Health Care Counsel

Arent Fox's health care law blog offers news, analysis, and insights for the health care industry.

Health Care Counsel
Hospitals and Acute Care
alert
Proposed Rule May Significantly Cut Reimbursement To Existing Hospital Off-Campus Outpatient Clinics Beyond Congressional Intent

On July 6th, CMS released a proposed rule (expected to appear in the Federal Register on July 15th) that, if it takes effect, could be devastating to hospital off-campus outpatient department reimbursement – an effect not intended by Congress, and certainly unwelcome to the healthcare industry.

Continue Reading →
False Claims Act, Fraud & Abuse Compliance
alert
Don't Have a Heart Attack...but Enforcement Scrutiny Increasing Against Some Cardiac Care Providers

* The following alert was originally published in California Healthcare News (CHN). To read it on the CHN website, click here.

There are reports of breakthrough healthcare treatments virtually every day. Heart disease – one of the leading causes of death in the United States – is no exception. Through advances in technology and other factors, certain life-saving procedures, which in the past could only be performed in the hospital setting, are now routinely performed at thousands of stand-alone surgery centers specializing in cardiac care which have cropped up throughout the country. Recently, state and federal authorities have taken action against some of these surgery centers, as well as hospitals, demanding a cessation of practice or refusing to provide reimbursement on a variety of grounds.

Continue Reading →
E-Health, HIPAA / Health Privacy & Security, mHealth, Telemedicine & E-health
alert
What Do Self-Driving Cars and Your Heart Monitor Have in Common? The Same Questions About Cybersecurity.

Arent Fox partner Sarah Bruno recently published a very interesting alert on new privacy and cybersecurity challenges facing the automotive industry in the age of autonomous vehicles, syncing software, and wearable devices that interact with your vehicle. What does this have to do with the health care industry, you ask? Both the automotive industry and the health care industry are among the largest in the United States. And both industries are the focus of rapid technology development that raise similar, complicated questions about data privacy and security, especially as those technologies increasingly interact with each other. 

Continue Reading →
Pharmaceutical & Device Compliance, Prescription Drug Pricing & Government Price Reporting, Wholesaler & Pharmacy Benefits Compliance
alert
CMS Releases Covered Outpatient Drug Final Rule FAQs

On July 6, CMS issued a set of Frequently Asked Questions to respond to questions raised by the Covered Outpatient Drug Final Rule that was published on February 1, 2016.  The FAQs can be accessed here; our January 28 article analyzing the final rule can be accessed here and our analysis of the delayed implementation of the revised 5i AMP methodology and 70/30 test can be found here.

For more information regarding the Covered Outpatient Drug Final Rule, please contact Stephanie Trunk or Erin Atkins in our Washington, DC office or the Arent Fox attorney who regularly handles your matters
 

Continue Reading →
Stark Law
alert
Provider Alert: Changes to the Stark Law Are Likely on the Way

In a surprising and promising development, the Senate Finance Committee released a Majority Staff Report on June 30, 2016 that gives the health care industry some hope that Congress may finally address some of the serious concerns with the implementation and enforcement of the Stark law. The Report is aptly titled “Why Stark, Why Now?” As stated by Senator Hatch, Senate Finance Committee Chair, the Report “reflects critical feedback from the stakeholder community on the law’s ambiguities, its unintended consequences, and the need for reform, and I am hopeful it jumpstarts the discussion on how Congress can modernize the law to make it work for patients, providers, and taxpayers.” 
 

Continue Reading →
Clinical Trials, Research & IRBs
alert
Legislation Introduced in Congress to Ease Medical Marijuana Restrictions

Last week, bipartisan legislation was introduced in the US Senate and the House of Representatives to amend the Controlled Substances Act and ease federal obstacles for medical researchers to conduct clinical studies on the medical benefits of marijuana.

The Marijuana Effective Drug Studies (MEDS) Act of 2016 was introduced by Senators Hatch (R-UT), Schatz (D-HI), Tillis (R-NC), and Coons (D-DE) in the Senate. Similar legislation was introduced by Representatives Harris (R-MD), Blumenauer (D-OR), Griffin (R-VA), and Farr (D-CA) in the House. The bill does not take a position on legalization of marijuana.
 

Continue Reading →
Telemedicine & E-health
alert
AMA Adopts Ethical Guidelines for Telemedicine, Finally

Telemedicine has been growing by leaps and bounds over the past decade, moving beyond teleradiology to include a broad range of specialties such as neurology, infectious diseases, and psychiatry. However, this expansion has not been without controversy, as highlighted by the American Medical Association’s (AMA) recent adoption of guidance for the ethical practice in telemedicine.

Continue Reading →
alert
Congress Aims to Make it Easier for Generic Drug Manufacturers to Appeal Delay Tactics in Court

Earlier this month, leaders on the Senate Committee on the Judiciary introduced bipartisan legislation designed to end what they describe as delay tactics used by brand-name drug manufacturers to block generic drug approval by the Food and Drug Administration. This legislation is part of an ongoing effort by Congress to address what it views as anti-competitive behavior (by drug manufacturers) that they believe bars consumers from having access to cost-saving generic drugs.

Continue Reading →
False Claims Act
alert
Duh, It's Fraud: Supreme Court Says the False Claims Act Isn't That Complicated

In a highly anticipated decision, the United States Supreme Court issued a unanimous opinion in Universal Services, Inc. v. United States ex rel. Escobar that threw out existing law related to the implied certification theory of liability under the False Claims Act.

Lower courts were split as to whether FCA liability existed for implied certifications of statutes, regulations, and contractual requirements that are conditions of payment and the existing law focused on whether representations were express or implied and whether they were specifically tied to a condition of payment. Background analysis regarding the case can be found here.
 

Continue Reading →
Telemedicine & E-health
alert
Joint Developments Raise Intellectual Property Concerns
*This article was originally published by For the Record. 
 
In order to improve patient care and internal IT operations, medical centers often need to enter joint development agreements with software companies and other technology vendors. Developing wearable medical devices, mobile and cloud-based services, and even "software as a medical device" requires a combination of the skills used to construct each of them.
 
However, joint collaborations can lead to unexpected intellectual property (IP) results and business outcomes. This article addresses those surprise outcomes, with special focus on the factors medical institutions must consider when structuring joint development agreements. Joint ownership of joint developments is a common approach, but it is not mandated nor is it always an ideal result. To avoid these risks, health care organizations can pursue specific contractual avenues.
 
Continue Reading →

Pages

SUBSCRIBE

Add the Arent Fox Health Care Law blog to your RSS feed reader.

Arent Fox In Your Inbox
To subscribe to Arent Fox Alerts and other news, click here.

ABOUT ARENT FOX LLP

Arent Fox LLP, founded in 1942, is internationally recognized in core practice areas where business and government intersect. With more than 350 lawyers, the firm provides strategic legal counsel and multidisciplinary solutions to clients that range from Fortune 500 corporations to trade associations. The firm has offices in Los Angeles, New York, San Francisco, and Washington, DC.