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Florida’s Prescription Drug Importation Plan Continues to Gain Support

Headshot of The Health Law Firm attorney George F. Indest, IIIBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On March 12, 2019, the Florida House of Representatives’ Health Quality Subcommittee voted 15 to 2 to approve House Bill 19 (HB 19) that would implement one of Florida Gov. Ron DeSantis’ recently announced health care proposals. In February 2019, the new Florida governor, who was criticized for not having a health care platform while he campaigned, announced the proposal that Florida start importing drugs from Canada.

HB 19 -Prescription Drug Importation Programs.

HB 19 was created for the purpose of safely importing cost-effective prescription drugs from Canada and other foreign nations under specified conditions. The proposed program would go into effect on July 1, 2019.

HB 19 provides eligibility criteria for prescription drugs and program participants; provides distribution requirements; provides annual reporting requirements; provides application and permitting requirements for certain participating entities; and provides that implementation of International Prescription Drug Importation Program is contingent on federal arrangement or obtaining federal guidance. Click here for more information on HB 19.

Two Programs, One Goal – Lowering Prescription Drug Prices.

The program will offer access to FDA-approved prescription drugs imported from Canada, allowing the drugs to be sold to Floridians at a much lower cost than they could otherwise purchase them here. “One of the biggest drivers of this country’s out of control healthcare spending is the cost of prescription drugs,” said Governor DeSantis.

According to the bill, the U.S. spends 30 to 190% more than other developed countries on prescription drugs, and up to 174% more for the exact same for prescription drugs. The proposed bill aims to lower these unnecessary high costs by establishing two different drug importation programs.

The first program would allow the state to import prescription drugs from Canada for use by the Florida Medicaid Program and prison health care system. It would be known as the Canadian Drug Importation Program. It would be run by the Florida Agency for Health Care Administration (AHCA).

The second program would be known as the International Drug Importation Program. It would be run by the Florida Department of Business and Professional Regulation and would be available to individual residents.

Despite gaining house support, both programs would still need approval from the federal government before they could be implemented in Florida.

To learn more about Gov. DeSantis’ proposal, click here to read his press release.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, 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.

Sources:

Sexton, Christine. “DeSantis prescription drug savings plan gets early House support.” Orlando Sentinel. (March 12, 2019). Web.

News Service of Florida. “DeSantis Drug Importation Plan Wins House Support.” Sunshine State News. (March 13, 2019). Web.

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.

KeyWords: Legal representation for pharmacies, representation of health care professionals, health law defense attorney, doctor attorney, nurse attorney, Legal Defense for Pharmacists, pharmacy defense attorney, representation for pharmacists, representation for pharmacies, Department of Health defense attorney, DOH investigation representation, quality assurance representation, DEA investigation, DEA attorney, DEA representation, prescription E-FORSCE representation, DEA defense lawyer, representation for overprescribing, Medicare investigation lawyer, representation for Medicaid investigation, representation for health care professionals, license defense lawyer, licensure representation, board representation attorney, representation for board investigations, whistleblower representation, qui tam representation, whistleblower attorney, whistleblower defense attorney, qui tam attorney, qui tam defense lawyer, representation for license defense, licensure defense attorney, protecting your professional license, Florida opioid crisis, Florida’s ongoing lawsuit for opioid crisis The Health Law Firm, Florida health law attorney, The Health Law Firm reviews, reviews of The Health Law Firm attorneys

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Florida Governor’s Prescription Foreign Drug Importation Plan Gains House Support

Headshot of The Health Law Firm attorney George F. Indest, IIIBy George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law

On March 12, 2019, the Florida House of Representatives’ Health Quality Subcommittee voted 15 to 2 to approve House Bill 19 (HB 19) that would implement one of Florida Gov. Ron DeSantis’ recently announced health care proposals. In February 2019, the new Florida governor, who was criticized for not having a health care platform while he campaigned, announced the proposal that Florida start importing drugs from Canada.

HB 19 -Prescription Drug Importation Programs.

HB 19 was created for the purpose of safely importing cost-effective prescription drugs from Canada and other foreign nations under specified conditions. The proposed program would go into effect on July 1, 2019.

HB 19 provides eligibility criteria for prescription drugs and program participants; provides distribution requirements; provides annual reporting requirements; provides application and permitting requirements for certain participating entities; and provides that implementation of International Prescription Drug Importation Program is contingent on federal arrangement or obtaining federal guidance. Click here for more information on HB 19.

Two Programs, One Goal – Lowering Prescription Drug Prices.

The program will offer access to FDA-approved prescription drugs imported from Canada, allowing the drugs to be sold to Floridians at a much lower cost than they could otherwise purchase them here. “One of the biggest drivers of this country’s out of control healthcare spending is the cost of prescription drugs,” said Governor DeSantis.

According to the bill, the U.S. spends 30 to 190% more than other developed countries on prescription drugs, and up to 174% more for the exact same for prescription drugs. The proposed bill aims to lower these unnecessary high costs by establishing two different drug importation programs.

The first program would allow the state to import prescription drugs from Canada for use by the Florida Medicaid Program and prison health care system. It would be known as the Canadian Drug Importation Program. It would be run by the Florida Agency for Health Care Administration (AHCA).

The second program would be known as the International Drug Importation Program. It would be run by the Florida Department of Business and Professional Regulation and would be available to individual residents.

Despite gaining house support, both programs would still need approval from the federal government before they could be implemented in Florida.

To learn more about Gov. DeSantis’ proposal, click here to read his press release.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, 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.

Sources:

Sexton, Christine. “DeSantis prescription drug savings plan gets early House support.” Orlando Sentinel. (March 12, 2019). Web.

News Service of Florida. “DeSantis Drug Importation Plan Wins House Support.” Sunshine State News. (March 13, 2019). Web.

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.

KeyWords: Legal representation for pharmacies, representation of health care professionals, health law defense attorney, doctor attorney, nurse attorney, Legal Defense for Pharmacists, pharmacy defense attorney, representation for pharmacists, representation for pharmacies, Department of Health defense attorney, DOH investigation representation, quality assurance representation, DEA investigation, DEA attorney, DEA representation, prescription E-FORSCE representation, DEA defense lawyer, representation for overprescribing, Medicare investigation lawyer, representation for Medicaid investigation, representation for health care professionals, license defense lawyer, licensure representation, board representation attorney, representation for board investigations, whistleblower representation, qui tam representation, whistleblower attorney, whistleblower defense attorney, qui tam attorney, qui tam defense lawyer, representation for license defense, licensure defense attorney, protecting your professional license, Florida opioid crisis, Florida’s ongoing lawsuit for opioid crisis The Health Law Firm, Florida health law attorney, The Health Law Firm reviews, reviews of The Health Law Firm attorneys

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2019 The Health Law Firm. All rights reserved.

Florida Sues Walgreens, CVS For Alleged Role in Helping Create and Increase Opioid Crisis

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

On November 19, 2018, the state of Florida announced that it is suing pharmacy chains Walgreens and CVS over their role in what it calls “unconscionable efforts to increase and expand the ongoing opioid crisis in Florida.” State Attorney General Pam Bondi’s office announced that it added the two companies to a lawsuit filed in May 2018, against opioid distributors and manufacturers.

The Supply and Demand Problem with Opioids.

The state alleges that the two chains are responsible for overselling addictive opioids, as well as not taking precautionary measures to stop illegal sales, helping to inflate the supply and demand. The companies join Purdue Pharma, the maker of OxyContin, as well as several other opioid distributors, as defendants in the lawsuit.

In a news release, Bondi noted that the companies failed to stop “suspicious orders of opioids” and “dispensed unreasonable quantities of opioids from their pharmacies.” Click here to read the press release.

As the Opioid Crisis Continues, So Do the DEA Investigations.

Both companies have previously paid to resolve Drug Enforcement Agency (DEA) allegations and have shelled out millions to settle allegations involving stores in Florida. In 2018, Walgreens agreed to pay $80 million to resolve a DEA investigation into inadequate record keeping and diversion related to opioids, according to the suit. Likewise, CVS agreed to pay $22 million in 2015 to resolve DEA allegations that its pharmacists were filling fake prescriptions for opioids and other drugs. Click here to read the amended complaint in full.

In the last decade, law enforcement has cracked down on opioid prescriptions and pill mill operations. Florida ‘s lawsuit comes at a time when more than 1,000 state and local governments across the U.S. are pursuing civil cases against opioid-makers and distributors.

Click here to read one of my prior blogs on this topic.

Contact Health Law Attorneys Experienced in Representing Pharmacies and Pharmacists.

The Health Law Firm represents pharmacists and pharmacies in DEA, DOH and FDA investigations, qui tam and whistleblower cases, regulatory matters, licensing issues, litigation, administrative hearings, 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.

Sources:

Sullivan, Emily. “Florida Sues Walgreens, CVS For Alleged Role In Opioid Crisis.” NPR. (November 19, 2018). Web.

Peters, Xander. “Florida files lawsuit against Walgreens, CVS for allegedly ‘playing a role’ in opioid crisis.” Orlando Weekly. (November 19, 2018). Web.

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.

KeyWords: Legal representation for pharmacies, representation of health care professionals, health law defense attorney, doctor attorney, nurse attorney, Legal Defense for Pharmacists, pharmacy defense attorney, representation for pharmacists, representation for pharmacies, Department of Health defense attorney, DOH investigation representation, quality assurance representation, DEA investigation, DEA attorney, DEA representation, prescription E-FORSCE representation, DEA defense lawyer, representation for overprescribing, Medicare investigation lawyer, representation for Medicaid investigation, representation for health care professionals, license defense lawyer, licensure representation, board representation attorney, representation for board investigations, whistleblower representation, qui tam representation, whistleblower attorney, whistleblower defense attorney, qui tam attorney, qui tam defense lawyer, representation for license defense, licensure defense attorney, protecting your professional license, Florida opioid crisis,  Florida’s ongoing lawsuit for opioid crisis The Health Law Firm, Florida health law attorney, The Health Law Firm reviews, reviews of The Health Law Firm attorneys

“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.

Health Care Professionals Need to be Compliant with Anti-Fraud Laws

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

The federal government has several tools available to help combat Medicare fraud. Among those are the Stark Act, Anti-Kickback laws and Civil Monetary Penalty Laws. Each of these typically focuses on a particular type of behavior that is prone to abuse by health care providers.

The Stark laws exist to combat the problems that can arise from physician self-referrals. Self-referrals are cases in which a physician orders a test or service and refers the patient to a provider in which the referring physician has a financial interest. This second provider will then bill Medicare for the service, essentially allowing the referring physician to cash in twice.

The concern is that if physicians are permitted to benefit from referring to an entity, they will be prone to order tests and services that are not medically necessary. I previously wrote an article on the legal ramifications of unnecessary tests, which was published in Medical Economics. Click here to read that article.

Obligations for Compliance.

Stark compliance is a two-way street. Not only is the physician prohibited from referring to an entity in which he has a non-exempt financial interest, the provider receiving the referral is prohibited from accepting it.

Medicare conditions payment of a claim upon the certification by the claimant that it is in compliance with the Stark law. What this means is that there is an obligation on the recipient of a referral to make sure that it is proper.

In the complicated world of healthcare business entities, it is incumbent upon the management of a supplier of Designated Health Services (DHS) to know who all of its owners, investors, and stakeholders are so that it can remain in compliance and avoid any charges of impropriety.

Exceptions to Stark Law.

Like many other regulatory frameworks, the Stark law have exceptions. The law provides a number of exceptions to the rules which allow otherwise impermissible referral arrangements to pass muster.

Because the exceptions are numerous and often subject to change, it is highly recommended that any new business arrangement, or substantial change to an existing one, is reviewed by a health law attorney experienced in the area of Stark law.

Contact Health Law Attorneys Experienced in Handling Stark Compliance.

If you are involved in referring or providing DHS it is crucial that your arrangements are reviewed for compliance with Stark and other anti-fraud laws.

Violations of these laws can carry severe financial and criminal penalties. One of the best ways to avoid these sanctions is to have your current or potential arrangement reviewed by an attorney who is experienced in these matters.

The Health Law Firm routinely advises healthcare providers on Stark compliance issues for practitioners and providers of all types of DHS. We can advise you on the legality of a particular arrangement and can assist with remedying any perceived compliance issues.

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

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.

KeyWords: Medicare representation, Medicare fraud representation, Medicare fraud defense lawyer, Medicare audit representation, Medicare fraud prevention, Stark Law attorney, Stark Law representation, Anti-Kickback representation, AKS defense lawyer, representation for healthcare fraud, health care fraud compliance, representation for health care professionals, health law defense attorney, health care fraud lawyer, Florida defense attorney, Florida defense lawyer, heath law attorney, health law lawyer, representation for health care professionals, The Health Law Firm reviews, reviews of The Health Law Firm attorneys, Florida health law defense attorney, protecting your professional license

“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 © 2018 The Health Law Firm. All rights reserved.

The Do’s and Don’ts When Applying for a Massage Therapist License

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

The process of obtaining a massage therapist license can be challenging and time consuming. When seeking initial licensure or applying for a license in another state, you should be aware of delays in the application process due to the investigation of credentials and past practice, as well as the need to comply with licensing standards.

The following are examples that would delay your application:

• Disciplinary or academic actions during postgraduate training (probation, suspension, remediation)
• Action by another state’s regulatory or licensing board
• Action by a different professional licensing board
• Misdemeanor or felony convictions
• Results of the criminal background check (remember, it shows arrests, not necessarily the results of the arrests)
• Civil judgments/malpractice
• Medical, physical, mental or chemical dependence impairment/condition within the last five years
• Adverse action against your clinical privileges by a hospital, ambultaory surcial center, Skilled nursing facility or otehr health facility or professional organization.
• Adverse action (e.g., termination for cause) by a former employer
• Action by a specialty board
• Lack of recent active practice
• Action by DEA against your DEA registration number
• Disciplinary action (especially court-martial) by the military
• Applications that require a petition of waiver or variance for a job

Not being 100% truthful about your history and education is the number one reason for denial of an application for a license! Don’t try to hide potentially derogatory information from a state licensing board, if it is required by the question or the instructions that further elaborate on the question. It is much better to come forward with the information and be up front.

This being said, you do not want to volunteer adverse information that a question does not ask. For example, if a question asks about felony convictions, DO NOT disclose misdemeanor convictions or traffic ticket convictions. If a question asks about convictions, DO NOT disclose arrests for which you were acquitted or were dismissed. If a question asks about medical malpractice law suits, DO NOT disclose civil law suits that were not related to malpractice.

Speeding up the Application Process.

There are ways to ease the process of applying for a massage therapist license and get your application processed quicker. Before submitting your application, contact the licensing board and request a copy of its current licensing requirements and the average time it takes to process applications.

The following are tips to help ease the process of applying for a massage therapist license:

1. Submit follow-up documents in a timely manner online or mail them to the correct address (as required). If you cannot obtain requested follow-up documentation, provide a separate, detailed explanation (preferably in the form of an affidavit), of why you cannot do so.

2. Keep in mind that any fees you pay have to be processed by the Department vendor. This may take a few days.

3. Identify any variation of names and nicknames.

4. Once you start the process, submit the application within 30 days so that your supplemental documents, including transcripts, will have an application file in which to be filed.

5. Have the correct address on the application for training programs you have attended and health facilities at which you have worked.

6. Send in necessary back-up documents in a timely manner.

7. Follow up with sources that are sending the Board of Massage Therapist your documents.

8. Watch for letters or e-mail from your reviewer. This is how you will be instructed on what additional documents or information may be needed for your application to be complete.

9. If asked for follow-up information from the Board, please read the request carefully to identify exactly what is needed to make your application complete.

10. Answer questions honestly and provide an explanation where appropriate. But do not provide information that is not being requested.

Massage Therapy professionals seeking a license should expect at least a 60-day period from the time they initially submit a completed application and the actual date licensure is granted.

For more information on the nursing licensing process, visit the Board of Massage Therapy.

For more information and ways that The Health Law Firm can help in licensure matters, visit our Video Q&A section or visit our website’s Areas of Practice page.

Contact Health Law Attorneys With Experience Handling Licensing Issues.

If you are applying for a massage therapy license, have had a license suspended or revoked or are facing imminent action against your license, it is imperative that you contact an experienced healthcare attorney to assist you in defending your career. Remember, your license is your livelihood, it is not recommended that you attempt to pursue these matters without the assistance of an attorney.

The Health Law Firm routinely represents physicians, dentists, nurses, medical groups, clinics, and other healthcare providers in personal and facility licensing issues.

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

Sources:

“Obtaining a Medical License.” American Medical Association (AMA). Web.

Florida Board of Massage Therapy, “Licensing FAQs” http://floridasmassagetherapy.gov/licensing/

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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“The Health Law Firm” is a registered fictitious business name of and a registered service mark of The Health Law Firm, P.A., a Florida professional service corporation, since 1999.
Copyright © 2018 The Health Law Firm. All rights reserved.