Colorado Health Law Blog

Home/Colorado Health Law Blog

Three Charged For $109 Million Medicare Fraud Scheme and HIPAA Violations

Attorney Carole C. Schriefer

By Carole C. Schriefer, J.D.

In October 2020, Massachusetts federal prosecutors charged three individuals for their alleged roles in a multi-million dollar plot to defraud Medicare. Two individuals allegedly collected patient health data and sold it to the purported mastermind, who then used it to submit $109 million in false Medicare claims.

Both individuals obtaining the personal health information were located in Florida, wouldn’t you know it. Each was charged with one count of receiving more than $1.6 million kickbacks in connection with a federal health care program. Prosecutors charged the third individual with criminal violations of the Health Insurance Portability and Accountability Act (HIPAA).

Stealing and selling personal health information is one of those HIPAA violations that will really, really get you in trouble. Very few people even know that such a HIPAA violation can be prosecuted as a federal felony crime.

Fraudulently Collecting & Using Patient Information.

According to court documents, both individuals in Florida owned marketing companies that enlisted foreign call centers to contact Medicare beneficiaries (which, I believe, I have received a number of). Using a prepared script, they allegedly asked if patients would be interested in receiving durable medical equipment (DME) such as knee braces or compression sleeves “at little to no cost.” (Does: “We are calling because of your back pain,” sound familiar?)

The call centers would then collect information including the Medicare patient’s name, address, insurance number, and doctor’s name and address, prosecutors said. The information was then sold to the third individual, who used it to file fraudulent Medicare claims for the DME that was never prescribed by a legitimate physician and was not medically necessary.

According to court records, the alleged co-conspirators used the same patients’ information repeatedly through a different shell company each time. More than 1,000 of the claims were made under the names of deceased beneficiaries. (Click here if you are deceased).

Click here to view the criminal information in this case.

Read the DOJ’s press release for more information.

Also, read one of my prior blogs on a similar case in Florida.

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

The attorneys of The Health Law Firm represent physicians, durable medical equipment (DME) suppliers, and other health care providers in Medicare audits, investigations and subpoenas, ZPIC audits, subpoenas and investigations, MAC audits, RAC audits, Department of Health (DOH) subpoenas and investigations, Department of Health and Human Services (DHHS) subpoenas and investigations, Medicaid Fraud Control Unit (MFCU) subpoenas, audits and investigations, OIG subpoenas, audits and investigations, and Department of Regulatory Agencies (DORA) subpoenas, audits, and investigations, in Florida, Colorado, Louisiana, the District of Columbia, Virginia, and throughout Florida and across the U.S. They also represent DME suppliers, physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions in Medicare and Medicaid investigations, audits, recovery actions, termination from the Medicare or Medicaid program, and state and federal administrative hearings and litigation.

For more information please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Sinay, Reenat. “Feds Charge 3 In Alleged $109M Medicare Fraud Scheme.” Law360. (October 2, 2020). Web.

Szaniszlo, Marie. “Three charged in multi-million dollar fraud scheme.” Sentinel Enterprise. (October 2, 2020). 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 © 2021 The Health Law

CVS Fined for Prescription Errors and Poor Staffing at Oklahoma Pharmacies

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 July 16, 2020, the Oklahoma State Board of Pharmacy fined CVS, the nationwide pharmacy chain, $125,000, after auditors found safety issues and “chaotic” scenes at four of its pharmacies. State regulators in Oklahoma cited and fined the nation’s largest retail pharmacy chain for conditions including inadequate staffing and errors made in filling prescriptions. Hopefully, this was isolated to the few stores involved.

Pharmacy Complaints.

In four separate administrative orders, the Oklahoma State Board of Pharmacy said that auditors responded to complaints at each of the pharmacies for issues including long waiting times, wrong information on prescription refills, and dosage mistakes. The state board inspected the four pharmacies from mid-2019 to early 2020. In one case, the complaint said the pharmacy had put someone on hold on multiple occasions, sometimes as long as an hour. In another case, a woman said that when she got her medication refilled, the name and other information on the bottle she received was for someone else.

The pharmacy chains have pushed back on customer and employees’ complaints, saying staffing is sufficient and errors are rare.

Pharmacy Audits.

On multiple occasions, state auditors visiting the pharmacies said they found understaffed facilities, with the phone continuously ringing, employees working around unopened (and, we assume, un-inventoried) delivery boxes, and long lines at the drive-through windows. According to the orders, one pharmacy stated that it was normal for them to be as much as two weeks behind in filling prescriptions as a result of understaffing. It should be noted that the audits took place predominantly before the COVID-19 crisis.

Additionally, in letters to state pharmacy boards and in interviews, pharmacists working for CVS allegedly admitted that they struggled to keep up with an increasing number of tasks including filling prescriptions, giving flu shots, tending the drive-through window, answering phones, and calling patients. According to the orders, many said they also struggled to meet corporate performance metrics that they characterized as excessive and unsafe.

As a routine customer of CVS Pharmacy (not in Oklahoma, of course), I can sympathize with the pharmacists, pharmacy technicians, and clerks. In many places, pharmacists are now being required to administer a laundry list of vaccinations (literally, ten different vaccinations), practice medicine to a limited scope, contact prescribing physicians, constantly order out-of-stock drugs, order diagnostic tests, and answer all sorts of customer questions. Now, with the COVID-19 pandemic, there is a steady flow of coronavirus tests to administer to customers at the drive-through window. I see first-hand how difficult it is for these front-line healthcare professionals to keep up on a daily basis.

The Oklahoma Board said it “strongly recommended” that CVS follow through on nearly a dozen recommendations for all of its Oklahoma pharmacies, including increased training for technicians and changes to how staffing needs were determined. Additionally, the Oklahoma Board advised eliminating tasks that might overburden pharmacists and removing some metrics they are required to meet. For example, phone calls pharmacists often must make could be outsourced to a corporate call center.

In a statement, CVS Pharmacy said it agreed with the Board to settle the matter to avoid the lengthy and costly hearing process. The orders specify that CVS neither admits to nor denies the violations. The company agreed to pay the fines and to make other efforts to address the problems without contesting the allegations.

While the fine of $125,000 is relatively small for CVS, as it’s the country’s fifth-largest company, the move did validate the concerns raised at multiple drugstore chains by pharmacists who say workplaces are putting the public at risk.

You can read all four orders in this case here: CVS Order – Bartlesville, CVS Order – Choctaw, CVS Order – Moore, and CVS Order – Owasso.

Visit our Areas of Practice page on our website to learn more about Board of Pharmacy Representation and how we can assist Pharmacists and Pharmacies in these types of cases.

 

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

We routinely provide defense for pharmacists, pharmacies, and pharmacy technicians; defense to complaints filed against their licenses; defense to complaints filed by patients; defense in litigation against pharmacists, pharmacies, and technicians; legal representation and defense to DEA and Board of Pharmacy audits, investigations, and subpoenas; legal representation in depositions in criminal cases, negligence cases, civil cases, or disciplinary cases involving other health professionals. We have experience in dealing with HIPAA privacy complaints, audits, and investigations. We have experience in defending in Medicare, Medicaid, Tricare, and health insurance audits. We accept most professional liability insurance that pharmacists carry.

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.

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 © 2021 The Health Law Firm. All rights reserved.

Certifying Emotional Support Animals and Protecting Your License, Part 1 of 2

Attorney Amanda I. ForbesBy Amanda I. Forbes, J.D., and Carole C. Schriefer, J.D.

In today’s stress-filed world if you are a mental health counselor or other professional counselor, it is likely that you will encounter a client seeking to obtain an Emotional Support Animal (ESA)
designation letter from you. Providing such a letter may cause you to face complaints, licensing, and disciplinary actions driven by hostile landlords, homeowners associations, and business establishments that do not want any sort of animals on their premises. Often cases wind up in civil litigation. The client may also try to retaliate against you, should the client be the victim of legal problems because of attempting to keep an ESA and not understanding the legal ramifications.

However, you, as an experienced, licensed mental health professional must know what to do and not to do to protect your license and your career.

This is part 1 of 2 in a blog series regarding Emotional Support Animals. Click here for part two. We also intend to do a follow-up blog series on working animals and how they are legally distinguished from ESAs.

Here are some tips to keep in mind should you decide to provide an ESA recommendation letter:

1. You must develop and document a properly established therapist-client relationship with the client prior to writing a recommendation–do whatever you would normally do for any other client seeking your help who walks in the door.

2. Confirm the actual, true identity of the client to be sure you know with whom you are dealing. Request and obtain at least two different forms of photo ID, one including a driver’s license for the equivalent. Check and verify the name and address on the Internet or with directory assistance. (I have a personal rule of thumb: “If you can’t find a person on the Internet, then he is a fake and does not exist”).

3. Obtain the client’s complete mental health history and medical history, requesting and obtaining other treater’s records just as you would do for any other client/patient.

4. If the client has been referred to you by another provider, especially one in a different medical or health specialty, request a written referral documenting the need for the referral to you.

5. Adequately and thoroughly make and document any decision that an ESA will benefit the client and help in treating any mental health symptoms. Be thorough and document it.

6. Assign a code from the Diagnostic and Statistical Manual, ed. 5 (DSM-5 ), to the patient, or obtain one from the patient’s regular treating psychiatrist, psychologist, or mental health therapist.

7. The most important element involved is to show that there is an actual medical necessity for the client to have an ESA or that there will be a therapeutic benefit for the client to have the ESA. If you cannot justify and document this, then do not approve the request.

8. Evaluate the ESA, preferably by an in-person meeting or tele-health conference, and determine that it will benefit the client, be sure to document this evaluation and comment on the weight, height, aggressiveness, and character of the ESA. It is most helpful to have a form the ESA’s veterinarian will complete, sign, and return to you for confirmation of this information and, perhaps, an indication that the animal is suitable in character. Keep this in your record.

9. Thoroughly document the above in your chart on the client.

10. Have a thorough knowledge of your state’s laws and professional licensing board’s regulations concerning ESAs. You might review past disciplinary cases in which counselors have received discipline relating to ESAs in your state.

Warning About Organizations that Target Mental Health Counselors, Psychoanalysts, and Professional Counselors Who Approve Emotional Support Animals.

Those mental health counselors, social workers, professional counselors, and therapists who are involved in the certification or approval of emotional support animals and working animals should be advised that there are a number of organizations and individuals out there who seek out and target those who certify or approve such animals. These organizations and individuals see many cases of abuse and improper certifications being used. They see individuals who appear to have no real medical need for such an animal “purchasing” such certifications. They view them as a merely “privileged” individual who merely buys such certification for their pet just so that can take the pet everywhere and garner attention for themselves.

Sometimes these organizations and individuals even pretend to be a patient seeking certification of an emotional support animal or a working animal. They do often contact counselors using fake names and pretending to be fake patients to see how far the therapist will go without even having a real patient. Then they file a complaint with the therapist’s professional board in an attempt to have disciplinary action taken against their license.

Therefore, it is imperative that you follow the tips mentioned in this article.

Guidance from the American Counseling Association:

The American Counseling Association (ACA) published a position paper titled: Emotional Support Animals-Human Animal Interactions in Counseling Interest Network Position Statement.

In that position paper the ACA stated:

As Licensed Professional Counselors, the assessment of DSM-5 diagnoses for human clients is within the scope of practice; however, the added practices of animal behavior, behavior assessment or Human-Animal Interventions are (most often) not. Emotional Support Animal may, in some specific circumstances, provide benefits to humans to minimize identified symptoms often associated with a DSM 5 diagnoses; however, because of the potential risks and unanticipated outcomes, the HAIC strongly suggests that counselors abstain from writing letters for persons seeking counseling or assessments for the sole purpose of obtaining an ESA recommendation letter.

Click here to read the ACA letter in full.

However, if the counselor already has an existing treating relationship with a client and the counselor is considering writing an ESA recommendation letter, then the ASA recommends:

[T]he counselor must have a thorough knowledge of the local, state, and federal laws and policies surrounding ESAs and appropriate knowledge, skills, and attitudes with the subject of therapeutic human-animal interactions before writing such a letter.

Click here to learn more.

The ACA also cautions:

The ACA’s Code of Ethics C.2.e Consultations on Ethical Obligations includes “taking reasonable steps with other counselors, the ACA Ethics and Professional Standards Department, or related professionals when they have questions regarding their ethical obligations or professional practice.” This may include working with animal trainers, behaviorists, or veterinary behaviorists to ensure that the clinician remains within their scope of practice. Since there is no overarching licensing or accrediting body for this matter, nor are there federal or state mandates at this time, the onus is on the clinician to ensure ethical practice.

https://www.unh.edu/sites/default/files/departments/student_accessibility_services_/aca.final_version_esa14556_002.pdf. (Emphasis added).

Don’t forget to read part 2 in this blog series to learn more.

Contact Health Law Attorneys Experienced Investigations of Mental Health Counselors, Psychologists, Social Workers, and Family Therapists.

The attorneys of The Health Law Firm provide legal representation to mental health counselors, psychologists, social workers, and family therapists in Department of Health (DOH) investigations, FBI investigations and other types of investigations of health professionals and providers. To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 and visit our website at www.TheHealthLawFirm.com.

In cases in which the health care professional has professional liability insurance or general liability insurance which provides coverage for such matters, we will seek to obtain coverage by your insurance company and will attempt to have your legal fees and expenses covered by your insurance company. If allowed, we will agree to take an assignment of your insurance policy proceeds in order to be able to submit our bills directly to your insurance company.

We also defend health professionals and health facilities in general litigation matters and business litigation matters.

To contact The Health Law Firm, please call (407) 331-6620 or (850) 439-1001 or Toll-Free: (888) 331-6620, and visit our website at www.TheHealthLawFirm.com.

About the Authors: Amanda I. Forbes, practices health law with The Health Law Firm in its Altamonte Springs, Florida, office. Carole C. Schriefer is an attorney and former registered nurse.  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.

By |2021-02-17T11:15:55-05:00February 17th, 2021|Categories: Colorado Health Law Blog|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Multiple Settlements with HHS for HIPAA Security Rule Violations & Data Breaches

Attorney Carole C. SchrieferBy Carole C. Schriefer, J.D.

In September 2020, the Department of Health and Human Services (HHS) announced three settlements to resolve alleged violations of the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security Rules. The settlements, totaling $10.6 million, stem from data breaches in which hackers were able to access and obtain individuals’ protected health information (PHI) from U.S. health providers. Combined, the three hacking incidents compromised the health information of more than 16 million patients.

Summary of the HIPAA Security Rule Settlements.

On September 21, 2020, the Office of Civil Rights, or OCR, the division of HHS which receives and investigates HIPAA complaints, announced a settlement with an orthopedic clinic in Georgia. The clinic agreed to pay $1.5 million after a 2016 hacking incident that compromised over 200,000 patient records. Part of the settlement included a Corrective Action Plan, or CAP, which the clinic agreed to adopt, to help prevent future breaches of privacy. Click here to view the resolution agreement and Corrective Action Plan (CAP).

On September 24, 2020, the OCR publicized a settlement with an information technology (IT) and health information management company. The business agreed to pay $2.3 million to settle claims of systemic security rule violations relating to a 2014 hacking incident impacting the personal health information (PHI) of more than 6 million individuals. Click here to read the settlement agreement.

Days later, the OCR released information about a $6.85 million settlement with Premera Blue Cross, the largest health plan in the Pacific Northwest. The settlement, the second largest to date, related to a 2015 cyber-attack which exposed the health information of more than 10 million individuals. To read the resolution agreement in full, click here.

In regard to these settlements, the OCR alleged that the following security rule violations had occurred:

1. Failure to conduct an adequate and thorough risk analysis;

2. Failure to implement sufficient mechanisms to record and examine system activities;

3. Failure to enter into business associate agreements with vendors with access to electronic protected health information;

4. Failure to implement reasonable security measures to reduce risks and vulnerabilities;

5. Failure to respond to and document a known security incident;

6. Failure to implement technical policies and procedures regarding access; and

7. Failure to implement procedures to regularly review system activity logs and reports.

Readers could use the above as a compliance checklist to make sure their own systems of records are being properly protected.

Consequences of HIPAA Security Rule Noncompliance.

The HIPAA Security Rule establishes a set of national standards for confidentiality, integrity, and availability of e-PHI. HHS is responsible for administering and enforcing these standards,along with enforcement of the HIPAA Privacy Rule. Therefore, the agency may conduct complaint investigations and compliance reviews. To learn more details about the HIPAA Security Rule, click here.

HHS looks for systems failures, prior breaches, missing risk analyses, or absence of or inadequate HIPAA policies. Without question, any compliance violations will result in an enforcement action. And as these three settlements have demonstrated, enforcement can be costly.

Don’t Wait Until It’s Too Late, Protect Yourself from HIPAA Security Rule Compliance Violations.

Businesses and organizations need to acknowledge the need to act and create a HIPAA security rule compliance plan. Locating existing security policies and the last completed risk analysis is an essential step in compliance. If it’s been over a year, perform or update risk analysis to identify risks or vulnerabilities on all systems that contain any e-PHI. Security rule compliance requires regular attention and detailed records. Take steps now to help protect e-PHI from data breaches, and avoid millions of dollars in settlements or fines.

Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

The Health Law Firm represent physicians, medical groups, nursing homes, home health agencies, pharmacies, hospitals, and other healthcare providers and institutions to investigate and defend alleged HIPAA complaints and violations and prepare Corrective Action Plans (CAPs). Our attorneys regularly defend OCR HIPAA audits, defend in HIPAA complaint investigations, assist in preparing a HIPAA Risk Analyses, defend in federal administrative actions and administrative hearing cases, and defend in civil or administrative litigation of HIPAA/breach of medical confidentiality law suits.

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Kraus, Anna and Carrier, Tara. “HHS Announces Multiple HIPAA Settlements Related to Data Breaches and the Right of Access Initiative.” Lexology. (October 6, 2020). Web.

Castricone, Dena. “The Crushing Cost Of HIPAA Security Rule Noncompliance.” Law360. (October 1, 2020). Web.

About the Author: Carole C. Schriefer is an attorney and former registered nurse. She practices with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456 or Toll-Free: (888) 331-6620. Its main office is in the Orlando, Florida area.

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

DOJ Charges 345 People Allegedly Involved $6 Billion in Fraud, Related to Healthcare

Attorney Carole C. SchrieferBy Carole C. Schriefer, J.D.

In September 2020, federal prosecutors charged 345 doctors, nurses, and other medical professionals allegedly involved in more than $6 billion in healthcare fraud. It is considered the largest Health Care Fraud and Opioid Enforcement Action in the Department of Justice’s history (DOJ). The schemes were related to telemedicine, illegal opioid distribution, and durable medical equipment, the DOJ said.


A National Fraud Operation.

According to the DOJ, the 345 defendants were responsible for submitting false and fraudulent claims that cost more than $6 billion to federal health care programs and private insurers. It included $4.5 billion related to telemedicine fraud, $1.5 billion connected to sober homes, and over $806 million linked to illegal opioid distribution and other forms of Medicare fraud.

Telemedicine fraud charges made up the bulk of the nationwide bust. A total of 86 defendants were telehealth executives who allegedly paid medical professionals to order unnecessary amounts of durable medical equipment, genetic tests, and pain medications.

The sober homes cases include charges against more than 12 defendants for allegedly submitting false claims for tests and treatments for patients with drug and alcohol problems. The defendants allegedly paid illegal kickbacks and bribes for the referral of hundreds of patients to substance abuse treatment facilities.

Similarly, included in the charges were health professionals and others involved in distributing more than 30 million doses of opioids and other prescription narcotics. These charges have already resulted in guilty pleas by more than 240 of the defendants.

The historic law enforcement action was put in motion in April 2020 and aimed to crack down on classic health care fraud schemes. The DOJ executes “takedowns” every year to spotlight concerns about fraud in certain areas by grouping similar schemes together. Since its establishment in 2007, it has charged more than 4,200 defendants who defrauded Medicare for more than $19 billion, the agency said.

Click here to read the press release issued by the DOJ.

To read about a similar record-breaking telehealth fraud case in Florida, click here.


Contact Health Law Attorneys Experienced in Handling Medicare Audits, 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), the Colorado Department of Regulatory Agencies, 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 (888) 331-6620 and visit our website at www.TheHealthLawFirm.com.


Sources:

Allen, Jackie. “DOJ charges 345 people involve in more than $6 billion healthcare fraud.” USA Herald. (October 3, 2020). Web.

Stawicki, Keven. “DOJ Charges 345 In Health Fraud Schemes Topping $6B.” Law360. (September 30, 2020). Web.

About the Author: Carole C. Schriefer is an attorney and former registered nurse. She practices with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456 or Toll-Free: (888) 331-6620. Its main office is in the Orlando, Florida area.

“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.

 

Yale University to Pay $87,500 Settlement For Allegations It Underpaid Female Doctors

By Carole C. Schriefer, J.D.

Yale University agreed to pay $87,500 to resolve discrimination allegations with the U.S. Department of Labor. The discrimination alleged that the Ivy League school paid four women cardiologists significantly less than their male colleagues from October 2016 to September 2017. While not admitting the allegations, the university agreed to the settlement which will reportedly cover the difference in pay for the women affected, the Office of Federal Contract Compliance Programs (OFCCP) said.

Alleged Pay Discrimination.

The OFCCP first detected the pay disparities during a routine compliance audit of the university’s medical school, the agreement said. The agency found that in 2016, Yale University paid four female cardiologists less than similarly situated male physicians at the School of Medicine’s Cardiovascular Medicine Section.

According to the settlement, Yale hired the doctors as part of the university’s “acquisition of community practices and hospitals associated with the Yale-New Haven Hospital System.” In 2018, Yale allegedly cut the women doctors’ employment category and moved them to a new faculty category. OFCCP claims that the medical school category is supposed to have a uniform compensation structure in place. Click here to read the settlement agreement in full.

In response to the allegations, a Yale was quoted as saying: “The conciliation agreement involves only four employees out of a workforce of over 16,000. OFCCP admitted that it found no pay disparities as to any but these four employees, who held roles in an employment category that has not existed for over two years.”

To read the press release issued by the Department of Labor, click here.

Additionally, read my recent blog on a previous discrimination lawsuit against Yale.

What does this show us? That at least in federal programs and in educational institutions and medical programs receiving federal funds, discrimination is prohibited and action will be taken to remedy it.

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

At the Health Law Firm, we provide legal services for physicians, including residents, and fellows, as well as medical students. We also represent other health professionals, clinical professors, dentists, psychologists, psychiatrists, mental health counselors, and other healthcare providers. We represent health facilities, medical 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, physicians, including those involved in clinical research, complaints, and investigations.

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:

Ottaway, Amanda. “Yale Settles OFCCP Claims That It Underpaid Female Doctors.” Law360. (October 5, 2020). Web.

Smith, Paige. “Yale University Settles DOL Claims of Pay Bias Against Women (1).” Bloomberg Law. (October 2, 2020). Web.

About the Author: Carole C. Schriefer is an attorney and former registered nurse. She practices with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456 or Toll-Free: (888) 331-6620. Its main office is in the Orlando, Florida area.

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 © 2020 The Health Law Firm

By |2020-12-21T15:24:46-05:00January 21st, 2021|Categories: Colorado Health Law Blog, In the News|Tags: , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |0 Comments

Veterans Urge Federal Court To Reconsider DEA Marijuana Classification

By Carole C. Schriefer, J.D.

On October 1, 2020, military veterans urged the U.S. Ninth Circuit Court of Appeals to reconsider the U.S. Drug Enforcement Administration’s (DEA) restrictive marijuana classification. The Iraq and Afghanistan Veterans of America (IAVA) said in an amicus curiae (friend of the court) brief that designating the drug a highly controlled substance has impeded medical research that could save lives.

Marijuana Claimed to Be a “Life-saving Treatment” for Veterans.

IAVA’s brief focused on suicide rates among returning soldiers. The group claimed the current status of marijuana on the drug schedules, listing it as a Schedule I drug, one without any medical use, under federal law inhibits studies to demonstrate its potential in the treatment of post-traumatic stress disorder (PTSD).

According to the IAVA’s brief, the Schedule I status of marijuana prevents the U.S. Department of Veterans Affairs (VA) and private practitioners from studying the benefits and risks of medical marijuana. This results in keeping life-saving treatment away from veterans suffering from PTSD who reside in states where they are not available.

The brief stated that 40% of veterans experience some form of PTSD that is not helped by treatments approved by the U.S. Food and Drug Administration. In 2019, IAVA conducted a survey showing that 20% of respondents used marijuana for medicinal purposes. Additionally, 90% of survey respondents support expanding clinical research for medical uses, and 90% would use it if it were an option.

To read IAVA’s amicus brief in full, click here.

Click here to read my recent blog on a proposed medical marijuana research bill.

Schedule I Drug.

Marijuana is listed as a Schedule I drug on the federal drug schedules. “Schedule I drugs, substances, or chemicals are defined as drugs with no currently accepted medical use and a high potential for abuse.” Some examples of Schedule I drugs include heroin, LSD, and ecstasy. Anyone viewing these drugs objectively would come to the conclusion that marijuana is simply not like the others.

It Is High Time for a Change.

Many veterans have returned from overseas combat severely affected by PTSD and other mental disorders. There is simply not enough available care through the VA to take care of them all. Moreover, many of these suffer from illnesses making them paranoid or suspicious of even seeking such care. Many are homeless. Many are able to function, some normal and some almost normally, by self-medicating with marijuana.

As more and more states authorize medical marijuana, the federal government should acknowledge that there is some benefit to its use and reclassify it. It is simply common sense. Too long has the public labored under the unjust and unsupportable assumption that incorrectly categorizes it as a Schedule I drug. It needs to be moved to Schedule V or Schedule IV. Medical bills would go down, drug bills would go down, and legitimate physicians, even federal physicians, would be allowed to prescribe it.

Contact Experienced Health Law Attorneys for Medical Marijuana Regulatory Matters and Other Health Care Licensing Matters.

The Health Law Firm attorneys can assist health care providers and facilities, such as doctors, pharmacists, and pharmacies, wanting to participate in the medical marijuana industry. We can properly draft and complete the applications for registration, permitting, and/or licensing while complying with Florida law. We can also represent doctors, pharmacies, and pharmacists facing proceedings brought by state regulators or agencies. We represent health-related businesses and medical professionals in all types of licensing and regulatory matters, including state and federal administrative hearings.

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:

Reisman, Sam. “Veterans Urge 9th Circ. To Hear Challenge To DEA’s Pot Status.” Law360. (October 7, 2020). Web.

Jeager, Kyle. “Military Veterans Group Asks Federal Court To Hear Marijuana Case Challenging DEA Classification.” Marijuana Moment. (October 8, 2020). Web.

About the Author: Carole C. Schriefer is an attorney and former registered nurse. She practices with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456 or Toll-Free: (888) 331-6620. Its main office is in the Orlando, Florida area.

“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 © 2020 The Health Law Firm. All rights reserved.

 

Tips If You Are Having Academic, Disciplinary or Legal Problems with Your Residency Program

By Carole C. Schriefer, J.D.

Here are some tips to set the record straight on various inaccurate information I have heard from physicians in medical residency programs in representing them in appeals of disciplinary actions including suspension and terminations.

1. Nothing you tell your Program Director, advisor, mentors, attendings, senior resident, or co-resident is confidential. Go ahead and pour your heart out about all of your problems and concerns, but none of it is confidential, even if you said it was “in confidence.” What is confidential: what you tell your priest or religious adviser (preacher, rabbi, imam) and what you tell your own personal physician or psychotherapist (unless you have signed a waiver) that you have hired and you are paying. Anyone else, it is not confidential. So if you tell your program director you were raped when you were younger, not confidential. If you tell your senior resident you suffer from panic attacks, not confidential. You tell your attending that you had cancer ten years ago, not confidential. This applies no matter what “magic words” you attach to it.

2. Take and use whatever time period is offered to you to retain counsel and prepare. If you are given ten (10) days to file an appeal or a request for hearing, take the full ten (10) days. Do not file it on the same day. Otherwise, you are using up valuable preparation time that you cannot get back.

3. Make sure that whatever you are required to file is actually received by the due date indicated. If a request for a hearing must be filed within fifteen (15) days, that means that it must be received within the fifteen days. Check after you send it or deliver it to make sure it has been successfully received.

4. It is never too early to hire an attorney. Hire an attorney to represent and advise you at the first sign of trouble. However, you must be sure to hire an attorney who is experienced in representing residents and fellows in disputes with graduate medical education programs. An experienced attorney can help you prepare any written submissions you make, organize your response and any documents you care to submit, and otherwise assist you in identifying what is relevant and what is not relevant.

5. Always read your program’s graduate medical education (GME) manual, residency manual, due process policy or whatever handbook or manual contains your hearing and appeal rights. Be familiar with them and follow them.

6. If you are given remedial actions you must take, documents your completion of each one. Whether the requirement you must perform is in a corrective action plan (CAP), a remediation letter, or a probation letter, document your completion of it in writing and report it to whatever authority gave you the requirement. Send a courtesy copy (“cc”) to your program director.

7. Make sure any correspondence you send to anyone is complete, correct and in the form of a professional business letter. Make sure it meets all of the requirements of a professional business letter. This is especially true for rebuttals, appeals, hearing requests, etc. What, you don’t know what this is? Then go online and Google it. Your letter should look very similar to any letter you received from your program director or institution. Be sure it has all of your return contact information on it as well as a date. Do not start your letter with “Hi,” “Hello,” or “Good day.” Do place a reference (“Re:”) line or subject line on your letter that states what the subject of your letter is.

8. Do not be afraid to appeal, file a discrimination complaint or exercise any of your legal rights. Often I hear from residents, after they are already terminated from their program, that they are afraid to get a lawyer involved. I usually ask: “What are you afraid of? What is the worst that can happen? You have already been terminated.” Remember, also, that if your program retaliates against you for exercising any of your rights, that is illegal. The ACGME would like to hear about that and in almost all cases, you will then have a legal cause of action upon which you can sue the program.

Contact a Health Care Attorney Experienced in the Representation of Medical Resident Physicians, Fellows, Medical Students, Dental Students and Residents, Pharmacy Students and Residents, Mental Health Counselor Interns, and other health professionals. The attorneys of The Health Law Firm, also represent those applicants accused of irregular behavior by the National Board of Medical Examiners (NBME), the United States Medical Licensing Examination (USMLE) Secretariat, and the Educational Commission for Foreign Medical Graduates (ECFMG), in responses, hearings and appeals, including on charges of “unprofessional conduct” and “improper behavior.”

The Health Law Firm and its attorneys have experience representing such individuals and those in graduate medical education programs in various disputes regarding their academic and clinical performance, allegations of substance abuse, failure to complete integral parts training, alleged false or incomplete statements on applications, allegations of impairment (because of abuse or addiction to drugs or alcohol or because of mental or physical issues), because of discrimination due to race, sex, national origin, sexual orientation, and any other matters.

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: Carole C. Schriefer is an attorney and former registered nurse. She practices with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456 or Toll-Free: (888) 331-6620. Its main office is in the Orlando, Florida area.

KeyWords: Irregular behavior defense lawyer, irregular conduct legal representation, graduate medical education (GME) defense attorney, resident physician legal representation, resident physician defense attorney, legal counsel for resident physician, international medical graduate attorney, graduate medical education defense lawyer, lawyer for medical students, medical resident physician attorney, residency program legal dispute lawyer, residency program litigation attorney, legal dispute with medical school lawyer, medical student legal counsel, disruptive physician attorney, impaired medical student legal counsel, impaired resident legal defense attorney, United States Medical Licensing Examination (USMLE) defense lawyer, USMLE defense attorney, National Board of Medical Examiners (NBME) defense counsel, Educational Commission for Foreign Medical Graduates (ECFMG) defense lawyer, ECFMG defense attorney, legal representation for USMLE investigations, legal representation for NBME investigations, legal representation for irregular behavior, irregular behavior defense attorney, irregular behavior defense counsel, health law attorney, The Health Law Firm reviews, reviews of The Health Law Firm attorneys, Philadelphia attorney for ECFMG hearing, Philadelphia lawyer for NBME hearing, Philadelphia legal counsel for USMLE hearing

“The Health Law Firm” is a registered fictitious business name 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.

 

 

 

 

 

 

 

HHS Announces New Changes to Regulatory Process: Secretary Must Sign All Agency Rulemaking

By Carole C. Schriefer, J.D.

In a September 15, 2020 memorandum, the current Secretary of the U.S. Department of Health and Human Services (HHS), Alex Azar, barred the Food and Drug Administration (FDA) and other federal health agencies under his authority from independently enacting any new federal regulations. The memo establishes that the Secretary must sign all agency rulemaking. This new policy affects all rules coming from all HHS agencies and offices, the department said, including the FDA, Centers for Medicare & Medicaid Services (CMS), and Office for Civil Rights. It doesn’t apply to guidance documents, emergency use authorizations, or vaccine or drug approvals.

How long this policy stands after President-elect Biden is sworn in is anybody’s guess. It is my guess that it won’t last long.

Why Make the Changes?

According to HHS, the new regulation-making procedures are to ensure consistency within HHS, compliance with congressional intent, the need to minimize the risk of litigation, and to provide public accountability. HHS regulations have been challenged in court based on the argument that officials who signed new regulations did not have the proper authority to do so.

The memo attempts to rationalize the change in the face of critics who claim that the move could negatively affect public trust in approval of COVID-19 vaccines and the entire approval process.

Rulemaking Process Before and After the Memo.

Before the policy change, the law and established departmental procedure required that all new regulations go through departmental and White House clearance and receive the Secretary’s approval. The regulations were typically signed by the Secretary and by the head of the agency involved. In some instances, other officials to whom authority had been delegated signed the new regulations.

Now, all HHS regulations will still go through departmental and White House clearance and will continue to be approved by the Secretary. But, the change effectively bars the FDA and other health agencies from signing off on any new regulations regarding the nation’s food, medicine, and other products under the HHS umbrella. The HHS Secretary himself must now sign all final regulations.

HHS released the following statement on this action:

“Before and after this action, no regulation issues from any part of HHS without the approval of the Secretary and the White House. The only change made by this memo is that, instead of the Secretary’s just approving all agency regulations, each regulation now also will be formally signed by him.”

Click here to read the HHS Statement on Regulatory Process.

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

Sources:

Stein, Shira. “HHS Secretary to Sign All Rules in Bid to Stem Litigation.” Bloomberg Law. (September 21, 2020). Web.

Keller and Heckman LLP. “A New Policy by HHS Secretary Alex Azar Will Prevent FDA and Other Health Agencies From Signing Final Rules.” National Law Review. (September 21, 2020). Web.

About the Author: Carole C. Schriefer is an attorney and former registered nurse. She practices with The Health Law Firm, which has a national practice. Its regional office is in the Northern Colorado, area. www.TheHealthLawFirm.com The Health Law Firm, 155 East Boardwalk Drive, Fort Collins, Colorado 80525. Phone: (970) 416-7456 or Toll-Free: (888) 331-6620. Its main office is in the Orlando, Florida area.

“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 © 2020 The Health Law Firm. All rights reserved.

Senate Republicans Reveal Sweeping New Legislation: The SAFE DATA Act

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

On September 17, 2020, Republican members of the Senate Commerce Committee introduced sweeping federal privacy legislation. The proposed law is called the Setting an American Framework to Ensure Data Access, Transparency, and Accountability (SAFE DATA) Act. The Act is a combination of bills previously introduced in the Senate: the Consumer Data Protection Act, Filter Bubble Transparency Act, and the Deceptive Experiences to Online Users Reduction Act. It hasn’t passed, yet, so let’s wait and see.

HAH! You thought you had learned all of the acronyms and abbreviations because you know what HIPAA, HITECH, FERPA, USCDPA, and FOIA mean. Let’s see how long it takes you to remember what this one stands for.

Details of the SAFE DATA Act.

This proposed legislation has three main components if passed into actual law. It:

1. Provides consumers with more choice and control over their data (allegedly),
2. Directs business to be more transparent and accountable (allegedly), and
3. Strengthens the FTC’s enforcement power (allegedly).

The Act would provide consumer rights, such as access, notice, deletion, opting-out, correction, and a right to data portability. It also prohibits covered entities from discriminating against consumers who utilize some of the proposed rights. It will prohibit organizations from denying goods or services to individuals because they have exercised any of their rights as set forth in the bill.

Implementation of the bill would be financed through a $100 million appropriation to the Federal Trade Commission (FTC) to enforce its provisions. Therefore, the FTC would gain the authority to obtain injunctions and impose other sanctions for violations.

Integrating Other Privacy Bill Provisions.

The SAFE DATA Act incorporates three main bill provisions into the proposal.

First, it includes the Filter Bubble Transparency Act (don’t ask). It requires a notice on public-facing websites that use algorithmic ranking systems

Second, it contains provisions from the Deceptive Experiences To Online Users Reduction (“DETOUR”) bill (ouch!). This provision makes it unlawful for an online service with more than 100 million authenticated users to use a user interface to impair user autonomy.

Third, like the United States Consumer Data Privacy Act (CDPA), the proposal requires companies to obtain affirmative, express consent from the customer before processing or transferring individuals’ sensitive data.

According to Julie Brill, former Commissioner of the FTC, a comprehensive privacy law would also address consent and collection issues related to COVID-19 health data, while at the same time promoting racial equality and prohibiting data discrimination. Boy, that’s great; who knew this was likely to be accomplished in our lifetimes.

View the proposed Safe Data Act in full.

You may also read one of my prior blogs to learn more about HIPAA privacy rights violations and medical confidentiality.


Contact a Health Law Attorney Experienced in Defending HIPAA Complaints and Violations.

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

For more information about HIPAA violations, electronic health records or corrective action plans (CAPs) please visit our website at www.TheHealthLawFirm.com or call (407) 331-6620 or toll-free (888) 331-6620.

Sources:

Cox, Ayeisha. “Lawmakers Introduce the SAFE DATA Act.” American Health Lawyers Association (AHLA). (October 2, 2020). Web.

Traylor. Christian. “Federal Data Privacy Legislation: Will it Help the US Remain Competitive in the Global Marketplace?” JD Supra. (September 29, 2020). Web.

Panakal, Dominic Dhil. “Senate Republicans Stitch Together Safe Data Ideas into New Bill.” The National Law Review. (September 24, 2020).

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 © 2020 The Health Law Firm. All rights reserved.

Load More Posts
Go to Top