Cory J. Fox

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FDA Issues Draft Memorandum of Understanding for 503A Drug Compounding

Photo of Lee H. RosebushBy Lee H. Rosebush, Cory J. Fox and Dena Kessler on Posted in Uncategorized
Included in the flurry of guidance documents recently issued by the FDA concerning human drug compounding is a long-awaited document of great importance to mail-order pharmacy compounders and entities that rely on interstate distribution of prescription compounded drugs—a Draft Memorandum of Understanding (MOU) between the FDA and each of the 50 states. As previously discussed, … Continue Reading

FDA Guidance Documents Change Compounding Landscape

Photo of Lee H. RosebushBy Lee H. Rosebush, Cory J. Fox, Nita Garg and Dena Kessler on Posted in Uncategorized
Almost a year and a half after adoption of the Drug Quality and Security Act (DQSA) in November 2013, which revised federal oversight of drug compounding, the Food and Drug Administration (FDA) continues to roll out guidance documents detailing its view on assorted issues concerning implementation of the statute. The FDA’s most recent offering is … Continue Reading

Now’s the Time to Comment on the FDA’s New Draft Documents on Compounding Policy

Photo of Lee H. RosebushBy Lee H. Rosebush and Cory J. Fox on Posted in Uncategorized
The U.S. Food and Drug Administration (FDA) has released five new draft documents related to drug compounding and repackaging by “outsourcing facilities,” state-licensed pharmacies, federal facilities and other healthcare entities. These documents are the latest in a series of policy guidance, including the documents released in July 2014 and December 2014, issued as part of the … Continue Reading

OCR Updates Breach Report Web Portal — Changes Could Impact Annual Breach Reports

Photo of Lynn SessionsBy Lynn Sessions and Cory J. Fox on Posted in Uncategorized
The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) recently launched an updated version of the portal covered entities must use to notify OCR regarding a breach of unsecured protected health information (PHI) under 45 C.F.R. § 164.408, and the changes could impact covered entities planning to submit their 2014 … Continue Reading

Ebola Information Quarantine: Balancing Patient Privacy With Public Health

Photo of Lynn SessionsBy Lynn Sessions and Cory J. Fox on Posted in Uncategorized
Of all the complex legal issues raised by the recent cases of Ebola in the U.S., those concerning the delicate balance between preserving patients’ privacy rights and the need to disseminate information to protect public health may be overlooked by providers. First, the laws may seem complex, consisting of a patchwork of state-level privacy and … Continue Reading

FDA Regulation of Laboratory Developed Tests on the Horizon

Photo of Lee H. RosebushBy Lee H. Rosebush, Nita Garg and Cory J. Fox on Posted in Uncategorized
At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of laboratory developed tests (LDTs). Under the Food and Drug Administration Safety and Innovation Act of 2012, the FDA is required … Continue Reading

Compounded Drugs and Medicare Part B: OIG Report Recommends Payment and Oversight Changes

Photo of Lee H. RosebushBy Lee H. Rosebush, Cory J. Fox and Greer Smith on Posted in Uncategorized
The U.S. Department of Health and Human Services (HHS) Office of the Inspector General (OIG) recently published a report titled “Compounded Drugs Under Medicare Part B: Payment and Oversight” (Report) in which it recommended that the Centers for Medicare & Medicaid Services (CMS) implement changes to the way Medicare Part B claims for compounded drugs … Continue Reading

Florida Gives Breach Notification Statute More Teeth

By Cory J. Fox on Posted in Uncategorized
Editor’s note:  This post originally appeared on BakerHostetler’s Data Privacy Monitor blog. On June 20, 2014, Florida Governor Rick Scott signed the Florida Information Protection Act of 2014 (FIPA), which will repeal Florida’s current breach notification statute at Fla. Stat. § 817.5681 and replace it with a new statute at Fla. Stat. § 501.171 effective … Continue Reading

FDA Releases Compounding Policy Documents

Photo of Lee H. RosebushBy Lee H. Rosebush and Cory J. Fox on Posted in Uncategorized
The U.S. Food and Drug Administration (FDA) has released five policy documents regarding compounded human drug products in connection with its continued implementation of the compounding provisions of the Drug Quality and Security Act (DQSA), enacted in November 2013. According to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research, as … Continue Reading

Stop the Presses! Senate Directs FDA to Meet With Stakeholders Before Enforcing Compounding Law

Photo of Lee H. RosebushBy Lee H. Rosebush and Cory J. Fox on Posted in Uncategorized
As previously discussed, the recent flurry of U.S. Food and Drug Administration (FDA) activity following passage of the Drug Quality and Security Act (DQSA) in November 2013, including the issuance of three draft guidance documents and six warning letters in the span of just a few months, has resulted in several important unanswered questions as … Continue Reading

FDA Regulation of Compounding Pharmacies: Unsolved Mysteries

Photo of Lee H. RosebushBy Lee H. Rosebush and Cory J. Fox on Posted in Uncategorized
The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the DQSA’s outsourcing facility provisions, published three draft guidance documents outlining its authority and enforcement priorities under Sections … Continue Reading

HHS Rule Grants Patients Direct Access to Lab Test Results

Photo of Lynn SessionsBy Lynn Sessions and Cory J. Fox on Posted in Uncategorized
The U.S. Department of Health and Human Services (HHS) recently published a Final Rule granting patients and their personal representatives access to the patient’s completed laboratory test reports directly from the lab maintaining the information. The Final Rule, published jointly by the Office for Civil Rights (OCR), the Centers for Medicare & Medicaid Services (CMS) … Continue Reading

Healthcare Privacy – 2013 Year in Review

Photo of Lynn SessionsBy Lynn Sessions, Kimberly M. Wong, Cory J. Fox and Anne Foster on Posted in Uncategorized
Editor’s Note: This post is a joint submission with BakerHostetler’s Data Privacy Monitor blog. On January 25, 2013, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published the long-awaited HIPAA Omnibus Final Rule (Final Rule), which includes the most sweeping changes to HIPAA since the Privacy and Security Rules were released. … Continue Reading

Texas to Launch Nation’s First Privacy and Security Certification “Safe Harbor”

Photo of Lynn SessionsBy Lynn Sessions and Cory J. Fox on Posted in Uncategorized
The Texas Health Services Authority (THSA) recently announced its selection of the Health Information Trust Alliance (HITRUST) Common Security Framework (CSF), the most widely adopted information privacy and security framework in the U.S. healthcare industry, to form the basis of the Texas Covered Entity Privacy and Security Certification Program, setting the stage for Texas to become the … Continue Reading

Senate Passes “Drug Quality and Security Act”

Photo of Lee H. RosebushBy Lee H. Rosebush and Cory J. Fox on Posted in Uncategorized
On November 18, 2013, the Senate, by voice vote, approved the Drug Quality and Security Act (DQSA), intended to bolster the Food and Drug Administration’s (FDA) oversight of compounding pharmacies in light of last year’s unfortunate incidents involving compounded medications and meningitis. The DQSA has received significant bipartisan support since its introduction and approval by … Continue Reading

Telemarketing: HIPAA Can Reverse the Charges Under the TCPA

Photo of Robert M. WolinPhoto of Lynn SessionsBy Robert M. Wolin, Lynn Sessions and Cory J. Fox on Posted in Uncategorized
The Telephone Consumer Protection Act (TCPA) generally limits automatically dialed and prerecorded telemarketing calls to wireless and residential phones. In the past, healthcare providers and other “advertisers” could rely on an established business relationship (such as a previous purchase) to circumvent the need to obtain a consumer’s written consent to receive certain telemarketing or advertising … Continue Reading

FDA Releases Unique Device Identification Final Rule, Draft Guidance

Photo of Lance L. SheaBy Lance L. Shea and Cory J. Fox on Posted in Uncategorized
On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI). According to the accompanying FDA Press Release, the UDI system is intended to provide a consistent method of identifying … Continue Reading

Regulation of Compounding Pharmacies Continues to Evolve with House Passage of “Drug Quality and Security Act”

Photo of Lee H. RosebushBy Lee H. Rosebush and Cory J. Fox on Posted in Uncategorized
In the current environment it seems that few, if any, pieces of legislation are moving through Capitol Hill. However, there is one area that has seen significant activity: the regulation of compounding pharmacies. Specifically, there has been bipartisan support for legislation intended to bolster the Food and Drug Administration’s (FDA) oversight of compounding pharmacies in … Continue Reading

New Survey Underscores Providers’ Responsibility for Preventing Medical ID Theft

Photo of Gregory S. SaikinPhoto of Lynn SessionsBy Gregory S. Saikin, Lynn Sessions and Cory J. Fox on Posted in Uncategorized
The Ponemon Institute’s recent publication of its fourth annual 2013 Survey on Medical Identity Theft (Survey) confirmed what many in the healthcare industry already knew: identity theft is a serious and often overlooked problem, and its continued expansion is significantly eroding patients’ trust in their healthcare providers. According to the Survey, the estimated number of … Continue Reading

After Recalls, Pharmacies Wonder How Well They REALLY Know Their Subcontractors

Photo of Lee H. RosebushBy Lee H. Rosebush and Cory J. Fox on Posted in Uncategorized
Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of pharmacy, the world of compounding is rapidly changing, and many pharmacies are turning to subcontractors for their … Continue Reading

Electronic Health Records: Adoption Accelerates, Debate Continues

Photo of Lynn SessionsBy Lynn Sessions and Cory J. Fox on Posted in Uncategorized
More than half of America’s doctors have now adopted electronic health records (EHRs), and the number of doctors and hospitals using EHRs continues to increase dramatically according to data recently released by HHS. This growth can be traced to the 2009 American Reinvestment and Recovery Act, which provided for incentive payments under Medicare and Medicaid to doctors … Continue Reading
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