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45 States Now Have Biosimilar Substitution Laws

February 11, 2019 | Blog | By Sarah Beth Kuyers

Forty-five states and Puerto Rico have now enacted laws that permit or require pharmacists to dispense an interchangeable biological product in certain situations. The remaining states that have not yet passed legislation on the topic are: Alabama, Arkansas, Maine, Mississippi, Oklahoma, and the District of Columbia. We have been tracking and summarizing these laws over the past three years, and you can find our updated chart... 
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ML Strategies Health Care Preview - Week of February 11, 2019

February 11, 2019 | Blog | By Eli Greenspan

Congress and the Administration are staring down the prospects of another government shutdown with talks breaking down over the weekend on a border funding deal. Democrats in the House continue to aggressively pursue drug pricing legislation, and are also touting reforms to the ACA to counteract actions taken by the Administration. Once we're beyond the shutdown, assuming a long-term deal can be struck, legislative direction on key issues should become clear. We cover this and more in this week's preview, which you can find...
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On January 9, 2019, AdvaMed announced revisions to its Code of Ethics.  As any medical product business knows, compliance with the AdvaMed Code of Ethics (the “Code”) is essential.  While the Code is voluntary, many states require medical product manufacturers and companies to adopt compliance programs consistent with the Code.  The amendments will be effective January 1, 2020.
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Mintz/ML Strategies’ 4th Annual Pharmacy & Pharmaceutical Industry Summit has been scheduled for Thursday, May 2, 2019 – mark your calendars! People from across the industry will gather for one day to share insights about issues that the players in this complex marketplace are tackling.
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As many of our readers know, we have been closely following the Polukoff False Claims Act (FCA) qui tam case, which is based on allegations that certain heart procedures performed by a cardiologist were not medically necessary.  The latest development in this case came a few weeks ago, when defendants Intermountain Health Care, Inc. and IHC Health Services, Inc. d/b/a Intermountain Medical Center (Intermountain) filed a Petition for a Writ of Certiorari with the United States Supreme Court. The Petition raised two issues: (1) whether a court may create an exception to Federal Rule of Civil Procedure 9(b)’s particularity requirement when the plaintiff claims that only the defendant possesses the information needed to satisfy that requirement; and (2) whether the False Claims Act’s qui tam provisions violate the Appointments Clause of Article II of the Constitution.
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Last week, the Office of the Inspector General for the Department of Health and Human Services (OIG) issued a favorable Advisory Opinion regarding a proposal by a pharmaceutical manufacturer (Manufacturer) to loan a limited-use smartphone to financially needy patients taking the digital version of an antipsychotic drug. The OIG concluded that the arrangement would not constitute grounds for the imposition of civil monetary penalties (CMPs) under the prohibition on beneficiary inducement (the “Beneficiary Inducement CMP”) or administrative sanctions under the Anti-Kickback Statute (AKS).
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CMS Proposes Changes to Medicare Advantage Program for CY 2020

February 6, 2019 | Blog | By Xavier Hardy, Bridgette Keller

CMS recently proposed several important changes for the Medicare Advantage (MA) program that relate to payment, benefit design, and new actions to combat the opioid crisis. Here, we take a look at the proposed changes to risk adjustment payments, supplemental benefits, and a value-based insurance design model; all working toward CMS’s goal of maximizing coverage and competition. In a prior post we discussed CMS’s Part D Payment Modernization Model and stay tuned for our upcoming discussion of CMS’s next steps to combat opioid misuse.
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On January 15, 2019, the Supreme Court heard oral arguments in Azar v. Allina Health Services, a prominent case involving a challenge by hospitals over when Medicare’s instructions to its contractors impact a “substantive legal standard” and thus must be issued through formal rulemaking. As discussed in our prior post, the Court is reviewing the U.S. Court of Appeals for the D.C. Circuit’s decision that threw out a Medicare rate calculation methodology for Disproportionate Share Payments (DSH) to hospitals adopted by the U.S. Department of Health and Human Services (HHS) for its failure to undergo notice and comment rulemaking. During oral arguments, the Court grappled with a broader question: what is the legal standard for when HHS must use formal rulemaking and not “interpretative” instructions to its contractors in the administration of the Medicare program?
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ML Strategies Health Care Preview - Week of February 4, 2019

February 4, 2019 | Blog | By Eli Greenspan

This week, we explore the Administration's proposed rule related to AKS safe harbors and what it means for the drug pricing debate. On Capitol Hill, Democrats in both chambers are beginning to examine behaviors by various companies in an effort to drive home the need for additional oversight. It's clear that drug pricing is going to be a hot topic for this Congress. What's unclear is whether both sides can find consensus in proposals that lower drug costs. We cover this and more in this week's preview, which you can find by...
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HHS Proposes to Remove Drug Rebate Protections

February 1, 2019 | Blog | By Susan Berson, Theresa Carnegie, Tara E. Dwyer, Matt Mora

On January 31, 2019, the U.S. Department of Health & Human Services (HHS) issued a proposed rule that would amend the discount safe harbor under the Anti-Kickback Statute (AKS) to eliminate protection for certain drug discounts paid by manufacturers to plan sponsors or their pharmacy benefit managers (PBMs) under Medicare Part D, and Medicaid managed care organizations (MCOs). Additionally, the proposed rule would create two new safe harbors to protect: (i) certain point-of-sale discounts on prescription pharmaceutical products; and (ii) certain fixed fee service arrangements between manufacturers and PBMs.
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ML Strategies Health Care Preview - Week of January 28, 2019

January 29, 2019 | Blog | By Eli Greenspan

The shutdown fight is over for now and Congress is ready to get the work of the 116th Congress underway. This week, there will be four relevant hearings to health care stakeholders, two of which will center around prescription drug pricing. The other two will look at pre-existing conditions and community health center related policies. On the regulatory side, we wait and see if the Administration will be putting forth any regulations in this space, in particular the discount safe harbor rule.
Viewpoint General
On January 18, 2019, CMS announced the Part D Payment Modernization Model, aimed at incentivizing Part D sponsors to reduce catastrophic phase federal reinsurance subsidy spending.  The model, which will begin January 2020, is a voluntary, five-year model open to eligible standalone Prescription Drug Plans (PDPs) and Medicare Advantage-Prescription Drug Plans (MA-PDs) that are approved to participate. 
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On January 24, 2019, CMS published its annual Notice of Benefit and Payment Parameters for 2020 ("Proposed 2020 Payment Notice") proposing parameters applicable to qualified health plans (QHPs) on the Exchanges for plan years beginning January 1, 2020.  Among several other proposals, CMS is proposing that issuers be permitted to exclude drug manufacturer coupons for prescription brand drugs that have a generic equivalent from counting toward patients’ annual limit on cost-sharing. 
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How Much Control Do Device Manufacturers Have Over Servicing?

January 23, 2019 | Blog | By Benjamin Zegarelli

In December, my colleague Aaron Josephson and I described our observations after attending FDA’s public workshop on Medical Device Servicing and Remanufacturing Activities. In this post, I want to share some additional thoughts about medical device servicing based on conversations I had with other workshop attendees about changing the device distribution and ownership paradigm to avoid issues about third party servicing and remanufacturing. This is a prominent consideration for original equipment manufacturers (OEMs) given FDA’s evident reluctance to regulate third-party servicers directly, meaning that there are no quality or safety requirements for third party repairs. Below, I describe why making OEM servicing mandatory is essentially impossible under the typical model of device sales to and ownership by health care professionals and institutions, as well as some alternative commercial models that might allow OEMs to cut third-party servicers out of the picture.
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Arizona 1115 Medicaid Waiver Update

January 22, 2019 | Blog | By Emma Zimmerman

In 2014, Arizona expanded Medicaid to the new adult group. Following the expansion, Arizona submitted, and CMS approved, an 1115 waiver extension to create the Choice, Accountability, Responsibility, Engagement (CARE) program. CARE adds premiums and cost sharing, healthy behavior incentive programs, and flexible spending accounts, called CARE Accounts, for certain adults in the expansion population. The program is approved to run through September 30, 2021.
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ML Strategies Health Care Preview - Week of January 22nd

January 22, 2019 | Blog | By Eli Greenspan

While Congress is still mired in a partial government shutdown, the Administration is continuing to put out relevant health care regulations and approving new Medicaid work requirements. With the first health care hearings of 2019 beginning next week, we should get a sense of the level of oversight the Administration will be facing this Congress. We cover this and more in this week's health care preview.
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OIG Advisory Opinion Allows Routine Waiver of Federal Cost-Sharing Obligations

January 18, 2019 | Blog | By Karen Lovitch, Cassandra Paolillo

In an Advisory Opinion posted earlier this week, the OIG gave the green light to a charitable pediatric clinic’s routine waiver of patient cost-sharing amounts on the basis.  The OIG’s analysis hinged on several factors that, taken together, led the OIG to refrain from exercising its enforcement discretion.
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Over the last few weeks, we published a number of posts examining important developments and trends in 2018 as well as what we expect to see in 2019. Our posts cover a range of topics, including enforcement and litigation, HIPAA and the FDA. In case you missed one, below are links to all of our Year In Review posts.
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The Buzz About Block Grants

January 16, 2019 | Blog

With the recent scoop from Politico that the Trump Administration is considering giving states the ability to implement Medicaid block grants, there has been considerable speculation on what the Administration is planning. Although we don’t know exactly what the Administration has in mind, there increasing skepticism on the legality of this move. So we are laying out the fundamentals and past history as we await the final guidance.
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ML Strategies Health Care Preview - January 14, 2019

January 15, 2019 | Blog | By Eli Greenspan

While Congress and the Administration are dug in entering the third week of a partial government shutdown, both branches of government are looking to shape other policy areas in 2019. The Administration is reportedly looking at reforming the Medicaid program and Congress is ramping up its oversight of prescription drug prices.

We cover this and what it will mean for this Congress in this week's preview.
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