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

FDA Delays “Intended Use” Final Rule until March 2018

Late last week, the U.S. Food and Drug Administration (FDA) announced that it was once again delaying implementation of the final rule issued January 9, 2017 related to amendments to its regulations regarding intended use (Final Rule). This implementation delay follows a Petition to Stay and for Reconsideration (Petition) filed February 8, 2017 by the Medical Information Working Group (MIWG), the Pharmaceutical Research and Manufacturers of America (PhRMA), and the Biotechnology Innovation Organization (BIO). The Petition argued that the Final Rule’s inclusion of a “totality of the evidence” standard is a new standard not found in the Food, Drug, and Cosmetic Act (FDCA) or case law related to intended use and was promulgated in violation in the APA because parties subject to this significant liability standard did not receive fair notice or a meaningful opportunity to comment.

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Filed under FDA, FDA Final Guidance

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

Enforcement Trend: Patient Assistance Programs

binoculars-clipart-as1859Multiple pharmaceutical companies have disclosed the receipt of subpoenas from various U.S. Attorney’s offices, including Massachusetts and the Southern District of New York, related to the companies’ patient assistance programs. Patient assistance programs also have been the subject of recent Congressional inquiries related generally to the increasing price of certain prescription drugs.

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Filed under Corporate Compliance, Government Enforcement

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