Health Law Blog - Healthcare Legal Issues

Investment Interest in Radiation Therapy Anti-kickback Statute Settlement

May 20th, 2018

Radiation Therapy Referral Kickback Arrangements with Investors.

Anti-kickback Statute Radiation Therapy InvestmentsA national operator of radiation therapy centers, has agreed to settle a False Claims Act action alleging that it submitted claims violated the Anti‑Kickback Statute by paying of $11.5 million and entering into a 5 year Corporate Integrity Agreement with the Office of Inspector General.  The arrangement involved payments to investors who were allegedly targeted because of their referral potential to the therapy centers.  The challenged arrangement involved a series of leasing companies that accepted investments from referring physicians.  The investment interests resulted in the payment of investment returns that the government considered to be remuneration for referrals in violation of the Anti-Kickback Statute.  The whistleblower who originally raised the issue will receive up to $1.725 million.

This case involves a garden variety claim of a kickback by investment interest.  The typical investment case involves targeting potential investors who are in a professional position to make referrals to the company in which they are asked to invest.  The referral source has a financial incentive to increase referrals.  This might be an excellent financial investment scenario, but the problem is that the investment return might well be an illegal kickback; which is potentially a federal felony.

Fraud Allegation for Unnecessary Breast Cancer Index (BCI)Testing

May 18th, 2018

Unnecessary Breast Cancer Testing Fraud Settlement

False Claim Breast Cancer Index TestingA company will pay around $2 million to settle allegations of making false claims to Medicare for Breast Cancer Index (BCI) tests that were alleged to be not reasonable and necessary for the diagnosis and treatment of breast cancer.

The government accused the company of knowingly promoting and performing BCI testing for breast cancer patients who had not been in remission for five years and who had not been taking tamoxifen.  The government alleged that performing BCI testing under these circumstances was not reasonable and necessary based on published clinical trial data and clinical practice guidelines.

This case highlights the need to assure that there is clinical support for providing and billing for services.  In this case, the government took the position that patients who did not meet certain criteria would not benefit from the BCI testing.

Unnecessary Inpatient Admissions Results in Hospital DOJ Settlement

May 17th, 2018

Unnecessary Inpatient Admissions – Hospital Fraud Settlement.

Hospital Admissions Fraud Risk AreaAn $18 million settlement was agreed by a hospital chain after allegations that claims were submitted to Medicare for patients who were admitted to an inpatient facility when they allegedly could have been treated on a less costly outpatient basis.  The government alleged that the hospital system billed Medicare for short-stay, inpatient procedures that should have been billed on a less costly outpatient basis.  The government also accused the hospital system of inflating reports to Medicare regarding the number of hours of outpatient observation care that was provided.

This is a fairly typical case where the allegation involved billing for services that were of a higher level than required by the patient.  In effect, the excess services are deemed to be medically unnecessary.  In this case, the services involved inpatient admissions that the government alleged could have been taken care of in a less costly outpatient setting.

A former employee was the whistleblower in the case and walks away with over $3.25 million from the settlement.

Whistleblower Settlements Increase Compliance Risk for Providers

May 16th, 2018

Recent Fraud Settlements Emphasize Risk of Whisttleblowers

Dermatology Risk Areas Fraud and AbuseOne of the reasons why compliance officers and health care attorneys read fraud settlements is to identify the issues that the government is focused on.  The cases that the government decides to pursue are very indicative of the areas of fraud enforcement that they feel are important.  These are not the only issues that should be considered, but government enforcement actions certainly tell us what types of arrangements the government considers important.

The misfortune of the defendants involved in these cases hold a potential learning experience for everyone else.  Others have an opportunity to focus on their own operations to identify whether they are at risk in any of the areas involved in these cases.

An ancillary lesson that these settlements hold is that each was initially raised by a whistleblower.  The False Claims Act gives whistleblowers a portion of the settlement in cases where the government decides to intervene.  This in effect creates a universe of potential claimants that can include almost anyone with original knowledge of the alleged practice.

Common whistleblowers include former or disgruntled employees.  It really does not matter of the employee is or was the worst employee in the world, they can still bring an action as a whistleblower.  Not only are they protected by a host of laws, they can also profit greatly if the claim is eventually decided in their favor.  Whistleblowers often receive awards in the millions of dollars.  This makes the area ripe for plaintiff’s attorneys who often take these cases on a contingency fee basis.  This makes it a relatively low-cost proposition for a whistleblower to bring a case forward, at least from the perspective of attorney fees.

Opioid Prescribing Results in Medicare Fraud Claim

May 15th, 2018

Overprescribing Opioids Without Demonstrated Medical Justification.

A settlement was recently announced by the Department of Justice that symbolizes another use of fraud enforcement by the government to combat the opioid epidemic.  Providers need to take notice of these enforcement actions as they indicate opioid related issues as significant compliance risk areas.

The government alleged that a chiropractor billed Medicare and a state Medicaid program improperly for painkillers, including Opioids. The case involved four managed pain clinics, all which were closed through the course of the case.  The settlement also required a nurse practitioner to pay $32,000 and surrender her DEA registration to settle allegations that she violated the Controlled Substances Act.

The Department of Justice issued a press release announcing the settlement that directly comments on the opioid issues involved in the case, leaving no ambiguity about what the government is up to.  The quotations are not part of the normal “canned” statements that are normally included in these settlements.  Every indication is that the opioid related language might be adopted a standard form as the government focuses in on these cases.

“More Americans are dying because of drugs today than ever before—a trend that is being driven by opioids,” said Attorney General Jeff Sessions. “If we’re going to end this unprecedented drug crisis, which is claiming the lives of 64,000 Americans each year, doctors must stop overprescribing opioids and law enforcement must aggressively pursue those medical professionals who act in their own financial interests, at the expense of their patients’ best interests.”

The government alleged that the defendants prescribed painkillers and caused pharmacy claims to be submitted where there was no legitimate medical purpose for the prescriptions.  Additionally, the government alleged that the clinics up-coded and billed Medicare for office visits that were not reimbursable at the levels sought.  In a demonstration of the commitment that the government has in this area, the clinics were also accused of billing for nurse practitioner services that were provided without the required collaboration arrangement in place.

The case was initially brought forward by a former office manager turned whistleblower who is set to earn $246,500 under the settlement.

Denial of Access to Deadbeat Patients

May 2nd, 2018

Private Practice Revises Access Procedure to Provide Access Despite an Outstanding Balance

A complainant alleged that a private practice physician denied her access to her medical records, because the complainant had an outstanding balance for services the physician had provided. During OCR’s investigation, the physician confirmed that the complainant was not given access to her medical record because of the outstanding balance. OCR provided technical assistance to the physician, explaining that, in general, the Privacy Rule requires that a covered entity provide an individual access to their medical record within 30 days of a request, regardless of whether or not the individual has a balance due. Once the physician learned that he could not withhold access until payment was made, the physician provided the complainant a copy of her medical record.

Health Care Compliance Resource Portal Launched by OIG

May 1st, 2018

Office Inspector General Launches New Compliance Resource Portal

by John H. Fisher, II, JD, CHC, CCEP

At a recent Health Care Compliance Association (HCCA) compliance institute, the Office of Inspector General announced it had launched a new resource portal focused on compliance issues.  A trip to the OIG’s web site, and sure enough, there is a brand spankin’ new compliance portal.  You can check out the portal at OIG Portal.

On first brush through the portal, it appears most of the items that are accessible already existed prior to the launch of the portal.  The portal creates some organization that did not previously exist to guide providers to various compliance resources the OIG has made available.

 

Contents  Listing of the OIG Compliance Portal

  • Toolkits
  • Provider Compliance Resource and Training
  • Advisory opinions
  • Voluntary Compliance and Exclusions Resources
  • Special Fraud Alerts, Other Guidance, and Safe Harbors
  • Resources for Health Care Boards
  • Resources for Physicians
  • Accountable Care Organizations

This is a site that compliance officers will want to have bookmarked in their browser.  We are likely to see new developments in compliance posted on the portal.  For example, it already references a toolkit on identification of opioid misuse risk will be coming soon to the portal.

When you get a chance, check out the new OIG resource and the tools that are available on the site.  It is definitely something with which people in compliance should have familiarity.  As usual, if you have any questions regarding compliance or other health care legal issues, please don’t hesitate to contact your Ruder Ware health care attorney.

Health Law Firm Opens Green Bay Office

May 1st, 2018

Green Bay Health Care Lawyer – Opening Office in Green Bay Wisconsin

I just wanted to let readers of our health care blog know that Ruder Ware will be opening a Green Bay office and that three Green Bay attorneys will be joining our firm. This will provide us with a presence in the Green Bay/Appleton Markets that will enhance our community presence and enable us to better serve our client in eastern Wisconsin. Our health care and compliance practice with be greatly enhanced as a result of this move.

This move will provide a local platform through which we can better serve our health care clients.

Health Care Law Practice – Green Bay Health Lawyers Ruder Ware

Ruder Ware has a long history of representing health care clients.  The firm recognizes that the highly regulated and complex nature of the industry demands the attention of a team of attorneys who, as a group, monitor constantly evolving laws and regulations and their impact on our health care clients.  At Ruder Ware, we offer a full-service solution to clients as our focus team consists of health care, business, employment, and litigation attorneys with knowledge of the health care industry.   As a result, we are able to take best practices from other industries and apply them to the health care industry, thereby increasing the ability to respond promptly to the rapidly changing health care environment.

Members of the focus team have served on the governing bodies of various health care organizations.  This service has provided our attorneys with the opportunity to counsel the health care community.  

Our dedicated team of attorneys represents health care providers in various matters including:

 Health Care Business Transactions and Corporate Law

Our attorneys have substantial expertise representing various health care providers such as:

Below is the official press release:

Media Contact:
Jamie Schaefer
COO
Ruder Ware, L.L.S.C.
P: 715.845.4336
E: jschaefer@ruderware.com

For Immediate Release

Attorneys Ronald Metzler, Christopher Pahl, and Chad Levanetz to join
Ruder Ware at its new Green Bay Office

WAUSAU, WI – April 27, 2018 – Ruder Ware is pleased to announce the opening of its Green Bay office and that Attorneys Ronald Metzler, Christopher Pahl, and Chad Levanetz will be joining the firm. The new office will be located at 222 Cherry Street, Green Bay, Wisconsin, which is the current location of Metzler, Timm, Treleven, S.C.

Attorney Ron Metzler – Having practiced law for over 30 years, Ron is a well-respected and well-known commercial attorney with close ties to the banking industry.

Attorney Chris Pahl – With his strong ties to the Green Bay community, Chris has built his practice around real estate development and condominium law as well as commercial transactions and estate planning.

Attorney Chad Levanetz – A seasoned litigation attorney, Chad counsels clients in the areas of real estate, construction, and general business disputes.

Stew Etten, Ruder Ware managing partner, stated, “Ruder Ware is always looking for outstanding attorneys to join our firm. With the opportunity to add Attorneys Metzler, Pahl, and Levanetz, the time was right to open a Green Bay office. We’re very excited to have attorneys of their caliber join our team of professionals.”

About Ruder Ware
Founded in 1920, Ruder Ware is the largest law firm headquartered north of Madison. With offices in Wausau, Eau Claire, and Green Bay over 40 attorneys provide legal and business advice to clients with operations of all sizes. Areas of practice include: Employment, Benefits & Labor Relations, Litigation & Dispute Resolution, Business Transactions, Trusts & Estates, and Fiduciary Services. Ruder Ware, Business Attorneys for Business Success. www.ruderware.com

Media Contact:
Jamie Schaefer
COO
Ruder Ware, L.L.S.C.
P: 715.845.4336
E: jschaefer@ruderware.com

Health Law Blog RSS Feed Information

April 16th, 2018

 RSS Feed for Health Law Blog

We have recently had some requests for RSS Feed information for the Healthlaw-blog.com Health Care Blog

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Faxing Patient Health Information to Wrong Number – Compliance Risk Area

March 13th, 2018

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

faxing phi wrong numberA 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 this does raise the importance of being precise at all stages of the patient encounter to assure that no inadvertent violations occur.  Care you should be taken when information about the patient is initially entered into the system.  Individuals at all levels who may be responsible for transmitting PHI must be deliberate about their actions.  How many people have called or faxed something to the wrong person before?  How many people have written down the wrong telephone or fax number before?  Everyone?

This OCR settlement just illustrates that sometimes these small errors can have big implications.  It does not appear to have been any significant fines or loss of employment in this situation.  But we cannot downplay the potential embarrassment or other negative consequences of mistakes like these.  It is one thing to text your friend Bob rather than your friend Bobbie, and weirdly from Bob’s perspective say how wonderful last night was and how you can’t wait to see him again.  Telling a patient’s employer about their health condition can have consequences that are much harder to laugh off.

John H. Fisher

Health Care Counsel
Ruder Ware, L.L.S.C.
500 First Street, Suite 8000
P.O. Box 8050
Wausau, WI 54402-8050

Tel 715.845.4336
Fax 715.845.2718

Ruder Ware is a member of Meritas Law Firms Worldwide

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Disclaimer
The Health Care Law Blog is made available by Ruder Ware for educational purposes and to provide a general understanding of some of the legal issues relating to the health care industry. This site does not provide specific legal advice and you should not use the information contained on this site to address your specific situation without consulting with legal counsel that is well versed in health care law and regulation. By using the Health Care Law Blog site you understand that there is no attorney client relationship between you and Ruder Ware or any individual attorney. Postings on this site do not represent the views of our clients. This site links to other information resources on the Internet; these sites are not endorsed or supported by Ruder Ware, and Ruder Ware does not vouch for the accuracy or reliability of any information provided therein. For further information regarding the articles on this blog, contact Ruder Ware through our primary website.