CMS Stark Proposals Allow “Holdover” Arrangements and Signature Window

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions.  The full text of these proposal and CMS comments and explanations is available at:

https://www.federalregister.gov/articles/2015/07/15/2015-16875/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions

http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-16875.pdf

Perhaps the most noteworthy of the lesser proposals were clarifications that:

  • “hold over arrangements” are permitted to satisfy the appropriate exception indefinitely as long as the agreement was in place for the term of at least a year and otherwise complied with the exception requirements and
  • a proposal to modify the current regulations to allow parties 90 days to obtain required signatures, regardless of whether the failure to obtain the signature in the first place was inadvertent.

CMS Limits Scope of Review for MACs

CMS issued a special edition MLN Matters meant to be effective August 1, 2015.  The guidance reflects CMS instructions to Medicare Administrative Contractors (MACs) and Qualified Independent Contractors (QICs) regarding the scope of review for redeterminations and reconsiderations of certain claims.

CMS acknowledges its concern that MACs and QICs were using their discretion to conduct appeals to develop new issues.  CMS states:

In some cases where the original denial reason is cured, this expanded review of additional evidence or issues results in an unfavorable appeal decision for a different reason.

CMS has instructed MACs and QICs to limit their review to the reason or reasons the claim or line item at issue was initially denied.

CMS Clarifies Written Agreement Requirement

CMS has acknowledged that arrangements among providers to satisfy the Stark exceptions need not be created in a single document.  Although a single written document memorializing the key facts of an arrangement could provide the surest and most straightforward means of establishing compliance with the applicable exception, there is no requirement under the physician self-referral law that an arrangement be documented in a single formal contract.  Depending on the facts and circumstances of the arrangement and the available documentation, a collection of documents, including contemporaneous documents evidencing the course of conduct between the parties, may satisfy the writing requirement of the leasing exceptions and other exceptions that require that an arrangement be set out in writing in any or all of the following exceptions.

  • Office and equipment leases
  • Bona fide employment agreements
  • Personal service agreements
  • Electronic health records

The full text of these proposal and CMS comments and explanations is available at:

https://www.federalregister.gov/articles/2015/07/15/2015-16875/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions

http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-16875.pdf

CMS Proposes New Stark Exceptions: Timeshare Lease

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions.  Over the next few days, I will post comment on what I consider the most significant new exceptions and clarifications.  The full text of these proposal and CMS comments and explanations is available at:

https://www.federalregister.gov/articles/2015/07/15/2015-16875/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions

http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-16875.pdf

New Timeshare Exception

CMS acknowledges that arrangements for the use of another provider’s premises, equipment, personnel, items, supplies or services by physicians who, for various legitimate reasons, do not require or are not interested in a traditional office space lease arrangement could be appropriate.  Under timeshare arrangements, a hospital or local physician practice may ask a specialist from a neighboring community to provide the services in space owned by the hospital or practice on a limited or as-needed basis.  CMS believes timeshare arrangements that include the use of office space can be structured in a way that does not pose a risk of program or patient abuse.

Therefore, CMS has proposed a new exception at 42 C.F.R. § 411.357(y) that would protect timeshare arrangements that meet certain criteria, including:

  1. The arrangement is set out in writing, signed by the parties, and specifies the premises, equipment, personnel, items, supplies and services covered by the arrangement;
  2. The arrangement is between a hospital or physician organization (licensor) and a physician (licensee) for the use of the licensor’s premises, equipment, personnel, items, supplies, or services;
  3. The licensed premises, equipment, personnel, items, supplies, and services are used predominantly to furnish evaluation and management services to patients of the licensee;
  4. The equipment covered by the arrangement, if any is: (i) located in the office suite where the physician performs evaluation and management services, (ii) used only to furnish DHS that is incidental to the physician’s evaluation and management services and furnished at the time of such evaluation and management services, and (iii) not advanced imaging equipment, radiation therapy equipment, or clinical or pathology laboratory equipment (other than equipment used to perform CLIA-waived laboratory tests).
  5. The arrangement is not conditioned on the licensee’s referral of patients to the licensor;
  6. The compensation over the term of the arrangement is set in advance, consistent with fair market value, and not determined in a manner that takes into account (directly or indirectly) the volume or value of referrals or other business generated between the parties;
  7. The arrangement would be commercially reasonable even if no referrals were made between the parties;
  8. The arrangement does not violate the anti-kickback statute (section 1128B(b) of the Act) or any federal or state law or regulation governing billing or claims submission; and

The proposed exception would apply only to timeshare arrangements where the licensor is a hospital or physician organization; it would not protect arrangements where the licensor is another type of DHS entity.

CMS Proposes New Stark Exception: Recruitment of Non-Physician Practitioners

In July 2015, CMS released proposals to provide several new Stark Law exceptions and to clarify issues regarding existing exceptions.  Over the next few days, I will post comments on what I consider the most significant new exceptions and clarifications.  The full text of these proposals and CMS comments and explanations are available at:

https://www.federalregister.gov/articles/2015/07/15/2015-16875/medicare-program-revisions-to-payment-policies-under-the-physician-fee-schedule-and-other-revisions

http://www.gpo.gov/fdsys/pkg/FR-2015-07-15/pdf/2015-16875.pdf

New Recruitment of Non-Physician Practitioners Exception

CMS has proposed to establish a new exception as 42 C.F.R. § 411.357(x) to permit remuneration from a hospital, a federally qualified health center (FQHC), or a rural health center (RHC) to a physician to assist the physician in employing a non-physician practitioner in the geographic area served by the hospital, FQHC, or RHC providing the remuneration.

  1. The proposed exception would apply only where the non-physician practitioner is a bona fide employee of the physician receiving the remuneration from the hospital (or of the physician’s practice) and the purpose of the employment is primarily to provide primary care services to patients of the physician practice.  CMS believes employment is greater proof a sincere commitment then just an independent contractor relationship.
  2. Primary care services includes general family practice, general internal medicine, pediatrics, geriatrics, and obstetrics and gynecology patient care services.
  3. “Non-physician practitioner” is defined for purposes of this exception, to include only physician assistants, nurse practitioners, clinical nurse specialists, and certified nurse midwives.
  4. There is a 2-year limit on the assistance which is intended to prevent ongoing payment to the physician that could serve as a reward for past referrals or an inducement to continue making referrals to the hospital, FQHC, or RHC, and the amount is proposed to not exceed 50% of actual salary, signing bonus and benefits or the amount equal to the excess of these costs over actual NPP receipts.

CMS Announces One Year Partial ICD-10 Relief for Physicians

By now, everyone knows ICD-10 coding starts October 1, 2015.

Starting October 1, 2015, Medicare claims with dates of service after October 1, 2015 will only be accepted if they contain a valid ICD-10 code. The Medicare claims system will be programmed not to accept ICT-9 codes after September 30, 2015.

However, Medicare announced in a July 7, 2015 letter it will not deny physician on other practitioner claims based solely on incorrect specificity of ICD-10 coding, as long as the code used is from the right family, for 12 months, i.e., until September 31, 2016.

CMS is also providing these ICD-10 resources:

https://www.cms.gov/Medicare/Coding/ICD10/index.html?redirect=/ICD10

http://www.roadto10.org/

https://www.cms.gov/Medicare/Coding/ICD10/Downloads/MedicareProviderICD-10.pdf

https://www.cms.gov/Medicare/Coding/ICD10/Downloads/ICD10QuickStartGuide20150622.pdf

 

Telehealth News

There are two interesting items in telehealth news.

Iowa Supreme Court Rejects Ban on Telemedicine Abortions

An Iowa Board of Medicine rule requires the presence of a physician when abortion inducing drugs are provided.  Planned Parenthood sued claiming the requirement of physician presence was unconstitutional on the basis that it discriminated against women, due to the fact that physician presence was not required for other telemedicine procedures.  The Iowa Supreme Court agreed with Planned Parenthood, and it is now up to the Iowa Board of Medicine to decide an appropriate regulatory response.

Medicare Telehealth

The Medicare proposed physician fee schedule for 2016 will be published in the Federal Register on July 15, 2015.  Although the proposed PFS does address telehealth, the proposed changes were hardly groundbreaking.

  • Medicare proposed to add codes for prolonged inpatient service and ESRD related services, and
  • To include CRNAs as approved distant site practitioners who may furnish Medicare telehealth services.

The copies of those pages of the proposed fee schedule dealing with telehealth can be found here.

Colorado Approves Direct Medicare Payment to CRNA’s

Medicare Regulations allows CRNA’s to administer anesthesia without physician supervision if the state governor opts out of the regular physician supervision requirement.

Governor Ritter of Colorado opted out in 2010, and his action was challenged by the Colorado Medical Society and the Colorado Society of Anesthesiologists.  That challenge was dismissed by Colorado trial courts, which decision was just affirmed on appeal by the Colorado Supreme Court.

The Colorado Medical Society continues to assert that Colorado law requires physician supervision of CRNA’s, and that the decision affects only Medicare reimbursement.  That issue was raised but not addressed in the proceedings.

While expecting continued litigation on the issue, the Colorado Association of Nurse Anesthetists (COANA) praised the decision as a victory for CRNA’s.

TelaDoc Wins Injunction Against Texas Medical Board re: Telehealth Restrictions

The Federal District Court of the Western District of Texas has ruled against the Texas Medical Board and granted TelaDoc’s Motion for a Preliminary Injunction prohibiting the Texas Medical Board from enforcing new rules requiring either a face-to-face or an existing physician patient relationship in order to prescribe medication.

The Court rejected the Texas Medical Board argument based on the standard of care.  The Texas Medical Board argued the standard of care would be jeopardized by allowing unrestricted telehealth encounters, but the court ruled that the standard of care for physicians remained in tact, assuming that physicians providing telehealth services would be held to the same standard of care as a physician engaged in a face-to-face encounter.  Presumably, this leaves the issue of whether the standard of care was observed in any particular encounter to the rules of professional licensing and malpractice.

The Court accepted the TelaDoc argument that the rules would likely violate the Federal Anti-Trust Laws and that it would substantially harm TelaDoc’s business model.

The ruling is certain to be appealed.

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