Fresenius to the U.S. Government: When It Comes to the FCA, You Snooze You Lose
In a nearly decade long lawsuit involving the dialysis company Fresenius, and allegations that the company violated the False Claims Act by conducting and then billing the government for medically unnecessary hepatitis B tests, Fresenius is now seeking to challenge that the government is time-barred because the government took too long to intervene in this case. Although the Court has yet to decide the challenge by Fresenius, the outcome of that decision will likely have a significant impact on future government decisions to intervene in False Claim Act cases.
Everyone...
Source: Policy and Medicine - September 25, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Guidances Being Issued Slower than Expected
We found an interesting Regulatory Focus story on the lack of FDA guidance documents since the start of President Trump’s tenure in office. FDA announced it intended to release more than 100 draft guidances in 2017 but has not been close to that amount. Recent guidances, to illustrate, can be found at the following link.
Unclear reason
Regulatory Focus speculates it could possibly be related to President Trump’s Executive Order aiming to reduce regulatory activity. Or, before Commissioner Gottlieb was confirmed, it may have been the lack of a top official at the agency. The answer from the administration is particula...
Source: Policy and Medicine - September 25, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
To Disclose or Not to Disclose … That is the Question: The DOJ’s FCPA Pilot Program – Insights from Year One and Beyond
This article examines settlement trends before and during the Pilot Program to answer the question of whether or not it is sensible to self-disclose.
Last month, Sandra Moser, the acting chief of the DOJ’s Fraud Section made it clear that the DOJ would be increasing its enforcement efforts of healthcare related companies. Although life science companies have not been immune to Foreign Corrupt Practices Act (“FCPA”) investigations in the past, Moser stated that the DOJ viewed the healthcare industry as ‘one that faces serious compliance and corruption challenges not only in high risk markets overseas but right here...
Source: Policy and Medicine - September 22, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Accountable Care Organizations Under Magnifying Glass
Calling into question whether value-based care will ever truly work, a recent report casts dark news for ACOs. As reported, nearly half of physicians participating in the Medicare Shared Savings Program (MSSP) ACO in 2015 did not know if they could receive shared savings or faced downside risk, according to a study. Even as there are flaws with fee-for-service, there are legitimate questions being raised about the feasibility of implementing value-based health projects, as evident in this latest MSSP study.
MSSP ACO Study
The survey was conducted between September 2014 and April 2015 and asked more than 1,400 doctors par...
Source: Policy and Medicine - September 22, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
MedPAC Discusses Pharmacy Benefit Managers
During September 7th’s Medicare Payment Advisory Commission (MedPAC) public meeting, its commissioners discussed issues related to pharmacy benefit managers (PBMs). The slides during the presentation can be found here and an issue brief here as well. The Commission discussed issues related to the conflicts of interest between PBMs and PBM-owned specialty pharmacies, the role for exclusive specialty pharmacy networks in Part D, whether CMS should mandate PBMs’ disclosure of data to plan sponsors, among other topics. The following discussion between the commissioners broke along two lines: those supporting PBMs and other...
Source: Policy and Medicine - September 21, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
False Claims Act Mid-Year Review: Significant Life Science Settlements, Post-Escobar Developments & Industry Round Up
Several significant False Claims Act settlements and judgments in the first six months of 2017 suggest this year will result in the eighth year of over $3 billion in FCA recoveries. Additionally, recent judicial decisions in FCA suits have further refined the test outlined in the Supreme Court’s 2016 Escobar decision, statistical sampling has resulted in significant FCA judgments, and the government continues to explore new frontiers for FCA liability.
The False Claims Act (“FCA”) continues to be a powerful tool for the government (and relators) to curb fraudulent conduct. FCA settlements and judgments to date in 20...
Source: Policy and Medicine - September 20, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Draft Released on Nevada Pharmaceutical Representative Registration Procedure
Nevada passed legislation earlier this year, putting many new restrictions and regulations on the pharmaceutical industry there. Now, we see that the state is moving much quicker than we had anticipated on implementing those regulations.
Timeline
The legislation had many different parts to it, touching just about every facet of the pharmaceutical industry. With many different parts, an extensive timeline is required, with many different deadlines.
It was required that by July 1, 2017, the Department of Health and Human Services (DHHS) was to adopt regulations to help them carry out the provisions of the bill, inc...
Source: Policy and Medicine - September 20, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Study Released on Comparison of International Regulatory Authorities
Pharmaceutical regulations vary widely across the world, and while our sister publication, Life Science Compliance Update, keeps compliance professionals abreast of new development and comparisons across continents and countries, an article published August 2017 in Nature Reviews Drug Discovery offers comparisons in terms of the regulators’ budgets, staff, new drug approvals and timelines for approvals.
Of the regulators in the more established major pharmaceutical markets (in this study, the United States, Europe and Japan are considered the regulators in such markets), the United States F...
Source: Policy and Medicine - September 19, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Ohio Drug Distribution Verification: America ’s Key Battleground State Shakes Up the Pharmaceutical Supply Chain
This article provides the historical context and current overview of Ohio’s laws, regulations, and sub-regulatory guidance concerning the distribution of prescription drugs, including drug samples, into and within the state, the verification requirements when distributing product to terminal distributors of dangerous drugs and prescribers, record retention responsibilities, and penalties for noncompliance. The article then examines the industry’s response from a major manufacturer, a distributor/third-party logistics provider, verification vendor, and compliance advisory vendors. It concludes with a call to action to t...
Source: Policy and Medicine - September 18, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
PhRMA and Bio Sue Nevada
On September 2, 2017, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) filed a lawsuit challenging the constitutionality of Nevada’s first-in-the-nation insulin transparency law. The two groups allege that implementing the law would violate patient rights and nullify trade secret protections. PhRMA and BIO are asking the U.S. District Court to declare that provisions of the Nevada law, passed during the 2017 legislative session, are preempted by federal law and violate the U.S. Constitution.
The complaint alleges that the law violates the Taking Clause of t...
Source: Policy and Medicine - September 18, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
HELP Committee Holds Hearing on Individual Health Insurance Market
The Senate Health, Education, Labor and Pensions (HELP) Committee recently held the first hearing of several about ways to stabilize premiums and help individuals in the individual insurance market. The Committee heard from five different state insurance commissioners regarding their experiences with the individual insurance marketplaces under the Affordable Care Act (ACA). Most of the testimony focused on the need to fund cost-sharing reduction (CSR) payments, increase flexibility under the ACA’s section 1332 waiver program and establish a federal reinsurance program. There was bipartisan interest in stabili...
Source: Policy and Medicine - September 15, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Joint Commission Releases Report Regarding Pain Assessment and Management Standards
The Joint Commission recently released a report to help hospitals better understand and comply with new pain assessment and management standards that will be applicable to all Joint Commission-accredited hospitals, effective January 1, 2018.
An independent, not-for-profit organization, The Joint Commission accredits and certifies over 21,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.
The August 29, 2017, issue of the...
Source: Policy and Medicine - September 14, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Retrospect and Looking Forward: A Review of Three Full Years of Open Payments Data and Media Coverage
Tomorrow, September 14, 2017, from 10:00 am EST – 11:00 am EST, qordata is hosting a webinar on the three years of Open Payments data that has been made public. The speaker is none other than our editor, Thomas Sullivan, who looks forward to sharing highlights on the full three years of Open Payments data, and give some insight on what likely lies ahead in the future.
In addition to reviewing the 2014-2016 Open Payments data, Mr. Sullivan looks forward to providing insights on the following:
Media coverage of Open Payments and the released data sets;
New State laws, including transparency laws and “gift bans”;
...
Source: Policy and Medicine - September 13, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
Novo Nordisk $58 Million Settlement and REMS - Off Label Prosecution Still Alive and Well
Novo Nordisk will pay roughly $58.7 million to resolve claims that the company’s sales force downplayed the importance of mandated United States Food and Drug Administration (FDA) warnings about the cancer risks of its diabetes prescription, Victoza.
In a civil complaint filed on September 5, 2017, in the U.S. District Court for the District of Columbia, the government asserted claims under the FDCA, alleging that at the time of Victoza’s approval in 2010, the FDA required a Risk Evaluation and Mitigation Strategy (REMS) to mitigate the potential risk in humans of a rare form of cancer associated with the drug - Medul...
Source: Policy and Medicine - September 13, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
FDA Warns Cipher Over “Misleading” Marketing Materials
The United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent a warning letter to Cipher Pharmaceuticals over promotional materials for its combination immediate- and extended-release opioid tramadol hydrochloride, ConZip.
The warning letter, addressed to Cipher President and CEO Robert Tessarolo, states that marketing materials for ConZip directed at healthcare providers are “false or misleading” because they omit “important risk information” regarding the use of ConZip and because of other “material facts.”
The FDA said the promotional materials for ConZip make claim...
Source: Policy and Medicine - September 12, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs
