MedTech Europe Changes Ethical Code
MedTech Europe represents the medical technology industries as a joint venture between EDMA and Eucomed and promotes a balanced policy environment that helps the medical technology industry meet Europe’s growing healthcare needs and expectations.
In 2015, MedTech Europe implemented a revised version of the 2008 Code of Ethical Business Practice to regulate interactions between members of the group and healthcare professionals. To help implement the code, in 2012, MedTech Europe created the Conference Vetting System. The Conference Vetting System attempted to address MedTech Europe members’ divergent interpretation of ...
Source: Policy and Medicine - October 11, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Belgian Sunshine Act Decrees Issued, Providing Guidance
On June 23, 2017, the Belgian “Sunshine Act” became law, requiring life science companies to disclose relationships with healthcare actors in the country. The Decree confirmed that the first publication of data under the statutory transparency regime will cover transfers of value for the year 2017 and will be published on betransparent.be by June 30, 2018.
The June 23 Decree notes that the provisions of the Sunshine Act apply to “premiums and benefits granted during calendar year 2017 to healthcare professionals, healthcare organizations and/or patient organizations.”
A second Decree was issued on August 22, 2017...
Source: Policy and Medicine - October 10, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
What California ’s New Drug Transparency Law Does – And Doesn’t – Do
We have written numerous times on the transparency bills in various states. California’s Senate Bill 17 is one of those bills that has worked its way through the statehouse and now sits at Governor Jerry Brown’s desk.
The bill aims to make drug prices more transparent for both public and private health plans by requiring pharmaceutical companies to notify health insurers and government health plans at least sixty days prior to raising prices more than sixteen percent over a two-year period of particular drugs with wholesale acquisition costs over $40. It would also require the companies to explain the reason behind th...
Source: Policy and Medicine - October 9, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Releases Draft Guidance for Industry: Statistical Approaches to Evaluate Analytical Similarity
The FDA announced a draft guidance for industry titled “Statistical Approaches to Evaluate Analytical Similarity”. The draft guidance offers advice to biosimilar sponsors on the evaluation of analytical similarity of a biosimilar to its reference product. FDA says this type of evaluation is performed as part of the biosimilar approval process to support a demonstration that the proposed biosimilar is highly similar to a reference product.
The draft guidance describes “the type of information a sponsor of a proposed biosimilar product should obtain about the structural/physicochemical and functional attributes of the...
Source: Policy and Medicine - October 6, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Announces the End of Part B Demonstration
The Centers for Medicare & Medicaid Services (CMS) announced it will officially withdraw the controversial Obama-era Medicare Part B Drug Payment Model Demonstration, almost ten months after the Obama administration announced that they would not finalize the demo. Under President Obama, CMS ultimately decided to withdraw the proposed rule after an overwhelming backlash from bipartisan lawmakers, the pharmaceutical industry, and patient stakeholders.
The Demonstration
The two-phase nationwide demonstration, driven by the Center for Medicare and Medicaid Innovation (CMMI), would have tested reformed Average Sales Price...
Source: Policy and Medicine - October 5, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
New Research Published on Generic Competition
As the FDA looks to boost generic competition, a new working paper published by the National Bureau of Economic Research (NBER) suggests that competition among generic drugmakers slows over time, potentially leading to higher prices for older treatments and drug shortages. The analysis authored by Ernst Berndt and Stephen Murphy of the Massachusetts Institute of Technology, and Rena Conti from the University of Chicago, reveals that generic drug prices have risen by a statistically significant margin over time as the rate of new entrants to the market has slowed and the number of firms competing for individual drugs has fa...
Source: Policy and Medicine - October 4, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
California Bans Prescription Discounts with Generic Equivalents
The California Assembly and Senate recently passed AB265, focused on amending price discounts permitted on prescription drugs. The legislation was initially offered by Assembly Members Wood and Chiu on January 31, 2017. The legislation passed the Assembly on May 31, 2017, followed by the California Senate on September 12, 2017.
Governor Jerry Brown has twelve days from the day the bills are presented to him to decide whether to sign or veto the bills before they automatically become law. AB265 was presented to the Governor on September 20, 2017, at 4:30 pm, meaning the twelve days are up and the bill automatically became ...
Source: Policy and Medicine - October 3, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Webinar: Risks and Opportunities in Today ’s Changing World of Continuing Medical Education
On Tuesday, October 31, 2017, our editor Thomas Sullivan will be a host of “Risks and Opportunities in Today’s Changing World of Continuing Medical Education,” a webinar. The webinar will discuss ways to take advantage of the unique opportunities presented in today’s healthcare environment and how you can minimize the risks to your Continuing Medical Education (CME) office.
Participants in the webinar will: gain perspective on the changing federal healthcare environment in the United States, including an overview of applicable rules and regulations; learn what the new Centers for Medicare and Medicaid Services (CM...
Source: Policy and Medicine - October 2, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
California Enacts Legislation on Reporting of Prescription Drug Costs
California’s Senate and Assembly have both passed legislation on publishing prescription drug prices (SB-17) and presented the legislation to California Governor Jerry Brown on September 19, 2017. Under California law, the Governor has twelve days to sign or veto the legislation before it becomes law automatically. For SB-17, those twelve days were up yesterday, October 1, 2017, and the legislation automatically became law.
What does the new legislation mean for those of us operating in California? The bill requires health plans and insurers that report rate information through the existing large and small group rate re...
Source: Policy and Medicine - October 2, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Webinar: Trump or Trumped – Update on CME and Federal Policy
On October 25, 2017, Andrew Rosenberg at Thorn Run Partners and Thomas Sullivan, our editor and President of Rockpointe Corporation, will present a webinar on CME and federal policy. The webinar will be hosted by the Alliance for Continuing Education in the Health Professions (ACEHP).
The webinar will focus on the various health reform plans that continue to swirl around Washington, D.C., and what they may mean for continuing medical education (CME). Some of the topics to be discussed during the webinar include: the Affordable Care Act (ACA) versus current Republican proposals; reviewing the Open Payment policy and CME ch...
Source: Policy and Medicine - September 29, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Senate Passes CHRONIC Care Act
On September 26, the Senate passed the CHRONIC Care Act is also known as the “Creating High-Quality Results and Outcomes Necessary to Improve Chronic Care Act.” The law passed with bipartisan support. “This legislation will improve disease management, lower Medicare costs and streamline care coordination services — all without adding to the deficit,” Senate Finance Committee Chairman Orrin Hatch (R-Utah) said in a statement.
Bill Specifics
There are several highlights from the bill. First, it extends the Independence at Home Model of Care. Specifically, it would extend the demonstration’s expiration date by t...
Source: Policy and Medicine - September 29, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Gottlieb Speaks to RAPS Regulatory Conference
United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently spoke with attendees of the Regulatory Affairs Professionals Society (RAPS) Regulatory Convergence conference about the steps the FDA is taking to make the clinical end of drug development more efficient and effective.
Gottlieb started by speaking and providing an overview of the history of medicine, all the way back to the “germ theory,” first proposed by Girolamo Fracastoro in 1546 through the late 1850s when Louis Pasteur and Robert Koch offered convincing evidence that germs caused disease and the 1870s, when sanitation was final...
Source: Policy and Medicine - September 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Taking Center Stage - Washington State ’s Medicaid Fraud Control Unit, the False Claims Act and Celgene
On July 26, 2017, the Washington State Attorney General (“AG”) Bob Ferguson (“Ferguson”) announced one of the State’s largest recoveries against the Pharmaceutical Company Celgene (“Celgene”) for allegations involving violations of the Medicaid False Claims Act, in particulars claims related to the company’s off-label marketing, fraudulent billing and providing kickbacks to doctors. The Washington State AG recovery represents a pivotal point in life science compliance, where State AGs similar to Seattle, are actively seeking recoveries against companies ...
Source: Policy and Medicine - September 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
New AAFP President to Focus on Administrative Burden
Michael Munger, MD, recently assumed the role of president of the American Academy of Family Physicians (AAFP). During his opening speech, he spoke about the progress being made in moving toward a value-based care approach and the angst many members feel about the increasing administrative burden on their practices.
Prior to his role as president, Munger served on the board for three years. During those three years, he noted that a recurring theme in conversations with other family physicians was what can be done about the overload of administrative work that is taking time away from meeting with patients.
“You all lov...
Source: Policy and Medicine - September 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Report Examines CME Preferences and Habits of Medical Education Teams
Life science teams employ several different types of independent medical education providers. These providers include dedicated third parties, hospitals, professional medical societies and academic institutions. Several factors such as corporate goals, public perception, drug program type and cost influence the CME provider decision.
Over three-fourths of surveyed global medical affairs teams consider dedicated continuing medical education (CME) providers as their first choice when funding CME programs, according to a recent survey done by Cutting Edge Information. The data found that apart from dedicated CME provid...
Source: Policy and Medicine - September 26, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
