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Health Update - September 2016

The Election’s Impact on Healthcare: Preparing for Potential Scenarios - Editor’s Note: Election 2016 will have a major impact on federal and state healthcare policy. To be prepared for all the possibilities, it’s...more

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program

Price increases threatening the availability of EpiPen® and EpiPen Jr® Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug pricing. Lost amid the public outcry, however, is a thorny regulatory issue:...more

Arkansas' New Telemedicine Rules a Small Step Forward

The Arkansas Legislative Council’s Rules and Regulations Subcommittee approved, on August 16, 2016, proposed regulations which, if accepted by the Arkansas Legislative Council, will remove some restrictions on telemedicine...more

EpiPens: the latest epic fail to halt Big Pharma’s relentless jacking up of prices

Martin Shkreli, the smirking Pharma CEO, has been replaced for now as the national symbol for outrage over Big Pharma’s price gouging. Enter, stage right: Heather Bresch, a 47-year-old executive-who also happens to be the...more

Letter to Colombian President Encourages Grant of Compulsory License for Imatinib

Last month, we reported on letters sent by two Senators and fifteen Representatives to the U.S. Trade Representative, seeking clarification regarding the Administration's position on compulsory licenses. The letters were...more

Illinois Revises Data Privacy Statute

Earlier this year, Illinois enacted a number of changes to the Illinois Personal Information Protection Act (“PIPA”). The amendments to PIPA, among other things, expand the definition of personal information subject to...more

Illinois Authorized Electronic Monitoring in Long-Term Care Facilities Act: Proposed Amendments

Effective January 1, 2016, Illinois now permits residents or families of residents in long-term care facilities to install cameras or other electronic monitoring devices (audio and visual) in resident rooms. Illinois'...more

States’ Efforts for Drug Price Transparency Stymied by the Pharmaceutical Industry

As we previously reported, in 2015 and early 2016, bills and voter initiatives were introduced in several states that would impose drug pricing controls and transparency requirements on pharmaceutical manufacturers. Of...more

Cybersecurity News & Notes – July 2016 #4

In Case You Missed It: U.S. Major party platforms address cybersecurity. The two major parties have released their 2016 election platforms, both of which include cybersecurity planks. The Republican platform’s perspective...more

Obama Administration, Congress Take Steps to Fight Opioid Epidemic

HHS has announced a series of actions to address the nation’s opioid epidemic, as Congress has cleared the Comprehensive Addiction and Recovery Act for the President’s signature. As part of the HHS activities, the Substance...more

Addressing the Opioid Crisis

Following the July 13 U.S. Senate's passage of Comprehensive Addiction and Recovery Act (CARA), providers, families and communities should evaluate the act's impacts. The reform, S. 524, is viewed as a comprehensive approach...more

Washington Healthcare Update

This Week: Double Issue — Congress leaves for seven weeks, Congress sends opioid legislation to the President…More co-ops fail…The Supreme Court rules on Texas Abortion Case and Washington state Pharmacists and Religious...more

FDA Reorganization Takes on Cancer Moonshot and Other Initiatives

On July 11, 1969, the United States accomplished the almost unthinkable –two men walking on the moon. Conjuring images of that moon landing, President Obama moved forward the “Cancer Moonshot” program at his January 2016...more

Missouri Governor Signs Biosimilar Substitution Law

Last month, Missouri Governor Jay Nixon signed into law Senate Bill 875, allowing pharmacists filling prescriptions for brand name biological products to substitute a less expensive biosimilar product if the biosimilar has...more

Additional Opioid Policy Changes Announced: What You Need to Know

Despite the July 4 holiday, the past week featured significant regulatory and legislative action addressing the use of opioids and pain management. The changes are in keeping with the Government-wide push to better understand...more

Third Party Administrator Update: TPA Regulatory and Legislative Developments

Polsinelli is pleased to share the June 2016 Third Party Administrator Newsletter. This newsletter covers topics throughout the year that impact TPAs. Information specific to Polsinelli's TPA practice is also included....more

Senate Finance Committee Chairman Releases White Paper Examining Potential Reforms to the Stark Law

On June 30, 2016, Senate Finance Committee Chairman Orrin Hatch released a white paper examining potential reforms to the Federal Stark law. The white paper, entitled “Why Stark, Why Now? Suggestions to Improve the Stark...more

28 Organizations Seek Clarification from President Obama Regarding Colombian Compulsory License -- U.S. Chamber of Commerce...

On July 5, 2016, we reported on two letters sent by two Senators and fifteen Representatives to Michael Froman, the U.S. Trade Representative ("USTR"), seeking clarification regarding the Administration's position on...more

Congress Proposes Legislative “Fixes” to Drug Industry Rules Believed to Be Contributing to High Costs

We spend a lot of time covering prescription drug costs on this blog, and even convened a Pharmacy Industry Summit earlier this year focusing on the various pressures that are contributing to higher drug prices. Although...more

Congress Jumps on Bandwagon to Reduce Biologic Drug Exclusivity Term

Ever since the Biologics Price Competition and Innovation Act (BPCIA) was passed along with the rest of the healthcare law commonly called "Obamacare" in 2010, the Obama Administration has included in every budget a proposal...more

New Proposed Legislation: Doctors Must Report Med Device-Related Deaths & Injuries

Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) announced plans to propose the Medical Device Guardians Act of 2016. According to a press release from Rep. Fitzpatrick, the Act is “a package of bills aimed...more

Illinois data breach law amended and includes new twists

Governor Bruce Rauner signed several new provisions into law amending Illinois’ Personal Information Privacy Act, including health insurance and medical information into the definition of personal information that triggers...more

The CREATE Act of 2016: Senate Listens to Generics Industry

Last week, co-sponsors Senators Leahy (D-VT), Grassley (R-IA), Klobucher (D-MN), and Lee (R-UT) introduced a bill (S. 3056), entitled the "Creating and Restoring Equal Access to Equivalent Samples Act of 2016" or the "CREATES...more

MedPAC Issues Recommendations on Medicare Drug, Post-Acute Care, and Other Payment Policies

MedPAC has released its June 2016 Report to the Congress on Medicare and the Health Care Delivery System. The report includes recommendations for a number of Medicare policy reforms and analyses of various health care market...more

Recent Congressional Health Policy Hearings and Markups

A number of Congressional committees have recently considered legislation and/or held hearings on various health policy proposals. ..The Ways and Means Committee approved seven bills related to health care coverage and...more

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