Category Archives: Medicare

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

Medicare Part B Demo Declared Dead

On Thursday, the Center for Medicare & Medicaid Services (CMS) announced that it would not move forward with its controversial Medicare Part B Payment Model  (Part B Demo).  The Part B Demo had come under heavy fire from industry groups, some patient organizations, providers and a bipartisan collection of policymakers in Congress. Continue reading

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Filed under Coverage and Reimbursement, Government Pricing, Health Care, Medicare, Uncategorized

CMS Issues Final MACRA Physician Payment Rule

On Friday, October 14th, the Center for Medicare & Medicaid Services (CMS) released the long-anticipated final rule with 60-day comment period (Rule) for the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) Quality Payment Program (QPP). The QPP provides incentive payments for participation in Advanced Alternative Payment Models (Advanced APM).  The provisions of the 2,400 page Rule take effect January 1, 2017.  When fully implemented, the Rule will generally transition providers from the current fee-for-service payment system into new value-based payment models.  Continue reading

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Filed under Health Care, Medicare, Telehealth, Telemedicine, Uncategorized

Washington Update: Senate proceeds towards “Cures”; CMS releases MA rates and Call Letter

Health care policy issues continue to stream out of Congress and the Administration.  The Senate held a markup of  various health bills as part of its effort to produce a companion to the House of Representatives-passed 21st Century Cures legislation and CMS released long awaited Medicare Advantage rates. Continue reading

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Filed under Coverage and Reimbursement, Medicare, 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

Heath Provisions in President’s Budget Take Aim at Drug Prices and Opioid Abuse

Today, the President sent Congress the $4 trillion Fiscal Year 2017 Budget Proposal – his last while in office.  While the Budget on the whole is dead on arrival in the Republican-controlled Congress, there are provisions worth noting because of their current newsworthiness and possible reemergence in future policy debates.  Moreover, proposals directed at addressing the problems associated with opioid abuse could attract bipartisan cooperation this year. Continue reading

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Filed under FDA, Health Care, Medicaid, Medicare, Part D, Uncategorized

Key Health-Related Provisions Tucked into Year End Spending Bill

Last week, Congress passed and the President signed into law the Consolidated Appropriations Act of 2016 (“the Omnibus”).   This legislation contains both $1.1 trillion in government spending for FY16 as well as $650 billion in tax breaks.  The Omnibus includes several health care related provisions, both on the funding and tax sides.  This post highlights some of the more significant items.

Key Appropriations Provisions

Title II, Division H, contains the funding and other provisions for the Department of Health and Human Services (HHS).  Some of the key provisions are summarized below.  The explanatory text for this title of the Omnibus has a description of the numerous HHS funding line items, along with directives and some specifics for each agency within the Department.

340B Drug Program: HRSA is requested to provide a briefing to update the Committees on Appropriations of the House of Representatives and the Senate on the status of 340B guidance, the secure website, and covered entities in the 340B drug program.

National Institutes of Health (NIH):   The Omnibus provides a $2 billion increase in funding from fiscal year 2015.  The total spending level for FY16 for NIH is $32 billion. Some of the initiatives receiving increased and/or new funding include:

  • $936 million for Alzheimer’s research (an increase of $350 million)
  • $200 million for Precision Medicine

Centers for Disease Control (CDC):  Overall, CDC receives a $300 million increase in funding for a total of $7.2 billion for FY16, as follows:

  • $1.2 billion for Chronic Disease Prevention and Health Promotion
  • $70 million for the prevention of prescription drug abuse
  • $579 million for Emerging and Zoonotic Infectious Diseases

Centers for Medicare & Medicaid Services (CMS): CMS receives $3.6 billion, the same amount appropriated in FY2015.

Prescription Drug Report –Of particular note is that the Omnibus directs the Secretary of HHS, in consultation with the Secretary of the Department of Veterans Affairs, to submit a report to the Committee on Appropriations of the House of Representatives and the Senate, using non-proprietary data, which is only available under current law. The report must be delivered in a time period not later than 180 days after the date of enactment of the Omnibus — December 18, 2015. This report must discuss the following topics: (1) price changes of prescription drugs (net of rebates) since 2003; (2) access to prescription drugs by patients in the four programs listed below; (3) health outcomes and patient satisfaction with care that addresses the four programs listed below; and (4) an analysis of the current cost and length of time necessary to bring new drugs to market. The report “should” include prescription drug prices (net of rebates) paid by Federal programs for the 10 most frequently prescribed drugs and the 10 highest cost drugs under Medicare Part B, Medicare Part D, Medicaid and the Department of Veterans Affairs.

Key Tax Provisions

Two Year Moratorium on the Medical Device Tax:   Section 174 of the tax proposals creates a two year moratorium of the 2.3 percent excise tax on the sale of medical devices that took effect in 2013.  The tax will not apply in 2016 or 2017.

Delay of the Tax on High Cost Health Plans a/k/a/ the Cadillac Tax: Title 1 of Division P contains a provision that delays the Cadillac Tax for two years (2018 and 2019). This makes the tax on high cost, health insurance plans effective in 2020.

One-Year Moratorium on the Health Insurance Tax (HIT).   Title 1 of Division P also includes language setting a one-year moratorium on the annual HIT (2016), making the tax effective in 2017. The annual HIT is, in essence, a sales tax on health insurance premiums.

Contact the Cooley Health Care & Life Sciences Regulatory Practice if you have  questions on these or other provisions of the Omnibus.

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by | December 23, 2015 · 4:02 pm