The Department of Justice (DOJ) recently intervened in a False Claims Act (FCA) case that raises a variety of interesting allegations, including payment of kickbacks by a compounding pharmacy to contracted marketing companies in the form of percentage-based compensation, to TRICARE beneficiaries in the form of copayment waivers, and to physicians who submitted prescriptions without seeing patients.  According to the complaint, Patient Care America (PCA), a Florida compounding pharmacy, implemented a scheme to manipulate the compounding formula for pain and scar creams that resulted in the submission of false claims to TRICARE.  The complaint also names two of PCA’s senior executives (one of which has since left the company) as well as the private equity firm that owns a controlling interest in PCA. Continue Reading DOJ Intervenes in False Claims Act Case Against a Compounding Pharmacy and a Private Equity Firm

CMS has slowly but surely been providing additional guidance to Medicare Plans (Medicare Advantage and Part D plans) regarding steps they can and should take to address the opioid epidemic as it relates to their beneficiaries. CMS’s most recent guidance to Plans regarding the opioid epidemic was included in the Advance Notice and Call Letter.

In November of 2017, in the proposed Medicare Advantage and Part D regulations for CY 2019 CMS set out a framework for Part D plans to monitor and reduce the potential misuse of prescription opioids. Continue Reading CMS’s Advance Notice and Call Letter: How Medicare Plans Can Report, Identify, and Address the Opioid Epidemic

As we predicted in our year-end post on civil and criminal enforcement trends, 2018 is already off to strong start in opioid-related enforcement against individual providers and associated practices.  Earlier this month, the Department of Justice (DOJ) announced that a Michigan physician, Dr. Rodney Moret, was sentenced to 75 months in prison for his role in conspiracies to distribute prescription pills illegally and to defraud Medicare. The conduct alleged against Dr. Moret is particularly extreme, but nevertheless reflects the government’s commitment to ferreting out opioid-related misconduct. Continue Reading Federal Enforcement Actions Continue to Focus on Opioid-Related Misconduct

Last week, Governor Andrew Cuomo unveiled his proposed $168 billion budget for fiscal year 2019, which proposes several changes to New York’s healthcare landscape.  Among other things, the budget contains amendments that would authorize the provision of certain health services by retail health clinics, and proposes a tax on private health insurance companies and not-for-profit health insurance conversions. Continue Reading New York Executive Budget Proposes Corporate Ownership of Retail Clinics, Tax on Not-for-Profit Health Insurance Conversions

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

Earlier this week, Mintz Levin’s Health Care Enforcement Defense Group published its most recent Health Care Qui Tam Update. This Update covers 34 health care-related qui tam cases that were unsealed in July 2017.

Here are some of the highlights:

– Of the 34 cases unsealed in July 2017, the government intervened (in whole or in part) in six cases and declined to intervene in 28.

– These 34 unsealed cases were filed in 21 different courts, including:

  • Five in the Southern District of Ohio;
  • Three in the District of Arizona; and
  • Three in the Western District of Virginia.

Continue Reading Mintz’s Health Care Enforcement Defense Group Publishes New Qui Tam Update

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