By Fisher, JD, CHC, CCEP

Physician Revises Faxing Procedures to Safeguard PHI After Faxing PHI to Employer  by Mistake

A medical office recently settled with OCR after it allegedly disclosed a patient’s HIV status when the office mistakenly faxed medical records to the patient’s place of employment instead of to the patient’s new health care provider.  The employee responsible for the disclosure received a written disciplinary warning, and both the employee and the physician apologized to the patient.  To resolve this matter, OCR also required the practice to revise the office’s fax cover page to underscore a confidential communication for the intended recipient. The office informed all its employees of the incident and counseled staff on proper faxing procedures.

Two things pop about about this instance.  First, this was clearly a privacy violation.  The patient’s protected health information, which incidentally revealed his or her HIV status, we sent to the employer.  Secondly, it was evident from the facts that this was a mistake.  We aren’t told exactly how this mistake was made.  Was the fax number written down in the wrong box on the patient’s records?  Did the employee who faxed the records put the incorrect number on the fax cover sheet?  We may never know.  But

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By Fisher, JD, CHC, CCEP

OCR Citation for Improper Disclosure of PHI in Response to a Subpoena

A health care provider or other covered entity under HIPAA is permitted to disclose protected health information if it receives a lawful order from a court or administrative tribunal.  this does not mean that a provider can simply release everything it has in a patient record when it receives a court order.  Some records, such as mental health or substance abuse records might have special protections or limitations that apply.  Additionally a provider should closely review the relevant order and only disclose the information that is specifically required by the order.

The ability to release information in response to a subpoena, as opposed to an order of a court, is subject to different rules.  Patient information can only be provided under subpoena if certain notification requirements of the Privacy Rule are met. The notification requirements require the provider who received the subpoena to obtain evidence that there were reasonable efforts to notify the person who is the subject of the information about the request.  This is intended to give the individual an opportunity to object to the disclosure, or obtain a protective order from the court.

The application of these rules are

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By Fisher, JD, CHC, CCEP

Authentication of Verbal Orders

In a past blog article, I discussed the need for physicians to promptly authenticate verbal orders. The failure of a physician to timely sign a verbal order can have reimbursement implications. In some cases, in some states, another responsible provider can sign a verbal order that is originally given by another practitioner. This option is not always available and depends a lot on whether state law permits the practice. Some states require the practitioner who gave the verbal order to authenticate the order. With the use of electronic medical records, practitioners cannot expect leniency on these types of requirements.

In states that permit one practitioner to authenticate for another, the authenticating proxy practitioner should understand that he or she is accepting responsibility for the authenticated verbal order. State scope of practice rules apply to cross authentication of orders. In otherwords, the practitioner authenticating the order must have practice authority to have provided the original verbal order. Facilities can develop policies that a more restrictive then what the law permits. Policy can eliminate or restrict cross authentication practices. There is inherent risk in permitting cross authentication because the authenticating provider did not give the original verbal order. Additionally, as

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Disputing Inaccurate Reports Under the Physician Payment Sunshine Act

In 2013, CMS issued final regulations interpreting and clarifying the requirements of the Physician Payment Sunshine Act (“Sunshine Act”) .  The final regulations clarify the reporting process, identifies exceptions and exclusions from the reporting requirements, and provides further details regarding what constitutes a reportable relationship.  The final rule delineates the specific data elements that reporting organizations are required to include and the reporting format that is required.  Reporting organizations that fail to make required reports are subject to potential civil monetary penalties.

Physicians are often surprised to see the information that reporting agencies submit.  Early on, errors in reporting were frequent as reporting companies struggled to integrate reporting requirements into their compliance process.  Reports tend to be more accurate now, but there are certainly instances where reporting organizations make reports that should be questioned.  A process is included to afford physicians and teaching hospitals to review and dispute the information that a reporting organization proposes to report.  The regulations require physicians to exercise diligence to review the information that is being submitted describing items of benefit that they are alleged to have received.  The regulations include a 45-day review and correction period, but report information does not automatically come to a physician unless affirmative action is taken to sign up to receive this information.

If the physician or teaching hospital receives notification, a process can be used to dispute the proposed disclosure with the applicable manufacturer.  There is a very short time window to dispute and resolve the issue before publication is made for the applicable year so it is critical that a dispute be invoked promptly upon receipt of notice of the proposed report.  Signing up for notifications also permits access to the web based dispute system.  The review period lasts for 45 days and reporting organizations have 15 days after the end of that period to correct data to resolve disputes.

Errors in amount, the nature of items reported, and methodology of calculating or allocating expenditures among numerous recipients are frequent areas of error.  For example, situations have occurred where expenditures that benefitted numerous physicians were allocated to a single physician.  The opportunity for error in reporting are endless; particularly given the multiple parties that can be involved in the reporting chain for the reporting company.

Inaccurate reporting is not without consequence to the subject of the report.  Inaccurate reports can be indicative of conflict of interest and can impact publication or reviewer credibility.  A report can also be an indication of further potential fraudulent payments and can result in further government investigation regarding the fair market value of services provided in a consulting or other relationship.  In extreme cases, payments that are inflated over fair market value for services that are actually and legitimately provided can indicate potential Anti-Kickback Statute and other compliance violations that can carry significant penalties.  If a review is based on an inaccurate or inflated report, a positive resolution can likely be reached with investigators.  However, anyone who has ever been involved in a government compliance investigation understands the intangible damage that the process can create.

In order to avoid complication that could result from inaccurate reports, physicians and other reporting subjects should be certain to register to receive notification of proposed Physician Sunshine Act reports.  Any inaccuracies should be disputed promptly.

Health Care Blog Articles Published by John Fisher

Here is a list of some of the recent health law related blog articles that I have recently posted across several different blog sites:

HIPAA Breach Notification Settlement – First Case of Untimely Notice of Breach

OIG Annual Work Plan for 2017 – Topics Covered

Skilled Nursing Facility and Nursing Home Initiatives OIG 2017 Annual Work Plan

Don’t Overlook Special Status of Behavioral Health Records

Off-Campus Provider-Based Departments Site-Neutrality

21st Century Cures Act Signed by President Obama

US Attorney Manual Updated to Incorporate Yates Memorandum DOJ Directives Incorporating the Yates Principles

Certification of Investigation of Individual Wrongdoing Under the Yates Memorandum

How Should Compliance Process Integrate the Yates Memorandum?

New Federal Prosecution Standards Require Revisions to Investigation Policies

300 Pages of New Regulations Ruining Health Care Attorney Lives Across the Country

60 Day Repayment Rule Affordable Care Act

ACO Primary Care Exclusivity Requirement – Not As Broad As Some Believe

Ambulatory Surgery Center Advisory Opinions

Antitrust Law Application In Rural Areas- Hospital Mergers

Antitrust Market Analysis In Provider Integration

Antitrust Policies Avoiding Spillover – Clinically Integrated Networks

Auditing Physician Payments For Stark Law

Bundled Payment Arrangements for Clinically Integrated Networks

Certification of Investigation of Individual Wrongdoing Under the Yates Memorandum

Clinical Integration Readiness Analysis CINs

CMS Releases Final Rules Under Medicare Shared Savings Program

CMS Releases the First Comprehensive Overhaul of Nursing Home Conditions of Participation in Over 25 Years

False Claims Act Basics – Known Overpayment Becomes False Claim

False Claims Act Liability – Conditions of Participation and Conditions of Payment

Final Rule Under the Medicare Shared Savings Program Released

HHS Releases Inflation Adjusted Federal Civil Penalties

How Should Compliance Process Integrate the Yates Memorandum?

Incident To Billing Rules Changed In New CMS Regulations

Major Revamp of Nursing Home Regulations Proposed By CMS

Medicare Shared Savings Program Changes Under 2016 Physician Fee Schedule Regulations

Medigap PHO Discount Program Receives OIG Approval

New Federal Prosecution Standards Require Revisions to Investigation Policies

Off-Campus Provider-Based Departments Neutrality

OIG Fraud Alert – Medical Director Compensation Arrangements

Outpatient Surgery Article On Using A Safe Surgery Checklist

Population Health Management and Clinical Integration

President Signs the 21st Century Cures Act

Primary Care Integration Strategies – Divisional Group Practice Mergers

Provider Self-Disclosure Decisions – Voluntary Disclosure Process

Referral Requirements – Can Employed Doctors Be Required to Make Referrals?

Reimbursement for Telemedicine and Telehealth Services

Telemedicine Credentialing By Proxy

When Can Violation of a Condition of Participation Result in False Claims Act Liability? Update on Escobar’s Materiality Standard

Clinical Integration is the word of the day for provider organizations.  Clinical integration projects have emerged in all corners of the State of Wisconsin.  Our law firm has been at the center of many of these clinical integration programs and the creation of Accountable Care Organizations.

In a recent Article published on the Health Law Blog, we cover the issue of Clinical Integration Readiness Assessment.  During early assessment and design stages, we attempt to encourage broad participation by providers.  We will normally recommend the creation of a governance and committee structure that is as inclusive as possible.  Clinical integration is primarily a process that physicians perform.  Mechanisms are created through which physicians collaborate across specialty, in an interdependent way toward the end goals of increasing quality and efficiencies.  Ideally, the process should be collaborative between physicians and institutional providers.  However, the dynamics between hospitals and physicians can sometimes adversely impact the working relationship.

Find more by reading the full post over at the Health Care Blog.  This is an issue that all Wisconsin health care providers will want to follow because it is changing the central dynamic of the health care system.

Are You Ready For Clinical Integration?

Ruder Ware Clinical Integration Practice

By John Fisher, JD, CHC, CCEP

Jointly Providing Health Care Fee Information to Payers 

As health care provider networks move down the path toward clinical integration, we are often asked to provide guidance on how information can be jointly provided to payors.  The antitrust laws recognize that collective sharing of some pricing information, even by otherwise competing providers, can be beneficial and does not necessarily violate antitrust laws.  However, there are significant limitations on what can be jointly provided and how the information can be shared.

At the outset, it should be clarified that collective negotiations by competing providers who are not financially or clinically integrated should never take place and constitutes a per se violation of federal antitrust laws.  Prohibited activities include any action in contemplation of or in furtherance of an agreement on fees or other aspects of reimbursement.  It is unlawful for a non-integrated group of competing providers to agree on or suggest a central fee schedule.  Any activity relating to prospective fees should be avoided.

Competing providers can jointly provide information on fees currently being charged or that have been charged in the past as long as certain safeguards are implemented and strictly followed.  The FTC and DOJ have stated that the joint provision

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By John Fisher, JD, CHC, CCEP

Expanding Physician Owned Hospitals – Stark Law Approval Process

The Stark Law prohibits physicians from owning interests or having financial relationships with entities that provide “designated health services,” including hospital services, unless an exception exists.  The Stark Law contained an exception that permitted investment in a “whole hospital” but that exception was seriously limited under the Affordable Care Act.  Physician-owned hospitals must now obtain CMS approval of any expansion projects.  CMS regulations define the process and requirements for obtaining CMS approval of expansion projects.

I posted an article on the Health Law Blog that summarizes some of the requirements for obtaining approval for expansion of a physician-owned hospital.

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By John Fisher, JD, CHC, CCEP

 

Analysis of all available resources makes it clear that there is no single formula for achieving clinical integration and each organization will be unique in the mechanisms and processes that are used to achieve required levels of collaboration and interdependence between providers.  Clinical integration is a process of continual assessment and enhancement.  When we are speaking of clinical integration from an antitrust standpoint, we must determine whether the systems and mechanisms are in place and continuously operating to enhance quality and efficiency.

For more coverage of clinical integration, visit the clinical integration section of the Health Law Blog.

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Wisconsin Law Release of Patient Medical Records

Wisconsin Law requires health care organizations to provide records are to patients “on request.”  Records can be provided directly to the health care provider subject to payment of the statutory fees.  Patient must deliver an “informed consent” to the organization consenting to release of their records.

Fees were revised as provided below:

(a) A patient’s health care records shall be provided to the patient’s health care provider upon request and, except as provided in s. 146.82 (2), with a statement of informed consent.

(b) The health care provider under par. (a) may be charged reasonable costs for the provision of the patient’s health care records.

(2) The health care provider shall provide each patient with a statement paraphrasing the provisions of this section either upon admission to an inpatient health care facility, as defined in s. 50.135 (1), or upon the first provision of services by the health care provider.

(3) The health care provider shall note the time and date of each request by a patient or person authorized by the patient to inspect the patient’s health care records, the name of the inspecting person, the time and date of inspection and identify the records released for inspection.

 (3f)

(a) Except as provided in sub. (1f) or s. 51.30 or 146.82 (2), if a person requests copies of a patient’s health care records, provides informed consent, and pays the applicable fees under par. (b), the health care provider shall provide the person making the request copies of the requested records.

 (b) Except as provided in sub. (1f), a health care provider may charge no more than the total of all of the following that apply for providing the copies requested under par. (a):

Revised Fees for Patient records:

 Wisconsin Medical Record Maximum Fees through June 30, 2014 — (last year’s fees noted for reference)

Paper copies

• First 25 pages: $1.04/page ($1.02/page)
• Pages 26-50: 77 cents/page (76 cents/page)
• Pages 51-100: 52 cents/page (51 cents/page)
• Pages 101 and above: 31 cents/page (30 cents/page)

Microfiche or Microfilm: $1.55/page ($1.52/page)

Print of an X-ray (per image): $10.32 ($10.15)

If the requestor is not the patient or a person authorized by the patient

• Certification of copies: $8.26 ($8.12)
• Retrieval fee: $20.65 ($20.30)

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