Tag Archives: legislation

New Mexico Poised to Add the ‘Data Breach Notification Act’ to the Patchwork of State-Level Data Privacy Laws

The New Mexico Legislature passed the ‘Data Breach Notification Act’ (the Act) on March 15. The Act is now with Governor Susana Martinez who has 20 days from the date the Act was passed to sign it into law. If enacted, the Act would require a person, other than a person who is subject to the Health Insurance Portability and Accountability Act of 1996 or the Gramm-Leach-Bliley Act, that “owns or maintains” records containing a New Mexico resident’s personal identifying information (PII) to notify the resident if his or her PII is “reasonably believed” to have been subject to a security breach. In most cases, notification will be required within 45 days.

Under the Act, PII is defined as an individual’s last name and first name or first initial in combination with one or more specified data elements, when the data elements are not Continue reading

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Filed under Privacy and Security, Technology, Uncategorized

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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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

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

Senate opts for “Step by Step” approach for innovation legislation

Tuesday, Senator Lamar Alexander (R-Tenn.), Chairman of the Senate Health, Education, Labor and Pensions (HELP) Committee announced  that he will pursue a “step by step” approach to crafting major biomedical innovation legislation.  This is a marked departure from both the House-passed 21st Century Cures bill and the previously announced Senate plan. Continue reading

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Filed under FDA, Health Care, Health Reform, Medical Devices, Telemedicine, 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

Changes to Sunshine Law Included in Proposed 21st Century Cures Legislation

As we recently discussed, a bipartisan group of representatives from the House of Representatives’ Energy and Commerce Committee released a new discussion draft of the 21st Century Cures initiative (Legislation) that seeks to accelerate new medical innovations and improve the way in which these innovations are brought to market. One notable inclusion in the Legislation is draft language that would exclude from federal Sunshine law reporting:

  • “peer-reviewed journals, journal reprints, journal supplements, medical conference reports, and medical textbooks”;
  • indirect payments or transfers of value provided to covered recipients “for speaking at, or preparing educational materials for, an educational event for physicians or other health care professionals that does not commercially promote a covered drug, device, biological, or medical supply”; and
  • payments or transfers of value made for the “sole purpose of providing the covered recipient with medical education, such as by providing the covered recipient with the tuition required to attend an educational event or with materials provided to physicians at an educational event.’’

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