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Are You Worried About Health Care Compliance Consequences? Have They Gone Too Far?

By Lance O. Leider, J.D., LL.M., The Health Law Firm

From large hospital systems to solo practitioners, there is no escaping health care compliance in the industry. The concept of compliance can spark different thoughts in different people. For example, some believe it is an unnecessary government intrusion and others believe it’s a way to improve the quality and costs of health care.

No matter your thoughts on health care compliance and government oversight, regulation of the health care industry will never be eliminated. In fact, we expect it to increase as more quality-based requirements are implemented.

We believe compliance and regulations are necessary, but we have to wonder if sometimes these laws go too far.

Those Cute Baby Photos Can Cost You.

As an example of laws going too far, photos of cooing newborn babies used to cover the bulletin boards of doctors’ offices. However, under the Health Insurance Portability and Accountability Act (HIPAA), these baby photos are considered protected health information, along the same lines as a medical chart or social security number. A report by The New York Times indicates many offices have removed these types of photos or moved them to private portions of the office. According to the Office for Civil Rights (OCR) Department of Health and Human Services (HHS), doctors’ offices are not allowed to post these photos without a specific written authorization from the parent.

To read more on this topic, click here.

Health Care Compliance Overview.

Health care compliance is the ongoing process of meeting or exceeding the legal, ethical and professional standards applicable to a particular health care organization or provider. Health care compliance requires health care organizations and providers to develop effective processes, policies, and procedures to define appropriate conduct, train the organization’s staff, and then monitor the adherence to the processes, polices and procedures.

Health care compliance covers numerous areas including patient care, billing, reimbursement, managed care contracting, OSHA, and HIPAA privacy and security to new a few.

To read a basic overview of health care compliance for organizations and providers, click here.

How to Deal with Compliance Overkill.

The primary purpose of health care compliance is to improve patient care. It is nearly impossible to overstate the complexity of health care compliance. Health care organizations and providers are not only required to comply with Medicare rules and regulations, but they are also required to comply with numerous other federal and state health care laws, rules and regulations.

When dealing with compliance issues, our recommendation is to use your common sense and best judgment. Fear usually leads to absurd situations. With all the fear and propaganda out there it is important to stick to your instincts and put patient care first.

Health care compliance is cumbersome, many may agree too cumbersome. However, it is here to stay.

Do you think health care compliance has gone too far? How do you try to keep up with health care compliance laws and regulations? Are you worried about compliance consequences?

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 health care 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 (850) 439-1001.

Sources:

Hartocollis, Anemona. “Baby Pictures at the Doctor’s? Cute, Sure, but Illegal.” The New York Times. (August 9, 2014). From: http://www.nytimes.com/2014/08/10/nyregion/baby-pictures-at-doctors-cute-sure-but-illegal.html?_r=0

Kirsch, M.D., Michael. “The Consequences of Zero Tolerance: Why HIPAA is Overkill.” Kevin M.D. (January 1, 2014). From: http://www.kevinmd.com/blog/2014/01/consequences-tolerance-hipaa-overkill.html

About the Author: Lance O. Leider is an attorney with The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Avenue, Altamonte Springs, Florida 32714, Phone: (407) 331-6620.

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

FDA Releases Draft Guidance to Revamp Drug Indication and Usage Labels

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

On July 6, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance outlining its recommendations for how drug companies should word the indications and usage sections on a drug’s label. The new guidance aims to increase readability and reduce redundant information on indications and usage.

Drug Indication Label.

Prescribers can expect to see revamped drug labels with clearer descriptions of the conditions and patient populations for which an FDA-approved drug is indicated. Also, described in the guidance are circumstances when it might be appropriate for an indication to be either broader or narrower than the parameters of the clinical studies that backed its approval.

In addition to suggesting what information labels should include, the draft guidance also indicates what should be omitted to avoid unnecessary clutter the label.

The FDA hopes this guidance will give health care providers more precise information on which conditions a drug is approved to treat and, therefore, help identify the correct treatment options for patients. To read the FDA’s draft guidance in full, click here.

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

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

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

Sources:

Gever, John. “Drug Labels to Get FDA Revamp.” MedPage Today. (July 6, 2018). Web.

Field, Emily. “FDA Releases Draft Guidance On Drug Indication Labeling.” Law360. (July 6, 2018). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

KeyWords: Food and Drug Administration (FDA) defense attorney, representation for FDA matters, legal representation for health care professionals, representation for prescribers, pharmacy representation, legal representation for pharmacies, pharmacy defense lawyer, pharmacist representation, legal representation for pharmacists, pharmacist defense attorney, health care compliance lawyer, health law defense attorney, The Health Law Firm reviews, reviews of The Health Law Firm attorneys

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

CMS Memorandum for Texting Patient Information Among Healthcare Providers

George F. Indest III headshot

June 21, 2018

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

The Centers for Medicare & Medicaid Services (CMS) released a Memorandum in an effort to clarify their stance and guidelines on texting between healthcare providers and staff.

Texting Patient Orders is Not Permitted.

CMS does not permit  health care providers to text patient orders to a care team member on any platform. Therefore, texting patient orders from a health care provider is not in compliance with the Conditions of Participation (CoPs) or Conditions for Coverage (CfCs).

Texting Patient Information on Secure Platforms.

Patient information that is sent via text messages  is permissible if accomplished through a secure platform only. However, Computerized Provider Order Entry (CPOE) is the preferred method of order entry. CMS holds to the long-standing practice that a physician should enter patient orders into the medical record via a hand written order or CPOE.

Compliance Plans.

Furthermore, in order to be compliant, all healthcare providers must utilize and maintain platforms that are secure, encrypted, and minimize the risks to patient privacy. It is expected that providers/organizations will implement procedures that routinely assess the security and integrity of the texting platforms that are being utilized. This is to ensure patient confidentiality and to avoid negative outcomes that could compromise the overall care of patients.

Using secure texting platforms, has the potential for healthcare organizations to streamline contact and improve patient outcomes. Click here to visit our website and read the CMS Memorandum in full.

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 health care 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 (850) 439-1001. Be sure to check The Health Law Firm Blog for regular updates.

Source: Center for Clinical Standards and Quality/Survey & Certification Group . “Texting of Patient Information among Healthcare Providers.” Centers for Medicare and Medicaid Services (CMS). (December 28, 2017). Web.

About the Author: George F. Indest III, J.D., M.P.A., LL.M., is Board Certified by The Florida Bar in Health Law. He is the President and Managing Partner of The Health Law Firm, which has a national practice. Its main office is in the Orlando, Florida, area. www.TheHealthLawFirm.com The Health Law Firm, 1101 Douglas Ave., Altamonte Springs, FL 32714, Phone: (407) 331-6620.

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