All posts by Jeff Schmerker

OTC Drug

OTC Drug Compliance Reform Act Will Impact Your Current & Future Offerings

Good news: This OTC Monograph legislation, now stalled in Senate, could help you innovate

Manufacturers of over-the-counter (OTC) drugs: Get ready for change. The Over-the-Counter Drug Safety, Innovation, and Reform Act promises to modify the regulatory system that oversees most OTC medications—and the OTC Monograph system. Anyone who develops and produces an OTC drug for marketing and sale in More..

ANDA

Heed New ANDA Requirements—Or Risk a Swift FDA Rejection

The agency has no tolerance for incomplete or inadequate submissions

Submitting Abbreviated New Drug Applications (ANDA), especially now, is no straightforward matter. The U.S. Food and Drug Administration (FDA) just released new Generic Drug User Fee Amendments (GDUFA) guidance and yet ANDA submitters are still encountering plenty of ambiguity—even while the FDA is cracking down More..

Medical Office Embezzlement

Root Out Medical Office Fraud: Limit Cash Access & Look for ‘Fraud Triangle’

Physician office embezzlement is more common than you think—and money is rarely recovered

Embezzlement is a depressingly common problem for medical offices, with Healthcare Management Systems reporting that three out of four physicians will suffer a significant loss due to theft in their careers—and, further, that the theft is typically fraud perpetrated by a trusted employee. Medical consultant More..

mobile devices

Mobile Tech Can Transform Healthcare—and Expose Patient Records

Learn how to text customers—without running afoul of HIPAA

The medical community has embraced the use of portable devices in health care settings—smartphones, tables, and laptops—both for personal and business uses. This convenience, however, comes with a major caveat—by using portable tech, staff may be violating the Health Insurance Portability and Accountability Act (HIPAA). More..

Opioid Epidemic

As Opioid Crisis Grows, Advocates Push for Revised Confidentiality Rules

Disclosure laws complicate full reporting, thwarting efforts to monitor epidemic

The opioid epidemic is officially a public health emergency, and more than 100 people are dying in the U.S. each day from opioid-related overdoses. Millions of dollars are being earmarked not only for treatment but also for monitoring requirements under which healthcare organizations are obliged More..

Write Effective FDA SOPs

9 Best Practices For Writing SOPs—Since FDA Requires Them But Offers Little Guidance

Compliance tip: Speak plainly and directly to “you”—so employees actually read your procedures

Almost every Food and Drug Administration (FDA) inspection includes a review of standard operating procedures (SOPs), and adverse agency findings often stem from SOP administration issues. Everyone should have good (if not great) SOPs—they are required for all life sciences sector companies. Yet the FDA More..

CMS Medical Student Documentation

CMS Allows Medical Student Documentation for Billable Services—But Proceed With Caution

Analysts See Risk and Reward: Less Paperwork, but Increased Potential Liability

The Centers for Medicare and Medicaid Services (CMS) recently issued a revision to the Medicare manual that everyone should be familiar with: Teaching physicians can use student documentation for billable services. But the ruling, which was quietly made, comes with plenty of caveats, so if More..