Last week, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services released a report analyzing CMS’ readiness to implement major parts of the Medicare Access and CHIP Reauthorization Act  of 2015 (MACRA). The report provides an inside look at the steps CMS is taking to implement MACRA’s Quality Payment Program (QPP), which is an ambitious transformation of the way in which the federal government reimbursements health care providers. The report highlights two key vulnerabilities for the MACRA transition, a process that will hopefully be smoother than the troubled roll out of HealthCare.gov.

Continue Reading OIG Report Offers Glimpse into CMS Progress Towards MACRA Implementation

Since congressional enactment and presidential signing of the Cures Act into law earlier this month, we have been blogging on discrete regulatory and clinical areas affected by its provisions (see here and here).  One small, but by no means insignificant, change is the Cures Act’s explicit recognition that drug and biologic manufacturers should have the ability to promote their products to payors and health plans through well-developed “health care economic information.” Continue Reading Cures Act Affirms Drug Companies’ Ability to Discuss Certain Information with Payors

As you have seen in our recent coverage, the 21st Century Cures Act is a major legislative undertaking, and it will have a great impact the medical device industry.

Join my Mintz Levin and ML Strategies colleagues Tom Crane, Bethany Hills, and Rodney Whitlock on January 18th for a MassMEDIC webinar, “Impact of the Cures Act on the Medical Device Industry,” when they will take a deep dive into important provisions for industry to consider.

Each presenter will bring their unique experience to the webinar to help illuminate opportunities the legislation presents to the med tech community, along with certain hurdles to clear. They will discuss the politics behind the law, from its passage to anticipated issues with its execution, before plunging in to some device-related details. Some specific items they will consider include:

  • the creation of a breakthrough device pathway,
  • FDA’s use of the least burdensome review requirements, and
  • a new “medical device” definition.

Mark your calendars and register today!

Join us in New York on Tuesday, January 24th, for a discussion on FDA priorities in 2017 and the potential impact on companies in the health care and life sciences industries.  In a joint presentation from Mintz Levin and ML Strategies, my colleagues, Bethany Hills, Joanne Hawana, and Rodney Whitlock, will discuss the following topics:

  • President Trump’s plans for FDA reform
  • Expected health care activity in the 115th Congress
  • Changing FDA regulatory priorities
  • Practical implications for industry

We hope you will join us! The program will run from 5:30 – 6:30, with a cocktail reception to follow.  Click here to register.

In the meantime, you can continue to follow our coverage of recent FDA developments here.

As we noted in our December 9th post, the 21st Century Cures Act (the “Cures Act”) requires FDA to develop a framework and guidance for evaluating real world evidence (“RWE”) in the context of drug regulation to support approvals of new indications for previously approved drugs, and to support or fulfill post-approval study requirements. This directive to apply RWE in the drug sphere is particularly interesting because FDA has issued a draft policy on the use of RWE in the context of medical devices, but has generally remained silent about applying RWE to pharmaceutical and biologic regulatory considerations.  In this post, we briefly review the Cures Act’s RWE provision, as well as FDA’s recent public remarks about the use of RWE, and we provide some predictions on how FDA will implement the RWE evaluation program.

Continue Reading 21st Century Cures Act Requires FDA to Expand the Role of Real World Evidence

The Centers for Medicare & Medicaid Services (CMS) has withdrawn its controversial rule implementing the Medicare Part B payment demonstration. The agency stated that after consideration of the comments, it will not move forward with the demo.

The demonstration was intended to test new reimbursement methods for Medicare Part B drugs and to promote value-based and cost-effective drug purchasing.  Despite its intentions, major patient, pharmaceutical, and physician groups criticized the scope of the rule and the speed in which CMS was implementing it.  Many worried it would restrict or limit access to certain drugs.  It also drew sharp criticism from several members of Congress, including President-elect’s nominee for the Secretary of Health and Human Services, Rep. Tom Price. Continue Reading The Medicare Part B Demo May be Dead, but Drug Pricing Concerns Still Linger

On Tuesday, President Obama signed the 21st Century Cures Act (the “Act”) into law.  The Act is a massive piece of legislation that has implications for many different aspects of the interconnected medical research, product development, and health care delivery enterprises. Our colleagues have previously discussed the Act’s many provisions that aim to speed up the process of bringing new drugs and devices to market. One of the Act’s most significant amendments to the Federal Food, Drug and Cosmetic Act will allow FDA to grant accelerated approval to regenerative medicine products, while also providing the Agency with wide discretion on creating new approaches to regenerative medicine. This legislative development is historic given increasing pressure from patients and other stakeholders to move regenerative medicine advancements more quickly from the lab into the clinic. Continue Reading President Obama Signs 21st Century Cures Act; Creates Accelerated Approval Pathway for Regenerative Medicine

More than two years since issuing the proposed rule, the HHS Office of the Inspector General (OIG) issued the long-awaited and highly anticipated final rule (the Final Rule) that provides amendments to the Anti-Kickback Statute (AKS) regulatory safe harbors and adds protections for certain payment practices and business arrangements under the beneficiary inducement provisions of the Civil Monetary Penalty Law (CMP). These amendments and updates to the AKS and CMP regulations attempt to clarify the OIG’s enforcement position in light of changes due to health reforms, to streamline the OIG’s advisory opinion workload, and to implement long-existing mandates enacted in statutes. This post discusses the amendments to the beneficiary inducement provisions of the CMP codified in 42 C.F.R. Part 1003 (CMP Regulations). Continue Reading At Long Last, OIG Issues Final Rule for Beneficiary Inducement Safe Harbors

On Wednesday, the U.S. Senate overwhelmingly passed the 21st Century Cures Act (the “Act”) by a vote of 94 to 5.  Spearheaded by Michigan Representative Frank Upton, the bill now heads to President Obama who has promised to sign it. The Act is ambitious, and will impact a wide swath of the U.S. health care system. The Act provides, among other things:

  • $4.8 billion over 10 years to support NIH research on precision medicine, neuroscience, cancer and regenerative medicine.
  • $1 billion in state grants to increase opioid abuse prevention and treatment services, including prescription drug monitoring programs, training programs and treatment programs.
  • Substantial changes to FDA regulations to accelerate the pace of bringing pharmaceuticals and medical devices to market.
  • New obligations on the part of both FDA and industry stakeholders to implement the research initiatives and regulatory changes mentioned above.
  • Other health care initiatives addressing health information technology, vaccines, national security and health care delivery.

At 996 pages, the Act cannot be summarized in one post. Instead, we plan to analyze the various aspects of the Act in multiple posts over the coming weeks. The remainder of this post will highlight provisions that support one of the Act’s primary objectives: the acceleration of drugs and devices to market. Continue Reading Senate Passes 21st Century Cures Act, but Can It Cure an Ailing FDA?

image3_417910087A Trump victory was not the only surprise on election night. California’s drug pricing initiative, which would have required state agencies to negotiate drug prices at least as low as those paid by the U.S. Department of Veterans Affairs, was defeated by a wide margin (46% to 54%). This clear-cut defeat came as a surprise to many considering that polls taken just a couple of months earlier showed widespread support for the initiative. The California ballot initiative was introduced last year in the midst of widespread criticism of soaring drug prices. The initiative had early support but floundered leading up to the election when major pharmaceutical companies expended considerable resources into the campaign to defeat it. Continue Reading In the Wake of the Election, What’s Next for State Drug Pricing Initiatives?