Healthcare

News & Analysis as of

Cybersecurity as a Regulatory Issue: The NAIC Considers The Anthem Breach And Weighs a “Cybersecurity Bill of Rights”

The Cybersecurity Task Force of the National Association of Insurance Commissioners (the “NAIC”) met last month, as part of on the NAIC’s 2015 Summer National Meeting in Chicago. The Task Force focused on two issues: the...more

HRSA Issues Long-Awaited 340B Program Omnibus Guidance Proposal

After much anticipation, the Health Resources and Services Administration (HRSA) late last week released its 340B Drug Pricing Program Omnibus Guidance Proposal (the Proposal). HRSA indicates that its goal in issuing the...more

Using Student Medical Records: Department of Education Issues New Guidance

When is it legal and proper for higher education institutions to use student medical records other than for a student's healthcare? In answering that question, institutions have to balance students' privacy interests,...more

HRSA Publishes 340B Drug Pricing Program Omnibus Guidance Notice: Significant Policy Ramifications Should Trigger Public Comment

On August 28, 2015, the Health Services Resources Administration (“HRSA”) published its 340B Drug Pricing Program Omnibus Guidance Notice in the Federal Register. Although many aspects of the Notice reiterate previous HRSA...more

FCC Sheds New Light on TCPA’s Exemption for Healthcare-Related Calls

As we have previously reported, the Federal Communications Commission (“FCC”) issued a Declaratory Ruling and Order (“Order”) on July 10, 2015, clarifying several sections of the Telephone Consumer Protection Act (“TCPA”) and...more

Omnibus Proposed Guidance Released for 340B Drug Pricing Program

Last week, the Health Resources and Services Administration (HRSA), part of HHS, released proposed new guidance for covered entities enrolled in the 340B Drug Pricing Program, as well as drug manufacturers required to make...more

Blue Cross of Northeastern Pennsylvania Denied Peer Review Protection

The Pennsylvania Superior Court has decided the Pennsylvania Peer Review Protection Act does not apply to alleged peer review activity conducted by Blue Cross of Northeastern Pennsylvania, because Blue Cross is not a...more

Send Lawyers, Guns and Money:* Providers Lining Up Against Anthem/Cigna and Aetna/Humana Mergers

In the wake of Anthem’s proposed acquisition of Cigna and Aetna’s proposed acquisition of Humana, providers are lining up to be heard. Take the American Medical Association (AMA), for example, which is urging federal and...more

Health Insurers Announce Merger Plans; Congress Announces Intention to Review

In the last few months, several of the largest commercial health insurers in the nation have announced their intentions to merge. First, Aetna (currently the nation’s third largest health insurer by revenue) announced its...more

HHS Releases Long-Awaited 340B Proposed Guidance

In August 27, 2015, the U.S. Department of Health and Human Services (HHS) released the long-awaited and much-anticipated proposed 340B Drug Pricing Program (340B Program) Omnibus Guidance (Proposed Guidance). The Proposed...more

Take 2: A lesson from the healthcare industry

There are certain mistakes made by doctors or other healthcare professionals that result in the need for further treatment. An example is sponge that is left behind during surgery, which generally necessitates further...more

U.S. Court of Appeals Reinstates Labor Department’s Wage Rule for Home Care Workers

On August 21, 2015, the United States Court of Appeals for the District of Columbia Circuit (DC Circuit) reinstated Department of Labor (DOL) regulations that require home care agencies and other third-party employers of...more

A summary and analysis of HRSA's proposed 340B program guidance

On August 28, 2015, the US Department of Health & Human Services (HHS) Health Resources and Services Administration (HRSA) published its long-awaited, if still only proposed, 340B program guidance (Proposed Guidance). 80 Fed....more

Colorado Medical Board Adopts New Telehealth Policies

On August 20, 2015, the Colorado Medical Board (the Board) adopted Policy 40-27, which sets forth important new guidelines for providers delivering healthcare services via telehealth technologies, including the ability to...more

Key Digital Health Investment Trends to Watch

Our fourth annual Digital Health Summit brought together a select group of investors active in the digital health, life sciences, medical device, and healthcare industries for a one-day meeting to discuss the future of...more

Employee Benefits Developments August 2015

Certain Closely Held For-Profit Employers Need Not Provide Women’s Contraceptive Services. Under the ACA, non-grandfathered group health plans must cover specified preventive services, including certain women’s preventive...more

Telehealth Commercial Coverage and Parity Laws: Trends, Challenges and Opportunities

There will always be differences among state laws on telehealth coverage, but what is remarkable is the rapidly increasing pace at which states have been adopting coverage statutes in the last few years, with currently 29...more

Health Alert (Australia) - August 31, 2015

In This Issue: -Judgments; Legislation; and Reports -Excerpts from Judgments New South Wales (NSW) 28 August 2015 - Smith v Pennington [2015] NSWSC 1168 The Supreme Court gave judgement for the...more

Texas Hospital Strikes Back at Aetna

On February 23, 2015, Aetna filed suit in Texas federal court against Robert A. Behar, M.D. and North Cypress Medical Center (North Cypress), alleging that Dr. Behar, the CEO of North Cypress, offered impermissible ownership...more

Comprehensive Care for Joint Replacement: CMS adopts mandatory approach to payment reform

On July 9, 2015, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule that seeks to implement a mandatory episode-based payment model for lower extremity joint replacement (and reattachment) care in...more

Court Revives DOL's Expanded Overtime and Minimum Wage Rules for Home Health Care Workers

On August 21, 2015, the U.S. Court of Appeals for the District of Columbia in Home Care Association of America v. Weil reversed a lower court decision and upheld the U.S. Department of Labor's (DOL) 2013 regulatory change...more

Proposed Changes to Stark Rule Would Create New Hospital Exceptions and Lessen Burden of Self-Disclosures

In a development that is limited in scope but still welcomed by hospitals, the proposed 2016 Physician Fee Schedule proposes a number of new exceptions to the physician self-referral or Stark law and other refinements that...more

Court Awards Employees of Home Health Care Companies Minimum Wage and Overtime Rights

Home health care providers could expect to pay their employees more after the Court of Appeals for the D.C. Circuit held an exemption of the Fair Labor Standards Act (FLSA) no longer applies to third-party employers of...more

AmerisourceBergen Guest Post: Solutions to Overcome Reimbursement Challenges in Personalized Medicine

The continued development and refinement of personalized medicine (PM) has offered an opportunity to revolutionize medical practice and improve outcomes by providing treatments for patients with the notion that “this drug is...more

When the Government Comes Knocking

This article will provide an outline of some of the most significant points for hospitals to use when confronted with a formal government investigation under the Criminal or Civil False Claims Act. As noted below, you should...more

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