Right to Try Fails in the House
The United States Senate previously approved legislation that would allow the terminally ill to access experimental drugs, commonly known as “Right to Try.” Recently, however, the United States House of Representatives failed to pass the legislation, with a vote of 259 to 140.
House Republicans tried to pass the bill under a suspension of the House rules, which requires any bill to take two-thirds support in order to pass, instead of a simple majority.
President Donald Trump previously showed his support for the bill in his State of the Union address in January 2018. “People who are terminally ill should not have t...
Source: Policy and Medicine - March 23, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Teva and McCaskill: A Game of Cat and Mouse
In Summer 2017, we wrote about Senator Claire McCaskill’s request to Teva Pharmaceutical Industries that they provide information about the distribution of opioids and its efforts to prevent drug diversion. In her original letter, McCaskill stated, “[t]his epidemic has reportedly arisen, in part, from the failure of opioid distributors to monitor the flow of hundreds of millions of painkillers to pharmacies across the United States and then on to the black market.”
In her initial letter, she requested several documents and pieces of information to “aid the Committee in understanding the role of manufacturers and d...
Source: Policy and Medicine - March 22, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Preparing for the 2018 Ethical MedTech, APACMed, and China Codes
Conclusion
As of January 1, 2018, these new rules have gone into effect throughout Europe, Asia and China. If you have any additional questions or concerns, a recording of the webinar can be viewed here.
Additional Resources can be found here:
Chart Comparing the Ethical Codes
China Code
APAC MED Code
MedTech Europe Code
Ethical Medtech - Conferences
Related StoriesPrivacy Upheaval – Exploring the Impact of the GDPR on Companies Sponsoring and Managing Global Clinical ResearchHCEA To Host Webinar on New International Ethics RulesACCME Introduces Guidance f...
Source: Policy and Medicine - March 21, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Prime Therapeutics Proves PBMs ’ Value
On February 20, 2018, Prime Therapeutics issued a press release that highlighted the way it – as a leading pharmacy benefit manager – has helped save its clients billions of dollars. The 2017 drug trend reports noted that its clients saw overall expenditure reductions (per member, per month) across all three lines of business (commercial, Medicare, Medicaid) as compared to 2016. Additionally, corresponding annual savings delivered to clients in 2017 exceeded $3 billion across all three lines of business.
“Our outstanding 2017 drug trend results are hard won, especially as we continue to see ongoing and significant p...
Source: Policy and Medicine - March 20, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA announces Public Meeting on Evaluating Inclusion and Exclusion Criteria in Clinical Trials on April 16
On April 16 from 8:30am to 5pm, the FDA will be holding a public meeting entitled “Evaluating Inclusion and Exclusion Criteria in Clinical Trials.” The event is convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA. The purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.
Meeting
The public ...
Source: Policy and Medicine - March 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
ACCME Announces New Collaboration with ABPath
The Accreditation Council for Continuing Medical Education (ACCME) and the American Board of Pathology (ABPath) are pleased to announce a new collaboration to simplify the integration of accredited continuing medical education (CME) and Continuous Certification (formerly referred to as Maintenance of Certification).
The ACCME and ABPath share a commitment to supporting pathologists’ continuing professional development and to improving pathologists’ performance and their care of patients. The collaboration is designed to expand the number and diver...
Source: Policy and Medicine - March 19, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
UnitedHealthcare Will Share Rebates with Patients
On March 6, 2018, UnitedHealthcare announced that beginning in 2019, the company will expand its pharmacy discounts to the seven million enrollees who are in fully insured commercial group plans at the point of sale for drugs, if a rebate is offered by the manufacturer.
The savings will apply to plan participants who are filling a prescription for a drug where the manufacturer provides a rebate. The savings from the rebates will be applied upfront, at the time of the sale, to ensure that patients are paying the lowest amount possible under their insurance plan. UHC notes that currently, rebates are used to keep premiums l...
Source: Policy and Medicine - March 16, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Benchmarking Insights 2017 Report Released
Recently, the Industry Alliance for Continuing Education (IACE) Benchmarking Working Group of the Alliance for Continuing Education in the Health Professions (ACEHP) issued its annual report, Benchmarking Insights 2017. This annual report is developed by surveying the medical education professionals of the pharmaceutical, biotechnology, and medical device industries to gain insights into standards and trends that are applied in commercial support of Independent Medical Education (IME).
Since 2009, the survey and subsequent report have been used as a way to learn and educate others about commercial supporters’ best pract...
Source: Policy and Medicine - March 15, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CARA 2.0 Introduced by Bipartisan Group of Senators
A bipartisan group of senators have introduced legislation framed as a follow-up bill to the Comprehensive Addiction and Recovery Act (CARA) of 2016. Dubbed CARA 2.0, the bill includes a combination of policy changes and increased funding authorizations that seek to restrict access to opioid-based painkillers and boost access to addiction treatment, including establishing a three-day initial prescribing limit on opioids for acute pain and aiming to increase the availability of treatment. The legislation was introduced by Sens. Rob Portman (R-OH), Sheldon Whitehouse (D-RI), Shelley Moore Capito (R-WV), Amy Klobuchar (D-MN),...
Source: Policy and Medicine - March 14, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
White House White Paper on Pharma Pricing Released
The objective of government in biopharmaceutical policy is to ensure that the private sector competes and invests in meaningful innovations that lower the price of health, rather than incentivizing market exclusivity and high prices on products. The two goals of reducing American prices and stimulating innovation are consistent but can be achieved through a combined strategy that corrects government policies that hinder price-competition at home, while at the same time limiting free-riding abroad.
One topic discussed in more detail in the report is how to reduce prices that are induced by Medicare and Medicaid reimburseme...
Source: Policy and Medicine - March 13, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
US Health IT Policy Lags Behind
As described in a recent opinion article, Health IT Now and the Bipartisan Policy Center convened a work group of organizations representing clinicians, patients, hospitals, and technology companies to assess the current regulatory landscape, identify the most pressing needs of users, and develop consensus on the ideal future role of government in a post-meaningful use era, and a rapidly evolving delivery system and technology environment. Their report can be accessed and read here.
“For too long, federal regulation of health IT favored reporting and process over care and treatment. HHS must create a new era in which go...
Source: Policy and Medicine - March 12, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Posts CY 2019 Notice and Call Letter
The Centers for Medicare and Medicaid Services (CMS) has posted the calendar year (CY) 2019 Advance Notice and Call Letter explaining proposed methodological and payment changes for Medicare Advantage (MA) plans, as well as key policies under Part D. The proposal includes opioid prescribing limits in Medicare Part D and changes to MA utilization of encounter data. It also expands MA supplemental benefits and reducing payments to Employer Group Waiver Plans.
Net Payment Impact
For MA plans, CMS estimates a +1.84 percent net increase on average relative to CY 2018 becau...
Source: Policy and Medicine - March 9, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Updates Physician Compare to Include 2016 Data and Star Ratings
CMS announced that it has updated its Physician Compare website to include 2016 data and new star ratings related to clinical quality. The first quality measures were added to Physician Compare in February 2014. Since then, CMS has continued a phased approach to public reporting.
2016 Performance Information on Physician Compare
Beginning in December of 2017, CMS started to publicly report certain 2016 performance information on Physician Compare. The information was designated as available for public reporting in the 2016 Physician Fee Schedule final rule. According to CMS, the primary audience for profile pages is pati...
Source: Policy and Medicine - March 8, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
New ESI Data Shows Medicine Spending Grew Just 1.5% in 2017
In early February 2018, Express Scripts Institute (ESI) released the 2017 Drug Report, which included new data that showed spending on medicines by ESI’s commercial plan sponsors grew just 1.5 percent in 2017, which is the smallest increase since they started tracking this data. Additionally, drug spending declined for almost half of commercial payers and Medicare, Medicaid, and exchange plans all saw very modest increases.
As you can see in this chart by the Drug Channels Institute, costs for traditional drugs declined, largely due to generic substitutions available in the blood cholesterol class and pricing pressures ...
Source: Policy and Medicine - March 7, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Issues New Draft Guidance on Submitting Formal Meeting Requests
A new draft guidance from FDA explains how sponsors can submit a formal request for a meeting, which can be face-to-face, teleconference/videoconference meetings or written responses only, what sponsors should include in that request, how FDA can respond, how long the agency can take to respond, and how the sponsor and FDA can go about conducting efficient, consistent, timely and effective meetings.
Meeting Types
FDA describes four types of meetings. Type A meetings are those that are necessary for an otherwise stalled product development program to proceed or to address an important safety issue. Before submitting a Typ...
Source: Policy and Medicine - March 6, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
