 12, 2018 | Blog | By Kristen Marotta

It has been a busy few weeks for HIPAA enforcement. On Tuesday, the Office for Civil Rights announced its third resolution of a HIPAA breach in as many weeks. In this latest matter, OCR announced that Pagosa Springs Medical Center (PSMC), a critical access hospital in Colorado, has agreed to both pay $111,400 to the Office for Civil Rights (OCR) as well as adopt a comprehensive, two-year corrective action plan (CAP) to address and settle potential HIPAA violations.
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ML Strategies Health Care Preview - December 10, 2018

December 10, 2018 | Blog | By Eli Greenspan

Congress has two weeks to finish up a partial spending deal. For many health care stakeholders, the focus is on finishing the reauthorization of the Money Follows the Person program and passing the ACE Kids Act. While there are other legislative items in the health care space still pending, the current thinking is that policy changes around the doughnut hole or the medical device tax will be left unaddressed.

We cover this and more in this week's health care preview.
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Another HIPAA Settlement for Failure to Enter Into a BAA

December 10, 2018 | Blog | By Sarah Beth Kuyers

Last week, the Office for Civil Rights (OCR) announced that it had reached a settlement with a contract physician group based in Florida to resolve potential HIPAA violations relating to the sharing of protected health information (PHI) with a vendor. The physician group, Advanced Care Hospitalists PL (ACH), agreed to pay $500,000 and to adopt a corrective action plan to address the alleged conduct.
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On November 26, 2018 the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule, Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses. This proposed rule is the Trump Administration’s latest action to curb prescription drug prices. The proposed rule outlines a number of provisions to for lowering drug prices and reducing out-of-pocket costs in the Part D program that build off the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs.
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The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently announced a no-fault settlement, including a $125,000 penalty and a two year corrective action plan for Allergy Associates of Hartford, P.C. The settlement was reached after a physician at Allergy Associates disclosed protected health information (PHI) about a patient to a local television station.
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Overview of the Virginia 1115 Medicaid Waiver Application

December 4, 2018 | Blog | By Emma Zimmerman

On November 20, 2018, Virginia submitted an application to CMS for a Section 1115 demonstration program entitled Virginia COMPASS (Creating Opportunities for Medicaid Participants to Achieve Self-Sufficiency). The application comes after Virginia voted in June 2018 to expand its Medicaid program to cover newly eligible non-disabled, non-pregnant adults ages 19 to 64 with income up to 138 percent of the federal poverty level (FPL), on the condition that the expansion include a work requirement and other measures. This waivers implements work requirements and other provisions linked to the state’s Medicaid expansion.
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Medical Products & FDA: What to Watch for in 2019

December 4, 2018 | Blog | By Aaron Josephson

Major legislation impacting FDA often accompanies user fee reauthorizations every 5 years. However, Congress has acted to address public health issues between user fee cycles. FDA regulates 20¢ of every U.S. consumer dollar spent on products ranging from heart valves to insulin to breakfast cereal, so there’s always something Congress can do in the realm of FDA’s statutory authorities. Many FDA-related bills are often bipartisan, too, which suggests action regardless of which party is in power. Here are a few key medical product issues we’ll be tracking in 2019.
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ML Strategies Health Care Preview - Week of December 3rd

December 3, 2018 | Blog | By Eli Greenspan

This week, Congress is expected to pass a two-week extension to avoid a partial government shutdown.
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Overview of CMS' 1332 Waiver Concepts

November 30, 2018 | Blog

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. 
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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.
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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.
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ML Strategies Weekly Health Care Preview - November 26, 2018

November 26, 2018 | Blog | By Eli Greenspan

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.
Viewpoint General

OIG Says Proposed MCO Incentive Program Protected by AKS Safe Harbor

November 19, 2018 | Blog | By Bridgette Keller

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.
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