Affordable Care Act

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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.

CMS Fights Medicare Fraud With Ban on New Home Health Agencies and Ambulance Suppliers in Three Cities

LOL Blog Label 2

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

The Centers for Medicare and Medicaid Services (CMS) announced it will temporarily ban new home health providers and ambulance suppliers from enrolling in Medicare, Medicaid and the Children’s Health Insurance Program (CHIP) in three fraud “hot spots.” According to CMS, the six-month moratorium begins July 30, 2013. It applies to newly enrolling home health agencies (HHAs) in Miami, Florida, and Chicago, Illinois. It also applies to newly enrolling ambulance suppliers in Houston, Texas. Existing providers and suppliers can continue to deliver and bill for services. The goal of the ban is to fight healthcare fraud.

Click here to read the press release from CMS.

Authority to impose a moratorium was included in the Patient Protection and Affordable Care Act (PPACA). According to a summary of the anti-fraud provisions in the Affordable Care Act, the Act allows CMS to prohibit new providers from joining the program where necessary to prevent or fight fraud, waste or abuse in certain geographic areas or for certain categories of services. This is the first time CMS is exercising its authority.

Why Moratorium Was Imposed in These Areas.

According to CMS, the decision to impose the moratorium was based on a number of factors, including a disproportional number of providers and suppliers relative to beneficiaries, a quick increase in enrollment applications from providers and suppliers, and extremely high utilization in these areas.

Miami Area a Hot Bed for Healthcare Fraud and Abuse.

The Miami area has stood out as one of the nation’s hubs of Medicare fraud, according to CMS. For example, in May 2013, a Miami patient recruiter for an HHA was sentenced to 37 months in prison for participating in a $20 million Medicare fraud scheme. Click here to read a previous blog. In that same month, workers from a Miami-area HHA were accused of bribing Medicare beneficiaries for their Medicare information, which was used to bill for home health services that were never rendered or not medically necessary. To read more, click here.

According to the Miami Herald, with a large number of elderly Medicare beneficiaries living in Miami, it’s not a surprise that healthcare fraud is so prevalent. South Florida allegedly accounts for one-third (1/3) of all healthcare fraud prosecutions in the nation. Click here to read the entire Miami Herald article.

The Affordable Care Act Offers the Government New Tools to Fight Healthcare Fraud.

In 2011 and 2012, the government reported recovery of $14.9 billion in healthcare fraud judgments, settlements and administrative impositions, according to CMS. In addition, CMS has revoked 14,663 providers and suppliers’ ability to bill the Medicare Program since 2011. The Affordable Care Act seeks to improve anti-fraud and abuse measures by focusing on prevention rather than the traditional “pay-and-chase” model of catching crooks after they have committed fraud. Click here to read a blog on the Affordable Care Act’s other fraud fighting tools.

What This Means for Health Care Professionals and Providers.

By knowing the government is beefing up measures to fight healthcare fraud, providers can attempt to avoid practices that are likely to lead to Zone Program Integrity Contractor (ZPIC) or Recovery Audit Contractor (RAC) audits. Additionally, a provider can be prepared for potential audits by increasing its documentation and compliance efforts.

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?

What do you think of CMS’ decision to invoke the moratorium? Do you think this should have been done sooner? Please leave any thoughtful comments below.

Sources:

Centers for Medicare and Medicaid Services. “CMS Imposes First Affordable Care Act Enrollment Moratoria to Combat Fraud.” CMS.gov. (July 26, 2013). From: http://www.cms.gov/Newsroom/MediaReleaseDatabase/Press-Releases/2013-Press-Releases-Items/2013-07-26.html

Chang, Daniel. “Feds Ban New Home Healthcare Agencies in Miami to Fight Medicare Fraud.” Miami Herald. (July 26, 2013). From: http://www.miamiherald.com/2013/07/26/3524612/feds-ban-new-home-healthcare-agencies.html

Beasley, Deena. “U.S. Bans New Home Health, Ambulance Providers in Three Regions.” Miami Herald. (July 26, 2013). From: http://www.reuters.com/article/2013/07/26/us-medicare-moratoria-idUSBRE96P14P20130726

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.

Physician Payment Sunshine Act Deadline is Here-Are You Ready?

GFI Blog LabelBy 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

As of August 1, 2013, the Physician Payment Sunshine Act (Sunshine Act) goes into effect. The Sunshine Act, contained in Section 6002 of the Patient Protection and Affordable Care Act (PPACA), is designed to highlight the financial relationship between doctors and the manufacturers of medical devices and pharmaceuticals. The act requires that light be shined on the payments being made to physicians by pharmaceutical and medical device manufacturers, bringing these out into the “sunshine.”

Some of the items tracked include gifts worth more than $10, five-star dinners, trips, money paid to physicians for speaking engagements, etc. The medical device and pharmaceutical manufacturers will be responsible for reporting the figures to the Centers for Medicare and Medicaid (CMS). However, it’s important that physicians keep their own records to verify the accuracy of the reports.

To read a summary of the Sunshine Act, click here.

What Has to be Reported and What Does Not Have to Be Reported.

All manufacturers of pharmaceuticals and medical devices will have to disclose how much money they pay physicians and hospitals in cash and gifts, as well as how much stock doctors and their families own in the particular manufacturer’s company.

As required by law, this information will be published by CMS starting in September 2014. There are several reporting exceptions, such as gifts less than $10, drug samples for patients and educational materials given to patients, according to a Huffington Post article.

To read the entire Huffington Post article, click here.

Physicians Need to Track Their Records.

The burden of collecting and reporting data will be the responsibility of the manufacturers of medical devices and pharmaceuticals, but physicians are encouraged to keep their own records. They will have 45 days to review disclosures and seek corrections if they dispute what is being reported. According to Modern Healthcare, CMS will not mediate disagreements but will note if a figure is being disputed.

Physicians can register with CMS starting January 1, 2014, to receive a consolidated report on activities each June for the prior reporting years.

To read the Modern Healthcare article, click here.

Helpful Resources for Physicians.

The Sunshine Act affects all physicians with a current medical license. The American Medical Association (AMA) has a “Physician Sunshine Act Tool Kit” available on its website to help physicians navigate the Sunshine Act changes. The AMA is also working on tools to aid physicians in talking with their patients about the transactions included in the new Sunshine Act database. Click here to access the AMA’s Physician Sunshine Act Tool Kit.

CMS is holding a national provider conference call on August 8, 2013. Doctors of medicine, osteopathy, chiropractic medicine, dentistry, dental surgery, optometry and podiatry are encouraged to participate and ask questions. CMS also recently introduced a free mobile app called “Open Payments Mobile for Physicians.” The app will help physicians and businesses track financial relationships.

Contact Health Law Attorneys Experienced in Representing Health Care Professionals.

The Health Law Firm routinely represents pharmacists, pharmacies, physicians, nurses and other health providers in investigations, regulatory matters, licensing issues, litigation, 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 are your concerns about the Sunshine Act? Are you ready for the law to go into effect? How have you prepared for the Sunshine Act? Please leave any thoughtful comments below.

Sources:

Robeznieks, Andis. “Reform Update: Aug. 1 Brings Deadline to Report Physician Payments.” Modern Healthcare. (July 29, 2013). From: http://www.modernhealthcare.com/article/20130729/NEWS/307299967/reform-update-aug-1-brings-deadline-to-report-physician-payments

Aronfeld, Spenser. “Here Comes the Sunshine Act – And It’s All Right.” Huffington Post. (July 16, 2013). From: http://www.huffingtonpost.com/spencer-aronfeld/here-comes-the-sunshine-act_b_3595394.html?view=print&comm_ref=false

Lasher Todd, Heather. “AMA Reminds Physicians: Sunshine Act Reporting Starts This Week.” American Medical Assocations. (July 30, 2013). From: http://www.ama-assn.org/ama/pub/news/news/2013/2013-07-30-sunshine-act-reporting-this-week.page

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.

CMS Extends Waivers under the ACO Shared Savings Program

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

On November 2, 2011, the Centers for Medicare and Medicaid Services (CMS) promulgated the interim final rule on fraud and abuse waivers for Accountable Care Organizations (ACOs) participating in the Medicare Shared Savings Program. The interim rule can be found at 76 Fed. Reg. 67801. The waiver was granted pursuant to the agency’s authority under the Affordable Care Act, specifically, 42 U.S.C. § 1899(f).

You can read our prior blog postings on the ACO waiver programs here.

Normally, interim final rules are only permitted to remain in effect for a maximum of three years (see 69 Fed. Reg. 78422). CMS regulations require the agency to publish a final rule within three years of a proposed or interim final rule. As the interim final rule is set to expire on November 2, 2014, the agency took advantage of the procedure that allows it to extend the life of the rule for an additional year by publishing a notice explaining the reasons why the regular timeline was not met.

Explanation for the Extension.

CMS stated that it is in the process of preparing a final rule, and allowing the interim final rule to expire would create a great deal of legal uncertainty for ACOs currently participating in the Shared Savings Program. According to CMS, this uncertainty has the potential to disrupt ongoing ACO business, plans, and operations.

Ultimately, CMS has learned through the course of its operation of the Shared Savings Program that certain modifications to the program are necessary. Although these modifications are not yet defined completely, CMS nevertheless believed the prudent course of action was to maintain the status quo during the rule making process.

Check back with us for updates on the process and any further information as the final rule is developed.

Comments?

Have you considered joining an ACO? Why or why not? Please leave any thoughtful comments below.

Contact Health Law Attorneys Experienced With Healthcare Business Practices.

The Health Law Firm routinely represents physician groups and practices with issues involving establishing, licensing, selling, merging, and intergroup affiliation. If you are considering establishing an ACO or have been approached to become a participant in one, you can contact The Health Law Firm at (407) 331-6620 or (850) 439-1001 or you can visit our website at www.TheHealthLawFirm.com.

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. 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.