News & Analysis as of

Covered Entities

340B Covered Entities Beware: CMS Proposes Drastic Drug Reimbursement Rate Cuts

by Polsinelli on

In its Outpatient Prospective Payment System proposed rule ("Proposed Rule"), CMS outlined a significant Medicare Part B payment reduction for separately payable, nonpassthrough drugs provided in the hospital outpatient...more

DFS Provides Answers to Cybersecurity FAQs

Hoping to provide greater clarity to financial institutions subject to its new cybersecurity requirements, New York’s Department of Financial Services (DFS) published a Frequently Asked Questions (FAQ) document to assist...more

New York’s New Cybersecurity Regulations and its Impact on your Sensitive Health Information

by Farrell Fritz, P.C. on

Effective March 1, 2017, the New York State Department of Financial Services promulgated regulations to help protect against cybercriminals and their efforts to exploit sensitive electronic data. These cybersecurity...more

State Updates on Cybersecurity Regulations: New York DFS Issues FAQs on Its Cybersecurity Regulations and Colorado Adopts Rules...

by Sedgwick LLP on

New York and Colorado have continued to take the lead in cybersecurity requirements for regulated financial institutions. The New York Department of Financial Services (DFS), which issued the first state cybersecurity...more

Proposed Rule Would Slash Medicare Payment for 340B Drugs

by Foley & Lardner LLP on

The Centers for Medicare and Medicaid Services (CMS) has proposed reducing the Medicare payment rate to hospitals for most separately payable drugs purchased under the 340B program from average sales price (ASP) plus six...more

Ten Tips For Actions By A Covered Entity After A HIPAA Breach By A Business Associate

by Fox Rothschild LLP on

This blog recently discussed tips for a covered entity (CE) in dealing with a HIPAA business associate (BA). Now, even though you have adopted all of the tips and more, in this dangerous and ever more complex data security...more

Six Questions and Answers About CMS’ Recommended Changes to 340B Medicare Reimbursement

In March, I posted about the Uncertain Future of the 340B Drug Discount Program.  When opining about What Could Happen Next I speculated about possible changes to government reimbursement for 340B drugs “so that government...more

NYDFS Updates FAQs to Clarify Cybersecurity Regulations

by Ballard Spahr LLP on

The New York Department of Financial Services (NYDFS) recently updated frequently asked questions (FAQs) about its cybersecurity regulations, 23 NYCRR 500, to address four new issues. NYDFS published its initial set of FAQs...more

The CFPB Issues Its Final Arbitration Rule

by MoFo Reenforcement on

Ending months of speculation and insider reading of tea leaves, on July 10, 2017, the Consumer Financial Protection Bureau (CFPB or Bureau) published a final rule regarding the use of arbitration agreements in specified...more

Five Takeaways from the OCR Reminder on HIPAA Obligations In Ransomware Incidents

by Poyner Spruill LLP on

Apparently prompted by the recent high-profile wave of ransomware attacks, the Department of Health and Human Services’ Office of Civil Rights (OCR) has reminded hospitals, healthcare systems, and other covered entities and...more

How Can Healthcare Organizations Prepare for the Next Cyberattack?

by Latham & Watkins LLP on

HHS OCR issues checklist, iterative guidance in wake of WannaCry and Petya attacks; Anthem breach settlement provides additional lessons. Key Points: ..Healthcare organizations are particularly vulnerable to ransomware...more

Concierge Medicine – Is it for you?

by Farrell Fritz, P.C. on

According to the 2016 Kaiser/HERT Employer Health Benefits Survey, the average annual premium for employer-sponsored family health insurance coverage in 2016 was $18,142 – representing a 20% increase since 2011 and a 58%...more

New York DFS Updates FAQs to Clarify Applicability of Cybersecurity Regulation

by BakerHostetler on

With the first compliance deadline now less than two months away, the New York Department of Financial Services (NYDFS) has provided additional clarity concerning its new Cybersecurity Requirements for Financial Services...more

Illinois “Geolocation Privacy Protection Act” Passes Both Houses, Headed to Governor’s Desk

by WilmerHale on

On Tuesday, June 27, the Illinois legislature passed HB 3449, the “Geolocation Privacy Protection Act.” If signed by Governor Bruce Rauner (R), the bill would prohibit a “private entity” from collecting, using, storing or...more

House Committee Issues Letter to HRSA Requesting Audit Documentation Regarding 340B Drug Pricing Program

by King & Spalding on

The House Committee on Energy and Commerce (Committee) sent a letter dated June 1, 2017, to the Health Resources and Services Administration (HRSA) Administrator expressing concerns about the growth and oversight of the 340B...more

House Bill Would Narrow Orphan Drug Exception

by Arnall Golden Gregory LLP on

A recent House bill, titled the "Closing Loopholes for Orphan Drugs Act," would narrow the exception for orphan drugs in the federal 340B Drug Pricing program. Representative Peter Welch (D-VT) introduced the bill on June 13,...more

HHS Publishes Health Care Cyber Attack Checklist

by Tucker Arensberg, P.C. on

HHS has published a very brief guide, in the form of a checklist, to explain the steps for a HIPAA covered entity or business associate to take in response to a cyber related security incident. You can access the checklist at...more

Healthcare Providers Beware: HIPAA Isn’t Your Only Concern Following a Data Breach–State Law Matters

by McGuireWoods LLP on

Healthcare service provider CoPilot Support Services (“CoPilot”) recently agreed to pay a $130,000 settlement after it waited over a year to notify patients of a data breach, in violation of New York’s breach notification...more

Healthcare Data Breach Enforcements and Fines

by Bryan Cave on

The Department of Health and Human Services’ (“HHS”) Office for Civil Rights (“OCR”) is responsible for enforcing the Privacy and Security Rules of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”)....more

HIPAA Settlements in April and May Highlight Key Compliance Concerns for OCR

by Williams Mullen on

After a break in March with no new settlement agreements, OCR returned in April and May with quite a few. The Health Care Data Aware Blog already posted about a $400,000 OCR settlement released April 12, 2017, which can be...more

My Entity Just Experienced a Cyber-Attack! What Do We Do Now?

by Balch & Bingham LLP on

On June 9, 2017, the U.S. Department of Health and Human Services (HHS), Office of Civil Rights (OCR) released a cyber-attack “Quick Response” checklist (the Checklist) for the benefit of HIPAA covered entities and business...more

OCR Releases Checklist On What To Do Following A Cyber Attack

by Murtha Cullina on

Since the WannaCry ransomware virus spread rapidly across the globe, businesses, both large and small, are again focusing on cyber-security. In a previous bulletin, we detailed five things that a business can do to help...more

New HHS Cybersecurity Preparedness Checklist

by Carlton Fields on

The Department of Health and Human Services’ Office of Civil Rights (OCR) recently published a checklist to guide HIPAA-covered entities and business associates through an appropriate response to a ransomware or cybersecurity...more

OCR Publishes Checklist and Infographic for Cyber Attack Response

OCR released a simple checklist and infographic last week to assist Covered Entities and Business Associates with responding to potential cyber attacks. As cybersecurity remains a pressing concern for health care entities,...more

Causes of Healthcare Data Breaches (Update)

by Bryan Cave on

Pursuant to the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), covered entities (e.g. healthcare providers and health plans) must notify the Department of Health and Human Services (“HHS”) of breaches...more

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Cybersecurity

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