Dena Feldman

Dena Feldman

Dena Feldman practices in the areas of health care, federal-state programs, and public policy and government affairs. Ms. Feldman advises clients on the federal rules and policies governing Medicare and Medicaid, including the new mandates of the Affordable Care Act. She has particular expertise regarding Medicare and Medicaid reimbursement for behavioral health services, including rules governing Medicare conditions of participation, institutions for mental diseases (IMDs), and treatment of forensic patients. Ms. Feldman also advises clients on health privacy issues arising under HIPAA, the HITECH Act, and state medical privacy laws.

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Health Care Task Force Pre-Releases Report on Cybersecurity Days Before Ransomware Attack

Last week, the Health Care Industry Cybersecurity (HCIC) Task Force (the “Task Force”) published a pre-release copy of its report on improving cybersecurity in the health care industry.  The Task Force was established by Congress under the Cybersecurity Act of 2015.  The Task Force is charged with addressing challenges in the health care industry “when … Continue Reading

HHS Issues Guidance on HIPAA and Cloud Providers

The Department of Health and Human Services (HHS) recently published guidance on HIPAA requirements governing the use of cloud computing entities, specifically cloud services providers (CSPs). In this guidance, HHS explains that CSPs that create, receive, maintain, or transmit protected health information (PHI) on behalf of a covered entity or business associate are considered business … Continue Reading

FDA Releases Draft Guidance on Dissemination of Patient-Specific Information by Device Manufacturers

Last month, the FDA released a draft guidance document on the sharing of patient-specific data associated with medical devices, including information recorded, stored, processed, retrieved, and/or derived from the device.  FDA noted that patients increasingly seek to play an active role in their own health care and that providing patients access to information regarding medical … Continue Reading

HHS Launches Portal Seeking Questions from Mobile Health Application Developers

On October 5, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services launched a new platform to enable developers of mobile health technology, as well as others “interested in the intersection of health information technology and HIPAA privacy protection.” OCR notes that there is currently “an explosion of technology … Continue Reading

Recent Action on Medical Device Tax

The medical device tax is back in the news, after recent congressional efforts to delay or repeal the tax.  The most recent efforts arose in the context of the “tax extenders” bill, which extends until the end of 2015 more than 50 tax provisions that are due to expire at the end of 2014.… Continue Reading

Analyst Report Indicates that Health Care Organizations, Including Internet-connected Medical Devices, Are Vulnerable to Attack

A recent analyst report indicates that health care organizations and internet-connected medical devices are increasingly vulnerable to cyber-attacks. The Health Care Cyberthreat Report was issued in February 2014 by the SANS Institute, which describes itself as a cooperative research and education organization that is a source of cybersecurity training, security certification, and research information.… Continue Reading

HHS OIG Releases Report on HIPAA Enforcement Efforts

Recently, the Office of Inspector General (OIG) at HHS released a report on the HIPAA enforcement efforts of HHS’s Office for Civil Rights (OCR).  Specifically, the OIG looked at whether OCR’s efforts to enforce HIPAA’s Security Rule were adequate.  The OIG’s findings may lead to increased enforcement efforts by OCR.… Continue Reading

Medical Device Tax Repeal Not Included in Final Budget Agreement

We previously reported about the prominent role played by the medical device tax in the government shutdown/debt ceiling negotiations.   At various points, repeal of the medical device tax was included in proposed measures to fund the government.  When full repeal appeared to be off the table, several sources reported that Congress had considered a two-year … Continue Reading

Medical Device Tax Repeal Considered in Government Shutdown Negotiations

The medical device tax has played a prominent role in negotiations over the continued government shutdown.  We have previously discussed legislative efforts to repeal the medical device tax here and here. Just after midnight on Sunday, September 29, two days before appropriations were scheduled to lapse, the House of Representatives passed a continuing resolution to … Continue Reading

Legislation Introduced to Protect Medical Devices from Effects of Sequestration

Under the Budget Control Act, popularly known as the sequester, mandatory spending cuts are in effect at agencies across the federal government.  The Act was enacted as part of negotiated compromise in the summer of 2011 to secure an increase in the federal debt ceiling.  As part of the debt limit increase, Congress established the … Continue Reading

New Study Shows Increased Enforcement Action

A new study released this week by medical device firm Emergo Group shows a steady increase in FDA inspections of medical device manufacturers since 2009.  The study showed that FDA quality system inspections between 2005 and 2009 numbered around 1500 inspections a year.  However, between 2010 and 2012, FDA averaged approximately 2000 inspections a year—about … Continue Reading

Medtronic Device to Undergo FDA/CMS Parallel Review

In 2011, the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) announced a pilot program for concurrent review of certain FDA premarket review submissions for medical devices and CMS national coverage determinations (NCD).  The agencies explained that the goal of the pilot program is to “facilitate the development of … Continue Reading

Congress to Hold Hearings on FDA Regulation of Mobile Medical Apps and Impact on Innovation

On March 19, 20 and 21, 2013, the Energy and Commerce Committee of the U.S. House of Representatives will hold a series of three hearings on “Health Information Technology to Explore Potential Regulations and Taxes on Smartphones, Tablets, and Mobile Apps.” The hearings will take place in three different Energy and Commerce subcommittees and will … Continue Reading

Legislation to Repeal Medical Device Tax Introduced

Two bills to repeal the medical device tax were introduced in Congress this month.  The device tax was enacted as part of the Affordable Care Act and finalized in IRS regulations late last year.  Representatives Erik Paulsen (R-MN) and Ron Kind (D-WI) introduced the “Protect Medical Innovation Act of 2013,” on February 6.  The House bill … Continue Reading

New HIPAA Rule Brings New Requirements for Business Associates

On January 17, 2013, the U.S. Department of Health and Human Services (HHS) released its long-awaited final rule implementing the changes required by the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009.  The omnibus final rule (available here) modifies many of the obligations applicable to covered entities and business associates under … Continue Reading

Medical Device Tax: IRS Issues Interim Guidance

This blog post continues our series looking at the final regulations on the excise tax imposed on the sale of certain medical devices under section 4191 of the Internal Revenue Code.  We previously reported on the final regulations here. On Wednesday, December 5, in addition to releasing the final rule, the IRS issued interim guidance … Continue Reading
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