A Compliance New Year ’s Resolution – Assess the Company’s Culture
This article will discuss the importance to evaluate an organization’s culture of compliance, and will introduce some considerations on how this can be done.
At the start of every New Year, we hear people discussing, exchanging, making and breaking New Year’s resolutions. Why should the company compliance program be any different? Frankly, we do not think it should. Therefore, for 2018, we propose that assessing the company’s culture top the compliance New Year’s resolution list.
Here are a couple of reasons why culture assessment should top the list.
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Source: Policy and Medicine - January 15, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Maine Updates Their Gift to Physicians Law Online
Maine has posted a revised version of their gifts to physicians law which bans cash payments from pharmaceutical manufacturers, wholesalers agents for research, consulting, promotional speaking related payments but exempts educational materials, modest meals, prescription drug samples, honorarium at educational events and education-related funding to institutions.
We have previously written about the Maine Legislature passing a new law to prohibit gifts from industry to health care practitioners.
On November 1, 2017, the law went into effect and can now be found online for reference.
For a refresher, the la...
Source: Policy and Medicine - January 15, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Media Has it Out for Pharma …Still
Many would say that the media is no friend to the pharmaceutical industry. However, CNN has recently started to (seemingly) build a case against Avanir Pharmaceuticals for its promotion and marketing of its pseudobulbar affect (PBA) drug, Nuedexta.
In October 2017, CNN published its first article on the subject, where it was noted that the company “aggressively targets frail and elderly nursing home residents for whom the drug may be unnecessary or even unsafe.” While PBA afflicts less than 1% of Americans, it is most commonly associated with patients who have multiple sclerosis (MS) or ALS.
Then, in December 2017, C...
Source: Policy and Medicine - January 12, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Nevada Proposes Drug Transparency Regulations
We have written many times on the Nevada law passed in Summer 2017 that requires patient advocacy organizations to report all payments they receive from industry, regardless of the nature of the payment.
The legislation was signed into law by Nevada Governor Brian Sandoval in June 2017 and now the Nevada Department of Health is working on regulations to implement the law.
The current draft regulations require manufacturers and pharmacy benefit managers to submit a report by April 1st of each year for the previous calendar year that outlines the costs and rebates related to drugs listed on the List of Essential Diabetes D...
Source: Policy and Medicine - January 11, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Bipartisan Senators Release Committee Report on Drug Pricing Investigation
This report is the culmination of the Senate Aging Committee's year-long, bipartisan investigation into the egregious price increases on a number of decades-old drugs acquired by pharmaceutical companies that act more like hedge funds. We must work to stop the bad actors who are driving up the prices of drugs that they did nothing to develop at the expense of patients just because, as one executive essentially said, “because I can.”
“The hedge fund model of drug pricing is predatory, and immoral for the patients and taxpayers who ultimately foot the bill—especially for generic drugs that can be made for pennie...
Source: Policy and Medicine - January 10, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
HHS OIG Releases Report on Potential Drug Misclassifications
In conclusion, the report recommended that CMS (1) follow up with manufacturers associated with potentially-misclassified drugs identified in this report to determine whether current classifications are correct, (2) improve its Drug Data Reporting for Medicaid System to minimize inconsistent data submissions and track potential classification errors for follow up, and (3) pursue a means to compel manufacturers to correct inaccurate classification data reported to the Medicaid rebate program. CMS concurred with all three recommendations.
Correction: Our story published January 8, 2018 New ...
Source: Policy and Medicine - January 9, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
New Jersey Finalizes “Gift” Ban of Physicians Working with the Pharmaceutical Industry
Conclusion
Companies have until January 15, 2018, to enter into any contracts with New Jersey Health Care providers that may exceed the $10,000 total cap for promotional speaking and consulting payments.
Unfortunately, these types of rules often work against their stated purpose which is to fight the “Opioid Crisis” our review of the open payments database showed a modest use of payments to physicians by opioid companies in New Jersey. Rather than consulting with companies to determine the optimal use for their products, NJ physicians will have to pay close attention to their payments or find outside work in the lega...
Source: Policy and Medicine - January 8, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Kmart Settles Whistleblower Case About Inflated Prices
Kmart Corp. has agreed to pay $42 million to the federal government and several states to settle a whistleblower lawsuit jointly litigated by Phillips & Cohen LLP and Korein Tillery that alleged Kmart overcharged government healthcare programs and private insurers for generic prescription drugs.
The “qui tam” (whistleblower) case filed in 2008 by former Kmart pharmacist James Garbe alleged that from 2004 to 2016 Kmart charged Medicare, Medicaid and Tricare as well as private insurers more for generic prescription drugs than it charged customers who paid cash.
According to the whistleblower’s complaint, Kmart so...
Source: Policy and Medicine - January 5, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
How 2016 Drug Spending Stacks Up
We have written many times about the way growth in drug spending has significantly been below the growth rate of overall national healthcare spending, despite the media spotlight on the issue.
Total nominal United States health care spending increased at a rate of 4.3% and reached $3.3 trillion in 2016. Per capita spending on health care also increased by $354, totaling $10,348. Health spending growth did decelerate in 2016, however, following faster growth in 2014 and 2015 associated with coverage expansions under the Affordable Care Act and strong retail prescription drug spending growth.
In 2016 the slowdown was broad...
Source: Policy and Medicine - January 4, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
PhRMA Challenges California SB17 in Federal Court
On December 8, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) filed a complaint in the United States District Court for the Eastern District of California, challenging SB 17, a law they allege is unconstitutional.
The law was approved this year in response to consumer outrage over a rise in drug spending and high costs for some prescription treatments, including new Hepatitis C medications and EpiPens to control allergic reactions.
SB 17 provides that if a manufacturer has increased the federally defined nationwide list price (wholesale acquisition cost, or WAC) of certain products by ...
Source: Policy and Medicine - January 3, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Gottlieb Announces Medical Device Approval Process Update
FDA Commissioner Scott Gottlieb announced in a blog post the agency would be updating its medical device approval processes in order to accommodate rapidly advancing technologies. He described the modernization of FDA’s review framework would include the addition of a voluntary, alternative pathway for demonstrating substantial equivalence, and allow more flexibility to use modern criteria as the reference standard. Additionally, the new pathway will permit comparisons to standards that more closely approximate the kind of novel technology being evaluated. The new framework will be offered in addition to the current 510(...
Source: Policy and Medicine - January 2, 2018 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
In Depth Review of CMS MACRA QPP Regulations
As we continue our coverage of the MACRA Quality Payment Program (QPP) rule, the following article provides a more in-depth look at the regulations promulgated by CMS. We drafted an initial summary when the rule was released in early November.
Biggest surprise: cost category of MIPS
In its proposed rule in July 2017, CMS proposed completely removing the cost domain from MIPS for 2018, despite the underlying statute requiring that cost account for 30% of the overall MIPS score by 2019. However, in the final rule, CMS shocked many when it reversed its position and finalized a cost domain weight of 10 percent for the 2018 p...
Source: Policy and Medicine - December 28, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
OPDP Letters Remain on Decline
The Office of Prescription Drug Promotion (OPDP) is known for monitoring company communications about medical products and when it considers those communications to be outside of regulatory parameters, issuing a letter warning the company of such promotion. For relatively minor violations, OPDP issues an Untitled Letter; for more serious violations, OPDP will issue a Warning Letter.
As can be seen in the below graph, in the late 1990s, OPDP was issuing over 100 Warning and/or Untitled Letters annually. Since that time, there have been peaks and valleys when it comes to the number of Letters issued. Nothing compares...
Source: Policy and Medicine - December 27, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
OIG Asks CMS to Track Medicare Costs from Device Failures
A recent Office of Inspector General (OIG) report suggests that the lack of medical device-specific information on Medicare claim forms complicates CMS efforts to identify and track Medicare costs related to the replacement of recalled or prematurely failed medical devices.
The OIG determined that Medicare costs related to the replacement of recalled or prematurely failed medical devices could not be identified and tracked using only claim data. However, using claim and other data in combination with complex and labor-intensive auditing procedures, OIG estimated that services related to the replacement of seve...
Source: Policy and Medicine - December 22, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
PhRMA Releases New Policy Proposals
On December 11, 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) issued statements of support for several policy proposals focused on resolving the opioid crisis. The proposals included: limits on prescribing, a ban on prescribing of Schedule II opioids in an office setting, ongoing prescriber training, and expanded access to addiction treatment options.
Along with the policy proposals came an announcement that PhRMA and the Addiction Policy Forum have entered into a multi-year, multi-million dollar initiative to combat the opioid crisis and implement the Forum's plan to help solve the opioid crisis....
Source: Policy and Medicine - December 21, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
