Telehealth, Net Neutrality and the Tipping Point

Telehealth is apparently reaching a critical mass where people are starting to review the potential problems of telehealth, rather than the potential opportunities.

In a MedLaw Blog post on December 6, 2017 and my related LinkedIn post, I referenced and included the link to the OIG’s audit plan, indicating OIG will begin to audit telehealth claims.  I mentioned this was a tipping point, because now obviously OIG is concerned that telehealth is being utilized too often and inappropriately.

In the December 11, 2017 edition of Modern Healthcare, Rachel Arndt mentioned that the pending repeal by FCC of the Net Neutrality Rules could generate considerable uncertainty about the telehealth industry, because throttling internet speeds with telehealth content would “deteriorate the overall quality of care, particularly in rural health areas”.

Conversely, the American Telemedicine Association recently stated:  “The truth is, nobody knows what the future will hold in the post net-neutrality world.”

Finally, I am attaching a link to an article I did for the Allegheny County Medical Society on the evolution of telehealth law, to provide some historical perspective regarding the growth of telehealth in the last 20 years.

Click this link to read the article on the Evolution of Telehealth Law.

Telehealth Reaches Tipping Point – Now Included in OIG Audit Plan

Telehealth has apparently reached the tipping point in its significance to the Medicare budget, because OIG has now announced that it will “review Medicare claims for telehealth services provided at distant sites that do not have corresponding claims from originating sites to determine whether those services met Medicare requirements.”

The expected issue date of the report is 2018, but you would expect the report to describe the impact or volume that Medicare payments for telehealth now have in the system.

Click this link to read the attachment.

West Virginia Doctor Secures Temporary Restraining Order Against Medicare Exclusion

In Robie v. Price, Dr. Robie successfully obtained a temporary restraining order prohibiting CMS from terminating his Medicare billing privileges prior to the exhaustion of his administrative remedies by the U.S. District Court for the Sothern District of West Virginia.

As most realize, exhaustion of administrative remedies is usually a prerequisite to further litigation for damages.  In this case, Dr. Robie had clearly not completed the administrative appeals process provided by the Medicare rules, but successfully, albeit temporarily, prevented his exclusion based upon denial of constitutional due process.  There are several key takeaways in this decision:

First, the Court concluded that the constitutional due process argument was entirely collateral to the Medicare administrative process and therefore conferred subject matter jurisdiction on the Court.

Second, although the Medicare program is usually construed as a benefit to Medicare beneficiaries, rather than to providing physicians a source of business or a private interest, the Court concluded that the damage to Dr. Robie’s practice and reputation would be so severe if he was excluded from Medicare, without due process, the TRO was appropriate.  As a corollary to this damages holding, the Court also concluded that, due to the medically underserved nature of the geographic area, the patients would also be damaged by this potential denial of care.

Third, the Court concluded that these damages would be potentially irreparable, and that there was a threat of more harm to the physician and the patients than there would be to the government and the Medicare program if the TRO was granted.

It is important to note CMS had not alleged any significant wrong doing on behalf of the physician, certainly not any allegations involving quality of care or threat to patient safety.  The underlying dispute centered around the sufficient production of Medicare records for CMS’ investigation.  Without the allegations of significant potential patient harm, I believe the court was much more willing to grant the injunctive relief.

This is a well reasoned opinion and I commend it to you.

Pennsylvania Supreme Court Rules that Only Physicians – Not Their Staff – Can Obtain Informed Consent

A recent Pennsylvania Supreme Court decision will have a major impact on how physicians across the Commonwealth obtain informed consent from their patients.    In Shinal v. Toms, 2017 WL 2655387 (Pa. June 20, 2017), the 4-3 Court ruled that only physicians, not members of their staff, may obtain informed consent from patients before performing medical procedures.

The plaintiff in this case sued her physician for medical malpractice after a brain surgery went wrong resulting in a stroke, brain injury, and partial blindness.  Before the procedure, the physician’s assistant provided the plaintiff with information about the procedure and obtained a signed informed consent form.  However, the plaintiff claimed she was never informed of the risks associated with the surgery, and, if she had known, she would have chosen a less-risky approach.

During trial, the judge instructed the members of the jury that, in determining whether the physician obtained the plaintiff’s informed consent, it could consider relevant information communicated by the physician’s assistant to the patient.  The jury returned a verdict in favor of the physician, and the plaintiff appealed.

The Pennsylvania Supreme Court reversed and held that the duty to obtain informed consent from a patient belonged solely to a physician who was performing the treatment and was non-delegable. In doing so, the Court explained that “a physician cannot rely upon a subordinate to disclose the information required to obtain informed consent. Without direct dialogue and a two-way exchange between the physician and patient, the physician cannot be confident that the patient comprehends the risks, benefits, likelihood of success, and alternatives.

The Court’s decision is limited to the major medical procedures enumerated in the MCARE Act, which requires physicians to obtain informed consent when performing major medical procedures such as surgery, radiation, a blood transfusion, inserting a surgical device, and administering an experimental medication or device. 40 P.S. § 1303.504.  The Court did not extend its ruling to require physicians, and not staff members, to obtain informed consent for routine or nonsurgical treatments.

This decision is now binding law across the Commonwealth, meaning that physicians who rely on their staff to obtain informed consent from patients for major medical procedures will need to change their practice so that patients are consenting to the physician who is performing the surgery.

Critics to this decision claim that this will place an unnecessary burden on already overworked physicians.  As the three justices who dissented from the majority noted, this “decision will have a far-reaching, negative impact on the manner in which physicians serve their patients. For fear of legal liability, physicians now must be involved with every aspect of informing their patients’ consent, thus delaying seriously ill patients access to physicians and the critical services that they provide.”

For more information, contact Lauren N. Rulli or (412) 594-5510.

Texas Telemedicine Law Finally Allows Complete Remote Treatment

The Texas Medical Board and Teladoc have been battling for seven years, and through several rounds of litigation over whether a patient relationship can be established for purposes of providing telemedicine services without an initial face-to-face or in-person visit. This all changed when Texas governor, Greg Abbott, signed Senate Bill 1107, which will take effect immediately if approved by two thirds of the members of the Texas legislature or on September 1, 2017 if not approved for immediate effect.

The ATA Telehealth Morning Update reported on Thursday, June 1, 2017, that Texas, which was the last state in the country to insist that personal contact was required to establish a valid physician patient relationship, has now resolved these issues.

Senate Bill 1107 provides the following:

a. The Bill allows the establishment of a physician patient relationship by either

1. Synchronous audio visual interaction, or

2. Asynchronous store and forward interaction when used in conjunction with synchronous audio, which could obviously be a telephone or video conferencing, as long as relevant video or photographic images are available or other relevant medical records.

b. The Bill excludes telemedicine medical services for prescribing abortifacient drugs or devices.

c. The Bill prohibits insurers from excluding services solely because they were provided by telemedicine means.

d. The Bill allows insurers to exclude services that are solely provided by audio, text or faxed methods of communication.

Click here to read 2017 Texas Senate Bill No 1107


Pennsylvania Releases Temporary Regulations for Physicians

On April 11, the Pennsylvania Department of Health (DOH) released Practitioner Temporary Regulations for physicians and practitioners (those physicians, pharmacists, physician assistants and certified registered nurse practitioners to be employed by a licensed dispensary).   In a press release issued yesterday, DOH Secretary Dr. Karen Murphy stated that “[t]he process for a patient to obtain medical marijuana will begin with the physician, so it’s vital to ensure that our regulatory process for those physicians is open and transparent.”

The press release also provides that “the Practitioner Temporary Regulations outline the process for a physician with an active Pennsylvania license to register as a practitioner in the Medical Marijuana Program. Registration allows a practitioner to certify a patient’s [with one of 17] serious medical condition[s][1] and offer his or her recommendations on a course of treatment for the patient that includes obtaining medical marijuana at a permitted commonwealth dispensary.” In order to become registered, physicians and practitioners must complete a 4-hour training course that: educates them on their responsibilities as medical professionals and marijuana laws and regulations; and,  provides latest scientific research information, best practices for recommending medical marijuana and dosage based on the patient’s serious medical condition.  Successful completion of the course shall be approved as CME or equivalent credits as determined by the overseeing professional boards for physicians and practitioners.

Marijuana is categorized as a Schedule I drug under the Controlled Substances Act (CSA) (21 U.S.C. 812(c)).  Schedule I drugs are defined as drugs with no currently accepted medical use in treatment in the United States and a high potential for abuse.  Because Marijuana is categorized as Schedule I, anyone convicted of trafficking offenses is subject to possible federal fines and imprisonment.   In order to address this concern, Section 2103(A)(3) of the Pennsylvania Medical Marijuana Act (the Act) provides that no practitioner shall be subject to arrest, prosecution or penalty in any manner, or denied any right or privilege, including civil penalty or disciplinary action by a Commonwealth licensing board or commission, for actions taken in accordance with the Act.  Furthermore, with respect to federal concerns, the Ninth Circuit Court of Appeals ruled in Conant v. Walters 309 F. 3d 629 (2002) that the federal government could neither punish nor threaten to punish a physician for discussing the merits of medical marijuana with a patient and issue a recommendation to use medical marijuana within a bona fide doctor-patient relationship, as that is considered to be protected by the First Amendment right of free speech.  On October 14, 2003, the Supreme Court declined to review the decision under Conant v. Walters, U.S. No.03-40 and has let the ruling of the Ninth Circuit stand. Doctors are not permitted to write prescriptions because the licensing for prescribing controlled substances is issued by the Drug Enforcement Administration (DEA), a federal organization.  The Practitioner Temporary Regulations is drafted to comply with both the Act and Conant, where registered physicians will write recommendations and not prescriptions to patients.  As such, Pennsylvania licensed doctors in good standing with their boards who are interested in becoming registered for the Medical Marijuana Program can at least initially rely on them for guidance.

The DOH is asking for feedback and comments to the Practitioner Temporary Regulations by April 20.  They will then finalize the Practitioner Temporary Regulations and release updated temporary regulations that will be effective for a period of 2 years.  Thereafter, the DOH will re-evaluate the Medical Marijuana Program and make any necessary revisions for its continued success.

For more information, contact Catia Kossovsky or follow me for updates on Pennsylvania and Federal legislation affecting the Pennsylvania medical marijuana industry.

[1] Amyotrophic Lateral Sclerosis (ALS),  Autism, Cancer, Crohn’s Disease, Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity, Epilepsy, Glaucoma, HIV (Human Immunodeficiency Virus) / AIDS (Acquired Immune Deficiency Syndrome), Huntington’s Disease, Inflammatory Bowel Disease, Intractable Seizures, Multiple Sclerosis, Neuropathies, Parkinson’s Disease, Post-traumatic Stress Disorder, Severe chronic or intractable pain of neuropathic origin or severe chronic or intractable pain in which conventional therapeutic intervention and opiate therapy is contraindicated or ineffective, Sickle Cell Anemia.


Western Pennsylvania Hospital Stark/Whistleblower/False Claims Case Provides Real World Guidance For Medical Directors’ Contracts

Emanuele v. Medicor Associates, was presented to the United States District Court for the Western District of Pennsylvania as cross motions for summary judgment, and provides some guidance regarding the Stark requirements for bona fide personal service contracting arrangements.

The case originated as a whistleblower allegation that Hamot Hospital had not complied with all of the elements of the Stark personal service contract exceptions for medical directors’ contracts, and therefore that billing for the related services raised False Claims Act billing issues.

The Court’s opinion provides valuable guidance regarding:

  1. Allowing a “collection of documents” to satisfy the written agreement requirement.
  1. Acknowledging that fully disclosed retroactive effective dates are not fatal, and
  1. Providing actual examples of real world facts establishing the elements of materiality and scienter for FCA cases.

The opinion is attached below.

Emanuele v. Medicor

Macranomics III: APMS

I am inserting a link to the third in a series of articles published by the Allegheny County Medical Society regarding Medicare Payment Reform pursuant to the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA).

This article deals with Advanced Alternative Payment Models, and provides basic information on how provider groups can qualify for a 5% Medicare Part B incentive payment, and be exempt from the potential negative MIPS payment adjustments.  The MACRA 5% bonuses for APM participation will start in 2019, assuming the provider groups meet the participation and reporting requirements in 2017 and 2018.

I think it is safe to assume the Trump efforts to repeal Obama Care will not impact the current MACRA rules in the short term, but it is probably not safe to assume that future changes will not be made.

Use this link to view the article “Macranomics: Advanced Alternative Payment Models” .

For additional information contact Mike Cassidy.