Taking the Pulse on New Regulations Impacting Health Care Auditing


The busiest time of year for auditing health care financial statements is upon us, and this year, there are have been several widespread changes in the health care industry that will impact how these audits are conducted:
 
  • Industry consolidation and the related business combination accounting rules;
  • Increased activity of risk-based payment arrangements; and
  • Taxes and net premiums written for health insurance.

 
These audit issues can be complex so external third party auditors and their clients should work together on these issues during the planning phase of the audit to avoid any delays and be able to satisfy the looming deadlines.
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A Wave of High-Profile Court Cases Has Major Impact on the BioPharmaceutical Industry


While the biotech and pharmaceutical industries face ever-increasing intense global competition, there have been numerous, recent, high-profile litigation cases affecting the industry. Consequently, there is ever-increasing pressure on the industry to comply with these new legal mandates. This article provides the author’s thoughts regarding several high-profile litigation cases that are having a major impact on these industries.
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The BPCIA “Patent Dance” – Waiting for the Music to Begin


The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway for biosimilar products to enter the market by ripening patent disputes prior to FDA approval. Although somewhat analogous to the 1984 Hatch Waxman Act, the BPCIA contains a more complex—and to date, untested—statutory framework for exchanging patent information followed by two possible “waves” of litigation prior to biosimilar launch. The so-called “patent dance” begins when the biosimilar applicant discloses it confidential application and manufacturing trade secrets to the pioneer. When the dance stops, the pioneer will have an opportunity to assert at least one of its patents in a first wave of litigation.
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Let’s Acknowledge the Elephant in the Room: Tackling Cross-functional Tension during Promotional Review and Busting Myths About One Another


The start of any new year is always chock-full of resolutions and I would like to suggest another important one: acknowledging the elephant in the room when it comes to cross-functional tension during promotional review.
 
Over the course of my 35-year career, I’ve seen too many promotional review meetings unravel because marketing and compliance functions (legal, regulatory, compliance) are pulling against one another instead of operating as partners. I am optimistic that in the years ahead, we can align these disparate functions so they value one another’s contributions to overcome the kind of thinking below:
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A Regulatory and Compliance Guide to New Year’s Resolutions


For better or for worse, the pharmaceutical industry is one of the most highly regulated industries in the country. There are a myriad of laws that apply throughout a drug’s life cycle from development, to approval, to marketing and promotion.
 
One only has to look to the Department of Justice’s most recent statistics on health care fraud recoveries to understand the legal and financial risk associated with failure to comply with applicable regulatory requirements. The pharmaceutical industry accounted for a substantial portion of the government’s $2.3 billion in health care fraud recoveries in fiscal year 2014, with one manufacturer alone paying $1.1 billion to resolve False Claims Act claims relating to off-label promotion and the payment of kickbacks.
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The Importance of an Audit-Ready Learning Solution


While audits are the commonplace in the pharmaceutical industry, the preparedness for those events varies. The companies that develop a risk-based approach to audits are able to remain competitive while meeting quality and government compliance standards on a regular basis. Conversely, the companies that have not implemented strong processes are putting themselves at risk for non-compliance.
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