It has been a few months since we reported on Federal Court wranglings with the Biologics Price Competition and Innovation Act, or BPCIA, which created the nation’s abbreviated marketing pathway for biosimilar products.

After the Supreme Court issued its first ruling on the BPCIA in June 2017 (see our prior post here), it sent the dispute between Amgen and Sandoz back to the Federal Circuit Court of Appeals to resolve the question of whether Amgen’s claims asserted under California law, including a claim of unfair competition, were preempted under the BPCIA. Continue Reading Biosimilar Market Developments Continue Apace in 2018

Today is the deadline for interested parties to submit comments to CMS regarding the proposed contract year 2019 Medicare Advantage and Part D regulations.  The proposed rule focuses on many issues.  In addition to the changes that CMS formally proposes, CMS has also included a request for information. CMS often uses a “request for information” in order to gain insight on an issue so that it can decide whether to formally make proposed changes relating to the issue in the future.  CMS’s request for information relates to the application of manufacturer rebates and pharmacy price concessions to drug prices at the point of sale.  CMS has been gathering information regarding these topics for many years.  You can read more here, here, here, and here.

CMS asks stakeholders to comment on CMS’s proposal: (a) to require that a percentage of manufacturer rebates be passed through at the point of sale, and (b) to require pharmacy price concessions (such as performance-based pharmacy adjustments) be reflected at the point of sale.  CMS specifically requests that all commenters provide quantitative analytical support for their responses wherever possible. Continue Reading In Proposed Regulations CMS Requests Information on Changes to Part D Negotiated Prices

On January 9th, the Senate Committee on Finance conducted its nomination hearing of Alex Michael Azar II, President Trump’s nominee for Secretary of Health and Human Services. Under President George W. Bush, Mr. Azar served in HHS, first as general counsel to HHS and then as deputy secretary. Mr. Azar was more recently an executive at Eli Lilly and Company. As summarized here, Mr. Azar received many questions regarding Medicaid, CHIP, the Affordable Care Act, and most notably and often, drug prices. Continue Reading Azar’s Nomination Hearing Highlights Medicare Negotiation of Part B Drug Prices

Americans today are facing an opioid epidemic that stems in part from the misuse of prescription drugs. CMS takes aim at this crisis in its CY 2019 Medicare Advantage and Part D  Proposed Rule (Proposed Rules) by setting out a framework for Part D plans to monitor and reduce the potential misuse of frequently abused prescription drugs. (Those interested in a high-level overview of the Proposed Rules should see our post from last month). Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes on the Opioid Epidemic

Medicare Part D plan sponsors and pharmacies are often confused by the program’s any willing pharmacy (AWP) requirements. Since the inception of the Medicare Part D program, the Centers for Medicare & Medicaid Services (CMS) has required Part D plan sponsors to: (i) have standard terms and conditions that are “reasonable and relevant;” and (ii) allow any pharmacy willing to accept the terms and conditions to participate in the sponsor’s network (AWP Requirements). The “standard terms and conditions” requirement does not require that Part D plan sponsors offer the same reimbursement terms to all pharmacies. Although CMS has tried to clarify these requirements through Call Letters and memos, CMS has not substantially updated these regulations over the past 10 years. Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Tries to Clarify Any Willing Pharmacy Rules

The rising cost of drugs in the U.S. is frequently in the news. So it is not surprising that in its contract year 2019 Proposed Medicare Advantage and Part D Regulations (Proposed Rule), the Centers for Medicare & Medicaid Services (CMS) seeks to address Part D drug prices. CMS proposes making certain changes that might lower drug costs (for Plan Sponsors and beneficiaries) and requests information regarding avenues to potentially lower Medicare beneficiaries’ point-of-sale drug costs. The three provisions in the Proposed Rule that most directly relate to drug pricing address: (1) generic drug formulary placement, (2) cost-sharing for follow-on biological products, and (3) whether and how to reduce point-of-sale drug prices based on manufacturer rebates and pharmacy price concessions that a Plan Sponsor might receive months after the beneficiary receives the drugs. We will concentrate on the first two provision in this post. The third provision, which is a request for information, will be discussed in a later post.  Continue Reading Proposed Medicare Advantage and Part D Regulations for CY 2019 – CMS Takes Aim at Drug Prices

Last Thursday, November 17, 2017, the Centers for Medicare & Medicaid Services (CMS) released its proposed contract year 2019 Medicare Advantage and Part D regulations. The proposed rule is scheduled to be published in the Federal Register on November 28, 2017.

The proposed rule focuses on many issues including but not limited to:

  • Implementing certain parts of the Comprehensive Addiction and Recovery Act of 2016, aimed at establishing additional methods that Part D plans can use to reduce abuse or misuse of frequently abused drugs;
  • Changes to certain Medicare Advantage provisions relating to marketing and delivery of information;
  • Establishing “preclusion lists” under Medicare Advantage and Part D to limit when a Medicare Advantage organization and Part D plan sponsor may pay for a service or drug based on the provider who prescribed or furnished the service or drug;
  • Part D Network requirements relating to any willing provider, including defining mail-order pharmacy;
  • Part D beneficiaries’ access to generic drugs and follow-on biological products;
  • Changes to medical loss ratio calculation and reporting; and
  • Updates to the Medicare Advantage and Part D Star Rating System.

Within the proposed rule, CMS also included a request for information regarding the application of manufacturer rebates and pharmacy price concessions to drug prices at the point of sale. CMS has been gathering information regarding this topic for a number of years but appears to be seeking more detailed information in this request.

In the coming weeks we will be issuing detailed posts on these topics as well as others.

Based on the significance and number of the changes proposed, we anticipate that CMS will receive many comments from all segments of industry and beneficiary groups that may be affected by the proposed changes.  Comments are due to CMS before 5:00 pm on January 16, 2018.

As Part of an ongoing series, we have previously provided details on the structure, funding, and evaluation of the Maternal, Infant, Early Childhood, Home Visiting (MIECHV) program, Medicare therapy caps, and community health center funding.  This post marks is the first in an exploratory series illuminating the structure, funding, and outlook of the Special Needs Plans (SNPs).  Additionally, drawing on potential riders affected by the current health care minibus, the “minibus” refers to a handful of policy provisions tied together in one piece of legislation. Undoubtedly, this minibus will carry a number of provisions into law. The number of riders who will be on board when the minibus leaves the station remains to be seen. However, as Congress gears up for a mega-package in December – including the debt limit and the budget – there is the potential to incorporate the minibus and/or a health care stabilization package. Continue Reading Special Needs Plans: A Minibus Rider

CMS has completed the 2016 Final Part D Payment Reconciliation. Each Medicare Part D plan sponsor’s reconciliation reports will be available on October 12, 2017.

By way of background, the Medicare Part D reconciliation process is intended to ensure that the federal government pays each Part D plan sponsor appropriately. To arrive at the reconciliation report, CMS : (1) reviews data provided by the plan sponsor and other sources throughout the year, (2) considers what a plan sponsor paid for drugs during the plan year, what direct and indirect remuneration (DIR) a plan sponsor paid to or received from outside parties, and the total value of prospective payments made by CMS to the plan sponsor for the plan year, and (3) determines whether additional money is owed to or from the plan sponsor. Continue Reading CMS Completes Final Medicare Part D Reconciliation for 2016

Last week, a number of health care industry associations sent letters to Congress detailing ways in which the government could relieve them of the burdens associated with “red tape.” The letters are in response to the first stage of a House initiative dubbed the “Medicare Red Tape Relief Project,” which was announced earlier this summer by the House Committee on Ways and Means’ Subcommittee on Health.  Continue Reading Hospitals and Others Respond to “Red Tape Relief Project” Requests