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This week, the House Energy & Commerce Committee is voting on seven more drug pricing bills. The Senate is going to be unveiling its cost-containment package in the coming weeks (if not days) and should include most, if not all, of the House-passed drug pricing bills. This action will set the stage for the summer work period, which is expected to focus heavily on drug pricing and other cost-containment measures, such as surprise medical bills. At CMS, the agency published a final rule last week that touched on several noteworthy drug pricing issues. We cover this and more in this week's preview, which you can find by clicking here. 
On May 10, 2019, the Food and Drug Administration issued highly anticipated final guidance that gives drug-makers more clarity on how to demonstrate that a proposed biosimilar product meets the statutory interchangeability standard under the Public Health Service Act (PHS Act or the Act). According to the Act, an interchangeable biosimilar may be substituted for the original biological product without the involvement of a prescriber, similar to the way generic drugs are routinely substituted for brand name drugs at the pharmacy level. The Final Guidance, entitled “Considerations in Demonstrating Interchangeability with a Reference Product,” is shorter than the draft version released over two years ago, in response to industry feedback, but generally tracks the original policy positions proposed in the draft, with a few notable exceptions summarized below.
Health Privacy

Health Care & Cybersecurity: A Powerful Combination

May 14, 2019 | Blog | By Cynthia Larose

The adoption of connected medical devices and the Internet of Medical Things (IoMT) has both enhanced the quality of patient care and increased the vulnerability of health care organizations. Sophisticated cyberattacks on hospitals and health systems threaten patient safety and impose substantial financial costs.
Viewpoint General

ML Strategies Health Care Preview: Congress's Summer Plans Filling Up Fast

May 13, 2019 | Blog | By Eli Greenspan, Alexander Hecht

Congress is circling an issue that is not black and white in terms of the stakeholders it could impact and how interests will align. The leaders of the Senate Health, Education, Labor, and Pensions Committee and the Senate Finance Committee are poised to release a cost-containment package in the coming weeks which will touch on surprise billing issues, drug pricing, and other access and transparency issues. While there is intense bipartisan interest in addressing some of these issues, it is unclear how exactly this package will reach the President's desk given the current political climate.
Viewpoint General
Last week, Mintz and ML Strategies welcomed stakeholders and thought leaders from across the pharmacy and pharmaceutical industry to the Boston Office for the 4th Annual Pharmacy & Pharmaceutical Industry Summit.
Viewpoint General

DOJ Issues Guidance on Cooperation Credit in FCA Settlements

May 10, 2019 | Blog | By Jane Haviland, Laurence Freedman

The U.S. Department of Justice (DOJ) issued policy guidance on May 6, 2019, about providing credit in False Claims Act (FCA) settlements to corporations for “disclosure, cooperation, and remediation." DOJ has never previously issued guidance regarding credit in FCA matters. This guidance, coupled with the passage of the Tax Cuts and Jobs Act in 2017 (which requires DOJ to specify the amount of “restitution” or “remediation” at the time of settlement), provides meaningful specificity as to what conduct constitutes disclosure, cooperation, and remediation, as well as data for evaluating whether credit is actually reflected in negotiated FCA settlements. This policy guidance is contained in the Justice Manual, Section 4-4.112.
Viewpoint General

FCA Relator and U.S. Weigh in on Defendants' Argument that the FCA is Unconstitutional

May 9, 2019 | Blog | By Samantha Kingsbury, Brian Dunphy

As part of our ongoing discussion of the Polukoff False Claims Act (FCA) qui tam case (involving allegations that certain heart procedures performed by a cardiologist, and billed for by two hospital defendants, were not medically necessary), we reported in February that some defendants filed a petition for a writ of certiorari with the United States Supreme Court. 
Viewpoint General
Yesterday, May 8, 2019, the Centers for Medicaid & Medicaid Services (“CMS”) released its final rule requiring drug manufacturers to disclose a drug’s wholesale acquisition cost (“WAC”) in direct-to-consumer television advertisements. The rule, which will become final 60 days after the official publication of the rule (which will be tomorrow, May 10, 2019) was proposal last fall. CMS is largely adopting the rule as published last fall with minor technical changes for clarification
Viewpoint General

ML Strategies Health Care Preview: House Poised to Pass First Drug Pricing Bills

May 8, 2019 | Blog | By Eli Greenspan, Alexander Hecht

This week, the House is poised to take action on drug pricing by passing two pieces of legislation. As the House moves bills through final passage, focus will shift to the Senate which will in the coming weeks unveil a legislative package around lowering costs for consumers. The scope of this package is still unclear, but it should include a number of proposals that could pass on a bipartisan basis. We cover this and more in this week's preview, which you can find by clicking here. 
Viewpoint General
FDA's Comprehensive Regenerative Medicine Policy Framework is nearing the halfway mark of the “grace period” the Agency extended for certain regenerative medicine product developers to come into compliance by obtaining investigational new drug applications (INDs) and working towards premarket approval of their products.
Viewpoint General

MLS Weekly Preview: Medicare For All Gets a Hearing

April 29, 2019 | Blog | By Eli Greenspan, Alexander Hecht

Following the two week recess, Congress is back in session and will have several high profile hearings this week. For starters, the Energy & Commerce Health subcommittee will continue reviewing prescription drug costs, this time focusing in on Medicare. In the Rules Committee, which does not typically host high profile hearings, they will hold the first committee hearing on H.R. 1384, one of the "Medicare for All" proposals.


The House is poised to pass several noteworthy drug pricing bills this work period, as well as legislation to strengthen the Affordable Care Act. Once the House votes on these bills, the question will then become what is the Senate able to pass and what is their appetite for taking it on this summer. We cover this and more in this week's preview.
Viewpoint General
As many of our readers know, we have been closely following the Polukoff False Claims Act (FCA) qui tam case in the Tenth Circuit for the lessons it might offer in defending FCA cases premised on allegations related to lack of medical necessity (among other topics).  Recently, we had the opportunity to consider this case from a different angle: the lessons it might offer to bankruptcy counsel advising clients who are or have been the subject of a health care fraud investigation and/or FCA qui tam case. 
Viewpoint General
As predicted by our colleagues earlier this month, outgoing Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (FDA) released a comprehensive press release setting forth actions for possible FDA regulation of CBD products. FDA also reinforced its position that introducing CBD or THC infused products into interstate commerce, including marketing CBD and THC dietary supplements, continues to be illegal.  In furtherance of this position, FDA released three warning letters to businesses marketing CBD products for using “egregious and unfounded claims aimed at vulnerable populations.”
Viewpoint General

Maryland Legislature Passes Bill Allowing Direct Advertising of Certain Laboratory Tests

April 12, 2019 | Blog | By Sarah Beth Kuyers, Karen Lovitch

The Maryland General Assembly recently passed a bill that permits any person to directly or indirectly advertise diagnostic laboratory tests in the state, with certain limitations.  The bill currently awaits the Governor’s signature and will go into effect on October 1, 2019. Maryland law currently prohibits any marketing of laboratory tests to consumers, as well as any direct-to-consumer (“DTC”) testing without a physician’s order. 
Viewpoint General

MLS Weekly Preview: Congress Keeping its Focus on Drug Costs

April 8, 2019 | Blog | By Eli Greenspan, Alexander Hecht

This week, Congress will continue to look at lowering health costs. The House has been focused on both drug costs and overall health care costs, advancing packages to strengthen the individual market in addition to a series of bipartisan drug pricing bills. We cover this and more in this week's preview.
Viewpoint General
On June 28, 2018, California passed the California Consumer Privacy Act (CCPA) and then further amended it on September 23, 2018. CCPA breaks new state law privacy ground, and this post addresses some of the confusion surrounding the exemptions for health information.
Viewpoint General

CMS’s New Part D Policies Address the Opioid Epidemic

April 3, 2019 | Blog | By Daryl Berke

In recent months, we’ve highlighted several changes that CMS is implementing to combat opioid misuse. In this post, we focus on CMS’s new Medicare Part D Opioid Overutilization Policies.


Last year, CMS published a road map outlining the agency’s approach to addressing the nation’s opioid epidemic. CMS’s strategy has three prongs: (1) prevent new cases of opioid use disorder (OUD); (2) expand treatment for individuals with OUDs; and (3) leverage data to improve the agency’s prevention and treatment options.


In line with that strategy, the agency published an article detailing its Medicare Part D Opioid Overutilization Policies for 2019. The policies focus on improving communication between and among Part D plans (PDPs) and providers to better coordinate efforts to prevent opioid misuse. As CMS points out, “Providers are in the best position to identify and manage potential opioid overutilization in the Medicare Part D population. Medicare prescription drug plans can assist providers by alerting them about unusual utilization patterns in prescription claims.”
Viewpoint General

FDA Silent on CBD Regulation at Cosmetics Conference, But Legislation May Be Imminent

April 1, 2019 | Blog | By Benjamin Zegarelli, Aaron Josephson

Regulation of cannabidiol (CBD) was a hot topic on Day 1 of ACI’s Cosmetics & Personal Care Products conference on March 28, 2019. Attendees asked many questions about legitimate uses of and claims for CBD, but definite answers were in short supply due to the current confusion over the legality of CBD as a product itself or other products, such as food or cosmetics, with CBD added.

When asked a direct question about FDA’s perspective on and plans for CBD regulation, Dr. Linda Katz, Director of FDA’s Office of Cosmetics and Colors and Acting Chief Medical Officer for Food Safety and Applied Nutrition, did not comment directly but referred all attendees to an upcoming public meeting on CBD in April 2019. It is possible that the public meeting could be the start of an FDA rulemaking process for CBD regulations. Even though Dr. Katz was unable to comment, there was still plenty of CDB advice to share with industry attendees.
Viewpoint General

ML Strategies Health Care Preview - Week of March 25, 2019

March 26, 2019 | Blog | By Eli Greenspan

This week, House Democrats are pressing forward with a health care package designed to lower drug costs and strengthen the Affordable Care Act (ACA). This package will provide a platform for Democrats to tout legislation that stabilizes the ACA or counteracts actions taken by the Administration. While this legislative package is sure to get a lot of attention following the Department of Justice announcement regarding Texas v. Azar, it's unclear how much support it will garner in the Senate.
Viewpoint General
The Supreme Court denied a petition for certiorari last Monday in U.S. ex rel. Prather v. Brookdale Senior Living Communities, Inc., No. 17-5826 (6th Cir. June 11, 2018), again declining to revisit or clarify the False Claims Act's “materiality” standard set forth in its 2016 decision in Universal Health Services v. United States ex rel. Escobar, 136 S. Ct. 1989 (2016). 

In Prather, the relator alleged that defendant Brookdale Senior Living Communities, Inc. (Brookdale), a home health provider, submitted bills for medical services that were “untimely” signed and certified by physicians in violation of Medicare regulations.  When submitting Medicare claims, Brookdale purportedly did not obtain the required physician certifications attesting that the medical services provided by Brookdale were necessary until months after establishing a patient’s plan of care.  Because Medicare regulations under 42 C.F.R. § 424.22(a)(2) require physician certifications “at the time the plan of care is established or as soon thereafter as possible,” the relator alleged that Brookdale’s untimely certifications rendered the claims false under the implied false certification theory.  The district court dismissed the complaint on materiality grounds, holding that the noncompliance was insubstantial and that the relator failed to allege that the government had ever denied a claim based on a violation of the timing requirement under the Medicare regulations.

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