Tag Archives: ACA

Off to the Races: First ACA Repeal and Replace Legislation Released

Following through on Republican campaign promises, two key Congressional committees released legislation yesterday that further the process of repealing and replacing the Affordable Care Act (ACA).  After more than 60 attempts to repeal the ACA since 2010, GOP members of the  House Energy and Commerce and Ways and Means Committees released details of the “American Health Care Act” (AHCA). Reaction to the AHCA has been swift and sharp portending a long road from producing legislation that can reach the President’s desk.  Continue reading

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Filed under Health Care, Health Reform, Medicaid, Medical Devices, The Affordable Care Act

Price Confirmed for HHS Secretary, other key agency and department positions next to be filled

Around 2 a.m., the Senate voted along party lines to confirm Representative Tom Price to become Secretary of the Department of Health and Human Services.  The vote was 52-47 with no Democrats voting in favor.  With repeated attacks on his policy record and questions about stock purchases, Price’s nomination was among the most controversial of President Trump’s cabinet selections.  With Price in place, now comes the work to fill out other key roles at HHS and develop the administrative process repeal and replace of Obamacare. Continue reading

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Filed under Medicaid, Medicare, The Affordable Care Act, Uncategorized

Final Medicaid Drug Rebate Program AMP Rule: Some Technical Highlights

We reported yesterday that the Centers for Medicare & Medicaid Services (CMS) Final Average Manufacturer Price (AMP) Rule (the “Final Rule”) was released and will be published in the Federal Register on February 1.  If you are still reading, despite the fact that we included “Technical Highlights” in today’s title, we will assume a certain level of familiarity with the Medicaid Drug Rebate Program in our discussion below.  However, although the issues addressed in the Final Rule are technical, the business implications are very real, and the Final Rule is significant to all manufacturers with marketed drug products participating in the Medicaid Drug Rebate Program (or who hope to participate someday).

Those of you who have been anxiously awaiting a final AMP rule for years now will be pleased to learn that some long-standing questions raised by CMS’s controversial 2012 proposed AMP rule have been answered (and, of course, some new questions have been raised).  Some highlights of the Final Rule, in no particular order:

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Filed under 340B, Compliance, Corporate Compliance, Coverage and Reimbursement, Fraud and Abuse, Government Pricing, Health Care, Health Reform, Medicaid, The Affordable Care Act

Final MDRP AMP Rule is Out! Will be Effective on April Fools Day 2016. (No joke.)

If you were looking for something fun to read while snow shuts down our nation’s capital tomorrow, the Centers for Medicare & Medicaid Services (CMS) just released the long-awaited Final Medicaid Drug Rebate Program Rule on Average Manufacture Price (AMP) (et al.)!  The publication of this Final AMP Rule follows the 2012 publication of CMS’s highly controversial proposed policies implementing various changes to the Medicaid Drug Rebate Program enacted under the Affordable Care Act.  This rule has significant potential to impact drug manufacturers’ calculations and policies regarding the Medicaid Drug Rebate Program and pricing more generally, and should be carefully reviewed by all interested parties.   It is being issued as a final rule with comment period.

We are currently reviewing the 657 pages of material, and plan to provide more substantive commentary in a subsequent post.  For those of you playing along at home, the rule is expected to appear in the February 1, 2016, Federal Register, and comments are expected to be due by 5:00 PM Eastern April 1, 2016 (which is also the effective date of the rule).  Separately, State Medicaid Agencies must comply with certain rule requirements by submitting a State Plan Amendment (SPA) by June 30, 2017 to be effective no later than April 1, 2017.

Stay tuned…

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Filed under 340B, Corporate Compliance, Coverage and Reimbursement, Fraud and Abuse, Government Pricing, Health Reform, Medicaid, The Affordable Care Act

HRSA 340B Drug Discount Program “Omnibus” Regulation Published – Comment Period Open Until October 27, 2015

On Friday, August 28, 2015, the U.S. Department of Health and Human Services (HHS) Health Resources and Services Administration (HRSA) proposed its long-awaited “Omnibus” regulation for the 340B Drug Discount Program in the Federal Register (the “Proposed Rule”).  The 340B Drug Discount Program is the program by which drug and biologic manufacturers are generally required to offer their products at potentially steeply discounted prices to certain purchasers, generally “safety net” entities such as certain hospitals (called “covered entities”).  Public comments on the Proposed Rule will be accepted by HRSA until October 27, 2015.  Pharmaceutical and hospital industry stakeholders are encouraged to review the proposals carefully to evaluate whether there are areas of particular concern. Continue reading

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Filed under 340B, Compliance, Coverage and Reimbursement, Government Pricing, Health Care

First Court Decision Interpreting the Overpayment Rule Issued This Week

Earlier this week, a key decision denying defendants’ motion to dismiss was issued in the case, Kane v. Healthfirst Inc., et al. and United States v. Continuum Health Partners Inc., et al. (case no. 1:11-cv-02325, S.D.N.Y.). This is the first court decision to interpret a provision of the Affordable Care Act that requires a person who has received an overpayment of Medicare or Medicaid funds to report and return the overpayment by the later of: (i) 60 days after the date on which the overpayment was “identified”; or (ii) the date any corresponding cost report is due, if applicable. 42 U.S.C. § 1320a-7k(d). Although the Centers for Medicare and Medicaid Services (CMS) issued a Proposed Rule in 2014 related to the process for reporting and returning overpayments, the deadline for issuing the Final Rule has been extended  until February 2016.

In Kane, the relator was a former employee of the company who allegedly provided to management a spreadsheet of over 900 potential overpayments caused by a software glitch. The employee was fired four days later and the company failed to return all of the overpayments due until it subsequently received a civil investigative demand in connection with the qui tam lawsuit that had been filed by the former employee under the False Claims Act (FCA). The Court determined that defining “identified”, and thus starting the 60-day clock, when a “provider is put on notice of a potential overpayment, rather than the moment when an overpayment is conclusively ascertained”, is consistent with FCA legislative history.  The Court further stated that the defendants’ position that its obligation to pay would not be triggered until after it had “done the work necessary to determine conclusively the precise amount owed to the Government”, thereby “relegating the sixty-day period to merely the time within which they would have to cut the check”, would create an “absurd result.”

We will continue to monitor this important case and provide significant updates. 



Filed under Fraud and Abuse, Government Enforcement, Health Reform

Supreme Court Upholds Federal Exchange Tax Subsidies in King v. Burwell

Today, the Supreme Court issued its highly anticipated ruling in King v. Burwell.  The case questioned whether individuals who purchased health insurance through the federal Healthcare.gov marketplace were entitled to receive tax subsidies pursuant to the Patient Protection and Affordable Care Act (ACA), or whether such subsidies were reserved for individuals who purchased health insurance through state exchanges.  The Supreme Court ruled 6-3 that Americans who purchased insurance through the federal exchange could keep the tax subsidies that made their insurance more affordable.  Chief Justice John Roberts drafted the majority opinion.

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Filed under Health Reform, The Affordable Care Act