Trump Nominates Alex Azar to Head HHS
A few weeks ago, President Donald Trump nominated Alex Azar to lead the Department of Health and Human Services (HHS), following in the footsteps of Tom Price. The nomination – announced where else other than Twitter – said “Happy to announce, I am nominating Alex Azar to be the next HHS Secretary. He will be a star for better healthcare and lower drug prices!”
Azar has a history of involvement in the pharmaceutical world, including serving as HHS General Counsel and Deputy HHS Secretary under President George W. Bush. Mike Leavitt, the HHS Secretary when Azar w...
Source: Policy and Medicine - December 1, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
ACCME Introduces Guidance for CME Providers on MEDTECH, APACMed and China Codes
Recently, MedTech Europe, the Advanced Medical Technology Association (AdvaMed), and the Asia Pacific Medical Technology Association (APACMed) introduced changes to their respective codes of conduct relating to professional development activities, including continuing medical education (CME). As such, the Accreditation Council for Continuing Medical Education (ACCME) has offered guidance for CME providers with respect to the changes.
Starting in 2018, it is expected that the revised codes will require member manufacturers to discontinue making direct payments to clinicians...
Source: Policy and Medicine - November 30, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Hospitals and Health Systems Sue CMS Over 340B Provisions
Three hospital groups, along with three health systems, have filed suit against the Department of Health and Human Services (HHS) regarding the Centers for Medicare and Medicaid Services’ (CMS) recent regulation that made substantial cuts to hospitals for 340B drugs. The American Hospital Association, Association of American Medical Colleges, America’s Essential Hospitals, Eastern Maine Healthcare Systems, Henry Ford Health System, and Fletcher Hospital Inc. brought the suit, challenging the changes made to the 340B program that were included in the calendar year 2018 hospital outpatient system (OPPS) and ambulat...
Source: Policy and Medicine - November 29, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
The Summit on Controlled Substances – Regulation, Litigation, and Enforcement
The American Conference Institute is proud to host the inaugural Summit on Controlled Substances - Regulation, Litigation, and Enforcement, on January 29-31, 2018 in Washington, DC. This event offers a one-of-a-kind opportunity to gather with stakeholders from every link in the supply chain to discuss the most pressing issues surroundings the controlled substances industry, most prominently the opioid overdose crisis.
Federal and state authorities continue to go after opioid manufacturers, distributors, pharmacies, pharmacists, physicians, nurses— anyone and everyone who has a hand in the chain of custody for the...
Source: Policy and Medicine - November 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
McCaskill Files Amendment to Eliminate Marketing Tax Deduction
Senator Claire McCaskill of Missouri recently filed an amendment to the tax bill to eliminate the deduction for pharmaceutical marketing. While the likelihood of a Democrat-proposed amendment to a Republican-controlled bill passing is slim, it is still important to understand the action McCaskill has taken.
Simply because the bill is controlled by the Republicans, the Republican majority in the Senate is thin, meaning bipartisan support is likely needed in order for any tax reform to be done. It is likely that McCaskill introduced this amendment to raise the profile of the issue and to see if there is any bipartisan suppo...
Source: Policy and Medicine - November 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Vermont AG Probing Pharma and Physician Relationships
The Vermont attorney general is investigating the extent to which drug and device makers may have violated state law by giving gifts or payments for other items to health care providers, according to a source familiar with the matter.
As some of our readers may recall, Vermont banned industry gift giving to health care providers over concerns that the payments influence the way physicians practice medicine and prescribe medications, a contentious issue that later led the federal government to create a database to which drug and device makers must report any payments to physicians and teaching hospitals.
The Vermont law p...
Source: Policy and Medicine - November 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Urine Testing: The Next Shoe to Drop?
Opioids have been a topic of discussion for months now, and every week it seems as though a new company or individual is in hot water over opioid prescribing practices, or over alleged opioid prescribing practices.
One facet of the opioid epidemic that has not been touched upon is the requirement many pain management physicians and others have that when a patient is under their care and receiving opioids and/or habit-forming prescriptions, the patient must affirm that they are not seeing other physicians for prescriptions and/or that all prescriptions are being filled at the same pharmacy. To that end, the patient typical...
Source: Policy and Medicine - November 22, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
ICER Expanding Probe
A nonprofit group, the Institute for Clinical and Economic Review (ICER), recently received a three-year $13.9 million grant from the Laura and John Arnold Foundation to expand its ongoing investigative scope on drug pricing to include all new medicines and price increases on existing treatments.
Up until now, ICER hasn’t had the resources to review all new medicines. The additional funding “puts us on a new trajectory,” according to Steven D. Pearson, president of ICER. “Now we’re going to be able to cover the landscape.”
ICER was essentially founded with a $5.3 million grant from the Arnold Foundation in 20...
Source: Policy and Medicine - November 21, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Could MIPS Data Be Used Against Physicians?
One of the major changes thanks to MACRA and its associated Quality Payment Program (QPP) is the creation of MIPS, of the Merit-based Incentive Payment System. Much has been made about this new way physicians will be evaluated under Medicare. However, we have not seen the take of MIPS scores being used in other domains, such as medical malpractice lawsuits, until we came across this consulting firm’s hypothetical. Could MIPS data be used against physicians?
Hypothetical Malpractice Case
As described on MyMipsScores’ blog:
“[H]ere is another collateral effect of the MIPS score. This one is for our friends in the l...
Source: Policy and Medicine - November 20, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Approves Sixth United States Biosimilar
Recently, the FDA announced that it approved Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), the second biosimilar to AbbVie’s blockbuster Humira and sixth biosimilar in the United States. “Cyltezo is the first biosimilar from Boehringer Ingelheim to be approved by the FDA and marks an important step towards our goal of providing new and more affordable treatment options to healthcare providers and patients,” said Ivan Blanarik, Senior Vice President and Head of Therapeutic Area Biosimilars at Boehringer Ingelheim. “Chronic inflammatory diseases collectively affect 23.5 million people in the U.S., and Cyltezo h...
Source: Policy and Medicine - November 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS RFI Issued Regarding CMMI and Payment Models
In September, CMS issued a "request for information" (RFI) to solicit new ideas that will revamp CMS' Center for Medicare and Medicaid Innovation (CMMI) and the payment models the center creates. Specifically, CMS “is seeking your feedback on a new direction to promote patient-centered care and test market-driven reforms that empower beneficiaries as consumers, provide price transparency, increase choices and competition to drive quality, reduce costs, and improve outcomes.”
New Model Design
According to the RFI, CMMI will approach new model design with several guiding principles:
Choice and competition in the mar...
Source: Policy and Medicine - November 16, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Not Moving Forward With October Update of Hospital Compare
The Centers for Medicare & Medicaid Services announced it will not update its overall hospital quality star ratings on Hospital Compare in October. “CMS decided not to proceed with the October update to continue its examination of potential changes to the Star Rating methodology based on public feedback,” the agency said. The star ratings released last December will remain on the Hospital Compare website until the next update, CMS said.
Flawed Methodology and Hospital Criticism
When the ratings were posted in July 2016, they were heavily criticized by hospital groups and the Medicare Payment Advisory Commission (...
Source: Policy and Medicine - November 15, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Changes to 340B Program Reduces Hospital Reimbursement for Pharmaceutical Products by 28.5%
Recently, the Centers for Medicare & Medicaid Services (CMS) issued the Calendar Year (CY) 2018 Hospital Outpatient Prospective Payment System (OPPS) and Ambulatory Surgical Center (ASC) Payment System final rule with comment period (CMS-1678-FC), which includes updates to the 2018 rates and quality provisions, and other policy changes. CMS adopted many policies that will support care delivery; reduce burdens for health care providers, especially in rural areas; lower beneficiary out of pocket drug costs for certain drugs; enhance the patient-doctor relationship; and promote flexibility in healthcare. This final rule p...
Source: Policy and Medicine - November 14, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Accountable Care Organization Performance Results
2016 was the fifth performance year for the Medicare Shared Savings Program (MSSP). 2016 brought $652 million in savings to Medicare via Accountable Care Organizations, according to the Health Care Transformation Task Force.
The Shared Savings Program offers providers and suppliers (e.g., physicians, hospitals, and others involved in patient care) an opportunity to create a new type of health care entity, an Accountable Care Organization (ACO). An ACO agrees to be held accountable for the quality, cost, and experience of care of an assigned Medicare fee-for-service (FFS) beneficiary population. The Shared Savings Program ...
Source: Policy and Medicine - November 13, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Insight into 21st Century Cures Implementation
Conclusion
The proposed FDA work plan describes activities that are intended to successfully achieve the Cures Act requirements in areas that are a high priority for any Innovation Account funding that is appropriated. Together with other funding sources, as available, FDA’s proposed Innovation Account funding allocations can help chart a path for advancing medical product development and reviews and help bring innovative new therapies and products to patients and health care providers in a more timely and efficient manner.
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Source: Policy and Medicine - November 10, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
