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
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
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
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
Last week the Food and Drug Administration (FDA) decided to delay finalizing draft guidance for Laboratory Developed Tests (LDT). First issued in July of 2014, the draft guidance would give FDA regulatory oversight of LDTs. This guidance marked a significant shift in the regulation of LDT as FDA has chosen not to exercise regulatory oversight or enforcement over LDTs. Continue reading
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
As Washington speeds towards Election Day on November 8th, it is a good time to examine the status of the key legislative and policy issues impacting the healthcare and life sciences sectors. Congress has few legislative working days remaining in 2016, but could make some headway on legislation to promote innovation as well as prevent certain rulemakings like the Medicare Part B demonstration project. In addition to closing out existing priories, Congress will turn its attention to new and recurring issues such as increasing the amount of generic drugs. Here is an overview of what’s left to be done this year during the “lame duck” session that begins in mid-November and what is on the horizon for 2017.