Opioid Class Action Suit Filed in Five States
On May 2, 2018, three law firms filed class action lawsuits against pharmaceutical manufacturers and distributors on behalf of individuals and businesses who have been handed higher insurance costs as a result of the opioid epidemic. The law firms filed suits on behalf of plaintiffs in five different federal courts: California, Illinois, Massachusetts, New Jersey, and New York. The complaints all charge major opioid manufacturers and distributors with fraudulent and deceptive marketing practices, negligence in distributing opioids into the marketplace, and other violations of state and federal law. In each of the lawsuits...
Source: Policy and Medicine - May 11, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Growth Rate of Spending on Medicine Slows
The IQVIA Institute for Human Data Science recently released a report focused on net spending on medicines in the United States in 2017, with an outlook to 2022. The report notes that spending on medicines grew less than one percent in 2017 – just a mere 0.6 percent. The report further found that the level and growth of spending, the price of new and old drugs, and the allocation of costs among patients, employers, health plans, intermediaries, and state and federal agencies, all “command great attention,” and therefore, the report aims to provide an “objective measure of medicine use” and the cost prescriptions...
Source: Policy and Medicine - May 10, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

CMS Announces Medicare Data Roll-Out
Conclusion During her remarks on the subject, Administrator Verma tried to differentiate this new path in relation to previous efforts CMS has taken to move towards a value-based system. She noted, “…what is different now is that we know we can’t achieve value-based care until we put the patient at the center of our healthcare system. And that requires that we empower patients with the data they need to become a consumer of healthcare and make informed decisions. Ultimately, the cornerstone of a patient centered system is data, quality data, cost data, a patient’s own data.”    ...
Source: Policy and Medicine - May 9, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Oklahoma Requires CME for Prescribers
Many states have taken the cue from the federal government and started their own investigation and research into opioids and the way opioids affect their particular state. Recently, Oklahoma joined the ranks of the states who have not just looked into the situation, but also went so far as to pass legislation to stymy the state’s opioid epidemic. One of the pieces of legislation passed was Senate Bill 1446, which asks the Oklahoma Board of Medical Licensure and Supervision to require continuing medical education (CME) for prescribers on opioid abuse and misuse, and also restricts initial prescriptions for opioids to a s...
Source: Policy and Medicine - May 8, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

House Introduces Bill to Require CME for Controlled Substance Prescribing
House of Representatives member Representative Susan W. Brooks recently introduced the ADAPT Act of 2018. The ADAPT Act (Abuse Deterrent and Prescriber Training Act of 2018) is an attempt to require training for prescribers of controlled substances. The bill would amend the Controlled Substances Act to include a requirement for all practitioners who are licensed under State law to prescribe controlled substances in Schedule II, III, IV, or V, a written certification that the practitioner has completed 3 hours of training under a specific training program, in all registration or renewal requests. The training program will...
Source: Policy and Medicine - May 7, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

ACCME Adopts New Strategic Plan
Conclusion The Board meeting and new strategic plan continue ACCME’s promise to continue to promote the development of high-quality CME that provides immediate and long-term benefits to society and fulfill the responsibility to maintain the highest standards of integrity and transparency.       Related StoriesACCME Announces New Collaboration with ABPathACCME Releases Report Highlighting 2017 SuccessesGottlieb Discusses Opioids and Lays Out Vision  (Source: Policy and Medicine)
Source: Policy and Medicine - May 4, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Maine Passes Drug Transparency Law – A Study
We try to keep our readers in the loop with transparency and other related legislation that are happening throughout the country. On May 1, 2018, the governor of Maine, Paul LePage, allowed legislation to pass into law without his signature that: (1) authorizes a study to review and overview drug prices and (2) has implications for top 25 drugs of different types. As noted in our previous article on the legislation, the Maine Data Health Data Organization now will be required to provide a report containing the following information about brand name and generic drugs by December 1, 2018, and annually thereafter: the 25 mos...
Source: Policy and Medicine - May 3, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

SCOTUS Denies Review of J & J Case
On Monday, April 16, 2018, the United States Supreme Court denied a request by Johnson & Johnson to review a whistleblower case against the company’s subsidiary, DePuy Orthopaedics, Inc.. Johnson & Johnson requested that the high court review a July ruling by the First Circuit Court of Appeals that revived a whistleblower lawsuit against the company. The lawsuit was filed by British orthopedic surgeons – Antoni Nargol and David Langton – who alleged that DePuy marketed defective metal-on-metal Pinnacle-branded hip implant devices to doctors who then turned around and sought government reimbursement for the p...
Source: Policy and Medicine - May 2, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Circuit Court Strikes Blow to Maryland Drug Pricing Measure
On April 13, 2018, the United States of Appeals for the Fourth Circuit struck down the first-in-the-nation law aimed at lowering the price of off-patent or generic drugs. The Court, in a two-to-one ruling, stated the law is in violation of the Commerce Clause of the United States Constitution and therefore, is unconstitutional. In 2017, Maryland became the first state to allow its attorney general to take legal action against drug companies after they increase the price of off-patent or generic drugs. The bill was passed by the Maryland legislature but became law without the signature of the state’s governor, Larry Hoga...
Source: Policy and Medicine - May 1, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

NQP Playbook Released on Shared Decision Making in Health Care Settings
In March 2018,  the National Quality Forum (NQF) released a guide for healthcare providers, the National Quality Partners PlaybookTM: Shared Decision Making in Healthcare. This recently-released Playbook offers vital guidance for the process of making shared decision making a standard of care for all patients, across settings and conditions. The National Quality Partners (NQP) Playbook: Shared Decision Making in Healthcare was developed with input from the NQP Shared Decision Making Action Team, including twenty public and private sector experts and stakeholders, holding a variety of positions including patients, cl...
Source: Policy and Medicine - April 30, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Maine and Colorado: Making Moves on Drug Price Transparency?
  We have been keeping up with proposed and passed legislation in several states that affect the pharmaceutical industry, especially those relating to drug price transparency. Many states over the past couple of years have been tweaking their rules regarding industry requirements for pricing transparency, largely in response to public outcry. The two most recent states to enter the transparency fray are Maine and Colorado, with each state introducing legislation that aims to regulate prescription drug price transparency. Maine In Maine, state Senator Eloise Vitelli introduced LD 1406 (SP 484), An Act to Promote P...
Source: Policy and Medicine - April 27, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Issues Order Restricting Sales of Contraception Device
Discussion Checklist – Acceptance of Risk and Informed Decision Acknowledgement. The labeling will now restrict the sale and distribution of the device only to healthcare providers and facilities that provide the required information to the patient. The patient must also be given the chance to review and sign the acknowledgement, as well as the physician implanting the device. Bayer, the device manufacturer, is required to implement the restrictions immediately and ensure that the process going forward results in health care provider compliance with the sales restriction. The FDA will review and monitor Bayer’s plan t...
Source: Policy and Medicine - April 26, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

McKesson Accused of Illegally Handling Cancer Medications
On April 4, 2018, a lawsuit was unsealed that shows McKesson Corporation – America’s largest drug distributor and one of the top five largest public companies of any kind in America – is being accused of illegally pooling leftover cancer medication from single-dose vials and selling it to healthcare providers. Those healthcare providers then in turn treated patients with it and typically billed the cost to government programs for reimbursement. The lawsuit, brought by a private company, Omni Healthcare, seeks unspecified damages from McKesson for violating the federal False Claims Act by selling the medication and p...
Source: Policy and Medicine - April 25, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

The End of Guidance Documents or Simply a Reminder of Well-Established Administrative Law Principles?
  As discussed in several news outlets, the Trump Administration recently announced that it would begin to enforce long-standing administrative law principles and limit the weight guidance documents carry in government actions against private companies and individuals. While the ramifications of this decision are still months away from realization, this article outlines the principles and the possible effects we will see in the future from this decision. Chaos and controversy seem to be synonymous with Trump Administration activities. This was certainly the case a fe...
Source: Policy and Medicine - April 25, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

9th Aggregate Spend and Open Payments Conference
On June 11th and 12th, 2018, the Ninth Aggregate Spend and Open Payments Conference will be held in Philadelphia, Pennsylvania at the Sonesta Philadelphia Hotel Rittenhouse Square. The organizers of the event recognize the importance of transparency reporting and the moving pieces that are involved in aggregate reporting of compensation data to avoid any conflicts of interest. Organizers note that while compliance leaders do their best to reduce any discrepancies prior to the Physician Payments Sunshine Act reporting deadline, they still spend millions of dollars annually to manage reporting errors. In an effort to contin...
Source: Policy and Medicine - April 24, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs