Category Archives: Legal News

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Trump Administration Announces Historic Price Transparency Requirements

Attached are links to the CMS Press Release and the Trump Executive Order on Improving Price and Quality Transparency in American Healthcare to Put Patients First. The Trump Executive Order was first issued on June 21, 2019. The CMS Press Release indicates action on two rules. First, the “proposed” transparency and coverage rule would require … Continue Reading

Anti-Kickback EHR and Cybersecurity Safe Harbor

As another part of the Regulatory Sprint to Coordinated Care, OIG proposed revisions to the existing EHR Anti-Kickback Safe Harbor and added a cybersecurity component. The initial EHR Safe Harbor was developed in response to President George W. Bush’s 2004 initiative to extend EHR nationwide within 10 years, i.e. 2014.  The proponents of those EHR … Continue Reading

$1,600,000 Civil Money Penalty for HIPAA Violations by the Texas Health and Human Services Commission

On November 7, 2019, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) announced a $1,600,000 civil money penalty for violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Breach Notification Rules. According to HHS, the Texas Health and Human Services Commission (TX HHSC) “operates state … Continue Reading

Regulatory Sprint to Coordinated Care: New Stark & Anti-Kickback Rules

On October 22, 2019, CMS and OIG (Office of Inspector General) released new proposed rules regarding Stark Law Exceptions and Anti-Kickback Safe Harbors in response to what has universally been christened as the “Regulatory Sprint to Coordinated Care”, first announced by HHS in June of 2018. As background, please remember that, although the Anti-Kickback Safe … Continue Reading

Federal Government Delays Hospital Transparency Regarding Commercial Rates

The federal government/Trump administration announced today a delay regarding a proposed rule requiring hospitals to disclose actual negotiated price rates.  See WSJ News. In January, 2019, as reported in the MedLaw Blog on January 10, 2019, CMS added a rule requiring hospitals to publish their standard charges beginning January 2019. As noted in that blog … Continue Reading

$2,154,000 Civil Money Penalty for Numerous HIPAA Violations by Jackson Health System

On October 23, 2019, the U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) announced a $2,154,000 civil money penalty for numerous violations of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Security and Breach Notification Rules between 2013 and 2016. According to HHS, Jackson Health System (“JHS”) is a … Continue Reading

Pennsylvania Commonwealth Court Again Declines to Extend Consent Decree

The Pennsylvania Commonwealth Court, on remand from the Pennsylvania Supreme Court, has again decided that the previously agreed termination date of the access provisions contained in the UPMC/Highmark Consent Decrees, i.e. June 30, 2019, is not a term subject to the modification provisions of those Consent Decrees, and is definite.  The adjudication of the Commonwealth … Continue Reading

Pennsylvania Patient Test Result Information Act Update: Act 112

The Patient Test Result Information Act was effective December 23, 2018. The Act requires entities performing diagnostic imaging services, defined to include any medical imaging test intended to diagnose the presence or absence of a disease, to provide notice of the results to patients.  The operative language states: “When, in the judgment of the entity … Continue Reading

Commonwealth Court Declines to Extend Consent Decree

Although there have been a number of issues raised by the Pennsylvania Attorney General in the UPMC/Highmark situation, including UPMC’s status as a charitable institution, the primary issue in the Attorney General’s lawsuit was a request to extend the June 30, 2019 termination date for the UPMC-Highmark Consent Decrees. The Commonwealth Court declined to extend … Continue Reading

New Federal Kick-Back Laws Regarding Opioid Treatment

“Eliminating Kick-Backs and Recovery Act of 2018” (EKRA) is a part of a group of laws recently passed by Congress to expand the law enforcement spectrum available to fight the opioid epidemic. EKRA is part of approximately 70 separate actions referred to as the SUPPORT Act, i.e. Substance Use-Disorder Prevention that Promotes Opioid Recovery and … Continue Reading

New Telemedicine Act in Pennsylvania

A new Telemedicine Act is wending its way through the legislative process in Pennsylvania.  Senate Bill 780 of 2017  (attached hereto as a PDF) has been unanimously passed by the Senate and referred to the House Professional Licensure Committee on June 19, 2018.  Pennsylvania is one of the few states that does not have a … Continue Reading

Physician Performance Reviews: Protected Peer Review Information or Litigation Traps?

Peer Review Confidentiality will become much more complicated with the addition of economic evaluation to physicians’ quality and efficiency.  Physicians will be surprised to learn that many “reviews” to which they may currently be subject to could have “quality implications”, and they should be concerned if those reviews were available to other third parties instead … Continue Reading

The New Capitation – What Goes Around, Comes Around!

On April 23, 2018, CMS issued a request for information on direct provider contracting models.  In that request, (attached hereto as a PDF), CMS stated as follows: “Under a primary care-focused DPC model, CMS could enter into arrangements with primary care practices under which CMS would pay these participating practices a fixed per beneficiary per … Continue Reading

OIG Gainsharing Opinion Facilitates P4P

Although it has been almost a decade since the OIG has issued a gainsharing opinion, OIG Advisory Opinion No. 17-09 confirms the federal government’s support of the pay for performance concept. OIG 17-09 is the first gainsharing opinion issued since the 2015 amendment of the Civil Money Penalty statute (42 U.S.C. § 1328-7a(b)(1)).  As you … Continue Reading

West Virginia Doctor Secures Temporary Restraining Order Against Medicare Exclusion

In Robie v. Price, Dr. Robie successfully obtained a temporary restraining order prohibiting CMS from terminating his Medicare billing privileges prior to the exhaustion of his administrative remedies by the U.S. District Court for the Sothern District of West Virginia. As most realize, exhaustion of administrative remedies is usually a prerequisite to further litigation for … Continue Reading

Texas Telemedicine Law Finally Allows Complete Remote Treatment

The Texas Medical Board and Teladoc have been battling for seven years, and through several rounds of litigation over whether a patient relationship can be established for purposes of providing telemedicine services without an initial face-to-face or in-person visit. This all changed when Texas governor, Greg Abbott, signed Senate Bill 1107, which will take effect … Continue Reading

Western Pennsylvania Hospital Stark/Whistleblower/False Claims Case Provides Real World Guidance For Medical Directors’ Contracts

Emanuele v. Medicor Associates, was presented to the United States District Court for the Western District of Pennsylvania as cross motions for summary judgment, and provides some guidance regarding the Stark requirements for bona fide personal service contracting arrangements. The case originated as a whistleblower allegation that Hamot Hospital had not complied with all of … Continue Reading

HHS Issues Rules Expanding OIG’s Exclusion Authorities

On January 12, 2017, the Office of Inspector General (OIG) of the Department of Health and Human Services (HHS) issued final rules implementing permissive exclusion authorities authorized by the Affordable Care Act expanding exclusion authority under Section 1128 of the Social Security Act.  The changes were first proposed on May 9, 2014 at 79 Federal … Continue Reading