Category Archives: Health Reform

CBO Releases AHCA Budget Score; As Costs Become Clearer, Road to Passage Gets Rockier

Yesterday, the Congressional Budget Office (CBO) released the budget “score” or cost, for the American Health Care Act (AHCA). The headline from the analysis is that the AHCA would cause 14 million people to lose health care coverage.  Notwithstanding passage by the House Energy and Commerce and Ways and Means committees last week, the big number of uninsured, coupled with the narrative opponents have created about  AHCA’s tax breaks, has made the road for passage longer and steeper. Continue reading

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Filed under Health Care, Health Reform, The Affordable Care Act

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

The ‘Searching for and Cutting Regulations that are Unnecessarily Burdensome Act’ Passes the House

On March 1st, the U.S. House of Representatives (House) passed the Searching for and Cutting Regulations that are Unnecessarily Burdensome Act (SCRUB Act) by a vote of 240 to 185, split mostly along party lines. If passed by the U.S. Senate and signed by President Trump, the SCRUB Act would establish the Retrospective Regulatory Review Commission (Commission) to find and recommend regulations for repeal, implement “cut-go” procedures for executive agencies to repeal certain regulations identified by the Commission, and provide for the future review of new rules every 10 years. It is unclear when and if the Senate will take up the SCRUB Act. However, the Act seems to be consistent with President’s stated goal of reducing the number and burden of regulations.

If the bill is enacted as passed by the House, the SCRUB Act would charge the Commission to review the Code of Federal Regulations to identify rules or sets of rules for repeal based Continue reading

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Filed under Health Care, Health Reform

21st Century Cures Clears Senate, President Expected to Sign into Law but Some Issues Remain

Today, the Senate voted overwhelmingly – 94-5 – to pass sweeping medical innovation legislation clearing the way for President Obama to sign it into law when it reaches his desk later this week. The 21st Century Cures Act, (Cures), a rare bipartisan major piece of healthcare legislation, provides $6.3 billion for research, streamlined approvals for drugs and devices as well as funding to improve the Food and Drug Administration’s (FDA)  ability to hire top quality scientific talent by increasing pay and improving the hiring process.  The House of Representatives recently passed Cures by a similarly wide bipartisan margin of 392-26.  The Senate vote marks a milestone victory for Cures champions including outgoing Energy and Commerce Committee Chairman Fred Upton (R-MI), Representative Diana DeGette (D-CO) and Senate Health, Education, Labor and Pensions Committee Chairman Lamar Alexander (R-TN). Continue reading

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Filed under FDA, Health Care, Health Reform, Technology, Uncategorized

Final Medicare 60-Day Overpayment Rule Provides Reasonable Framework for Providers

Published today in the Federal Register was a long-awaited Final Rule implementing a requirement from the 2010 Affordable Care Act requiring Medicare Part A and B providers and suppliers to report and return overpayments to Medicare by the later of 60 days after the date an overpayment was identified, or the due date of any corresponding cost report, if applicable (Overpayment Rule). The Proposed Rule was previously published on February 16, 2012. Additionally, the final rule implementing overpayments in Medicare Parts C and D was previously published in May 2014. Case law interpreting the Overpayment Rule has been limited to date.

The Final Rule includes several significant clarifications, including the following:

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Filed under Fraud and Abuse, Health Reform, Medicare

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