New Federal Kick-Back Laws Regarding Opioid Treatment

“Eliminating Kick-Backs and Recovery Act of 2018” (EKRA) is a part of a group of laws recently passed by Congress to expand the law enforcement spectrum available to fight the opioid epidemic. EKRA is part of approximately 70 separate actions referred to as the SUPPORT Act, i.e. Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients in Communities Act.

EKRA adds a new Anti-Kickback rule to the existing healthcare fraud enforcement spectrum. It expands the Anti-Kickback scope to all healthcare programs, rather than just the classic federal programs (Medicare, Medicaid and TriCare), and essentially eliminates Safe Harbor protection by statutorily narrowing the available protections.

EKRA states that “whoever” (which is an unlimited category not limited to just providers or doctors, such as the Stark Act) with respect to a “healthcare benefit program” (which is defined as any healthcare program that affects interstate commerce):

• Solicits or receives remuneration in return for referring a patient or patron to a recovery home, clinical treatment facility or laboratory, or
• Pays or offers any remuneration directly or indirectly to induce referrals of an individual to a recovery home, clinical treatment facility or laboratory or in exchange for any individual using such services

Shall be fined not more than $200,000, imprisoned not more than 10 years, or both for each occurrence.

The only exceptions, which thereby eliminates the application of other Safe Harbors, is that the act shall not apply to

1. A discount or other reduction in price obtained by a provider or other entity under a healthcare program if the reduction is properly disclosed and appropriately reflected in cost or charges.

2. A payment made by an employer to an employee or an independent contractor (who have “bonafide” relationships with the employers) if the payment is not determined by or does not vary by

• The number of individuals referred to a particular recovery home, clinical treatment facility or laboratory,
• The number of tests or procedures performed, or
• The amount billed to or receipt from the healthcare benefit program from the individuals referred to a particular recovery home, clinical treatment facility or laboratory.

3. Bonafide drug discounts.

4. Payments made as compensation for services under the personal services and management contract Safe Harbor provisions of 42 CFR 1001.952(d).

5. Waivers or discounts defined in 42 CFR 1001.952(h)(5) or other co-insurance or co-payments of the healthcare program.

 

 

2018 National Practitioner Data Bank Guidebook

In October 2018, the National Practitioner Data Bank (NPDB) published the third edition of the NPDB Guidebook.

NPDB publishes monthly “NPDB insights”.  I could not send the link to that, but I have attached a copy of the page announcing the new Guidebook here:  NPDB Insights.

I am also attaching a link to the Guidebook.  https://www.npdb.hrsa.gov/resources/aboutGuidebooks.jsp

You can also obtain all of these by logging on to the NPDB homepage:  https://www.npdb.hrsa.gov/

 

Allergy Practice Pays $125,000 HIPAA Settlement for Disclosing Patient Protected Health Information to Reporter

The U.S. Department of Health and Human Services, Office for Civil Rights (“HHS”) just announced a $125,000 settlement for a disclosure of patient protected health information (“PHI”) to a reporter.

In 2015, a patient of Allergy Associates of Hartford, P.C. (“Allergy Associates”) contacted a local TV station about a dispute that the patient had with Allergy Associates regarding her use of a service animal.  A reporter for the TV station contacted Allergy Associates for comment, and Allergy Associates disclosed the patient’s PHI to the reporter.

After the disclosure, HHS initiated an investigation and notified Allergy Associates.  Even after it was notified of the investigation, Allergy Associates failed to discipline the individual who had disclosed the patient’s PHI.

To settle the matter, Allergy Associates has agreed to pay HHS $125,000 and enter into a Corrective Action Plan.

You can read the HHS Press Release and the Resolution Agreement here: https://www.hhs.gov/hipaa/for-professionals/compliance-enforcement/agreements/allergyassociates/index.html

If your office would like guidance on how it can prevent HIPAA violations from occurring, please contact Danielle Dietrich via email,telephone: 412-594-5605 or on Twitter at @DLDietrich, or any of our other attorneys at the firm.

2019 Medicare Physician Fee Schedule Provides Future “Telehealth” or “Communication-Based” Billing Opportunities

The final Medicare 2019 Physician Fee Schedule https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Payment/PhysicianFeeSched/index.html rule was posted on November 1, 2019, to be effective January 1, 2019.  It includes Section II(D) entitled “Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services”, with several subsections.

  1. Brief communication technology-based services (EG Virtual Check-In) (HCPCS Code G2012)
  2. Remote evaluation of prerecorded patient information (HCPCS Code G2010)
  3. Interprofessional Internet Consultations (CPT Codes 99451, 99452, 99446, 99447, 99448 and 99449)
  4. Additional Medicare Telehealth Services
  5. Expanded Telehealth Home Dialysis
  6. Telehealth Substance Abuse Disorder Prevention and Treatment

This post will be devoted to the Communication-Based Codes and Virtual Check-In.  CMS has proposed to allow certain “modernized” services, as distinguished from the traditional established Medicare Telehealth rules which have specific technology and location requirements.

Starting January 1, 2019, Physicians or NPPs who are authorized to bill for E/M services may report time-based codes for services to existing patients for specified consults and referrals that do not involve or require a face-to-face patient encounter.  These are identified as interprofessional “telephone/internet/electronic” health record assessment and health management services provided by a consulting physician based upon time devoted, as follows:

  • 99446 (5-10 minutes)
  • 99447 (11-20 minutes)
  • 99448 (21-30 minutes)
  • 99449 (31 minutes or more)

 These services include verbal or written reports to other physicians or qualified health care professionals treating the patient.  Furthermore, CPT codes 99451 and 99452 include time devoted to preparing written reports.

CMS has also introduced two codes for non-face-to-face evaluations of patients used to determine whether the patient requires an office visit (i.e. a Virtual Check-In).

  • G2010 (Remote evaluation of recorded video and/or images submitted by an established patient [e.g., store and forward], including interpretation with follow-up with the patient within 24 business hours, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment).
  • G2012 (Brief communication technology-based service, e.g. virtual check-in, by a physician or other qualified health care professional who can report evaluation and management services, provided to an established patient, not originating from a related E/M service provided within the previous 7 days nor leading to an E/M service or procedure within the next 24 hours or soonest available appointment; 5-10 minutes of medical discussion).

 

Opioid Update: New Federal Law

Opioid Update: New Federal Law – The Substance Use-Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act

On October 24, 2018, President Trump signed into law the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act, also known as the SUPPORT for Patients and Communities Act (H.R. 6).  According to the White House, this Act “addresses the opioid crisis by reducing access to and the supply of opioids and by expanding access to prevention, treatment and recovery services.” [i]

The Act itself is quite long (250 pages) and the full text can be found here: https://www.congress.gov/bill/115th-congress/house-bill/6.  It contains a number of provisions including increased access to telehealth services, increased Medicare coverage for women and children, stiff penalties for illegal kickbacks in return for patient referrals for recovery treatment and loan repayment for those providing substance use disorder treatment in underserved areas.

An upcoming issue of the Allegheny County Medical Society’s Bulletin will contain an article by this author, providing a more extensive summary of the SUPPORT for Patients and Communities Act.

If you have questions or concerns about how these new laws will affect you or your practice, please contact our firm.

Danielle Dietrich is a healthcare and litigation attorney in Tucker Arensberg’s Health Care Practice Group. She is licensed to practice law in Pennsylvania, Ohio and West Virginia.  Danielle can be reached via email; telephone: 412-594-5605 or on Twitter at @DLDietrich.

                       

[i] https://www.whitehouse.gov/briefings-statements/president-donald-j-trump-signed-h-r-6-law/

2019 Proposed Medicare Fee Schedule

The 2019 proposed Medicare Fee Schedule was published on July 27, 2018 by CMS at https://s3.amazonaws.com/public-inspection.federalregister.gov/2018-14985.pdf.

Pages 61 through 91 of the Executive Summary are devoted to: Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services.  Click here to read: Modernizing Medicare Physician Payment by Recognizing Communication Technology-Based Services.

This subsection is devoted to explaining both additions to the existing list of covered Medicare Telehealth Services and an identification of and an explanation for covering those additional services by Medicare.

CMS is careful to distinguish its process for simply adding services to the existing list of covered Medicare Telehealth Services and the addition of new types of services outside of the existing telehealth structure.  CMS believes that simply adding services to the existing list of Medicare telehealth services would require those additional services to be subject to the limitations on Medicare telehealth services as established in Section 1834(m) of the Social Security Act, which CMS do not intend to do.

Following is a list of discrete technology base services which CMS proposed to add as separately identifiable physician services payable under the Medicare Physician Fee Schedule, and for which CMS is seeking comment:

  1. Brief Communication Technology-Based Service, e.g. virtual check-in (HCPCS Code GVCI1)
  2. Remote Evaluation of Pre-Recorded Patient Information (HCPCS Code GRAS1)
  3. Interprofessional Internet Consultation (CPT Codes 994×6, 994×0, 99446, 99447, 99448 and 99449)

The attached pages of the Executive Summary go into great detail regarding the explanation of these types of services, and explaining in the blog post would occupy too much space but you can refer directly to the attached executive summary.

On page 74 of the attached summary, CMS provides an additional list of services they propose to expand under Section 1834(m) of the Social Security Act.  You should refer to the Executive Summary for that as well.

 

 

Medicare Telehealth Services

Just as a point of providing information, please note that CMS has revised its Medicare Learning Network (MLN) booklet for telehealth services.  The February 2018 edition is included in this link.  https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/TelehealthSrvcsfctsht.pdf

The 2019 proposed Medicare Physician Fee Schedule Rule also seeks comments on proposed expansion of telehealth services.  That will be the subject of the next Blog post.

 

New Telemedicine Act in Pennsylvania

A new Telemedicine Act is wending its way through the legislative process in Pennsylvania.  Senate Bill 780 of 2017  (attached hereto as a PDF) has been unanimously passed by the Senate and referred to the House Professional Licensure Committee on June 19, 2018.  Pennsylvania is one of the few states that does not have a dedicated Telemedicine Act and Pennsylvania is attempting to address the two major issues in telemedicine in one Act, i.e. payment parity and professional regulation.

Payment Parity

Although the payment issues are only addressed briefly in the Act, the provisions are significant.  Section 6 entitled “Insurance Coverage of Telemedicine”, provides as follows:

  1. Health insurance policies issued, delivered, executed or renewed in the Commonwealth after the effective date of this Section (which has not yet been determined) shall provide coverage for telemedicine delivered by a participating network provider who provides a covered service via telemedicine consistent with the third party insurers’ medical policies.
  2. A health insurance policy may not exclude a healthcare service for coverage solely because the service is provided through telemedicine.
  3. A health insurer shall reimburse a healthcare provider for telemedicine if the health insurer also reimburses the same participating provider for the same service through an in-person encounter.

This concept is known in the industry as payment parity because it provides for equal coverage and payment.

Telemedicine Regulation

The telemedicine regulation section is essentially a licensing provision which also defines the key concepts regarding the performance of telemedicine.  The regulatory provisions of this Act provide as follows:

  1. Healthcare providers validly licensed in the Commonwealth are authorized to practice telemedicine in accordance with the Act, which essentially means they may deliver telemedicine services to residents of the Commonwealth of Pennsylvania.  Delivery of telemedicine services in other states is regulated by the other states and usually requires licensing in the state of the patient’s location.  Conversely, an out-of-state provider providing telemedicine services to residents of the Commonwealth must comply with this Act, and be licensed by Pennsylvania.
  2. Healthcare providers providing telemedicine services to individuals located in the Commonwealth who do not have an established provider-patient relationship must do the following:

    a. Verify the location and identify of the individual receiving care, and
    b. Disclose the healthcare provider’s identity, geographic location and medical specialty or credentials.

  3. Healthcare providers must:

a. Obtain informed consent regarding the use of telemedicine technologies.
b.  Provide an appropriate examination or assessment using telemedicine technologies.
c.  Establish a diagnosis and treatment plan.
d. Create and maintain electronic medical records within 24 hours.
e. Provide a visit summary to the individual if requested and have an emergency action                                       plan in place for medical and behavioral health emergencies and referrals.

Telemedicine Technologies

The appropriate telemedicine technologies are defined as electronic information and telecommunication technologies including but not limited to interactive audio and video, remote patient monitoring or store and forward systems that meet the requirements of HIPAA.  Healthcare providers may utilize interactive audio without interactive video if used in conjunction with store and forward technology and the provider makes a determination that the same standard of care can be provided, but the provider must inform the patient that the patient has an option to request interactive audio and video.

Allowable technologies do not include audio only medium, voicemail, fax, email, instant messaging or text messaging or online questionnaires–or any combination thereof.  That raises the issue of how the Board of Medicine would react to a physician performing those acts, since it is defined as “not being telemedicine”.  I presume that would be seen as practicing medicine in an unauthorized manner.

Note that the Act excludes provider-to-provider a consultations from the definition of telemedicine, but that has always been the case and it is fairly obvious since the other physician is presumably not a patient and the consulting physician is not providing a service it could be billed to a patient; there is no face-to-face encounter and no telemedicine encounter.

Physician Performance Reviews: Protected Peer Review Information or Litigation Traps?

Peer Review Confidentiality will become much more complicated with the addition of economic evaluation to physicians’ quality and efficiency.  Physicians will be surprised to learn that many “reviews” to which they may currently be subject to could have “quality implications”, and they should be concerned if those reviews were available to other third parties instead of being protected as confidential peer review information.

P4P as Peer Review Information

It occurred to me not all that long ago that pay for performance (P4P), value based purchasing (VBP) and other reimbursement and physician compensation models would generate incidental “quality” information.  If physicians were being paid to achieve certain quality goals, it only stands to reason that the evaluation information would also document failure to reach those quality goals as well–perhaps an embarrassing detail.  This information is typically not generated and handled as “peer review information” for either hospital employed physicians or private practice physicians participating in some type of bundled payment arrangement–which are too numerous to define or list.

Pennsylvania Peer Review

By way of brief review, in Pennsylvania and most other states, there are peer review confidentiality laws providing that peer review records are not discoverable by third parties–typically meaning that malpractice plaintiffs cannot get copies of your peer review records to identify issues with a particular patient, a class of patients or procedures.

  • In Pennsylvania, “peer review” means the procedure for evaluation by professional health care providers of the quality and efficiency of services ordered or performed by other professional health care providers, including practice analysis, inpatient hospital and extended care facility utilization review, medical audit, ambulatory care review, claims review, and the compliance of a hospital, nursing home or convalescent home or other health care facility.
  • A “review organization” means any committee engaging in peer review, including a hospital utilization review committee, a hospital tissue committee, a health insurance review committee, a hospital plan corporation review committee, a professional health service plan review committee, a dental review committee, a physicians’ advisory committee, any committee to gather and review information relating to the care and treatment of patients for the purposes of (i) evaluating and improving the quality of health car rendered; (ii) reducing morbidity or mortality; or (iii) establishing and enforcing guidelines designed to keep within reasonable bounds the cost of health care. It shall also mean any hospital board, committee or individual reviewing the professional qualifications or activities of its medical staff or applicants for admission thereto.

There is also a case law in Pennsylvania providing that these peer review records are not confidential from the physicians subject to the peer review and hospitals should not be able to refuse to provide that information to physicians upon request or as part of some medical staff or peer review disciplinary or investigative process.

The Pennsylvania Supreme Court ruled, on March 27, 2018, in Regenelli v. Boggs, Monogahela Valley Hospital and UPMC/ERMI that physician performance reviews of an ER physician, who was provided by ERMI to Mon Valley Hospital, performed by a management physician within ERMI, were not protected peer review activities, and therefore the performance reviews were not protected from discovery by a third party malpractice plaintiff for a variety of reasons:

  1. Peer review conducted by the director of the Mon Valley Emergency Department, employed by ERMI, was not part of the peer review process of Mon Valley Hospital;
  2. ERMI was not a healthcare provider covered by the Pennsylvania Peer Review Protection Act.
  3. The contractual agreement between ERMI and Mon Valley Hospital did not create a collaborative peer review organization whose activities would have been protected by the Pennsylvania Peer Review Protection Act.

Although this is only a decision in one state, this decision highlights an issue that Robert Harrison and I presented to a conference of the American Health Lawyers Association in New Orleans in February, 2018, entitled “Peer Review Re-Engineered:  The New Paradigm of Employed Physicians and Peer Review”, regarding the protection of performance reviews arising from pay for performance reimbursement programs.  In that presentation, we posit that continuing “economic evaluation” of physicians under pay for performance and value based purchasing arrangements by individuals or entities not covered by a recognized peer review or confidentiality statute risks potential disclosure in third party litigation regarding malpractice, reimbursement, audit, compliance, etc.

This question presents several distinct issues, and the answers also depend upon the context of the evaluation.

First, is this for an employed physician, a physician under contract under a payment arrangement such as an ACO, or an independent medical staff member?

Second, is this a quality assessment, a utilization or efficiency assessment or a compensation assessment, i.e., is the employee or the contracted physician receiving a bonus or being penalized for hitting or failing to hit quality marks or targets?

Third, is this assessment being conducted in a quality/peer review context or an HR or financial context?

Fourth, is it the intent of the evaluator to maintain the confidentiality of this process?

In reverse order, if maintaining confidentiality is the significant issue, then only the quality/peer review evaluation will be confidential and then only from outside third parties (but not from the physician). An HR evaluation will presumably be part of the physician’s employee file and accessible under state law and any other type of context provides no confidentiality.

If confidentiality is one of the fundamental requirements, then the evaluation must be done as part of the peer review process as defined by the state peer review confidentiality law, and the peer review process must be modified so that it encompasses these P4P or performance evaluations which would presumably, without some advance planning, not be part of the peer review process.

If it is simply an incentive or compensation-based evaluation for an employed physician, none of the confidentiality rules would otherwise apply, but you must ask yourself whether you want the failure to hit certain quality targets to be public information.

Takeaway

The “Takeway” here is that you should understand this evaluation process, and the potential consequences, before blindly participating.  Furthermore, it is incumbent on the “reviewers”, whether a hospital financial or HR department, the compensation analyst, or the “quality management team” to have figured out how they intend to deal with these issues–before they create the information.

The New Capitation – What Goes Around, Comes Around!

On April 23, 2018, CMS issued a request for information on direct provider contracting models.  In that request, (attached hereto as a PDF), CMS stated as follows:

“Under a primary care-focused DPC model, CMS could enter into arrangements with primary care practices under which CMS would pay these participating practices a fixed per beneficiary per month (PBPM) payment to cover the primary care services the practice would be expected to furnish under the model…”

I believe this used to be called capitation, although way back then it was called PMPM (per member per month).  Comments are due by May 25, 2018.  I wonder if Helen Hunt’s character in “As Good As It Gets” would still like to submit a comment?

 

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