Pharmaguy's Insights Into Drug Industry News
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Pharmaguy's Insights Into Drug Industry News
Pharmaguy curates and provides insights into selected drug industry news and issues.
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Opioid Crisis Complicates GOP’s Health-Law Push

Opioid Crisis Complicates GOP’s Health-Law Push | Pharmaguy's Insights Into Drug Industry News | Scoop.it

The nation’s worsening opioid crisis has become another sticking point in Republican plans to dismantle major portions of the Affordable Care Act, with key GOP senators hesitating to support a bill that could threaten addiction treatment for millions of people.

Several provisions of the ACA, also known as Obamacare, allowed millions of Americans seeking substance-abuse treatment to gain coverage, including through an expansion of the Medicaid health program for the poor. But the House bill repealing the ACA, passed in early May, would roll back that Medicaid expansion beginning in 2020 and allow insurance companies to charge some people with drug addictions higher premiums or deny them substance-abuse coverage.

Concerns about those provisions cut into Republican support for the replacement measure in the House. Of the 20 Republicans who voted against the House bill, 16 represent states that saw significant increases in drug-overdose death rates in recent years.

Two of those lawmakers hail from Ohio, which, through the state’s ACA expansion, has enrolled more than 500,000 new Medicaid recipients who have behavioral-health needs, including those with drug addiction and different mental-health disorders.

Now, the same concerns are emerging as a factor as the Senate takes up the House bill and ponders how to change it.

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Docs Complain to CMS About ‘Sunshine’ Data Disclosures

Docs Complain to CMS About ‘Sunshine’ Data Disclosures | Pharmaguy's Insights Into Drug Industry News | Scoop.it
A group of medical societies and pharmaceutical industry trade groups is pushing the government to flesh out data that will be published next month showing how much drug makers pay doctors.


They sent a letter today to the Centers for Medicare and Medicaid Services to ask the agency to explain what context will be provided to help the public understand the justification for payments, such as speaking fees and grants used to bankroll clinical research.


The letter is signed by more than 20 medical societies and organizations including the American Urological Association, as well as heavyweight industry trade groups Biotechnology Industry Organization and the Pharmaceutical Research & Manufacturers of America.


The missive was sent as CMS plans to post the payment data in an online, searchable database as required in the Sunshine Act provision of the Affordable Care Act. The provision was passed in response to concerns that medical practice may be unduly influenced by industry.


The law requires most drug and device makers to report to CMS detailed information about payments and gifts provided to U.S. doctors and teaching hospitals. The disclosures are being made in stages, but September marks the debut when payments will appear publicly.

Supporters of the Sunshine Act say the transparency will provide useful information to patients about the relationships their doctors may have with drug or device makers, and serve as a deterrent to the more extreme examples of industry money unduly influencing medical care.


But some doctors and companies fear payment data will be misinterpreted by the public, or painted with a broad brush. They say there are legitimate interactions that serve to advance medicine, and that doctors should be compensated for services such as consulting for a company about the development of a new product.


Some medical societies teamed up with industry groups to form Partners for Healthy Dialogues, to defend such interactions between industry and doctors, and some of its members signed the letter sent to CMS.


The medical societies and industry trade group lament what they write in the letter is a dearth of context that accompanied CMS’s milestone release of Medicare Part B payments to physicians earlier this year.


Some medical groups say the data did not include context to show which doctors may be abusing the system and which were receiving big payments because of high overhead costs.

Pharma Guy's insight:


A survey revealed that of the more than 1,000 physicians questioned, over half admitted they didn't know that the law requires pharmaceutical and medical device companies to report on expenditures annually, without physician review of the data to correct any inconsistencies or errors, prior to submission to the government. 63% were deeply concerned that a record of these payments will be available in a publicly searchable database.


Listen to this podcast: Physicians Unprepared for Sunshine Law


Questions/Topics Discussed


  • Background regarding the sunshine law, including important dates for implementation.
  • Survey methodology
  • A summary of survey results and what they tell us -- pharma companies might be surprised!
  • How can physicians review the data before it goes public to correct inaccuracies.
  • What is at stake for pharma companies if they do not work more closely with physicians regarding access to the data?
  • What the industry must do to educate their physician clients about the Sunshine Law
  • Will this new form of "Big Data" eventually lead to a significant decrease in payments of all kinds to physicians by the drug industry?


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