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Healthcare Companies Call On Trump To Promote Value-Added Healthcare

Over 100 health care companies – including providers, insurers, biopharmaceutical companies, professional associations and consumer groups – joined to write the Trump administration to urge him to “continue focusing on...more

Feb. 13 Deadline Looms for Provider-Based Departments Seeking Mid-Build Exception

A new section of the 21st Century Cures Act provides much-needed relief for hospitals with an off-campus provider-based department (off-campus PBD) that was mid-build or under development as of November 2, 2015 (the Mid-Build...more

Lack of Timely Action and Knowledge of Risk Results in $3.2 Million Civil Monetary Penalty for HIPAA Violations

Children’s Medical Center of Dallas (Children’s) was hit with a $3.2 million civil penalty from the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) for failing to take steps to properly protect...more

CMS Issues Final Rule on New Medicare and Medicaid Conditions of Participation for Home Health Agencies

The Centers for Medicare & Medicaid Services (CMS) recently issued a final rule, 42 C.F.R. pt. 484, implementing significant changes to the conditions of participation (CoPs) that home health agencies (HHAs) must satisfy to...more

Children’s Medical Center of Dallas Clobbered by OCR

In a rare move by the OCR, it assessed a $3.2 million fine against Children’s Medical Center of Dallas (Children’s) after it issued a Notice of Proposed Determination against Children’s and Children’s failed to request a...more

Feds Two-Step on Texas Sovereignty has Far-Reaching Compliance Implications

The recent federal grand jury indictment of 21 health care executives, investors, and physicians in connection with the now defunct Dallas-based Forest Park Medical Center effectively turned the Texas health care compliance...more

Key HIPAA Settlement Agreements by HHS’s Office for Civil Rights in 2015 & 2016

The last time this blog presented an overview of key HIPAA settlement agreements at the Office for Civil Rights in the U.S. Department of Health and Human Services was a review of 2014. The number of complaints that year had...more

Potential Implications to the ACA Under the Incoming Republican Administration – Part IV: Pharmacies

The Affordable Care Act (ACA), as a whole, did not have a significant impact on pharmacy services per se. However, a complete repeal would likely impact certain areas of pharmacy services including the drug benefit for the...more

Beyond the Label: FDA Addresses Permissible Scope of Communications With Payors and Physicians

The draft guidances create a grey area between “on-label” and “off-label” communications that will require careful navigation as manufacturers develop HCEI analyses and promotional communications....more

Jan. 31 Deadline: Off-Campus Provider-Based Relocations Requests

For relocations that occurred between 11.2.15 and 12.31.16, providers must submit relocation requests by 1.31.2017. The CY 2017 OPPS Final Rule brought significant changes to the way Medicare reimburses hospitals for...more

Is there operating room for compulsory PI insurance

Since its inception on 30 August 2010, the regulations requiring health professionals to have professional indemnity insurance have lain dormant in a state of moratorium, almost as a distant memory some do not wish to recall....more

Cancer Services Provider Confronts Ransomware Bully

My newest hero in the fight against ransomware is Little Red Door Cancer Services of East Central Indiana (Little Red Door). I am sending a donation to it to celebrate its courage in the last few weeks. Little Red Door...more

Drug Manufacturer Pricing Under the Microscope: HRSA’s 340B Civil Monetary Penalty and Drug Pricing Final Rule

The Health Resources and Services Administration recently surprised the 340B Drug Pricing Program community with the release of its regulations pertaining to drug manufacturer ceiling price calculations and civil monetary...more

Data Breach Class Action Reinstated Against Horizon Healthcare Services Inc.

The U.S. Court of Appeals for the Third Circuit has vacated a district court's dismissal of a data breach class action filed against Horizon Healthcare Services Inc., in the wake of the 2013 theft of two computer laptops...more

France tightens grip on industry payments to HCPs (again)

On 19 January 2017, major modifications were adopted in France to the regulations on interactions between the industry and healthcare professionals (and other stakeholders). These new regulations, a.k.a. "anti-benefits...more

Potential Implications to the ACA Under the Incoming Republican Administration – Part III: Hospitals

President Trump has been clear in his intention to repeal the ACA. In fact, among President Trump’s first executive orders was one seeking to “minimize the economic burden” associated with the Patient Protection and...more

SAMHSA Issues Final Rule for Update to Part 2

The Substance Abuse and Mental Health Services Administration (SAMHSA) issued its final rule updating proposed changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations (also known as 42 CFR Part 2...more

Health Care E-Note - January 2017

On October 4, 2016, The Centers for Medicare and Medicaid Services ("CMS") released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more

Burr Alert: New Requirements of Participation for Skilled Nursing Facilities

On October 4, 2016, The Centers for Medicare and Medicaid Services (“CMS”) released the final rules regarding the requirements of participation for skilled nursing facilities. One of the most significant changes to the...more

Texas Court Enjoins Enforcement of Regulation that Would Forbid Discrimination in Healthcare on the Basis of Gender Identity and...

As LGBTQ rights have taken center stage in political and social issues, FordHarrison has been following ground-breaking litigation related to LGBTQ rights and providing updates. In the latest decision, a federal judge in...more

Tennessee Health Services and Facilities Report: January 2017 Newsletter

The Tennessee Health Services and Development Agency ("HSDA") is responsible for regulating the health care industry in Tennessee through the Certificate of Need Program. A Certificate of Need ("CON") is a permit for the...more

Birmingham Medical News: End in Sight for Medicare ALJ Backlog?

As providers who are currently undergoing a Medicare claims appeal know, there is a lengthy delay to having an appeal actually heard by an Administrative Law Judge (“ALJ”). Some estimates indicate that it will currently take...more

Does Compelling the Disclosure of Documents Allegedly Protected by Attorney-Client Privilege Constitute a Final, Appealable Order?

Last month, the Ohio Supreme Court issued a ruling in Burnham v. Cleveland Clinic, 2016-Ohio-8000, on an interesting issue – “whether an order compelling the production of documents allegedly protected by the attorney-client...more

New Hampshire Psychiatric Hospital Patient Records Posted Online by Former Patient

The New Hampshire Department of Health and Human Services has notified up to 15,000 patients of its psychiatric hospital (New Hampshire Hospital) that their names, addresses, Social Security numbers, Medicaid ID numbers and...more

Joint Commission Confirms Ban on Texting of Patient Care Orders

After briefly considering a reversal of its prohibition on texting orders, The Joint Commission (TJC), in consultation with the Centers for Medicare & Medicaid Services (CMS), announced last month that its ban would continue...more

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