Tuesday, March 26, 2013

A Majority of all Medicare Claims for Breast-Cancer Drug Were Billed Incorrectly

By Lance O. Leider, J.D., The Health Law Firm, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

It’s no surprise that the government is aggressively pursuing Medicare fraud. Recently, the Department of Health and Human Services (HHS), Office of Inspector General (OIG), made a surprising discovery. An audit uncovered that more than three-quarters (3/4) of all Medicare claims for the breast-cancer drug Herceptin were billed incorrectly, according to Modern Healthcare. This was found during an audit conducted on physicians and hospitals from around the country between January 1, 2008, and December 31, 2010.

To read the entire Modern Healthcare article, click here.


Audit Results Not Uncommon.

Three different audits were released to the public by the HHS OIG. All of these audits showed roughly the same information. Health care providers have been billing Medicare for full multiuse vials of the drug Herceptin, when patients actually only need a smaller portion. Medicare does not pay healthcare providers for any part of the drug that is discarded, because it can be preserved for up to 28 days and reused. The auditors suggest that payment from Medicare for an entire multiuse vial is likely to be incorrect. We saw a similar situation with the drug Avastin and Lucentis being used by ophthalmologists several years ago.

The results of the audits were released in January 2013. One audit found eighty-five percent (85%) of 1,073 Herceptin vials used in Ohio and Kentucky were billed incorrectly. In Illinois, Indiana, Michigan and Wisconsin, the government auditors found that seventy-eight (78%) of 713 claims investigated were wrong. The overpayment amount was around $682,000, for these audits.


Florida Overcharged Amost 80% of Bills.

According to the report, HHS auditors found overcharges in seventy-eight percent (78%) of bills for 1,330 vitals of Herceptin submitted to First Coast Service Options, Inc. This company serves as the Medicare Administrative Contractor (MAC) for HHS District Nine, which primarily includes providers in Florida, Puerto Rico, and the U.S. Virgin Islands. The overcharges for Herceptin were $1,325,409.

In the report, the government recommends that First Coast Service Options, Inc., do a number of things. The first is to recover the more than one million dollars in overpayments. It’s also recommended that First Coast Service Options, Inc., implement system edits that review multiuse vial drugs that are billed with units of service equivalent to the dosage of an entire vial. The government also suggests that these audit results be used as an educational tool for teaching correct billing practices to physicians and hospitals.

Click here to read the entire report on District Nine.


Responding to a Medicare Audit.

Remember, there is no such thing as a “routine” Medicare audit. The fact is that if you find yourself or your practice at the center of a Medicare audit, there is some item you have claimed as a Medicare provider or the amount of claims Medicare has paid in a certain category that has caused the audit. We’ve come up with a list of actions that we use and recommend you take when responding to a Medicare audit. Click here to view that list.


Don't Wait Until It's Too Late; Consult with a Health Law Attorney Experienced in Medicare and Medicaid Investigations.


The best time to respond to and defeat an allegation of overpayment is at the very beginning. That is why it is essential that you obtain qualified counsel to help you through the process. The attorneys of The Health Law Firm represent healthcare providers in Medicare audits, ZPIC audits and RAC audits throughout Florida and across the U.S. They also represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions and termination from the Medicare or Medicaid Program.


For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.

Comments?

Why do you think hospitals and physicians incorrectly bill for Herceptin? Are audits like these necessary? Please leave any thoughtful comments below.


Sources:

Carlson, Joe. “OIG Finds Widespread Herceptin Overcharges.” Modern Healthcare. (January 21, 2013). From: http://www.modernhealthcare.com/article/20130121/NEWS/301219959/oig-finds-widespread-herceptin-overcharges

Jarmon, Glorida. “The Medicare Contractor’s Payments to Providers in Jurisdiction 9 for Full Vials of Herceptin were often Incorrect.” Office of Inspector General (January 2013). From: http://www.thehealthlawfirm.com/uploads/Herceptin%20FL%20Overcharges.pdf


About the Authors: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.
Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Wednesday, March 20, 2013

Don't Land on the Office for Civil Rights’ “Wall of Shame”

By George F. Indest, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law
As of February 2013, there are 537 cases listed on the Office for Civil Rights’ (OCR) “Wall of Shame.” These are breaches of unsecured health information affecting 500 or more individuals. The reports of these breaches of patient confidentiality are required by the Health Information Technology for Economic and Clinical Health (HITECH) Act.
The OCR continuously updates this list of breaches on its website. These breaches include a brief summary of each case that OCR has investigated and closed, as well as the names of private practice providers who have reported breaches of unsecured health information to the OCR.
Click here to see the OCR’s “Wall of Shame.”


Most Breaches on the “Wall of Shame” Involve Laptops and Portable Devices.
Six healthcare organizations listed on the “Wall of Shame” reported security breaches that involved one million or more patient records. Among the largest breaches reported was one by the TRICARE Management Activity, which reported 4.9 million records lost when back up tapes for computer systems went missing. Another major breach involved WellPoint, the largest managed health care company in the Blue Cross and Blue Shield Association. The company reported 31,700 of its customer records were compromised during a three-year time frame. The breach was believed to be caused by an unauthorized hack into a network server.
According to an article in Modern Healthcare, a majority of the breaches on the “Wall of Shame” involve laptops, backup disks and other portable devices that were stolen. These devices contained patient information and were not encrypted. Had the files been protected by encryption, these organizations would not have landed on the list.
Click here to read the article from Modern Healthcare.


New HIPAA and HITECH Rules.

The OCR under the U.S. Department of Health and Humans Services (HHS) recently released stronger rules and protections governing patient privacy. On January 17, 2013, the HHS announced the omnibus rule to strengthen the privacy and security protection established under the Health Insurance Portability and Accountability Act (HIPAA) of 1996. These changes also improve the HITECH Act by making it clear when breaches must be reported to the OCR. Once reported, the breaches are then placed on the “Wall of Shame.” It’s important to review these changes, as to stay off the list. Click here to learn more on the new HIPAA rules.


It's In Your Best Interest to Get a HIPAA Risk Assessment.
Since the HIPAA laws have changed, you need to edit your privacy forms and procedures. Many health providers simply don't have the time to re-review their policies and revise documents. A HIPAA risk assessment is a thorough review and analysis of areas where you may have risk of violating the HIPAA laws.  Federal regulations require that covered entities have this assessment done. To learn more on HIPAA risk assessments, click here.


Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.
The attorneys of The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in investigating and defending alleged HIPAA complaints and violations and in preparing Corrective Action Plans (CAPs).
For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.


Sound Off.
Have you ever heard of the “Wall of Shame? What do you think of this list? Please leave any thoughtful comments below.


Sources:
Modern Healthcare. “Hoping for ‘Progress’ on Health Data Breaches.” Modern Healthcare. (January 8, 2013). From: http://www.modernhealthcare.com/article/20130108/BLOGS02/301089998/joe-blog-sad-sign-of-progress-in-health-data-breaches
Mearian, Lucas. “‘Wall of Shame’ Exposes 21M Medical Record Breaches.” Computerworld. (August 7, 2012). From: http://www.computerworld.com/s/article/9230028/_Wall_of_Shame_exposes_21M_medical_record_breaches


About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.



The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved. 

Friday, March 8, 2013

Stryker Orthopaedics Facing Dozens of Hip Implant Lawsuits

By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

As of February 2013, more than 80 lawsuits have been consolidated into multicounty litigation (MCL) in the Superior Court in New Jersey against Stryker Orthopaedics. Patients are claiming the company’s Rejuvenate and ABG II modular-neck femoral hip systems are defective, according to a number of news sources. The case is on track to becoming one of the largest mass-tort litigations in the country.

In July 2012, Stryker issued a voluntary recall of the Rejuvenate and ABG II modular-neck femoral hip systems. (Click here to see the press release from Stryker.) The company is currently in the process of sending out letters to surgeons urging them to perform clinical exams, such as blood work and cross sectional imaging, on patients who had implants installed. The letters state that Stryker will compensate patients for any tests or work that has to be done.
Click here to read a letter from Stryker to a surgeon.

Unfortunately, for some, this notice is too late. Hundreds of patients are already experiencing pain from the Stryker hip implants, which has forced them to have the implants removed. Even after surgery some patients alleged they have permanent damage and are demanding compensation.

Early Lawsuit Filed from Florida Patient.
According to the Palm Beach Post, one of the first lawsuits against Stryker came from a Boca Raton retiree. Her hip replacement came with a promise to last for decades. The device allegedly failed within months. Click here to read the patient’s entire story.

According to Drug Watch, most patients who received Stryker’s devices allegedly suffered from muscle, nerve and bone damage as the metallic components of the device rub against each other, causing metallic elements to be released into the body and be absorbed into the blood stream and body tissue. To read the entire article from Drug Watch, click here.


More Lawsuits to Come - Contact an Experienced Health Lawyer.
Since the implants were recently recalled, it’s expected that there are many more cases out there.
Many of the people who have already filed lawsuits claim Stryker marketed and sold a defective device and failed to warn the public, among other issues.

If you or a family member received a Stryker Rejuvenate or ABG II hip implant and suffered complications, you don’t have to face the medical issues alone. Contact an experienced attorney that is board certified in health law. Before you talk about settling, call an attorney.

Stryker Lawsuits Similar to DePuy.

According to an article in The Records, similar mass-tort cases in New Jersey include hundreds of lawsuits filed against DePuy Orthopaedics. More than 2,500 plaintiffs in that case alleged similar complaints due to a metallic hip part. DePuy’s product, ASR, was recalled by the company in August 2010. The cases being heard involve potentially hundreds of millions of dollars in settlements or verdicts. Click here to read the entire article from The Records.


Contact Experienced Health Law Attorneys.
If you or a family member received a Stryker Rejuvenate or ABG hip implant and suffered complications you don’t have to face the medical issues alone. Our attorneys are available seven days a week to answer your questions. We can help you decide whether filing a lawsuit is the right option for you. Our attorneys include those who are board certified by The Florida Bar in Health Law, as well as licensed health professionals who are also attorneys.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.


Comments?
Did you or someone you know have a Stryker Rejuvenate or ABG II modular-neck femoral hip implant? What has been your experience? Did you know about the recall? Are you in need of legal assistance? Please leave comments below.


Sources:
Markos, Kibret. “Mahwah-based Stryker Orthopaedics Faces Hip Implant Lawsuits.” The Records. (February 28, 2013). From: http://www.northjersey.com/mahwah/Over_80_lawsuits_on_hip_implants_filed_against_Mahwah-based_Stryker_Orthopaedics_.html?c=y&page=3

Singer, Stacey. “Artificial Hips Corrode, Poisoning Some Patients, Local Lawsuits Say.” The Palm Beach Post. (January 27, 2013) From: http://www.palmbeachpost.com/news/lifestyles/health/artificial-hips-corrode-poisoning-some-patients-lo/nT7jf/

Hooks, Beau. “Stryker Hip Replacement Lawsuits.” Drug Watch. (February 2013). From: http://www.drugwatch.com/stryker/lawsuit-hip-replacement/

Guilfoyle, Jeanine. “Stryker Initiates Voluntary Product Recall of Modular-Neck Stems.” Stryker. (July 6, 2012). From: http://www.stryker.com/stellent/groups/corporate/documents/web_prod/147504.pdf


About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone:  (407) 331-6620.




The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.

Tuesday, March 5, 2013

Department of Health and Human Services Introduces HIPAA Omnibus Rule


By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law, and Lance O. Leider, J.D., The Health Law Firm

With the popularity of electronic health records (EHRs), social media and everything in between, the U.S. Department of Health and Human Services (HHS) has released stronger rules and protections governing patient privacy. On January 17, 2013, the HHS announced the omnibus rule to strengthen the privacy and security protection established under the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

Click here to read the entire 563-page rule.
Now, I can’t say that I’ve had enough free time to read the entire document yet, but I can tell you about the major parts of the omnibus rule, and what it means for healthcare providers.


Protecting a Patient's Information During Data Exchanges.
HHS is expanding the government’s jurisdiction over healthcare providers, health plans and other entities that process health insurance claims to include their contractors and subcontractors with whom providers share protected health information. As the industry embraces new care delivery models, including accountable care organizations (ACOs) and integrated delivery systems, data is exchanged between physicians, hospitals and additional providers to improve care and reduce costs. This all has to be done while keeping patient data safe. According to the HHS, some of the largest breaches involve business associates and not the covered entities themselves.

The government is committed to doing more HIPAA compliance audits and collecting more fines.  The fines the government collects will help to fund the audit process. Because of this rule, we will see audits of business associates and their subcontractors, not just covered entities.

Under the new rule, penalties have been increased for noncompliance based on the level of negligence with a maximum penalty of $1.5 million per violation.


Don’t Land on the Office for Civil Rights’ “Wall of Shame.”
The changes also improve the Health Information Technology for Economic and Clinical Health (HITECH) breach notification requirements by making it clear when breaches must be reported to the Office for Civil Rights (OCR), according to the HHS.

Once reported to the OCR, the breaches are then placed on what is commonly known in the healthcare industry as the “Wall of Shame.” It’s a comprehensive list of privacy breaches each affecting more than 500 people. We’re currently working on a “Wall of Shame” blog, so more on that later.


Take Notes of New Regulations Regarding Patient Information in Marketing.
One part of the final rule also sets new regulations for how patient information can be used for marketing and fundraising. It ensures that such information cannot be sold without a patient’s permission. According to an article in Fierce Healthcare, this provision is a huge win for patient advocates and privacy groups who blast hospitals for mining patient data to target affluent or privately insured patients. Hospitals using health and demographic data from patients’ records to target advertising could be in hot water.

Click here to read the entire Fierce Healthcare article.


If You are Unsure of Your Policies and Procedures, Get a HIPAA Risk Assessment.

Since the HIPAA laws have changed, you need to edit your privacy forms and procedures. Many health providers simply don't have the time to re-review their policies and revise documents. A HIPAA risk assessment is a thorough review and analysis of areas where you may have risk of violating the HIPAA laws.  Federal regulations require that covered entities have this assessment done. A HIPAA risk assessment can significantly reduce, if not entirely eliminate, your exposure to regulatory and litigation sanctions.

When the OCR auditor comes to visit your office to check for HIPAA compliance, they will ask for your risk assessment. Do you have one? Does your staff know who your HIPAA compliance officer is? Call an experienced health law attorney to complete a risk assessment of your practice today. To learn more on HIPAA risk assessments, click here to read a blog we wrote.


Update Notice of Privacy Practices.
Healthcare providers, now is the time to revise your Notice of Privacy. The final rule will be effective on March 26, 2013. Covered entities and their business associates will have until September 21, 2013, to comply.


Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.
The attorneys of The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals and other healthcare providers and institutions in investigating and defending alleged HIPAA complaints and violations and in preparing Corrective Action Plans (CAPs).

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or (850) 439-1001.


What Do You Think?
What do you think about the new HIPAA rules? Do you think these updates were necessary? Do you think it will be difficult for health professionals to comply? Please leave any thoughtful comments below.


Sources:
HHS Press Office. “New Rule Protects Patient Privacy, Secures Health Information.” U.S. Department of Health and Human Services. (January 17, 2013). From: http://www.hhs.gov/news/press/2013pres/01/20130117b.html
Struck, Kathleen. “HIPAA Rules Fortify Patient Privacy.” MedPage Today. (January 21, 2013). From: http://www.medpagetoday.com/PracticeManagement/InformationTechnology/36940
Conn, Joseph. “New Rule: Hospital, Physician Partners Face Penalties for Privacy Leaks.” Modern Healthcare. (January 17, 2013). From: http://www.modernhealthcare.com/article/20130117/NEWS/301179957/new-rule-hospital-physician-partners-face-penalties-for-privacy&utm_source=home&utm_medium=web&utm_campaign=most-popular-box
Caramenico, Alicia. “New HIPAA Rule a Delicate Balance Between Privacy, Sharing.” Fierce Healthcare. (January 18, 2013). From: http://www.fiercehealthcare.com/story/new-hipaa-rule-delicate-balance-between-privacy-sharing/2013-01-18


About the Authors: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law.  He is the President and Managing Partner of The Health Law Firm, which has a national practice.  Its main office is in the Orlando, Florida, area.  www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.
 
Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com  The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone:  (407) 331-6620.

 
"The Health Law Firm" is a registered fictitious business name of George F. Indest III, P.A. - The Health Law Firm, a Florida professional service corporation, since 1999.

Copyright © 1996-2012 The Health Law Firm. All rights reserved.