The California Hurdle - SB 790 and Pharma
This article reviews the changes SB 790 calls for, and what compliance professionals should keep an eye on.
The California Senate passed a bill (“SB 790”) in May 2017 that, if enacted, will change how pharmaceutical companies interact with health care professionals (“HCPs”). While standards and requirements for transfers of value are not new to pharmaceutical companies, SB 790 introduces new concepts for California, including:
• new standards for ‘allowable expenditures,’ which includes limitations on sponsorship of conferences or seminars that are educational, policy making, medical, or scientific;
To Rea...
Source: Policy and Medicine - July 21, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Accountable Care Organizations: Risk and Reward
In January 2015, HHS set the target of funneling 50% of Medicare payments through alternative payment models and tying 90% of fee-for-service payments to quality or value by the end of 2018. MACRA is part of that shift by changing the way Medicare pays physicians. Now, as reported by Modern Healthcare, the prospect of rewards from value-based care arrangements like ACOs is luring a “small but growing” number of ACOs into risker contracts with Medicare. However, as the article stresses, this is still a minority number of ACOs, with the vast majority in “upside-only” models where they share in savings but do not risk...
Source: Policy and Medicine - July 20, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Largest Fraud Takedown Announced by AG Sessions
On Thursday, July 13, 2017, United States Attorney General Jeff Sessions and Department of Health and Human Services (HHS) Secretary Tom Price, M.D., announced the largest ever health care fraud enforcement action by the Medicare Fraud Strike Force. The action charged 412 defendants across forty-one federal districts for their alleged participation in health care fraud schemes involving $1.3 billion in false billings.
The 412 defendants include 115 doctors, nurses, and other licensed professionals. Of the 412 defendants, over 120 of them were charged for their roles in prescribing and distributing opioids and other danger...
Source: Policy and Medicine - July 19, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Effectiveness, The Holy Grail of Compliance - Both the DOJ & OIG Weigh In
This article serves to compare and contrast the compliance guidelines as set forth by the DOJ and OIG within weeks of each other.
More than 25 years have passed since U.S. Sentencing Commission put forth the now infamous seven elements of an effective compliance program. Since then, Compliance Officers continue to chase the “holy grail” of effectiveness. Unfortunately, determining whether a compliance program is effective and how to measure for effectiveness has proven both elusive and difficult. Compounding the challenge is that in the historical period, compliance program guidance has been limited and infrequent. Bu...
Source: Policy and Medicine - July 19, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
United States House of Representatives Passes PDUFA
On Wednesday, July 12, 2017, the United States House of Representatives passed a bill via voice vote to reauthorize the prescription drug, generic drug, medical device and biosimilar user fee programs through 2022.
The current user fee programs expire September 30th, though the United States Food and Drug Administration (FDA) has said that if the reauthorization bill is not signed by President Donald Trump before August 1st, the FDA will be forced to send out layoff notices to about 5,000 employees.
“This legislation will save lives,” Representative Greg Walden said on the House floor, noting he thinks the Senate wil...
Source: Policy and Medicine - July 18, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
This is Not Your Parent ’s Compliance Program – The New Era of Compliance Resourcing at Small to Mid-Size Pharmaceutical Companies
This article explores the output of industry experts in attendance at CBI’s small to mid-sized breakout regarding the need for minimum compliance program resources as well as survey data showing that certain companies are funding their compliance programs in line with these needed minimum resources.
In April 2017, life science compliance professionals from around the country once again made the annual pilgrimage to Washington DC for CBI’s Annual Pharmaceutical Compliance Congress. Now in its 14th year, it is one of the largest annual gatherings of such professionals in the United States. What is remarkable abou...
Source: Policy and Medicine - July 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
CME Continues to Grow and Evolve
The Accreditation Council for Continuing Medical Education (ACCME®) recently released the ACCME Data Report: Growth and Evolution in Continuing Medical Education — 2016. The 2016 report includes data from a community of over 1,800 accredited continuing medical education (CME) providers that offer physicians and healthcare teams an array of resources to promote quality, safety, and the evolution of healthcare.
Key Report Takeaways
The report highlights the fact that CME is a vibrant – and growing – community. Last year, ACCME along with more than 1,800 accredited CME providers offered close to 159,000 educat...
Source: Policy and Medicine - July 17, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
PhRMA Report Shows More than 240 Immuno-Oncology Treatments in Development
In early June 2017, the Pharmaceutical Research and Manufacturers of America (PhRMA) – in partnership with the American Cancer Society Cancer Action Network (ACS CAN) – released a report that found there are over 240 immuno-oncology medicines and vaccines currently in development.
Immuno-oncology treatments are found through research into the role of the body’s immune system in fighting cancer. New immuno-oncology treatment options are allowing the patient’s own immune system to fight cancer similar to the way it fights disease-causing viruses and bacteria. The treatments can help the patient’s own immune system...
Source: Policy and Medicine - July 14, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Drug Approvals on an Uptick
Already in 2017, the FDA has approved a number of new drugs, which Regulatory Focus points out as a trend away from the low number of new drugs approved in 2016. They caution, however, it is unlikely to match the approval highs from 2014 and 2015. The pace for 2017 may not continue at this level and we could see an average, or perhaps slightly above average year for approvals.
2017 vs. Past
It has been reported that coming into 2017, the environment was looking better for approvals. According to the FDA’s Office of New Drugs, 36 new molecular entity NDAs were received by FDA through mid-December 2016, already beating t...
Source: Policy and Medicine - July 13, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Prices Testifies On Proposed Budget Cuts
We continue to follow the President’s budgets with potential cuts to the NIH and possible legislation to address drug prices. With that in mind, HHS Secretary Tom Price’s testimony in front of a House appropriations subcommittee is particularly relevant. The head of HHS reiterated his support for the President’s cuts to NIH and noted that he is working on a plan to lower the cost of drugs in the United States. Chairman Tom Cole’s (R-Okla.) remarks before Price’s testimony can be found here.
Price’s testimony
The Secretary faced a number of questions regarding the promotion of Obamacare plans along with drug p...
Source: Policy and Medicine - July 12, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Some Programs Entirely Eliminated Under Trump Budget Proposal
Many highly criticize President Trump’s fiscal year 2018 budget, for a variety of reasons. Many are opining that the projected spending cuts across the government would be dramatic, including cuts to “Obamacare” outlays by $1.25 trillion, through the American Health Care Act’s program amendments. Health care is implicated further, as the proposed budget would cut Medicaid spending by $610 billion and cut the Children's Health Insurance Program (CHIP) by $5.8 billion, while extending it through 2019.
Medicaid would be cut even beyond proposed reductions in the AHCA bill, by increasing the stringency of per capita c...
Source: Policy and Medicine - July 11, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
The Ohio “Drug Price Relief Act” Has Some Enemies
In November 2017, the state of Ohio will have a proposed statute included on the ballot for voters to approve, known as the “Ohio Drug Price Relief Act.” The proposal was written by California activist Michael Weinstein, the same author of California’s “Proposition 61,” which was not only defeated (53% to 47%) in the 2016 election season, but was also opposed by every major newspaper in the state.
The Ohio proposition would prohibit Ohio from paying more for prescription drugs than the lowest price paid by the United States Department of Veterans Affairs. It would also give the four co-sponsors of the ballot iss...
Source: Policy and Medicine - July 10, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
President ’s Opioid Commission Held First Meeting
On June 16, 2017, the President’s Commission on Combating Drug Addiction and Opioid Crisis held its first meeting to discuss ways in which to curb the current opioid epidemic through best practices of prevention and treatment. During the meeting, Commission members and panelists discussed the challenges of effectively addressing the opioid crisis through means of both prevention and treatment. The meeting also concentrated on the importance of a collaborated effort between agencies to implement comprehensive solutions. The administration reiterated their commitment to the issue, and stated that the President “cares dee...
Source: Policy and Medicine - July 7, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Comparison of House v. Senate Health Care Draft Bills
A topic of much discussion, but few solutions, has been healthcare in America. President Donald Trump was supposedly elected, in part, because of his promises to “Repeal and Replace” the Affordable Care Act, aka “Obamacare.” Many politicians and reporters were talking about passing the replacement bill prior to the summer Congressional recess. We are currently in that recess, and clearly, no such bill has been passed.
In today’s hyper-partisan world, it is tough to get all senators or representatives from one side of the political aisle to vote for something together; the idea that senators or representatives fr...
Source: Policy and Medicine - July 6, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
MedPAC Takes Anti-Pod Stance
The Medicare Payment Advisory Commission (MedPAC) released its annual Report to the Congress on Medicare and the Health Care Delivery System (the “Report”) on June 15, 2017. While the report makes many suggestions, one important one is the discussion of physician-owned distributorships of implantable medical devices (PODs). The discussion – and thereby, the report – call for action to reduce the number of PODs.
This negative commentary follows a 2016 report critical of PODs from the majority staff of the Senate Finance Committee, which concluded that PODs are “harmful to patients and payers.” The MedPAC Report...
Source: Policy and Medicine - July 5, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
