Florida Legislation Allows Pharmacy Technicians to Administer Immunizations

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

On July 1, 2022, Florida passed HB 1209, allowing registered pharmacy technicians to administer immunizations to patients. The new law utilizes pharmacy technicians to seek certification to provide immunizations and become “Certified Registered Pharmacy Technicians.” These pharmacy technicians will then be allowed to administer all vaccines listed by the CDC in the Adult Immunization Schedule or recommended by the CDC for international travel. Additionally, it includes vaccines authorized by the FDA under an emergency use authorization or by the Florida Board of Pharmacy in response to a state of emergency declared by the Governor.

This is a big step in medicine, once again broadening the ability of health professionals to provide more efficient and less expensive health care. In the past, properly qualified pharmacists were allowed to administer vaccines, but even then, there was a shortage.

Certification Requirements.

To become certified by the Florida Board of Pharmacy, a registered pharmacy technician must complete six hours of approved immunization-related training. As a renewal condition, an additional two hours of approved continuing education must be completed each cycle, according to the Board of Pharmacy website. For more information, click here.

In comparison, for certification, registered pharmacists must have 20 hours of education to administer vaccines. Registered pharmacist interns (persons with five years of college) who are also under the supervision of a certified pharmacist must take the same 20-hour immunization course that the pharmacists take to become certified to administer immunizations.

While this new Florida law seems to adopt a substantial lessening in training requirements, remember the 20-hour course allows pharmacists to administer vaccines independently. The six-hour course is for pharmacy technicians to administer vaccines under the pharmacist’s supervision. The technician certification program or programs authorized will have to be approved by the Florida Board of Pharmacy in consultation with the Florida Board of Medicine and the Florida Board of Osteopathic Medicine.

Stay Informed and Prepared.

The Board of Pharmacy has the authority to adopt rules to add new vaccines as added by the Centers for Disease Control (CDC) and the Food and Drug Administration (FDA), but it often takes many months to do so. Pharmacies and the pharmacists, pharmacist interns, and pharmacy technicians who are responsible need to monitor these situations closely.

Pharmacies should print a copy of the CDC adult immunization schedule, the CDC’s recommended vaccines for international travel, and the FDA’s list of vaccines with emergency use authorizations and have this readily available for its staff to review. They should also update this list at least once a month. This will help the pharmacy staff keep on top if either of these federal agencies, the CDC or the FDA, changes its list of immunizations. As we’ve seen from the COVID-19 pandemic, keeping track of vaccine schedules and emergency use authorization changes can be very confusing.

Click here to read Florida HB 1209 – Administration of Vaccines, in full.

Consult With A Health Law Attorney Experienced in the Representation of Pharmacists and Pharmacies.

We routinely provide legal representation to pharmacists, pharmacies, and other health professionals who have received complaints against their licenses, notices of investigations, Medicare or Medicaid audits, Drug Enforcement Administration (DEA) audits, investigations, subpoenas, search warrants, and orders to show cause (OSC) or who are facing formal or informal administrative hearings.

The lawyers of The Health Law Firm are experienced in both formal and informal administrative hearings and in representing physicians, physician assistants, and other health professionals in investigations and at Board of Pharmacy hearings. Call our office now at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website www.TheHealthLawFirm.com.

Sources:

Dix, Martin. “A Jump Forward For Fla. Pharmacy Technicians’ Vax Authority.” Law360. (August 19, 2022). Web.

Sexton, Christine. “Checking the pulse of Florida health care news and policy.” Florida Politics. (August 16, 2022). Web.

Dix, Martin. “Florida Legislation Authorizing Pharmacy Technicians to Administer Vaccines Contains Some Surprises.” Akerman. (July 28, 2022). 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or toll-free (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

 

 

 

 

 

 

2022-09-28T10:23:19-04:00September 28th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

How Medical Information Bureau (MIB) Reports Can Affect Your Insurance Policy Rates

Attorney Amanda ForbesBy Amanda I. Forbes, J.D.

When you apply for insurance, an insurance company will look at various factors regarding your history to determine how much your insurance policy will cost. Most insurers obtain a report from the Medical Information Bureau (“MIB”) and use this in determining the risk you pose and, hence, your policy premium.

The MIB checks past records to identify any errors, misrepresentations, or omissions made on an insurance application. An MIB report is similar to a credit report except it is specifically tailored for the insurance process. Click here to learn more.

What Does the MIB do?

Since 1902, the MIB has worked as a not-for-profit organization in the United States and Canada. Its members (e.g., life insurance companies, health insurance companies, disability insurers, etc.) use the MIB to help them determine a person’s “risk and eligibility during the underwriting of life, health, disability income, critical illness, and long-term care insurance policies.” Learn more about the organization here.

Insurance applications, whether for health, life, disability, critical illness, or long-term care, will almost always have several health questions that help the insurance company determine an appropriate risk classification for that individual. The higher the risk, the higher the premium, usually. Traditionally, some applicants in very high-risk categories (transplant patients, those with serious long-term chronic medical conditions) or in high-risk professions (e.g., parachuting instructors, trapeze artists, explosives experts) may not be able to obtain insurance at all.

Sometimes an applicant for an insurance policy may try to obtain lower premiums by knowingly omitting key information on their applications. Because of this, insurance companies started to rely on MIB reports to identify and prevent insurance fraud. The MIB provides information that can be used to identify false or incomplete applications.

It is estimated that the MIB saves its member companies over $1 billion annually (Note: I think this estimate probably comes from the MIB). It can do this because the information it provides to its members allows them to evaluate and assess risk more accurately. MIB’s members share information with MIB in a coded format to protect individuals’ privacy.

MIB Pre-Notices.

When a member company wants to search MIB’s database or report information to the MIB, it must first give the individual MIB a “pre-notice.” However, this is often buried in the fine print of the insurance application. The MIB “pre-notice” advises the individual that a report of their medical condition may be provided to MIB.

When the individual later applies for insurance with a different company that is a member of MIB, then MIB may provide that company with an MIB report.

After the individual receives MIB “pre-notice,” they are requested to sign an authorization. The authorization advises the individual that MIB is an information source, as well as others that may have records about the individual (e.g., primary care physician). The signed authorization permits the member company to receive and share information with MIB. Learn more about MIB “pre-notice” here.

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, home health agencies, hospitals, ambulatory surgical centers, pain management clinics, nursing homes, and any other healthcare provider. It also includes medical students, resident physicians, and fellows, as well as medical school professors and clinical staff. We represent health facilities, individuals, groups, and institutions in contracts, sales, mergers, and acquisitions. The lawyers of The Health Law Firm are experienced in complex litigation and both formal and informal administrative hearings. We also represent physicians accused of wrongdoing, patient complaints, and in Department of Health investigations.

To contact The Health Law Firm, please call our office at (407) 331-6620 or toll-free at (888) 331-6620 and visit our website at www.ThehealthLawFirm.com

About the Author: Amanda I. Forbes, practices health law with The Health Law Firm in its Altamonte Springs, Florida, office. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com. The Health Law Firm, 1101 Douglas Ave. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or toll-free: (888) 331-6620.

“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 © 2021 The Health Law Firm. All rights reserved.

 

DOJ Drops Charges in Appalachia Opioid Case After Supreme Court Ruling

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

On August 12, 2022, the U.S. Department of Justice (DOJ) announced that it dropped charges against the remaining defendants in a case against a former Ohio drug distributor. In 2019, Miami-Luken, two of its executives, and two pharmacists were charged with unlawfully conspiring to distribute millions of addictive painkillers across rural Appalachia.

The Original Indictment.

The DOJ issued an indictment against the five defendants in 2019 and charged all with conspiracy to distribute a controlled substance. It alleged Miami-Luken had sent millions of Class II and III narcotic painkillers to pharmacies that served rural towns in Appalachia. The indictment said that this occurred from about 2008 to 2015 when the opioid crisis was at its height.

During that time, the government alleged that Miami-Luken sent over “six million doses” of drugs to a West Virginia pharmacy and “regularly exceeded the internal threshold limit” set for that area. The charges were tied to alleged violations of the Controlled Substances Act. For more information about the charges, read the DOJ’s press release.

In a lengthy motion to dismiss, the former drug distributor said the claims were not clearly prohibited by the Controlled Substances Act and said the case was “the first time that the DOJ has relied on Drug Enforcement Administration (DEA) guidance letters interpreting a federal statute — the Controlled Substances Act — as the basis for a criminal prosecution.”

Pharmacy Fraud Cases using gavel and stethoscope with spilled opioid pills

As an aside, I note that the DEA (and when DOJ is representing it, DOJ adopts the same tactic) routinely engages in what I call “bean counting” to exaggerate the perception of the seriousness of the matter. They do this by counting the number of individual pills prescribed or dispensed when, overall, it really is not that significant. Let’s say a hypothetical patient suffering from chronic pain

is prescribed 20 mg of a narcotic medication thrice daily. Such prescriptions are normally written for a thirty (30) day supply. The DEA (and sometimes the DOJ) will multiply these out and allege the doctor prescribed 90 pills X 12 months or 1,080 pills. If the pharmacists did not have 20 mg size pills and filled it with 10 mg pills (doubling

the number of pills, but not the dosage), this doubles the number of pills to 2,160. It sounds like a tremendous number, but it is actually the average that would be prescribed for such a patient.

And then, when one considers that a pharmacy probably has thousands of patients each month who get their prescriptions filled, this greatly magnifies the number of individual pills. Then take it a step further, and consider a medical distributor that may be distributing medications to a hundred different individual drug stores. This multiplies out the number to a much greater one. Using a figure such as “six million pills distributed” sounds much more terrible than “three thousand patients received an average dosage of pills that were distributed through the drug distribution company.” Defense attorneys must do everything possible to eliminate or reduce the impact of such “bean counting” or “pill counting” in such cases.

In March 2021, U.S. District Judge Matthew W. McFarland of the Southern District of Ohio refused to toss the case, saying the motion was “premised on the mischaracterization of the crime.”

Unopposed Motion to Dismiss the Charges.

This time, Surprisingly, there was a motion by the DOJ to dismiss the case. Judge McFarland granted the government’s unopposed motion to dismiss the charges against the remaining defendants, including former Miami-Luken President Anthony Rattini, who died last year. Another former Miami-Luken executive had accepted a plea deal in December 2021.

View the government’s motion to dismiss the indictment without prejudice and stipulation.

View Judge McFarland’s order granting the motion to dismiss the indictment.

It’s important to note that the government did not specify why the charges were dropped; however, the move came shortly after a U.S. Supreme Court ruling that made such cases harder to prove. The decision in Ruan v. U.S. said that prosecutions under the Controlled Substances Act for excessive prescribing of opioids and other addictive drugs must show that doctors knew they lacked a legitimate medical purpose.

Click here to read my previous blog to learn more about this topic.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities, and other health care providers in cases involving allegations of over-prescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and hearings at state and federal levels.

To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Weld, Elliot. “Appalachia Opioid Charges Dropped After High Court Ruling.” Law360. (August 12, 2022). Web.

Raymond Nate. “Opioid distributor Miami-Luken, execs seek dismissal of indictment.” Reuters. (May 1, 2020). Web.

Overley, Jeff. “DOJ Indicts Opioid Distributor, Execs Over Painkiller Sales.” Law360. (July 18, 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

Attorney Positions with The Health Law Firm. The Health Law Firm is always looking for qualified attorneys interested in the practice of health law. Its main office is in the Orlando, Florida, area. If you are a member of The Florida Bar and are interested, forward a cover letter and your resume to: PAlexander@TheHealthLawFirm.com or fax to: (407) 331-3030.

“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 © 2022 The Health Law Firm. All rights reserved.

2022-09-07T23:39:52-04:00September 7th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Supreme Court Rules Against HHS in Hospital Medicare Reimbursement Case

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

On June 15, 2022, the U.S. Supreme Court said the federal government improperly cut more than $1 billion a year in Medicare reimbursements to hospitals.  This came in a ruling that limits regulators’ power to control what the program pays for certain drugs.  In this case, the Supreme Court justices sided unanimously with a group of hospitals suing over drug reimbursement rates for facilities that serve low-income communities. In writing for the court, Justice Brett Kavanaugh said the U.S. Department of Health and Human Services (HHS) improperly calculated reimbursement rates using a methodology Congress authorized for use only in limited circumstances.

Were the Reimbursement Cuts Unlawful?

The Supreme Court overturned a lower court’s 2020 decision that HHS had the authority to reduce the yearly Medicare reimbursement rates for a group of hospitals serving low income communities. Click here to view the July 31, 2020 decision.

The high court found the U.S. Court of Appeals for the District of Columbia Circuit erred in 2020 when it allowed the HHS to reduce Medicare payments, by roughly $1.6 billion, for outpatient drugs that had helped subsidize the operations of the hospitals.  The Supreme Court’s decision did not extend so far as to undermine HHS authority, but only stated how the agency acted unlawfully in accordance with its varying rates for hospitals under the 340B Drug Pricing Program.

“In short, the statute allows HHS to set reimbursement rates based on average price and affords the agency discretion to ‘adjust’ the price up or down. But unless HHS conducts a survey of hospitals’ acquisition costs, HHS may not vary the reimbursement rates by hospital group,” Justice Kavanaugh wrote in the ruling.


Regulating Reimbursement Rates Under the 340B Program.

Under Medicare, health care providers get reimbursed by the government for expenses, including medications used in hospital outpatient departments. Previously, hospitals had been getting reimbursed at a rate based on the average price of the drugs. However, in 2018, the HHS, under then-President Donald Trump, cut payments for outpatient drugs by 28.5% to hospitals receiving money under the 340B program.

The department found that reimbursements were too high because these hospitals obtain the drugs from manufacturers at a deep discount, an issue that also resulted in excessive patient co-payments. Additionally, the resulting cut dealt “a crushing blow to providers that were already operating on razor-thin  margins and to the vulnerable populations they serve,” the hospitals told the justices in a court filing.

Justice Brett Kavanaugh wrote for the court that “absent a survey of hospitals’ acquisition costs,” the HHS “may not vary the reimbursement rates for 340B hospitals. The HHS’s 2018 and 2019 reimbursement rates for 340B hospitals were therefore contrary to the statute and unlawful.”

Click here to read the Supreme Court’s Opinion in the case, American Hospital Association v. Becerra, 20-1114.

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, Medcaid 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 toll-free at (888) 331-6620.


Sources:

Stohr, Greg. “Supreme Court Sides With Hospitals on Medicare Reimbursement.” Bloomberg Law. (June 15, 2022). Web.

Chung, Andrew. “U.S. Supreme Court faults Medicare cuts to hospitals for outpatient drugs.” Reuters. (June 15, 2022). Web.

Gresko, Jessica. “High court rules against government on drug reimbursement.” Associated Press. (June 15, 2022). Web.


About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with The Health Law Firm, which has a national practice. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 331-6620 or Toll-Free: (888) 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.
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2022-08-24T00:34:03-04:00August 24th, 2022|Categories: Health Facilities Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

The Do’s and Don’ts If You Are Under Investigation For Discipline on Your Professional License, Part 2

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

You are reading Part 2 of this blog series. To read Part 1, click here.

If you are notified that you are under investigation, DO NOT take the easy way out by immediately relinquishing your license. And DO NOT hide your head in the sand by thinking the case will just go away on its own. DO NOT think that you can just talk to the investigator, explain your side, and the case will go away. Also, DO NOT request an informal hearing or agree to a settlement agreement (consent order) in which you admit the facts alleged against you are all true.  If you do this you are, in effect, “pleading guilty.” If you are innocent of the charges, request a formal hearing and contest the charges; defend yourself.

DO immediately seek the advice of an attorney who has experience in such professional licensing matters and administrative hearings.  These attorneys are out there, but you may have to search for one.  Do this before you talk to or make any statement (oral or written) to an investigator.

DO purchase professional liability insurance that includes legal defense coverage for any professional license investigation against you, whether it is related to a malpractice claim or not.  This insurance is cheap and will provide you with needed legal assistance at the time when you may be out of a job and not have money to hire an attorney.  However, beware of the insurance policy that only covers professional license defense related to a malpractice claim.

DO NOT count on your employer to provide this type of insurance for you. In fact, most of such complaints against your license may well be filed by your employer or ex-employer.

If you are a traveling nurse or other contract or temporary type of health professional, always purchase your own insurance.

Our Advice On Professional Liability Insurance.

We strongly encourage nurses, mental health counselors, and all licensed health professionals and facilities to purchase independent insurance coverage.  Make sure it covers professional license complaint defense expenses under all circumstances.

Also, make sure you have enough coverage to actually get you through a hearing. For example, $25,000 coverage for just professional licensure defense is the absolute minimum you should purchase;   $50,000 may be adequate, but $75,000 or $100,000 may be what you need in such a situation.  You can usually buy the higher limits for a few dollars more (and I do mean only a few). If necessary, such insurance is usually cheap enough that you can actually purchase two or more different policies.

Also, I will repeat, make sure it covers your legal defense in an administrative disciplinary proceeding against your license, even if there is no malpractice claim filed against you or likely to be filed against you. We also recommend that you purchase coverage through an insurance company that allows you to select your own attorney and does not make you use one that the insurance company picks for you.

Companies we have dealt with in the past which provide an inexpensive quality insurance product for professional license defense costs include CPH & Associates Insurance, Nurses Service Organization (NSO) insurance, Healthcare Providers Organization (HPSO) Insurance, and Lloyd’s of London Insurance.

To learn more, visit our Video Q&A section on our website and watch our video titled, “Should I voluntarily relinquish my professional license because I am being investigated?” and visit our YouTube page.

Click here to read one of our prior blogs for even more information on how to fight back against adverse NPBD reports.

Don’t forget to read part one of this blog series here!

Contact Health Law Attorneys Experienced with Investigations of Healthcare Professionals.

The attorneys of The Health Law Firm provide legal representation to medical professionals in Department of Health (DOH) investigations, licensing matters and other types of investigations of health professionals and providers. To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free at (888) 331-6620 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

DOJ Files False Claims Suit Against Nursing Homes Over “Substandard Services and Nonexistent” Care

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

On June 15, 2022, the U.S. Department of Justice (DOJ) announced it has sued three nursing homes in Ohio and Pennsylvania, citing their “grossly substandard skilled nursing services.” The False Claims Act (FCA) complaint against the American Health Foundation (AHF), its affiliate AHF Management Corporation, and three nursing homes alleges the facilities fraudulently billed the Centers for Medicare & Medicaid Services (CMS) for often “nonexistent care.”

According to the complaint, all three AHF nursing homes not only provided substandard nursing home care services that failed to meet required standards of care but also did not maintain adequate staffing levels between 2016 and 2018.

Click here to view the complaint filed by the DOJ in the U.S. District Court for the Eastern District of Pennsylvania.

FCA Violations For “Substandard or Nonexistent Care.”

The government alleged AHF Management and its entities violated the FCA stemming from reimbursements for “grossly substandard” care provided at the Cheltenham, Wilmington Place, and Samaritan nursing homes.

“The defendants knowingly submitted, or caused the submission of, false claims to Medicare and Medicaid for nursing home care and services that were blatantly substandard or nonexistent,” the complaint read. “The Medicare and Medicaid programs provided reimbursement for the claims, but these payments were by mistake as CMS didn’t know the true and full extent of the defendants’ failure to provide patients with proper treatment and care.”

Alleged Patient Conditions and Mistreatment.

Examples of the appalling conditions described in the complaint included housing elderly and medically vulnerable patients in “pest-infested” buildings whose belongings were often stolen; giving residents unnecessary medications, including antibiotic, anti-psychotic, anti-anxiety, and hypnotic drugs; subjecting residents to verbal abuse; neglecting to provide residents with activities or stimulation, and failing to provide needed psychiatric care.

Additionally, the complaint outlines the suicide of a resident who was admitted with a history of self-harm and was later hospitalized after slashing his wrists but still was not provided psychiatric services. Tragically, just weeks after readmission, the resident committed suicide by hanging himself from a bedsheet in a shower room, justice officials said.

“Nursing homes are expected to provide their residents, which include some of our most vulnerable individuals, with quality care and to treat them with dignity and respect,” said Assistant Attorney General Brian M. Boynton, head of the DOJ’s Civil Division in a statement. He continued, “the department will not tolerate nursing homes, or their owners or managing entities, who abdicate these responsibilities and seek taxpayer funds to which they are not entitled.”

To read the DOJ’s press release in full on the case, click here.

The United States’ complaint stems from an investigation that the DOJ initiated as part of its “National Nursing Home Initiative.” The department launched the initiative in March 2020 to identify and investigate nursing homes that provide grossly substandard care.

Click here to learn more about the Justice Department’s nursing home initiative.

The case is United States v. American Health Foundation Inc., case number 2:22-cv-02344, in the U.S. District Court for the Eastern District of Pennsylvania.

Contact Health Law Attorneys Experienced in Handling False Claims Act (FCA) Violations, Investigations, and other Legal Proceedings.

The attorneys of The Health Law Firm represent healthcare providers in defending audits and investigations by the Department of Health and Human Services, the Department of Justice, The Drug Enforcement Administration (DEA), the Florida Department of Health (DOH), Medicaid Fraud Control Unit (MFCU), state boards of medicine, state boards of pharmacy, and state boards of nursing. They also represent health professionals and providers in administrative litigation (state and federal) and civil litigation (state and federal). They represent physicians, nurses, medical groups, nursing homes, home health agencies, pharmacies, dentists, pharmacies, assisted living facilities, and other healthcare providers and institutions in recovery actions and termination from Medicare and Medicaid Programs.

To contact The Health Law Firm please call (407) 331-6620 or toll-free at (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

D’Annunzio, P.J. “Feds Hit Nursing Home With FCA Suit Over ‘Nonexistent’ Care.” Law360. (June 15, 2022). Web.

Marceas, Kimberly. ‘Grossly substandard’ care leads to False Claims charges for Ohio-based nursing home operator. McKnights Long Term Care News. (June 16, 2022). Web.

“Nursing Homes Face DOJ False Claims Suit Over Standards of Care.” Bloomberg Law. (June 15, 2022). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law is an attorney with The Health Law Firm, which has a national practice. Its main office is in Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

 

Additional Negative Consequences for Discipline on Your Professional License, Part 1 of 2

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

Do you have a medical, pharmacist, counselor, or nursing license in more than one state?  Do you have a license in more than one profession?  Have you been notified that an investigation has been opened against your professional license?  Are you thinking about resigning your professional license or voluntarily relinquishing (giving up) your license?  Then you should be aware of some important facts you may not have known.

First, you should never voluntarily relinquish or resign your professional license after you know that an investigation has been opened or that disciplinary action has been taken against you.  A resignation is considered to be a “disciplinary relinquishment” and is treated the same as if your license had been revoked on disciplinary grounds.

Second, this will be reported to other states, professional agencies, the National Practitioner Data Bank (NPDB), and to any certifying bodies for certifications you have. It will also be reported to other national professional bodies (such as the National Council of State Boards of Nursing, the National Association of Boards of Pharmacy, or the American Board of Internal Medicine).  Other states and other professional boards will most likely initiate disciplinary action based on the report of the first one.

Protect Your License from These Types of Adverse Actions.

Following is a list of some of the adverse actions you can expect to be taken after discipline on your license (or if you give up your license after receiving notice of investigation):

1. A mandatory report to the National Practitioner Data Base (NPDB) which remains there for 50 years. Note: The Healthcare Integrity and Protection Data Bank HIPDB have now merged into the NPDB.

2. The action must be reported to and included in the Department of Health (DOH) profile that is available to the public online (for those having one) and remains for at least ten years.

3. Any other states or jurisdictions in which the professional has a license will also initiate an investigation and possible disciplinary action against him or her in that jurisdiction.  (Note:  I have had two clients who had licenses in seven or more other states; even states where the license was no longer active initiated action).

4. The Office of the Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) will take action to exclude the provider from the Medicare Program.  If this occurs (and many of these offenses require mandatory exclusion) the provider will be placed on the List of Excluded Individuals and Entities (LEIE) maintained by the HHS OIG.

a.  Note that if this happens, you are prohibited by law from working in any position in any capacity for any individual or business, including hospitals, nursing homes, home health agencies, physicians, medical groups, insurance companies, etc., that contract with or bill Medicare or Medicaid.  This means, for example, you are prohibited from working as a janitor in a nursing home that accepts Medicare or Medicaid, even as an independent contractor.

b.  Also, if this happens, you are also automatically “debarred” or prohibited from participating in any capacity in any federal contracting, and you are placed on the U.S. General Services Administration’s (GSA) debarment list.  This means you are prohibited by law from working in any capacity for any government contractor or anyone who takes government funding.  This applies, for example, to prevent you from being a real estate agent involved in selling property financed by a government-backed loan, prohibited from working for an electrical company that bids on contracts for government housing projects, working as a school teacher in a public school, etc.

c.  Additionally, if this happens, your state is required to terminate you “for cause” from the state Medicaid Program.  In many states, this will also be an additional ground for revocation of your license.

5. Any profile or reporting system maintained by a national organization or federation (e.g., NURSYS profile maintained by the National Council of State Boards of Nursing, American Medical Association physician profile, or the Federation of State Board of Physical Therapy profile) will include the adverse action in it, generally available to the public.

6. If you are a nurse practitioner or other professional with clinical privileges at a hospital, nursing home, HMO, or clinic, action will be taken to revoke or suspend the clinical privileges and staff members if you have such. This may be in a hospital, ambulatory surgical center, skilled nursing facility, staff model HMO, or clinic.  This will usually be for physicians, physician assistants (PAs), advanced registered nurse practitioners (ARNPs), certified registered nurse anesthetists (CRNAs), nurse midwives, or certified nurse anesthetists (CNAs), podiatrists, clinical psychologists or clinical pharmacists.

7. Third-party payors (health insurance companies, HMOs, etc.) will terminate the professional’s contract or panel membership with that organization.

8. The U.S. Drug Enforcement Administration (DEA) will act to revoke the professional’s DEA registration if he or she has one.

9. Many employers will not hire you or will terminate your employment if they discover your license has been disciplined in another state.

What Should and Shouldn’t You Do?

If you find yourself notified that you are under investigation, don’t take the easy way out by immediately relinquishing your license. Don’t hide your head in the sand by thinking the case will just go away on its own. Do not request an informal hearing or a settlement agreement in which you admit the facts alleged against you are all true.  If you do this, you are “pleading guilty.” If you are innocent of the charges, request a formal hearing and contest the charges; defend yourself.

Do immediately seek the advice of an attorney who has experience in such professional licensing matters and administrative hearings.  They are out there, but you may have to search for one.  Do this as soon as you get notice of any investigation and especially before you have talked to or made any statement (including a written one) to any investigator.

Do purchase professional liability insurance that includes legal defense coverage for any professional license investigation against you, whether it is related to a malpractice claim or not.  This insurance is cheap and will provide needed legal assistance at the time when you may be out of a job and not have money to hire an attorney.  Beware of the insurance policy that only covers professional license defense if it is related to a malpractice claim.

Professional Liability Insurance.

We strongly encourage all licensed health professionals and facilities to purchase their own, independent insurance coverage.  Make sure it covers professional license defense under all circumstances.  Make sure you have enough coverage to actually get you through a hearing. $25,000 coverage for just professional licensure defense is the absolute minimum you should purchase;  $50,000 may be adequate but $75,000 or $100,000 may be what you really need in such a situation.  For a few dollars more (and I do mean only a few) you can usually purchase the higher limits.

Also, I will repeat, make sure it covers your legal defense in an administrative disciplinary proceeding against your license, even if there is no malpractice claim filed against you or likely to be filed against you.

We also recommend that you purchase coverage through an insurance company that allows you to select your own attorney and does not make you use one that the insurance company picks for you.

Companies we have encountered in the past that provide an inexpensive top quality insurance product for professional license defense costs include CPH & Associates Insurance, Nurses Service Organization (NSO) insurance, Healthcare Providers Organization (HPSO) Insurance, and Lloyd’s of London Insurance.

To learn more, visit our Video Q&A section on our website and watch our video titled, “Should I voluntarily relinquish my professional license because I am being investigated?” Additionally, click here to read one of our prior blogs for even more information on how to fight back against adverse NPBD reports.

Contact Health Law Attorneys Experienced with Investigations of Healthcare Professionals.

The attorneys of The Health Law Firm provide legal representation to medical professionals in Department of Health (DOH) investigations, licensing matters, and other types of investigations of health professionals and providers. To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free at (888) 331-6620 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 Avenue, Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

2022-07-11T18:21:32-04:00July 11th, 2022|Categories: Dental Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Helpful Tips Healthcare Professionals Should Be Following for Professional Correspondence

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

I review many letters, e-mails, memoranda, and other types of correspondence prepared by my physician and nurse clients during my legal representation. These come to me often because of a dispute with a hospital, their peers, an insurance company, a lawsuit filed by a patient, a complaint being investigated by the licensing agency, an investigation of an incident, or another serious matter.

In many cases, way too many cases, such correspondence is unprofessional and defeats the purpose of the reason you are sending the correspondence. Sometimes the “letter” is so bad, that it will be disregarded by the reader to whom it was directed. I have seen this from doctors, nurses, dentists, psychologists, owners of health care businesses, and many, many other highly educated professionals who really should know better.

When I receive a “letter” that has no return address on it, no date on it is not addressed to a person or organization, has typographical errors and misspellings, does not have a paragraph, or is not signed, I cringe.

When such documents are dictated and transcribed by a professional medical transcriptionist, they are usually properly formatted and many of the errors I note below are avoided. However, when the health professional types (or word-processes) his or her own document or, worse yet, hand writes it, this is when I see the most errors.

To avoid these errors that make your correspondence and written communications look unprofessional, follow these tips.

Remember Why You Are Writing.

Remember, the basic purpose of your correspondence is to communicate ideas effectively. In many cases, it will be to invoke your legal rights in certain situations (such as an appeal or a hearing request). Sometimes, it will attempt to persuade your hospital, peers, or employer to take a certain action or refrain from a certain action. Remember that your correspondence is often the first impression that the other side will have of you. Do you want it to be an impression that you are sloppy, lazy, unprofessional, not knowledgeable, uneducated, or confused?

Whether you are communicating in a letter or via e-mail, these rules still hold true. In many (if not all) situations involving legal proceedings or legal issues, it is probably best to communicate via a letter sent by U.S. mail or some other reliable delivery service (e.g., Federal Express, Airborne Express, DHL, etc.). Even if you are transmitting your information via e-mail, it is my suggestion to prepare it in the form of a paper letter (if your e-mail is not set up to insert your letterhead and signature block automatically) and then scans it in and send it electronically.

I discourage legal communications via e-mail in serious matters because e-mails are often difficult to obtain, isolate, and authenticate when you need them for hearings. Additionally, they are rarely secure, often available to many others who shouldn’t see them, and easily susceptible to being accidentally sent to others who should not see them at all.

Horror Stories of Unprofessional Correspondence.

Why do I feel this article is necessary? Because of all the truly horrible correspondence I have seen written by allegedly highly educated professionals, mostly physicians and nurses. That’s why!

True “Horror Stories” About Unprofessional Correspondence

Here are just a few examples of true “horror stories” regarding unprofessional correspondence:

The physician never wrote a separate response to any charges or allegations made against him after receiving letters from the Medical Staff advising him he was under investigation. He would just hand write (scribble, actually) his remarks on the bottoms and in the margins of whatever document was sent to him and then send it back.

A nurse practitioner was required to respond to serious negligence charges, resulting in an adverse outcome for a patient. On unlined paper, she hand-wrote a response letter that was not addressed to anyone, not dated, not signed, and did not state who was sending it. There was no name or signature on it.

A physician was required to provide his analysis of a patient’s case for peer review purposes within the hospital. His typed letter of three full pages, single-spaced, contained one long paragraph. I used to work for a Medical Corps Admiral when I was a Navy JAG Corps officer. The Admiral, a very educated and proper professional, would just glance at such correspondence and state: “I can tell this doctor doesn’t have any idea what he is talking about.” Failing to follow good correspondence procedures will show others your thoughts lack organization and cohesion. A document that lacks organization reflects a mind that lacks organization.

A health professional was required to complete an application for clinical privileges. He wrote all of the answers by hand, not even staying within the lines on the form, writing over the questions printed on the form and around in the margins of the application. This is what he signed and turned in to the credentials committee at the hospital. Believe me, this did not look very professional.

A physician was requested to respond to a medical staff inquiry from the hospital. Her response came back typed (actually word-processed) in a type font that was 22 characters per inch (cpi), almost too small to read. Perhaps she was just trying to save a sheet of paper. But many of us would have had to pull out a magnifying glass or put on reading glasses in order to be able to read it. Once it is scanned or faxed and then photocopied or re-scanned and re-faxed several times, it will be completely illegible. If you are actually trying to communicate your ideas, make your correspondence easier to read, not harder to read. This is my cardinal rule.

A dentist was notified of a pending complaint investigation being opened against her dental license. She wrote her response to the charges back to the investigator, without using any business address or title, and began her response statement with “Dear Sharon,”. Do not treat others informally, especially in professional or formal situations. You will be deemed to be unprofessional when you do so. The investigator is not your friend, your sister, or your mommy. Do not address her by her first name. Do not end the salutation with a comma, like you would a love letter. End it with a colon like you would a professional business letter.

30 Tips for Good Professional Correspondence.

Here are some pointers on professional communications that should be followed in all of your professional written communications about business, professional or legal matters, even in e-mails. Please note, that the terms below in quotation marks have certain defined meanings. If you don’t know what these terms mean, look them up.

1. Always remember that the reason you are sending the correspondence is to attempt to effectively and accurately communicate your position and ideas. If you are trying to make your message indecipherable or difficult to understand, ignore these tips. If you are trying to come across as someone who doesn’t give a damn about how he or she is perceived, ignore these tips. If you want to come across as unprofessional, ignore these tips.

2. Make sure you include your complete and correct “return address” and contact information if you are not using your own letterhead. This includes your physical or mailing address, telephone number, telefax number and e-mail address, so that the other party knows exactly how to reach you. In cases where you already have this on your letterhead, be sure to use your letterhead (but only your own). Also, it appears more professional to create a letterhead with the information in it and to use your new letterhead instead of having a professional business letter with a typed “return address.” However, a typed “return address” is better than none.

3. Don’t use someone else’s letterhead. Don’t use your hospital, medical group or institutional letterhead for your own personal communications, unless you are the owner. Use your personal letterhead (see above), instead. If you are being accused of poor utilization review, unprofessional conduct, or personal use of hospital (or company) property, then using someone else’s letterhead just helps prove the charge against you.

4. Date your correspondence. Date your correspondence. Date your correspondence. Nothing shows a lack of professionalism and lack of attention to detail as sharply as undated correspondence. It will certainly be difficult to prove when your letter or document was sent if you do not have a date on it. A year or two later, it may be completely impossible to do so. In case I forgot to mention it, be sure to date your correspondence.

5. Use titles or honorifics. In the “business address” of your correspondence, always use the complete name of the person to whom you are writing (if known) together with that person’s honorific or professional title (e.g., Mr., Ms., Dr., Nurse, Prof., Dean, etc.) This shows both respect and professionalism.

6. Always use the complete mailing address, including the title, of the person to whom you are sending the letter. The business address of your correspondence includes not only the person’s name and honorifics but the title or position and division within the institution or organization to which you are sending it. In the case of large organizations, you should include the building and suite or room numbers and any internal routing codes, designations, “mail stops” or other organizational routing codes, that the agency or business you are writing requires to route its mail internally. Large organizations, especially government agencies and insurance companies, all have large mail rooms that sort and route all mail the organization receives from any source. Correct internal routing codes will help ensure that your correspondence gets to the correct person or official in a timely manner. Often today companies scan or have all e-mails saved by a clerk, as well

7. Always use a salutation. This is self-explanatory but see below.

8. In your “salutation,” always use the person’s last name with a title or honorific. It is customary to use the term “Dear” in a salutation in formal writing, so this is permitted. But you may leave it out. For example, “Dear Secretary Jones:” or “Secretary Jones:” or “Dear Dr. Johnson:” or “Dr. Johnson:”; all of these are correct. Never refer to the person by that person’s first name in any type of formal correspondence or correspondence that anyone else might read. Never say: “Dear Sue:” or “Sharon:”. Even if you know these people well enough to call them by their first names, don’t do it in this situation; it’s unprofessional and may be interpreted as “talking down” to the person.

9. Always end your “salutation” with a colon, not a comma. A comma is only used in informal communications to those you know well or socially, such as a letter to your mother or a note to your girlfriend. Unless this is your mother or your girlfriend to whom you are writing, use a colon. For example, “Dear Secretary Jones,” or “Dear Sue,” is incorrect. “Dear Secretary Jones:” or “Ms. Smith:” is correct.

10. Type (or word-process) your correspondence or have it typed (or word-processed) for you; this is one reason transcriptionists, secretaries and clerks have jobs. Do not send handwritten letters in formal or professional matters. Do not write on the other person’s correspondence or documents and send them back. Prepare and send a professional-looking letter or e-mail, even if you must pay someone to type it for you (and if you are sending an e-mail, I know you can type a little bit yourself, anyway). To do otherwise is to show laziness, disrespect and unprofessionalism.

11. Always use a type font in your correspondence (including e-mails) of at least 12 points (10 characters per inch). Do not use small, difficult-to-read type fonts, for example, the size of the type font that most e-mail software defaults to. Smaller type fonts than 12 points become difficult to read, especially if scanned/rescanned, faxed/refaxed, or copied/recopied. Change the default font in your e-mail software or computer word processing software, if necessary. You can do this, regardless of how difficult it may seem at first; I know you can do it because I can do it. Make your professional correspondence easier to read, not more difficult to read.

12. Never use unprofessional-looking type fonts for your communications. Stay away from script-type fonts, italics, or novelty-type fonts. These are notoriously more difficult to read and look unprofessional. You are not publishing a flyer for a high school bake sale. Times New Roman, CG Times, and similar type fonts are more professional looking and easier for a person to read. Use Courier or Letter Gothic type fonts if necessary.

13. Keep the correspondence to which you are responding unmarked. One reason to not write on or mark up the other person’s documents or correspondence is that you may need them as evidence in a court of law or a hearing someday. Nothing looks less professional than a document you are trying to use as evidence when a different person has made handwritten marks all over it. The impression is similar to one in which a child with a box of crayons has gotten to it. You don’t want this or need this. Show respect and self-control. Keep the other side’s documents pristine. They will look much better that way as your “Exhibit 1” in the court hearing.

14. Use a good concise, descriptive reference line or subject line (often called the “re:” line). Make it a very brief summary. State what the content of your letter is actually about. State if you are responding to a letter or document that you received from the “addressee” (the person to whom you are addressing your correspondence) of your letter.

15. Include the recipient’s routing information. If the intended receiver of your letter or correspondence (the “addressee”) included reference numbers, file numbers, account numbers, case name and numbers, a policy number, an investigation number, a routing number, or other similar information on its letter to you, repeat these back in the reference line of your correspondence. This will help make sure that your correspondence gets routed to the correct file and recipient more timely. This is especially crucial in large organizations and government agencies.

16. The contents of the body of your correspondence should be easy to read and easy to understand. To this end, be sure to use short sentences and short paragraphs. Each paragraph should convey one idea. Use headers and section titles, if necessary, to organize your correspondence, especially if it is lengthy. Remember, headings within your letter that help to organize it are like street signs in a busy city. They will really help any subsequent reader (and this may be a judge, a jury or a Board of Mediciney) to navigate his, her or its way through your letter.

17. Be sure to skip a line between each paragraph and, preferably, indent the first line of each paragraph. [Note: Some writers will tell you not to indent the first line of each paragraph in professional correspondence; however, I feel that this makes the correspondence more difficult to read, so I encourage indenting or tabbing in on the first line of each paragraph.] This makes it easier on the reader and more likely that your ideas will not get lost in a crowd of words.

18. Keep your paragraphs short and to the point. Nothing turns readers off as much as a single lengthy paragraph written from margin to margin taking up the whole page. I suppose some people may have never been taught what paragraphs are. However, I am willing to bet that most were. These rare used even in foreign countries.

19. In longer correspondence, use section headings (in bold or underlined) or headings for each issue, to better organize it. Think of these as road signs on a long road. They help the reader to know where he or she is at any given time, and where he or she is going.

20. When using headers, skip two lines before the header and one line after the header. This helps to set off the new section and header and show a definite division.

21. Keep your language objective and professional. Do not ever use profanity [Oops, I just went back and removed the word “damn” I used above.] Do not ever use any comments even remotely resembling racism, sexism, or antisemitism or prejudice. Do not be sarcastic.

22. Be direct and concise in your language. To the greatest extent possible, use the same terminology and wording that the other party uses, or has used, or the wording used in whatever statutes, regulations, policies, procedures, instructions, or governing documents with which you are dealing (but also, be sure you know what the words and terms mean).

23. If you intend to request a formal hearing say “I request a formal hearing.” If you want a full refund, state: “I request a full refund.” If you want to appeal the decision, state: “I want to appeal the decision.” Don’t be wishy-washy or vague. For example, don’t say, “I am looking for an attorney to file an appeal for me,” when what you mean to say is “I appeal the decision” or “I request an appeal.” Say precisely what you want. Don’t be vague or leave the reader guessing.

24. If there are any deadlines by which you must respond, be aware of these and make sure your response is received by that date. Remember “received” means “actually received” by the correct person (or office) at the correct address. It does not mean “mailed by” or “postmarked by.” If you have correspondence or a document to which a response must be received by a ceratin date, you need to make sure it is actually in the receiving person’s hands by that date, even if you must hand carry it to that person. I will usually send important documents by two different methods, in case the mail man dies, the courier service’s plan crashes or the e-mail server goes down.

25. In closing your correspondence conclude by stating what action is next, whether this is action you intend to take, or action you are requesting the other party to take. For example: “I expect to hear from you within ten days as to whether you grant my request or not.” “Please contact me with hearing dates within the next fourteen days.” “I will forward you a refund within five days.” “I will send you my records within five days.”

26. Always advise the other party of exactly how they should contact you; provide multiple means of contacting you. If you are very busy or have an assistant who is authorized to act for you, provide that person’s name and contact information to use as an alternate, as well. Then be available to receive the return communication(s). Don’t give telephone numbers you never answer. Don’t provide an incorrect address (e-mail or physical).

27. In dealing with dates and deadlines, remember that ten days is ten days; fourteen days is fourteen days, twenty-one days is twenty-one days. Made up rules such as “weekends and holidays don’t count” are just that, made up (outside of formal court proceedings). If the other party has given you “fourteen days to respond,” this means fourteen days from the date on the letter, unless specifically stated otherwise. Fourteen days means fourteen days, unless it is specifically stated otherwise (e.g., “you have fourteen business days to reply”).

28. Include a professional closing above your signature. This should be “Sincerely,” “Sincerely yours,” “Respectfully,” “Respectfully submitted,” or some other professional closing. Do not conclude with “Love,” or “Very truly yours,” despite the tradition.

29. In your signature block, include your full typed name, with credentials and title or position listed. For example, your full name, followed by your degree and other credentials (e.g., “John J. Smith, M.D., F.A.A.C.P.”) should be on the line immediately below where you sign. Next should be listed your position within your organization (if applicable) (e.g., “Chair, Pediatrics Department”).

30. If you have enclosures, list them at the end of the correspondence, giving a brief or shortened description and numbering them (this is slightly different from military correspondence). List and number them in the order you discuss them in your correspondence. Be sure they are properly organized, labeled, and divided, especially if any are lengthy.

Following these simple rules, most people learn in middle school will help to keep your correspondence professional looking and in conformity with what most professionals see on a daily basis. If your correspondence is professional-looking, people will be more likely to think you are a professional and to treat you professionally.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., Board Certified by The Florida Bar in Health Law 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, Suite 1000, Altamonte Springs, Florida 32714, Phone: (407) 331-6620 or Toll-Free: (888) 331-6620.

“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 © 2022 The Health Law Firm. All rights reserved.

Supreme Court Explores Doctor Intent in “Pill Mill” Criminal Prosecutions Under the Controlled Substances Act

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

Physicians and other healthcare professionals usually have broad scope to prescribe most drugs, including potentially dangerous ones. However, over the past decade, many limits, often imposed arbitrarily through criminal prosecutions or drastic administrative sanctions, have been used to impose limits.

The question was recently put before the U.S. Supreme Court as to how far a physician’s judgment can be allowed to go in the context of prescribing controlled substances before it becomes criminal. This was in the context of criminal prosecution of a physician for allegedly over-prescribing.

On March 1, 2022, the U.S. Supreme Court confronted the question of whether good faith is a defense for a doctor criminally prosecuted for unlawful distribution of controlled substances. For nearly 90 minutes, the Supreme Court heard oral arguments from both sides, struggling with the exact wording of the Controlled Substances Act (CSA), the clarity of the relevant federal regulation, and the proposition that a doctor who lacked subjective criminal intent could nevertheless go to jail for a substantial period of time, up to life imprisonment.

The two physicians whose cases are being considered are Xiulu Ruan, who was sentenced to 21 years in prison in 2017 for allegedly running a “pill mill,” and Shakeel Kahn, who was sentenced to 25 years in prison in 2019 for crimes including drug distribution of controlled drugs resulting in the death of a patient. The court consolidated their cases for the Supreme Court’s hearing.

Controversial Legal Standards Used to Convict.

The legal standard in question centers heavily on a disputed sentence in the Controlled Substances Act (CSA) that says, “Except as authorized by this subchapter, it shall be unlawful for any person knowingly or intentionally” to distribute controlled substances. The central question is how juries should assess the intentions of a doctor accused of prescribing narcotic painkillers outside “the usual course of his professional practice.”

The U.S. Department of Justice (DOJ) argued that the criminal intent standard is an objective one — or an “honest effort” to comply with professional norms. On the other hand, the attorneys for the doctors who were prosecuted argue that the standard must be subjective; that is did the doctor subjectively believe they were not prescribed for a legitimate medical purpose. This distinction gives rise to whether there is merely a violation of regulation as opposed to a crime having been committed.

Throughout the oral arguments, various justices seemed to cast doubt on whether deviating from mainstream standards on opioid prescribing is sufficient to throw physicians in jail, which could result in years or life in prison. In some states, this might even result in a death sentence, pretty drastic for what would otherwise be medical negligence.

How This Ruling Will Impact Future Prosecutions.

This case and the upcoming ruling raise alarms for healthcare providers and advocates for pain patients. Many fear that the ruling could enable even more aggressive prosecutions of opioid prescribers. They warn that such a decision could discourage doctors from providing opioids even when they’re fully warranted. In addition, the outcome could affect civil litigation accusing large pharmaceutical companies of recklessly selling prescription narcotics.

After hearing the oral arguments, the Supreme Court seemed likely to demand more substantial proof of intentional wrongdoing when the DOJ prosecutes opioid prescribers. A decision from the High Court is expected by late June 2022. The cases are Ruan v. U.S., case number 20-1410, and Kahn v. U.S., case number 21-5261, in the Supreme Court of the United States.

We will definitely keep you posted on the outcome of this case.

Click here to read one of my blogs about controlled substances and compliance.

Contact Health Law Attorneys Experienced in the Representation of Health Professionals and Providers.

The Health Law Firm and its attorneys have represented physicians, pharmacists, nurses, clinics, dentists, pharmacies, health facilities, and other health care providers in different cases involving allegations of over-prescribing narcotics and pain medications. These include criminal investigations by local police and law enforcement authorities, investigations by the U.S. Drug Enforcement Agency (DEA), U.S. Department of Justice (DOJ), complaints against professional licenses by the Florida Department of Health, investigations, and prosecutions by the Medicaid Fraud Control Units (MFCU), and other types of cases. Having attorneys familiar with the medical standards of care and guidelines for prescribing narcotics and having access to expert medical and pharmacy professionals who can testify as expert witnesses in such cases is also crucial. We have represented professionals in administrative investigations and administrative hearings at both the state and federal levels.

To contact The Health Law Firm, please call (407) 331-6620 or Toll-Free (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.

Sources:

Overley, Jeff. “High Court Poised To Make DOJ’s Job Harder In Opioid Cases.” Law360. (March 1, 2022.) Web.

Gluck, Abby. “In opioids “pill mill” case, justices grapple with physician intent.” SCOTUS Blog. (March 2, 2022). Web.

Joseph, Andrew. “Fight over opioid prescribing — and when it turns criminal — heads to Supreme Court.” STAT News. (February 28, 2022). 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. Suite 1000, Altamonte Springs, FL 32714, Phone: (407) 331-6620 Toll-Free: (888) 331-6620

“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 © 2022 The Health Law Firm. All rights reserved.

2022-06-24T16:22:15-04:00June 24th, 2022|Categories: Pharmacy Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments
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