Source: https://www.healthcarebusinesstoday.com/category/legal/page/2/
Timestamp: 2019-04-20 07:20:23+00:00

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For many entrepreneurs and healthcare leaders who firmly believe in their product, they must consider America as only a slice of the pie when it comes to revenue potential. For example, the medical device market is expected to reach $150 billion in 2017 in the U.S. alone, a tremendous figure that demonstrates rapid growth. However, when looking outside America, the global medical device market is set to reach close to $400 billion. Now, while there are thousands of companies in this industry each targeting their own respective market segment, their revenue opportunity grows significantly when efforts go international.
With medical billing fraud and abuse cases increasingly driven by data analysis, it has never been more important for healthcare providers to carefully assess the claims data they provide to the government.
In analyzing billing data, government investigators are looking for providers with suspect billing patterns, including high utilization of expensive billing codes, being a top biller for any particular code, or billing in a manner that is different from other providers of the same type.
For example, a Tennessee pain management clinic recently drew the attention of federal investigators because it was an outlier in its billing for urine drug screens. The clinic paid $312,000 to resolve allegations that it was ordering medically unnecessary screens in violation of the federal False Claims Act.
To avoid these kinds of entanglements, healthcare providers need to monitor and to analyze their own claims data. The key questions healthcare providers need to ask are: What billing codes are they most commonly using? Are the people choosing which codes to bill properly qualified and up to date? Does the electronic medical records system make it easy for providers to capture necessary information to support the billing?
It’s a new year and that brings new challenges for hospitals enrolled in the 340B Drug Pricing Program after the Centers for Medicare & Medicaid Services (CMS) formally implemented a new rule that cuts the reimbursement to certain covered entities by $1.6 billion.
The 2018 Medicare Hospital Outpatient Prospective Payment System (OPPS) Final Rule was finalized in November 2017 and immediately met with resistance. A number of hospital associations and several health systems joined to sue CMS – claiming the changes would reduce access to care – and a bipartisan bill was introduced before the House seeking to reverse the ruling. Due to a procedural issue, the lawsuit was deemed premature since damages had not yet been incurred, and CMS’s rule went into effect on Jan. 1, 2018, per the original time frame.
Despite efforts to halt the rule continuing into 2018 – the same complainants plan continued legal action – all 340B hospitals covered under OPPS must now comply with the new CMS rule.
A federal court in New Mexico recently declined to dismiss tort claims asserted by a registered nurse against her employer, a government-run hospital, where she obtained treatment for a sexual assault. In denying the motion to dismiss, the court effectively rejected the federal government’s attempt to escape claims based on invasion of privacy for the disclosure of information regarding the assault (G.R. v. United States).
However, the court withheld ruling on the government’s motion to dismiss plaintiff’s claim for “negligence per se” based on the violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Instead, the court certified for the New Mexico Supreme Court the question of whether the claim fails, as there is no private right of action afforded by HIPAA. This case serves as a valuable reminder for hospitals of the broad implication of liability for disclosing private information, including the potential impact of HIPAA violations beyond mere regulatory enforcement.
The plaintiff sued her employer, Gallup Indian Medical Center, for the dissemination of information relating to treatment she received there after she fell victim to a physical and sexual assault. Her lawsuit claims the hospital disclosed private details of the assault to coworkers who were not her direct care providers. Specifically, G.R brought tort claims for public disclosure of private facts, intentional infliction of emotional distress, negligence, and negligence per se. The claim for negligence per se – a theory whereby an act is considered automatically negligent because it violates an existing statute – was premised on the hospital’s alleged HIPAA violation.
[Read more…] about When Does a Deed Need Criminal Defense?
— Hospitals across the country should take note of these developments in Florida in order to understand best practices for protecting their internal reviews and evaluations.
In 2004, the availability of hospital records regarding adverse incidents in Florida changed dramatically. Prior to that date, statutes that protected the confidentiality of the peer review process § 395.0193 and § 766.101, credentialing § 395.0191, risk management reports of adverse incidents § 395.0197 and risk management reports of quality assurance § 766.1016, provided hospitals with confidentiality in their internal review.
The courts recognized that these privileges were “[d]esigned to provide that degree of confidentiality necessary for the full, frank medical peer evaluation… .” Crugar v. Love, 599 So. 2d 111 (Fla. 1992). The legislature had determined that without the privilege, the peer review process would not be honest and beneficial. Feldman v. Glucroft, 522 So. 2d 798 (Fla. 1988). These statutory privileges had the effect of preventing the discovery of otherwise relevant information in litigation. Holly v. Auld, 450 So. 2d 217 (Fla. 1984).
With the passage of what has become known as Amendment VII, public policy was flipped to the position that “disclosure of information [ ] will allow patients to better determine from whom they should seek health care, evaluate the quality and fitness of heath care providers currently rendering service to them, and allow them access to information gathered through the self-policing process during the discovery period of litigation… .” Florida Hospital Waterman, Inc. v. Buster, 932 So. 2d 344 (Fla. 5th DCA 2006). Under Amendment VII, a patient was given a right to access records of any adverse medical incident and any record made or received in the course of business. The language of the Amendment was interpreted broadly to confer upon any person who is receiving or has received medical care the right of access to any document pertaining to medical negligence, intentional misconduct, and any act of neglect of a facility or provider which caused or could have caused injury or death to a patient. Florida Hospital Waterman, Inc. v. Buster, 984 So. 2d 478 (Fla. 2008). There is no limitation on whether the adverse incident is the same or similar to the incident being litigated. Ampuero-Martinez v. Cedars Healthcare Group, 139 So. 3d 271 (Fla. 2014). Many asked if there was any confidential evaluation that a hospital could perform.
Soon after Amendment VII was enacted, some hospitals began attempting to build confidentiality through the involvement of an attorney in the review of an adverse incident. Courts have since determined that Amendment VII does not vitiate the opinion work-product privilege, but it does supersede the fact work-product privilege. Fla. Eye Clinic, P.A. v. Gmach, 14 So. 3d 1044 (Fla. 5th DCA 2009). Because of this distinction, it is not enough for a hospital’s attorney to simply be present during an adverse incident review. Conferring privilege through work-product requires the attorney to inject her mental impressions, conclusions, opinions and theories. Even opinions communicated by the hospital’s employees to the attorney are not protected from Amendment VII. Acevedo v. Doctors Hosp. Inc., 68 So. 3d 949 (Fla. 3d DCA 2011).
Another avenue for obtaining confidential evaluation of an adverse incident is an external medical review. The application of Amendment VII to external medical reviews for purposes of litigation was recently reviewed, and the Second District held that external medical reviews maintain confidentiality. Bartow HMA, LLC v. Edwards, 175 So. 3d 820 (Fla. 2d DCA 2015). The court determined that an external medical review done for litigation was not a record “[m]ade or received in the course of business,” nor was it a record pertaining to an adverse incident because it was not a functional equivalent of a facility’s internal peer review. However, the external review cannot be used as a vehicle to outsource the internal peer review, as the court noted that their decision would have been different if there was no internal peer review of the incident.
Also important is that the Second District has clarified that documents pertaining to adverse medical incidents in general, but not related to a specific adverse medical incident, are not covered under Amendment VII. Bartow HMA, LLC v. Kirkland, 171 So. 3d 783 (Fla. 2d DCA 2015). For example, the court specified that general policies regarding handling of patient cases, reports from departments that do not reference adverse incidents, credentialing committee reports, committee minutes regarding hiring and hospital development plans, and documents generally related to handling sentinel events are not covered under Amendment VII.
Arguably, the most valuable tool in keeping adverse incident reviews confidential is the use of a Patient Safety Evaluation System (PSE) pursuant to the federal Patient Safety and Quality Improvement Act (PSQIA). In 2005, the federal PSQIA was signed into law, and it embraced policy opposite to that embodied by Amendment VII. It conferred confidentiality on a review to encourage providers to share information without fear of liability. The PSQIA provides for confidential review of medical errors when facilities opt to create a PSE that collects information and forwards it to a Patient Safety Organization (PSO) for evaluation and feedback. The PSO must also share information with the Network of Patient Safety Databases. The First District Court recently held that documents put into the PSE for reporting to a PSO are confidential, preempting Amendment VII. Southern Baptist Hosp. of Fla., Inc. v. Charles, 178 So. 3d 102 (Fla. 1st DCA 2015). The First District held that this confidentiality also applies if the document serves the dual function of satisfying a state reporting requirement—such as incident reports required under § 395.0197.
In conclusion, while there are limited avenues for a hospital to keep their review of adverse incidents confidential, a hospital does have the ability to maintain some level of confidentiality through use of the tools outlined above. It is vital to know what information remains protected and what information is not covered by Amendment VII so that plaintiff’s counsel is not provided unnecessary ammunition in litigation.
As of right now, every other state has a statute in effect which insulates the peer review process from litigation discovery. However, Florida too had a broadly written statute which, until Amendment VII was enacted, provided strong confidentiality of the peer review process. As happened in Florida, the protections in other states could be wiped out with a similar constitutional amendment. In states which have public referendums to enact constitutional amendments, there is no guarantee the majority of the electorate will know or understand the implications of such an amendment on the candidness and effectiveness of the peer review process. In addition, courts in many states have nibbled around the edges of the privilege for unusual circumstances such as statements made by the attending physician, criminal cases, and employment disputes. Should the privilege continue to erode in your state, hospitals there should take note of these developments in Florida in order to understand best practices for protecting their internal reviews and evaluations.
David R. Bear is the managing attorney of Bear Legal Solutions in Orlando, a Florida. His practice includes investigating and litigating allegations of malpractice by physicians, nurses, and other health care providers; allegations against hospitals of negligent hiring and retention; and allegations of premises liability for medical facilities. David can be reached atDavid@BearLegalSolutions.com or 321–888-3955 and his firm can be viewed at http://www.bearlegalsolutions.com.

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