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Controlled Substance Prescribing Exceptions During Public Health Emergencies

In light of the novel coronavirus pandemic, health care practitioners should be aware of relaxed guidelines for prescribing controlled substance. This blog post describes when practitioners can prescribe controlled substances...more

Settlement Reached in the First Federal Opioids Trial

This post is an update from our earlier blog post, available here, on the bellwether federal opioids trial in the Northern District of Ohio.  Just hours prior to the start of the trial in a consolidated case involving two...more

Proposed Drug Rebate and PBM Service Fee Regulations Abandoned by Administration

As reported here in February, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released two new significant proposed regulations that would have had a transformative effect on the drug...more

Court Invalidates Final Rule Requiring Advertisements to List Drug Prices Finding that CMS Exceeded Its Statutory Authority

In a much anticipated decision, a federal judge ruled this week that the Trump Administration’s rule requiring drug manufacturers to list drug prices in television advertisements exceeds the agency’s authority. Back in May...more

Federal Government’s Charges against 60 Medical Personnel for Illegal Prescribing and Distributing of Opioids Demonstrates...

Today, the Federal Government announced enforcement actions against 60 defendants in eleven federal districts, including 31 doctors, seven pharmacists, eight nurse practitioners, and seven other licensed medical professional...more

President Trump Gives Speech on Prescription Drug Prices and Releases Blueprint to Lower Drug Prices and Reduce Out-of-Pocket...

On May 11, 2018, President Trump gave his long-awaited speech on his administration’s plan to lower prescription drug prices. In addition, the administration published its Blueprint to Lower Drug Prices and Reduce...more

Iowa Legislature Sends Bill Imposing Additional Requirements for Prescription Monitoring Program Reporting to Governor for...

Last week, with bipartisan support, both the Iowa House and Senate passed, unanimously, HF 2377 (“An Act Relating to the Regulation of Certain Substances, Including the Regulation of the Practice of Pharmacy, Providing...more

FDA Chief and HHS Secretary Cite Prescription Drug Prices as Top Priorities for Agencies; President Trump Scheduled to Speak on...

All eyes are on the federal government as top officials have recently signaled upcoming actions which could impact the prices of prescription drugs. In the past two weeks, leaders from both the FDA and HHS have made...more

OIG issues Advisory Opinion on a Retail Pharmacy’s Paid Membership Program Which Includes Federal Health Care Program...

On September 7, 2017, the OIG posted an advisory opinion regarding a retail pharmacy chain’s proposal to extend to federal health care program beneficiaries the option to participate in a paid membership program that includes...more

Opioid Epidemic Declared a National Emergency; Proposed Law Calls for Mandatory E-Prescribing of Controlled Substances to Curb...

Today, in a move that is widely supported by those in both political parties and across the country, President Trump declared the opioid epidemic a national emergency. Doing so will allow for additional resources to be used...more

New Medicare Proposals that Reduce Payment to Hospitals for 340B Drugs in 2018

On July 13, 2017, CMS released several proposed rules impacting health care, including the 2018 Outpatient Prospective Payment System (OPPS) proposed rule which, among other proposals, could have a significant impact on 340B...more

New York Times Obtains Copy of Draft Executive Order on Drug Prices; FDA Blogs that it is Working to Lift Barriers to Generic Drug...

On June 20, 2017, the New York Times reported that it had obtained a draft proposal of President Trump’s Executive Order on drug prices. The draft Executive Order, which has not been published, has been characterized as...more

Expected Executive Order to take on High Drug Prices; Senate Committee Hears Recommendations on Drug Supply Chain from Experts

According to an article posted today on the BioCentury website, the Trump administration is drafting an executive order that will take on the high costs of pharmaceuticals by instructing “executive agencies to use value-based...more

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