House Holds Hearing on Opioid Crisis
Discussion at the hearing largely focused on the desire to pass bipartisan legislation to address the opioid crisis as well as to determine best practices to identify over-prescribers and reduce instances of fraud. Opening Statements Chairwoman Lynn Jenkins opened the hearing by highlighting statistics regarding rising opioid related overdose death rates in her home state of Kansas. She went on to state that the “immense cost opioids impose on society” have caused a loss of productivity and put undue burden on the U.S. economic system. To lessen this burden, Jenkins stressed the importance to provide Medicare, specif...
Source: Policy and Medicine - February 15, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Should ACOs Be Revamped?
In an article authored by the American Enterprise Institute’s Resident Fellow and Milton Friedman Chair, James C. Capretta, he argues Medicare Accountable Care Organizations (ACOs) haven’t produced savings for the federal government. He believes ACOs would become more efficient and innovative if they were forced to compete with the other options beneficiaries have for getting their Medicare-covered benefits. Creation of ACOs Capretta describes the initial purpose of ACOs. They were created to address Medicare’s problematic fee-for-service program which has been found to foster waste and overuse of services. While M...
Source: Policy and Medicine - February 14, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

OIG Releases Review of QPP
The Office of the Inspector General (OIG) released a review of the Quality Payment Program (QPP), concluding CMS has made progress towards implementing the QPP, but challenges remain. CMS appears on track to deploy the IT systems needed for data submission but the OIG has identified two vulnerabilities that are critical for CMS to address in 2018 because of their potential impact on the program's success. OIG Study According to the OIG, it interviewed CMS staff and reviewed internal CMS documents as well as publicly available information. The OIG conducted qualitative analysis to identify key milestones (both those achie...
Source: Policy and Medicine - February 13, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Announces Study on Consumer and HCP Deception Perception
This study would assess whether consumers and healthcare professionals (HCPs) are able to “identify claims as false or misleading, and whether they would be willing to report deceptive drug promotion to the FDA.” The proposed project involves two studies examining volunteer participants’ ability to detect and report deceptive presentations in prescription drug promotion. The studies will be conducted concurrently and will focus on different health conditions. HCPs will view mock pharmaceutical websites targeted toward physicians while consumers will view mock consumer-targeted pharmaceutical websites. The goal will ...
Source: Policy and Medicine - February 12, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

New PhRMA Website Tackles Pharmaceutical Cost and Coverage
On January 24, 2018, the Pharmaceutical Research and Manufacturers of America (PhRMA) launched a new website, LetsTalkAboutCost.org. The new website aims to provide consumers with easily understood information about the cost and coverage of medicines. The website utilizes an interactive quiz format to educate consumers about medicine spending and pricing trends, insurance coverage of medicines, the biopharmaceutical supply chain, the role of hospital markups and other health care cost issues. The website asks questions such as “Who decides what I pay for my medicine?” and then answers them directly after. For examp...
Source: Policy and Medicine - February 9, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

CMS Improper Payment Rate Dips Below 10%
In 2017, the improper payment rate for fee-for-service Medicare dropped to 9.5%, the first time since 2013 that figure has been below 10%. By comparison, the rate was 11% in 2016, and there was a $4.9 billion year-over-year decrease in estimated improper payments, according to a blog post by Kimberly Brandt, principal deputy administrator for operations at the Centers for Medicare & Medicaid Services. Last year, CMS officials said the improper payment rate dropped from 12.1% in 2015 to 11% in 2016 chiefly because of the two-midnight rule, which set a new benchmark for impatient hospital claims. But in both of those ye...
Source: Policy and Medicine - February 8, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

New Jersey " Gift " Ban Revision?
During his last few days as Governor of New Jersey, Chris Christie’s administration enacted an aggressive regulation in an stated attempt to combat the opioid epidemic. The regulation was finalized in late December 2017 and required that beginning January 15, 2018, any contracts and payments entered into by prescribers directly with the pharmaceutical industry will be subject to a $10,000 annual cap. This cap includes payments from industry for consulting and speaking and includes a $15 per meal cap, but exempts research and education-related payments. Current New Jersey Governor Phil Murphy may now be trying to m...
Source: Policy and Medicine - February 7, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

New Jersey Gift Ban in Jeopardy?
During his last few days as Governor of New Jersey, Chris Christie’s administration enacted an aggressive law in an attempt to combat the opioid epidemic. The regulation was finalized in December 2017 and required that beginning January 15, 2018, any contracts and payments entered into by prescribers directly with the pharmaceutical industry will be subject to a $10,000 annual cap. This cap includes payments from industry for consulting and speaking and includes a $15 per meal cap, but exempts research and education-related payments. Current New Jersey Governor Phil Murphy is now trying to modify that rule, according to...
Source: Policy and Medicine - February 7, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Tomorrow: CMS To Host Open Payments Webinar/Q & A
Tomorrow, February 7, 2018, the Centers for Medicare and Medicaid Services (CMS) will be hosting a Webinar and Question and Answer session with CMS Open Payments program experts from 2:00 pm to 3:00 pm EST. CMS has been hosting these every few months for stakeholders to get some of their important questions answered. During this webinar/Q&A session, the Open Payments team will present an overview of system enhancements and data submission activities and will then be able to respond to your questions about the 2017 Open Payments program year. If you have a question, you must go online and register at least fifteen minutes...
Source: Policy and Medicine - February 6, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Senator Cassidy Introduces Legislation on 340B Program
Recently, Louisiana Senator Bill Cassidy introduced the Helping Ensuring Low-income Patients have Access to Care and Treatment, (the “HELP Act”). The legislation would close loopholes in the United States Department of Health and Human Services’ (HHS) 340B program and hold hospitals accountable for passing on prescription drug discounts to patients. The HELP Act would increase transparency and strengthen the reporting requirements to prevent abuse and ensure that 340B discounts are being used efficiently and to lower drug costs. The bill would prohibit any new enrollments in the 340B program for at least two years ...
Source: Policy and Medicine - February 6, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA Releases Guidance on IND Sponsors
In December, the FDA issued a guidance describing best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effective drugs. The guidance applies to communications between IND sponsors and FDA during the IND phase of drug development, including biosimilar biological product development (BPD). Guidance Communications between FDA and industry are often opportunities to share information on clinical trials and for the agency to provide ...
Source: Policy and Medicine - February 5, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

FDA REMS Blueprint on Opioids Finalized
On January 30, 2018, the United States Food and Drug Administration (FDA) finalized the “Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.” The Blueprint includes educational messages for health care providers involved in the treatment and monitoring of patients with pain. It also includes information on pain management, including the principles of acute and chronic pain management; non-pharmacologic treatments for pain; and pharmacologic treatments for pain (non-opioid analgesic and opioid analgesic).  This REMS represents a major ...
Source: Policy and Medicine - February 2, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

State of the Union De-Briefing
Conclusion Overall, there were statements by the President that earned cheers and some jeers from both sides of the political aisle. While lip service can be effective in providing a motivating speech, we will have to wait to see what changes are actually effectuated in the future.         Related StoriesE&C Health Subcommittee Votes to Advance Allowing Truthful Off Label CommunicationBipartisan Senators Release Committee Report on Drug Pricing InvestigationGottlieb Announces Medical Device Approval Process Update  (Source: Policy and Medicine)
Source: Policy and Medicine - February 1, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

Transparency Bill Reintroduced in Oregon
During the 2017 Oregon Legislature session, Senator Steiner Hayward and Representative Rob Nosse introduced legislation on prescription drug advertising that would have required manufacturers to disclose prices in any advertisement for prescription drugs in Oregon. The bill was introduced on February 14, 2017 and was referred to the Health Care Committee. On March 9, 2017, the Health Care Committee held a public hearing, but when the legislature adjourned on July 7, 2017, the bill remained in Committee, and therefore, it died on the vine. On January 22, 2018, Representative Nosse introduced HB 4005, “Prescription Drug P...
Source: Policy and Medicine - January 31, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs

CME Continues to Evolve for Providers and Practitioners
Several articles about continuing medical education (CME) were recently published in the Journal of the American Medical Association (JAMA). One article discussed the importance of regulatory alignment with the boards while the other discussed the proposed CME pyramid. CME Pyramid Medical education is an evolving field and as of late, there has been an increased focus on addressing professional practice gaps – the gaps between what physicians are doing and what they should be doing. Therefore, an outcomes framework has been proposed in the form of a pyramid that provides perspective on how addressing these practice gap...
Source: Policy and Medicine - January 30, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs