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Wow. It ' s been three months since I last checked in with you, my loyal readers. All 3 of you. As you might guess from reading my ranting over the past 11-plus years, I ' ve been in the midst of a dilemma, in this case trying to figure out what my future should hold. There are many directions to go, many options to consider, and many needs to satisfy. But I think I ' ve got it. Finally.To be totally honest, my basic instinct was to retire completely at the end of the year. Which was my intentionlast year, but somehow I stayed on. And I will indeed continue to work for another year, although I ' ll cut back my weeks e...
Source: Dalai's PACS Blog - October 5, 2016 Category: Radiology Source Type: blogs
Memo To The President: The Pharmaceutical Monopoly Adjustment Act Of 2017
Since 1980, Congress has enacted many laws granting pharmaceutical manufacturers monopolies that no other industry enjoys. These extra monopolies were created with the expectation that monopoly profits would spur greater investment in research to find important new drugs. In fact, they have caused US consumers to pay higher prices for medicines for longer periods of time while making the pharmaceutical industry far more profitable than any other industry. I believe the next president and Congress should take several key steps, which I outline below, to roll back these costly, unnecessary monopolies.
The Current Landscape
C...
Source: Health Affairs Blog - September 13, 2016 Category: Health Management Authors: Alfred Engelberg Tags: Costs and Spending Drugs and Medical Technology Health Policy Lab Bayh-Dole Act Big Pharma Gilead Hatch-Waxman Act johnson & johnson pfizer Source Type: blogs
Lynn’s facial redness gone in 3 days on the Wheat Belly Detox!
Lynn shared her “before” and “during” photos, just 3 days into her Wheat Belly 10-Day Detox experience.
“This is how much my skin redness has calmed since starting my Wheat Belly Detox 3 days ago. I was always getting asked if my blood pressure was up. I have always had great blood pressure, so that was never the issue. However, I never understood why my face would get red like this. Then I noticed it was especially after I ate.
“The ‘before’ pic was taken during Christmas time, therefore the redness isn’t from sun but from the wheat and grains. Also both pics are witho...
Source: Wheat Belly Blog - April 8, 2016 Category: Cardiology Authors: Dr. Davis Tags: Wheat Belly Lifestyle facial change gluten grains Inflammation redness skin Source Type: blogs
Stephen’s return from the medical quagmire
Stephen shared his 60-day Wheat Belly experience:
“Started Wheat Belly 60 days ago after a major health crisis. I found out I had type 2 diabetes 2 and very bad cholesterol. My numbers 60 days ago were: cholesterol 189, triglycerides 475, LDL could not be measured as it was so bad, HDL was 32. Two weeks ago: 20 pound weight loss, wearing a 15.5-inch neck size shirt compared to an 18. Triglycerides 79, LDL 25, HDL 40, cholesterol 81.
“I was first told on January 24, 2016 that my glucose level was 157. Forty five days later, my average glucose was 107 when measured by my diabetes counselor by downloading the data...
Source: Wheat Belly Blog - April 7, 2016 Category: Cardiology Authors: Dr. Davis Tags: Wheat Belly Success Stories cholesterol diabetes gluten grains HDL statins triglycerides Weight Loss Source Type: blogs
Update on Biosimilars US Regulation 1st Quarter 2016
Yesterday the FDA approved Inflectra the Pfizer/Celltrion version of Remicade, becoming the second biosimilar and the first monoclonal antibody to proceed through the the FDA 351 (k) pathway for biosimilars. But given current resource allocations towards towards biosimilars at the FDA it may be a while before we see large numbers of approvals.
he biosimilars pathway will be significantly impacted by FDA guidance in the coming year. In 2015, FDA issued guidance documents but did not go so far as to settle fundamental questions related to the labeling of biosimilars, the requirements of interchangeability, and...
Source: Policy and Medicine - April 5, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Courts to Finally Take Up CMS Recovery Audit Contractors Appeals Backlog
According to HHS, a backlog exists of more than 800,000 appeals from health care providers challenging denied Medicare claims, most of them generated by the program's Recovery Audit Contractors (RACs). That is about 10 times as many as the program can adjudicate in a year at its current funding levels. However, a federal appeals court has given new life to a lawsuit that seeks to force the government to complete the appeals more quickly. The court's ruling sends the case back to the district court for reconsideration. This moved was quickly celebrated by the American Hospital Association.
We have previously reported on p...
Source: Policy and Medicine - April 3, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Offering Free Biosimilars CME Course
There is a ballooning interest in biosimilars and interchangeable products in the pharmaceutical industry, especially with the first biosimilar in the United States being approved in 2015. The Food and Drug Administration continues to review other marketing applications for proposed biosimilar products.
The FDA has announced that they have developed a free, Continuing Education Course for healthcare professionals, FDA Overview of Biosimilar Products. This course was created for healthcare professionals to strengthen their knowledge and understanding of biosimilars and interchangeable products. For example, biosimilars an...
Source: Policy and Medicine - March 4, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Guidance: Determining the Extent of Safety Data Collection Needed in Late-Stage Premarket and Postapproval Clinical Investigations
The FDA finalized a guidance it originally released in 2012 that is aimed to help industry collect safety data in late-stage premarket and postapproval clinical investigations. The FDA says in the guidance that selective safety data collection may be possible for some late-stage premarket and postapproval clinical investigations because "certain aspects of a drug's safety profile will be sufficiently well-established and comprehensive data collection is not needed."
Safety Databases
Safety databases collect information to accurately assess and characterize the risks of a new drug. A sponsor collects safety-related data...
Source: Policy and Medicine - February 29, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Responsibility in Drug Advertising Act of 2016 - Introduced to Restrict DTC - Direct to Consumer Advertising
United States House of Representatives member Rosa DeLauro introduced a bill the Responsibility in Drug Advertising Act to the House of Representatives that would restrict most direct to consumer (DTC) advertising of a new drug for the three years following the drug's approval. The only way around the three-year long DTC ban is if the Department of Health and Human Services (HHS) waived the waiting period. Such a waiver would come only after the drug sponsor submits an application requesting such to HHS and HHS determined that DTC advertising of the drug would "have an affirmative value to public health."
The legis...
Source: Policy and Medicine - February 24, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Robert Califf Confirmed as FDA Commissioner 89-4
Despite months of hand-wringing and opposition, the Senate overwhelmingly voted to confirm Dr. Robert Califf as the next Food and Drug Administration commissioner by a bipartisan vote of 89 - 4. This confirmation follows a cloture vote from earlier this week, despite opposition from some a small group of Senate Democrats, including presidential candidate Bernie Sanders. The opposition was because some alleged Califf had huge ties to the pharmaceutical industry. In the end only four Senators voted against his nomination Senators Blumenthal (D-CT), Markey (D-MA), Manchin (D-WV) and Ayotte (R-NH).
Most responded to...
Source: Policy and Medicine - February 24, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Understanding Medicare Access and CHIP Reauthorization Act of 2015 (MACRA), Merit-Based Incentive Payment System (MIPS) and Alternative Payment Models (APM’s)
Discussion
MACRA enshrines the concept of value vs. volume and a seismic shift from fee for service to value based payments. There will be tremendous need for education for today's clinicians to further understand MACRA and all its ramifications. Big questions need to be answered such as what the rule will look like, what does it mean to bear more than nominal financial risk, what will be included in value, will MIPS Meaningful Use, PQRS and Value Based Modifiers be similar to the current system .
Fortunately, there will be opportunities to let your voice be heard on this very important program.
&#...
Source: Policy and Medicine - February 18, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Congress Seeks Feedback on Site-Neutral Provision of Bipartisan Budget Act of 2015
House Energy and Commerce Committee Chairman, Representative Fred Upton, and Subcommittee on Health Chairman, Representative Joseph Pitts, have begun to solicit input from members of the healthcare community on certain policy changes, including changes made to certain Medicare hospital reimbursements on a prospective basis. Representatives Upton and Pitts are requesting feedback on policies that have the potential to amend or expand the site-neutral provision included in the Bipartisan Budget Act of 2015.
Representatives Upton and Pitts write,
Given the wide breadth of suggestions, ideas, concerns and proposals shared ...
Source: Policy and Medicine - February 17, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Senate HELP Committee Moves Closer to Creating Corollary to 21st Century Cures
Last week, the Senate Health, Education, Labor, and Pensions (HELP) Committee approved a series of seven bills to work up medical innovation legislation that will eventually likely become the Committee's response to the 21st Century Cures Act passed by the House of Representatives.
Last month, HELP Committee Chairman Lamar Alexander of Tennessee estimated that the Senate's version will not mirror the House bill, and that the Senate's effort will focus on priorities that are identified by the Committee's members, such as improving federal electronic health record programs.
Last week's productive meeting was not the last...
Source: Policy and Medicine - February 16, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
US Continues to Face Drug Shortages
Once again we are facing national shortage of key drugs, including anesthetics, painkillers, antibiotics, and cancer treatments. We have written several times about previous drug shortages, all resulting in little to no beneficial long-term action.
The American Society of Health-System Pharmacists maintains a list of drug shortages, which is currently 150 drugs and therapeutics long. The 150 drugs are at inadequate supply levels for a multitude of reasons, ranging from manufacturing problems to federal safety crackdowns to drug makers abandoning low-profit drugs. While the shortages have long been public knowledge, what ...
Source: Policy and Medicine - February 15, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CMS Issues Final 60 Day Payment Rule
The Sixty Day Rule
The Centers for Medicare and Medicaid Services (CMS) has finally issued its final rule related to the reporting and refunding of Medicare Part A and Part B overpayments, also known as the "60 Day Rule." The Final Rule requires healthcare providers to repay an overpayment and to notify the federal government, the state, and any "intermediary, carrier or contractor to whom the overpayment was returned in writing of the reason for the overpayment," within sixty days of first identifying the overpayment. Providers who fail to heed the sixty day reporting and return window can face potential civil monetary ...
Source: Policy and Medicine - February 12, 2016 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
