Tag Archives: health law

Internal Medicine Specialists Should Be Aware of Impending Medicare Audits

6 Indest-2008-3Coming to a medical practice near you. . . It’s scary, it’s horrible, and it could cost you a lot of money!

It’s the dreaded Comprehensive Error Rate Testing (CERT) audit.

The Horror! The Horror!

First Coast Service Options, the Medicare contractor for Florida, announced a new prepayment audit program that will impact Internal Medicine Specialists. The prepayment program is focused on Initial and Subsequent Hospital Evaluation and Management Services, CPT Codes 99223 and 99233. The program is being launched due to the high CERT error rate associated with these codes.

The audits will start on October 21, 2014.

What is the CERT Program?

CMS created the CERT program to measure the paid claims error rate for Medicare claims submitted to Medicare administrative contractors, carriers, durable medical equipment regional carriers, and Medicare Administrative Contractors (MACs). CMS receives more than two billion claims annually. The CERT program randomly selects approximately 120,000 of these claims for review to determine whether the claims were properly paid.

Statistical samples are selected and the CERT documentation contractor (CDC) submits documentation requests to those providers who submitted affected claims. Once the requested documentation has been received, the information is forwarded to the CERT review contractor (CRC) for review. The CRC will review the claims and supporting documentation to measure compliance with Medicare coverage, coding and billing rules. Click here to read my previous blog on the CERT Program.

How Internal Medicine Specialists Can Avoid CERT Audits.

First Coast is only targeting Internal Medicine Specialists as their data analysis suggests the specialty is the primary contributor to an elevated CERT error rate. Errors are normally cause by insufficient documentation to justify the service.

Healthcare providers designated as Internal Medicine with First Coast Service Options need to pay special attention to this audit program and the documentation requirements for billing 99223 and 99233 codes. If you find yourself or your practice the target of a CERT audit, click here for tips on how to respond.

Our Thoughts on the CERT Program.

In working with the CERT Program, we have been pleasantly surprised when our personal phone calls to the CERT auditors have been answered and actual accurate information provided, as well as letters and documents we provided being promptly acknowledged. Like with any other audit, however, we urge those being audited to seek the advice of an experienced health law attorney who may be able to assist in heading off and avoiding a more serious investigation or a large repayment demand.

Comments?

Have you heard of CERT audits? Has your practice encountered a CERT audit? Please leave any thoughtful comments below.

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

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.

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 © 1996-2014 The Health Law Firm. All rights reserved.

Watch Out for Legal Pitfalls Associated with Telemedicine

Lance Leider headshotBy Lance O. Leider, J.D., The Health Law Firm

With all the new technologies, mobile medical applications, expansion of access to health care under the Affordable Care Act (ACA), and the emphasis on quality care, telemedicine is at the forefront of the health care industry.

Now is the time to educate yourself on the new opportunities in practicing telemedicine. As with any new health care business model, you also have to assess the risks and be sure you are complying with the ever increasing number of regulations.

Where Telemedicine Stands Today.

The Centers for Medicare and Medicaid Services (CMS) can be credited for the telemedicine revival. In 2011, CMS issued a final rule permitting a more flexible process for credentialing and privileging practitioners who provide telemedicine services. Telemedicine escalated in 2013, when federal and state legislation and major insurers expanded the types of reimbursable telemedicine services. Now in 2014, there are more partnerships between insurers and health care delivery systems to provide patients access to specialists through telemedicine programs.
For example, WellPoint, Inc., and Aetna, Inc., among other health insurers, are letting millions of patients schedule online visits with health care professionals. These insurance companies are working together with companies that offer virtual visits with doctors who, in some states, can prescribe drugs for anything from sinus infections to back pain. According to Bloomberg, this is a major advancement for telemedicine. To read the entire article from Bloomberg, click here.

The Current Status of Telemedicine in Florida.

In March 2014, the Florida Boards of Medicine and Osteopathic Medicine adopted updated standards for practicing telemedicine. The final rule, 64B8-9.0141, Florida Administrative Code, defines telemedicine as:

the practice of medicine by a licensed Florida physician or physician assistant where patient care, treatment, or services are provided through the use of medical information exchanged from one site to another via electronic communications. Telemedicine shall not include the provision of health care services only through an audio only telephone, email messages, text messages, facsimile transmission, U.S. mail or other parcel service, or any combination thereof.

The rule states that the standard of care shall remain the same regardless of whether a physician provides services in person or by telemedicine. Also, those providing telemedicine services are responsible for the safety, security and adequacy of their equipment.

Several other parts of the new Florida telemedicine rule are worth noting:

1. Telemedicine is sufficient to establish a physician-patient relationship;
2. All regulations regarding patient confidentiality and record keeping are applicable;
3. The rule specifically exempts medical advice given by emergency responders including EMTs, paramedics and emergency dispatchers;
4. The rule also does not apply to physicians or physician assistants providing emergency care under conditions requiring immediate medical care; and
5. Florida law presently prohibits prescribing controlled substances via telemedicine.


Telemedicine and the Potential Legal Issues.

As telemedicine grows, so will the oversight and scrutiny by state medical boards and federal and state regulatory agencies. Here are some areas to be mindful of:

- Reimbursement: This is continuously an issue with telemedicine. Medicare reimbursement for telemedicine services is limited and generally requires face-to-face contact between patients and providers. Medicaid reimbursement varies from state-to-state, and only about 20 states have enacted statutes that require reimbursement for certain telemedicine services. This means health care providers need to review Medicare and Medicaid reimbursement policies, state health insurance regulations, and provider payer contract requirements so that they are aware of the reimbursement requirements that may affect their billing. Educate yourself on what will and what won’t be reimbursed, and only submit compliant claims to avoid audits.

- Fraud and Abuse: As a telemedicine provider, you will most likely initiate business arrangements between distinct health care entities that may include the lease of equipment or the use of a product owned, in part, by physicians. Arrangements like this need to be written with federal fraud and abuse laws in mind, including the Anti-Kickback Statute and the Stark Law. For more advice on telemedicine-related fraud issues, review advisory opinions issued by the Office of the Inspector General (OIG).

- Medical Staff Bylaws: Health care organizations that depend on information from a distant-site hospital or telemedicine entity to credential and privilege telemedicine practitioners must revise their medical staff bylaws and policies to include criteria for granting privileges to distant practitioners, and a procedure for applying the criteria. Additions should also include what category of the medical staff distant-site telemedicine practitioners will join, the level of involvement they may have in medical staff committees, and what procedural rights they should be given.

- Credentialing and Privileging: Under CMS’ final rule, health care organizations may rely on the credentialing and privileging decisions of distant-site hospitals or the information provided by other telemedicine entities when determining privileges for distant-site practitioners who provide telemedicine services, as long as certain conditions are met, including a compliant written agreement.

- Patient Privacy: Providers are responsible for ensuring they have secure communication channels, implementing business associate and other confidentiality and privacy agreements, educating staff regarding the appropriate use of telemedicine, and understanding how and what patient information is being collected and stored.

- Compliance with State Requirements: Most states require physicians engaging in telemedicine to be licensed in the state where the patient is located. It would be wise for health care organizations to seek the legal guidance of an experienced health law attorney to navigate individual state requirements.

- Interactions with Pain Management Laws: Our practice has seen many physicians become the subject of some kind of government investigation or action resulting from the remote practice of medicine in a pain management setting. These telemedicine rules do not alter the status quo in pain management. Physicians are still required to see patients in a face-to-face encounter in order to prescribe controlled substances for the treatment of pain. There are discussions among the members of the Florida  Boards of Medicine and Osteopathic Medicine to permit limited prescribing of controlled substances through telemedicine. However, the boundaries of a future rule are unclear. Considering the hard-line stance the Boards have taken toward pain management in general, it is unlikely that any final rule would authorize the remote practice of pain management.

Health care providers need to stay mindful of the listed legal issues, and any others that may come up. It is important when practicing telemedicine to ensure your services are compliant, and you appropriately protect patient safety and privacy.

Comments?

Does your practice use telemedicine? In your opinion what are the benefits and what are the difficulties of telemedicine? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals and Providers.

At the Health Law Firm we provide legal services for all health care providers and professionals. This includes physicians, nurses, dentists, psychologists, psychiatrists, mental health counselors, Durable Medical Equipment suppliers, medical students and interns, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other health care provider. We represent facilities, individuals, groups and institutions in contracts, sales, mergers and acquisitions.

The services we provide include reviewing and negotiating contracts, business transactions, professional license defense, representation in investigations, credential defense, representation in peer review and clinical privileges hearings, Medicare and Medicaid audits, commercial litigation, and administrative hearings. To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at http://www.TheHealthLawFirm.com.

Sources:

French, Marie. “The Doctor Will Click on You Now.” Bloomberg. (July 13, 2014). From: http://www.bloomberg.com/news/2014-07-14/the-doctor-will-click-on-you-now.html

Kadzielski, Mark and Kim, Jee-Young. “Telemedicine: Many Opportunities, Many Legal Issues, Many Risks.” JD Supra. (July 30, 2014). From: http://www.jdsupra.com/legalnews/telemedicine-many-opportunities-many-l-18993/

About the Author: 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. http://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 © 1996-2014 The Health Law Firm. All rights reserved.

Miami Medical Clinic Owner Pleads Guilty to $20 Million in Medicare Fraud

6 Indest-2008-3By George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

The owner of a Miami-based medical clinic pleaded guilty on January 8, 2014, for her involvement in several health care fraud schemes that allegedly cost the Medicare program around $20 million. The schemes allegedly involved fraudulent billing for home health care services and therapy prescriptions to patients that may not have required them, according to the Associated Press. The owner operated Merfi Corp., a medical clinic that employed physicians, physician assistants and other medical professionals authorized to dispense prescriptions for home health care services.

Click here to read the Associated Press article.

The medical clinic owner faces up to 10 years in prison and is scheduled to be sentenced in March 2014.

Medicare Fraud Scheme Involved Kickbacks and Brides.

According to an article on Home Health Care News, through Merfi, the owner and her co-conspirators were allegedly given kickbacks and brides for providing fraudulent home health and therapy prescriptions and other medical documentation to owners and operators of other home health agencies and patient recruiters. The fraudulent documents were then used to bill Medicare.

To read the entire article from Home Health Care News, click here.

Case Investigated by Medicare Fraud Strike Task Force.

This case was investigated by the Medicare Fraud Strike Task Force. This task force has charged more than 1,700 defendants who have collectively billed the Medicare program for more than $5.5 billion since the agency’s inception in March 2007. To learn more about the Medicare Fraud Strike Force’s anti-fraud efforts, click here to read a previous blog.

What You Need to Know about Medicare and Medicaid Audits.

I previously wrote a two-part blog on the increased number of Medicare and Medicaid audits being initiated against health professionals who treat home health care, assisted living facility (ALF) and skilled nursing facility (SNF) residents. This area of medical practice has been identified as one fraught with fraud and abuse. To learn more on the areas being targeted and how to respond to different types of audits click here for the first blog, and click here for the second.

Physicians, Nurse Practitioners and Physician Assistants Must Check Out Their Employers.

I have previously written blogs warning licensed health practitioners about illegal health care clinics. Often the individuals involved in fraudulent acts will use an unlicensed health clinic as a vehicle to process false claims. Licensed health professionals should jealously protect their Medicare and Medicaid provider numbers and make sure that they do not allow their name or numbers to be used in false billing activities. Check out any company or corporation that employs you to be sure it is properly licensed, as necessary. To read a previous blog I wrote on unlicensed health clinics, click here.

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

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?

Do you think similar schemes are fairly common? Do you think we will see more news stories like this with the increased anti-fraud efforts of the Medicare Fraud Strike Task Force? Please leave any thoughtful comments below.

Sources:

Associated Press. “South Florida Woman Guilty in $20M Medicare Fraud Scheme.” Miami Herald. (January 8, 2014.) From: http://www.miamiherald.com/2014/01/08/3858269/fla-woman-guilty-in-20m-medicare.html

Oliva, Jason. “Miami Clinic Owner Pleads Guilty to $20 Million Home Health Fraud.” Home Health Care News. (January 8, 2013). From: http://bit.ly/1h87Xv4

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.

CMS Delays Stage 3 Meaningful Use for Medicare and Medicaid EHR Incentive Programs

MLS Blog Label 2By Michael L. Smith, R.R.T., J.D., Board Certified by The Florida Bar in Health Law, and George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On December 6, 2013, the Centers for Medicare and Medicaid Services (CMS) announced a revised timeline for the implementation of Stage 3 meaningful use measures for the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs.

According to CMS, Stage 2 will be extended through 2016, and Stage 3 will begin in 2017 for those hospitals, physicians and other eligible providers that have completed at least two years of Stage 2 meaningful use. These changes affect two groups of eligible providers: providers who started Stage 1 in 2011, and who are currently scheduled to start Stage 3 in 2016, and those providers who started Stage 1 in 2012, and who are scheduled to start Stage 3 in 2016.

This announcement does not change when providers must start Stage 2, nor does it affect the requirement for hospitals and critical access hospitals to upgrade to EHR technology to receive incentive payments. The Medicare and Medicaid EHR incentive programs are staged in three steps with increasing requirements for participation. Eligible providers who do not meet meaningful use requirements will still be penalized with reduced Medicare reimbursement starting January 1, 2015.

To read more from CMS, click here.

Reasons for the Timeline Change.

According to Modern Healthcare, CMS stated that the goal of the timeline change is two-fold. First, to allow CMS and the Office of National Coordinator (ONC) to focus on assisting providers to meet Stage 2 demands for patient engagement, interoperability and information exchange, as well as use data collected during the phase to inform policy decisions for Stage 3.

CMS expects that it will release a notice of proposed rulemaking for Stage 3 in the fall of 2014, and the corresponding ONC notice for proposed rulemaking for the 2017 Edition of the ONC Standards and Certification Criteria will also be released at that time. Click here to read the entire article from Modern Healthcare.

What this Means for You.

If you begin participation with your first year of Stage 1 for the Medicare EHR Incentive Program in 2014:

- You must begin your 90 days of Stage 1 of meaningful use no later than July 1, 2014 and submit attestation by October 1, 2014 in order to avoid the 2015 payment adjustment.

If you have completed one year of Stage 1 of meaningful use:

- You will demonstrate a second year of Stage 1 of meaningful use in 2014 for a three-month reporting period fixed to the quarter for Medicare or any 90 days for Medicaid.
- You will demonstrate Stage 2 of meaningful use for two years (2015 and 2016).
- You will begin Stage 3 of meaningful use in 2017.

If you have completed two or more years of Stage 1 of meaningful use:

- You will still demonstrate Stage 2 of meaningful use in 2014 for a three-month reporting period fixed to the quarter for Medicare or any 90 days for Medicaid.
- You will demonstrate Stage 2 of meaningful use for three years (2014, 2015 and 2016).
- You will begin Stage 3 of meaningful use in 2017.

Contact Experienced Health Law Attorneys.

The Health Law Firm routinely represents physicians and medical groups on EHR issues. It also represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, inspections and audits involving the DEA, Department of Health (DOH) and other law enforcement agencies. Its 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?

What do you think of the revised timeline for the implementation of Stage 3 meaningful use? Will this affect you? If so, how? Please leave any thoughtful comments below.

Sources:

Conn, Joseph. “Meaningful-Use Deadline Pushed Back One Year.” Modern Healthcare. (December 6, 2013). From: http://bit.ly/1kkAtsC

Tagalicod, Robert and Reider, Jacob. “Progress on Adoption of Electronic Health Records.” Centers for Medicare and Medicaid Services. (December 13, 2013). From: http://www.cms.gov/eHealth/ListServ_Stage3Implementation.html

About the Authors: Michael L. Smith, R.R.T., J.D., is Board Certified by The Florida Bar in Health Law. He is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. http://www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 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. http://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.

Central Florida Pain Management Clinic Falls Victim to Civil Forfeiture

DPP_12By Christopher E. Brown, J.D., The Health Law Firm

On June 14, 2013, Drug Enforcement Administration (DEA) agents, along with local police and sheriffs’ deputies raided a Longwood, Florida, pain management clinic. In addition to criminal charges, the physicians and employees associated with this clinic face another lesser known threat,  the civil forfeiture of their money and property. During the raid agents took everything from the clinic that could help them build a criminal prosecution. This included paper records, computer equipment and prescription drugs. In addition to the Longwood pain management clinic, DEA agents also searched homes in Brevard County, Florida, where associates of the Longwood clinic allegedly live. To read more on the raid, click here.

This is just one example. Recently we’ve noticed that it is becoming more common for government prosecutors and agencies, including the Medicaid Fraud Control Unit (MFCU), the U.S. Attorney’s Office, and local sheriff and police departments to use the Florida Contraband Forfeiture Act against health professionals and health facilities in health-related cases.

The Difference Between Criminal and Civil Forfeiture Laws.

There are two types of forfeiture laws, criminal and civil.  Criminal forfeiture laws allow the seizure of property only after a conviction beyond a reasonable doubt. On the other hand, civil forfeiture laws allow the government to gain possession of a person’s property immediately and without any determination of guilt.

Property is Subject to Forfeiture if Criminally Derived.

Under the idea that the property is itself guilty by association, federal and local law enforcement authorities may take your property without convicting or arresting you, putting the burden on you to prove that property was not associated with a criminal enterprise.  The property seized does not have to belong to the alleged bad actor or criminal.  This can occur because civil forfeiture is a civil lawsuit against property. The legal action has less to do with a person’s guilt and more to do with the property’s use as an instrumentality in a crime.  If the property has been used in association with or to aid criminal acts, the property is subject to civil forfeiture proceedings.

This is what the physicians and employees of the Longwood clinic are now facing.  While these individuals’ homes and property may not be directly associated with criminal activity, the government is still arguing that the property is subject to forfeiture because the money used to buy it was “criminally derived.”

Fighting Civil Forfeiture.

We believe the main purpose in the government’s use of civil forfeitures is to shut down the alleged criminal and make it so he or she cannot hire an attorney to defend the person(s) accused. This does, unfortunately, often work. However, a prompt, aggressive defense to these actions may recover the property or funds seized and, more importantly, a good defense can be used to help resolve any pending criminal charges.

The key to success in civil forfeiture actions is to immediately consult with an experienced attorney after the property has been seized.  Your best defense is to act as quickly as possible. To read more what defenses can be used to fight civil forfeiture, click here for a previous blog.

Contact Health Law Attorneys Experienced in Civil Forfeiture Cases.

The Health Law Firm routinely represents physicians, nurses, pharmacists, dentists, mental health counselors and other health providers in investigations, regulatory matters, licensing issues, litigation, civil forfeitures, inspections and audits involving the Drug Enforcement Administration (DEA), Federal Bureau of Investigation (FBI), Department of Health (DOH) and other law enforcement agencies. Its 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?

What do you think of the Civil Forfeiture Act being used against health care professionals and health facilities? Please leave any thoughtful comments below.

About the Author: Christopher E. Brown, J.D., 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 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.

Top Medicare Prescribers Collect Speaking Fees from Drug Makers-Coincidence?

LOL Blog Label 2By 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

A recent investigation by ProPublica found that certain doctors who prescribed certain drug brands the most, also have financial ties to the companies that manufacture those prescription drugs. Using Medicare payment data, ProPublica and National Public Radio (NPR) researched physicians who prescribed the most heavily promoted drugs of 2010 and 2011. It was discovered that many of the doctors allegedly had financial relationships with prescription drug manufacturers. ProPublica states that they initiated this investigation out of fear that pharmaceutical payments are influencing doctors to prescribe an expensive, brand name drug over a cheaper, generic version.

To read the ProPublica analysis released June 25, 2013, click here.

According to ProPublica, the company is an independent, nonprofit newsroom that produces investigative journalism in the public interest.

By The Numbers.

The ProPublica analysis looked at a number of drug companies. Until now, doctors’ prescribing practices have not been made public. Disclosure of these records is now mandated in the Affordable Care Act.

According to NPR, at least 17 of the 20 doctors who prescribed the blood pressure medicine Bystolic the most often collected money from the maker, Forest Laboratories. Forest paid those doctors speaking fees for promoting Bystolic at seminars to other doctors. These fees allegedly ranged from $1,250 to $85,750. Additionally, seven of the speakers allegedly received at least $1,000 for meals. Nine of the top 10 prescribers of Exelon, an Alzheimer’s drug, collected speakers’ fees from Novartis. Eight of the top 10 Nucynta prescribers were paid by the painkiller’s manufacturer, Johnson & Johnson, for similar services, according to NPR.

Click here to read the entire NPR article.

Drug Makers Shell Out Millions in Fines for Using Illegal Kickbacks.

Federal whistleblower lawsuits against several pharmaceutical companies have alleged that these speaking payments are little more than “thinly veiled kickbacks,” which are illegal. According to NPR, three years ago Forest paid $313 million to the federal government to settle allegations about its marketing of drugs. The lawsuit alleged the company made cash payments disguised as consulting fees to doctors.

Novartis is currently fielding two different lawsuits filed by the U.S. Department of Justice (DOJ). The first lawsuit was filed on April 23, 2013, alleging the company gave illegal kickbacks to pharmacists. A second lawsuit was filed on April 26, 2013, alleging illegal kickbacks were paid by Novartis to health care providers. According to the DOJ, the government’s complaint seeks damages and civil penalties under the False Claims Act, and under the common law for paying kickbacks to doctors to induce them to prescribe Novartis products that were reimbursed by federal health care programs.  Click here to read a previous blog on these lawsuits.

Individual providers are also liable for accepting prohibited remunerations from drug companies. The use of these databases for mining prescribing/promoting practices is likely to lead to increased scrutiny on physicians.

What the Law Says About Using Kickbacks.

For years drug companies have paid doctors to speak about new drugs at educational conferences with other health care professionals. The practice is legal, but considered questionable.

Under the Anti-Kickback Statute, it’s a felony for health care professionals to accept bribes in exchange for recommending a drug or service covered by Medicare, Medicaid, TRICARE or the Department of Veterans Affairs health care program.

Relationship Between Physicians and Pharmaceutical Companies Allegedly Does Not Influence Prescribing Practices.

In a survey, doctors said they are not influenced by relationships with pharmaceutical companies, according to a FiercePharma article. The doctors with a relationship to Forest state a number of reasons for prescribing Bystolic versus other blood pressure dugs. None of the reasons for prescribing Bystolic related to the money they received from Forest.

In the same FiercePharma article, drug makers said they do not choose speakers based on a doctor’s prescribing habits. Click here to read the FiercePharma article.

So is this all a coincidence?

Contact Health Law Attorneys Experienced with Investigations of Health Professionals and Providers.

The attorneys of The Health Law Firm provide legal representation to physicians, nurses, nurse practitioners, CRNAs, pain management doctors, dentists, pharmacists, psychologists and other health providers in Department of Health (DOH) investigations, Drug Enforcement Administration (DEA) investigations, FBI investigations, Medicare investigations, Medicaid investigations and other types of investigations of health professionals and providers.

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

Comments?

Is it a coincidence that top prescribers also collect from drug makers? As a health care professional, would you be influenced to prescribe one drug if you were getting paid by the drug maker? Please leave any thoughtful comments below.

Sources:

Staton, Tracy. “Top-Prescribing Docs Collect Cash From Drugmakers.” FiercePharma. (June 25, 2013). From: http://www.fiercepharma.com/story/top-prescribing-docs-collect-cash-drugmakers/2013-06-25

Ornstein, Charles, Weber, Tracy and Lafleur, Jennifer. “Top Medicare Prescibers Rake In Speaking Fees From Drugmakers.” National Public Rado. (June 25, 2013). From: http://www.npr.org/blogs/health/2013/06/25/195232541/top-medicare-prescribers-rake-in-speaking-fees-from-drugmakers

Ornstein, Charles, Weber, Tracy and Lafleur, Jennifer. “Top Medicare Prescibers Rake In Speaking Fees From Drugmakers.” ProPublica. (June 25, 2013). From: http://www.propublica.org/article/top-medicare-prescribers-rake-in-speaking-fees-from-drugmakers

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.

Supreme Court Rules that Government Regulators Can Sue Over Pay-for-Delay Agreements Between Brand and Generic Drug Manufacturers

George F. Indest III, Board Certified by The Florida Bar in Health Law

George F. Indest III, Board Certified by The Florida Bar in Health Law

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

The U.S. Supreme Court ruled on June 17, 2013, that pay-for-delay agreements between brand name and generic drug manufacturers are subject to anti-trust scrutiny. These pay-for-delay agreements, or reverse payments, are usually a form of settlement between the two manufacturers in patent litigation. The Supreme Court decided that each instance must be considered on a case-by-case basis. This verdict rewrites the rules governing the release of generic drugs. It is likely to increase the number of generic drugs in the marketplace and reduce the price of generic drugs.

To read a previous blog on pay-for-delay agreements, click here.

What is a Pay-for-Delay Agreement?

Pay-for-delay agreements came as the result of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. The Hatch-Waxman Act gives generic drug manufacturers an incentive to challenge brand name drug patents because the first generic drug manufacturer to received U.S. Food and Drug Administration (FDA) approval to launch a generic copy of a brand name drug can receive a 180-day marketing exclusivity period for the product. The FDA cannot approve any other generic applications for the same drug until the first-to-file generic manufacturer has sold its product for 180 days or has given up its exclusivity period. Click here to read the Hatch-Waxman Act.

Brand name manufacturers often challenge generic drug manufacturers who try to sell their product prior to patent expiration. This results in litigation to determine whether the generic manufacturer is violating the brand name manufacturer’s patents.

Instead of going to court over this, brand name manufacturers often choose to pay a settlement to the generic drug manufacturers for agreeing to delay the launch of its competing product.

Why the Supreme Court Overruled Court of Appeals Decision.

The 5-3 vote overruled the 11th Circuit Court of Appeals decision that said pharmaceutical companies can’t be sued unless the patent litigation is a sham or a generic drug maker agrees to delay introduction of a generic drug into the market even after the patent has expired.

A Med Page Today article lists the Supreme Court’s five reasons why the appellate court made a mistake in giving blanket immunity to pay-for-delay agreements from the decision written by Justice Stephen Breyer:

-  “A reverse payment, where large and unjustified, can bring with it the risk of significant anticompetitive effects.”

-  “One who makes such a payment may be unable to explain and to justify it.”

-  “Such a firm or individual may well possess market power derived from the patent.”

-  “A court, by examining the size of the payment, may well be able to assess its likely anticompetitive effects along with its potential justifications without litigating the validity of the patent.”

-  “Parties may well find ways to settle patent disputes without the use of reverse payments.”

Click here to read the entire Med Page Today article.

Pay-for-Delay Agreements Allegedly Cost Patients Millions of Dollars a Year.

According to Bloomberg, the high court’s decision may discourage brand name and generic pharmaceutical companies from reaching settlements. It’s been found that pay-for-delay agreements can delay a generic drug almost 17 months before it can be put on the market. In the meantime, patients must pay higher prices for the brand name version. This also impacts Medicare and Medicaid programs. The Federal Trade Commission (FTC) claims pay-for-delay agreements cost consumers $3.5 billion a year in the form of higher drug prices.

To read the Bloomberg article, click here.

The Case of the FTC v. Solvay Pharmaceuticals.

The Supreme Court case center around AndroGel, a treatment for low testosterone in men, made by Solvay Pharmaceuticals, Inc. The FTC sued Solvay and three generic drug companies. According to Bloomberg, the FTC said that a payment made by Solvay, the holder of a patent on AndroGel, to the generic drug manufacturers represented an unlawful restraint of trade because it was intended to keep cheaper, generic versions of AndroGel off the market until 2020.

FTC Enthusiastic About the Decision.

In a statement, the FTC Chairwoman said the Supreme Court’s decision is a “significant victory for American consumers, American taxpayers and free market.” She also stated, “The court made it clear that pay-for-delay agreements are subject to antitrust scrutiny.”

Click here to read the full statement from the FTC.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in investigations, regulatory matters, licensing issues, litigation, inspections and audits. The firm’s 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?

What do you think of the Supreme Court’s ruling? Do you agree or disagree? What effect do you think it will have on the pharmaceutical industry? Please leave any thoughtful comments below.

Sources:

Stohn, Greg. “Drugmakers Opened to ‘Pay for Delay’ Suits by High Court.” Bloomberg. (June 17, 2013). From: http://www.bloomberg.com/news/2013-06-17/drugmakers-opened-to-pay-for-delay-suits-by-high-court.html

Frieden, Joyce. “Supreme Court Split on Pharma ‘Pay for Delay’ Deals.” Med Page Today. (June 17, 2013). From: http://bit.ly/18SfhKb

Kaplan, Peter. “Statement of FTC Chairwoman Edith Ramirez of the U.S. Supreme Court’s Decision in FTC v. Actavis, Inc.” (June 17,2 013). From: http://www.ftc.gov/opa/2013/06/actavis.shtm

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.

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