Emergency Rulemaking Amends Single-Bed Certification Rules

On September 18, 2014, the Washington Department of Social and Health Services (“DSHS”) amended its rules regarding single bed certifications for psychiatric patients, publicized in this  Rule Making Order.  The new rules were issued in response to the recent Washington State Supreme Court decision regarding psychiatric boarding which declared the use of single bed certifications to detain involuntary mental health patient at non-certified evaluation and treatment facilities unlawful.   The amended rules made two key changes impacting hospitals and other non-certified facilities where single bed certification is sought.

First, the facility that is the site of the proposed single bed certification must confirm that it is willing to provide treatment to the consumer suffering from the mental disorder for whom the single bed certification is sought.  This revision now gives facilities a role in the issuance of single bed certifications.

Second, the amended rules expanded the available criteria to support the single bed certification.  In addition to criteria available under the prior rule, criteria to support the issuance of a single bed certification now includes that the patient can receive appropriate evaluation and treatment in a residential treatment facility, a hospital with a psychiatric unit, a hospital that can provide psychiatric services, or a psychiatric hospital.

While the amended rules expands the opportunity for ITA patients to receive necessary services at non-certification evaluation and treatment facilities, the practical effect of actually providing services to ITA patients remains to be seen.  For example, hospitals and other facilities may be hesitant to confirm their willingness to provide treatment in order for the single bed certification to be issued.  Ambiguity also exists regarding the treatment to be provided under a single bed certification.

The amended rules went into effect September 18, 2014.  It is expected that DSHS will issue new final rules to be effective when the Washington State Supreme Court’s 120-day stay on its decision expires on December 26, 2014.

For more information about Washington’s Involuntary Treatment Act or mental health services, please contact Lee Kuo.



Washington Supreme Court Bans “Psychiatric Boarding”

On August 7, 2014, the Washington State Supreme Court ruled that “psychiatric boarding” under Washington’s Involuntary Treatment Act (“ITA”) is unlawful.

“Psychiatric boarding” is a term used to describe the practice of leaving mentally ill patients in hospital emergency rooms because there is no space at certified evaluation and treatment facilities.  Certified evaluation and treatment facilities are the facilities authorized under the ITA to detain involuntary mental health patients.

County mental health officials began using authority granted under the ITA to issue “single-bed certifications,” which permits mental health officials to leave patients at hospitals which are not certified evaluation and treatment facilities, to address the increasing – and now common – problem of insufficient space at the certified facilities.

In its clear opinion, the court held that the ITA does not authorize single bed certifications to avoid overcrowding at certified facilities.  In doing so, the court recognized that the ITA repeatedly provides that persons who are involuntarily detained under the ITA must be held in certified evaluation and treatment facilities in order to receive the proper evaluation, stabilization and treatment afforded to these patients under the ITA:  “Patients may not be warehoused without treatment because of lack of funds.”

Although the court’s opinion may be a catalyst towards forcing the state to address failures and flaws in its mental health system, the immediate impact of the ruling has left hospitals and county mental health professionals scrambling to figure out what to do.  If mental health professionals are unable to detain psychiatric patients who present at hospital emergency departments and who otherwise meet the criteria for detention but no evaluation and treatment bed is available, hospitals will find themselves in the difficult position of choosing between either allowing a mentally ill patient to leave the hospital or detaining the patient without clear legal authority under the ITA to do so.  The issue is further complicated for hospitals as they must also consider their EMTALA obligations in this situations.

A copy of the court’s ruling can be found here.   For more information about Washington’s Involuntary Treatment Act or mental health services, please contact Lee Kuo.

AMA Adopts Telemedicine Guidelines

On June 11, 2014, the American Medical Association (“AMA”) approved a list of guiding principles regarding the practice of telemedicine.  The AMA’s adoption of the telemedicine guiding principles follows the trend of position statements, guidelines, and other policy statements addressing the practice of telemedicine already adopted by other medical specialty societies and state medical associations, which follows the increased use of telemedicine in the delivery of health care services.

The guiding principles approved by the AMA stem from a report developed by the AMA’s Council on Medical Service.  In its report, the Council recommends a set of principles to ensure the appropriate coverage and payment for telemedicine services.  The principles are aimed at supporting future innovation in the use of telemedicine, while ensuring patient safety, quality of care and the privacy of patient information, as well as protecting the patient-physician relationship and promoting care coordination and communication.  The AMA’s announcement of its policy adoption can be found here; access to the Council’s report is included in the announcement.

The principles recommended in the Council’s report and adopted by the AMA include the following:

  • A valid patient-physician relationship must be established before telemedicine services are provided.  This relationship may be established through a face-to-face examination, a consultation with another physician who has an ongoing patient-physician relationship with the patient, or meeting other standards of establishing a patient-physician relationship as developed by major medical specialties.  Exceptions to the foregoing include on-call, cross coverage, emergency medical treatment, and other exceptions that become recognized as meeting or improving the standard of care, where establishing such a relationship may not be applicable or necessary.
  • Telemedicine providers must abide by state licensure laws and state medical practice laws and requirements in the state in which the patient receives services.
  • Telemedicine providers must be licensed in the state where the patient receives services, or be providing these services as otherwise authorized by that state’s medical board.
  • Patients seeking care delivered via telemedicine must be offered a choice of providers.  Patients must also have access to the licensure and board certification qualifications of the telemedicine providers in advance of their visit.
  • The delivery of telemedicine services must be consistent with state scope of practice laws.
  • The standard and scope of telemedicine services should be consistent with related in-person services.  The services must follow evidence-based practice guidelines, to the degree they are available, to ensure patient safety, quality of care, and positive health outcomes.
  • The patient’s medical history must be collected as part of the telemedicine service.  The telemedicine service provided must be properly documented and should include providing a summary of the visit to the patent.
  • The telemedicine services must include care coordination with the patient’s medical home and/or existing treating physicians.  At a minimum, this includes identifying the patient’s existing medical home and treating physician(s) and providing such physician(s) with a copy of the medical record.
  • The delivery of telemedicine services must abide by laws addressing the privacy and security of patients’ medical information.

In addition to the above standards, the AMA also adopted recommendations offered in the Council’s report supporting additional research, pilot programs, and demonstration projects regarding telemedicine.

For more information about telemedicine services, please contact Lee Kuo.


Upcoming HIPAA Audits Will Include Business Associates

On February 24, 2014, the Department of Health and Human Services (“HHS”) published a notice of its proposed collection of information in connection with its HIPAA audit efforts.  Comments on the proposed collection request must be submitted by April 25, 2014.

The notice indicates HHS’s intent to survey up to 1,200 organizations, including both covered entities and business associates, to determine the organizations’ suitability for HIPAA audits by HHS.  The survey will seek information about an organization’s patient visits, use of electronic information, revenue, and business locations, among other things.  The notice hints that some sort of technology will be used to complete the survey, as HHS’s time estimate of 30-60 minutes to complete the survey includes the time needed to “develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information…”. The notice does not include details on the criteria HHS will use to select an organization for an audit.

One of the notable items of this notice is HHS’s announcement that this round of HIPAA surveys will include business associates as well as covered entites.  This is a clear signal that HHS is getting serious about HIPAA compliance by all organizations who handle protected health information.

For more information about HIPAA audits and HIPAA enforcement, please contact Lee Kuo.

2013: A Critical Year for Medicare Incentive Programs

Amid all the recent attention given to the long-awaited modifications to HIPAA under the HITECH Act published earlier this year, it may be easy for Medicare providers to overlook the fact that 2013 is an important year for three Medicare payment incentive programs:  (1) the Physician Quality Reporting System Program; (2) the Electronic Prescribing Program; and (3) the Medicare Electronic Health Record Incentive Program.  As discussed below, there are important milestones and deadlines in 2013 for each of these programs associated with either receiving incentive payments or avoiding payment adjustments.

Physician Quality Reporting System (PQRS) Program

The PQRS Program is intended to promote the reporting of quality information by eligible professionals (EPs).  The incentives and payment adjustments for the PQRS program are based on whether an EP satisfactorily reports data on program-specified quality measures for covered physician fee schedule (PFS) services furnished to Medicare Part B fee-for-service (FFS) beneficiaries.  EPs can qualify to receive an incentive based on the 2013 reporting year (i.e. January 1, 2013 – December 31, 2013) equal to 0.5% of an EP’s total estimated Medicare PFS allowed charges for the 2013 reporting period.

The 2013 reporting year is also a critical year for the PQRS program because it is the first reporting year that will be used to apply the program’s payment adjustments.  Although the payment adjustments do not begin until 2015, the adjustments are based on information reported in the two-year “look back” reporting period, i.e., the 2013 reporting year for the 2015 payment adjustments, the 2014 reporting period for the 2016 payment adjustments, etc.  To avoid the payment adjustment for a particular year, an EP must satisfactorily report data in the applicable reporting period.  CMS will penalize EPs for failing to participate in the PQRS program in 2013 by reducing the 2015 Medicare PFS allowed charges by 1.5%.

Furthermore, one way an EP practicing in a group practice can report data for the PQRS program is through the group practice reporting option (GPRO).  Under the GPRO, a group practice may make PQRS reports for all individual EPs in the same group practice.  The deadline for a group practice to elect to report using the GPRO is October 15, 2013.

Electronic Prescribing (eRx) Incentive Program

The eRx Incentive Program is intended to encourage electronic prescribing by EPs.  2013 is the last year that EPs who are successful e-prescribers can qualify to earn an incentive payment.  The incentive payment for 2013 is equal to 0.5% percent of an EP’s total estimated Medicare PFS allowed charges for the 2013 reporting period (i.e., January 1, 2013 – December 31, 2013).  At the same time, the 2013 six-month reporting period from January 1, 2013 – June 30, 2013 is the final reporting period to avoid the 2014 eRx payment adjustment.  The 2014 payment adjustment for EPs who are not successful e-prescribers is equal to 2.0% of the EP’s Medicare PFS allowed charges.  An EP may be exempt from the 2014 eRx payment adjustment if the EP meets one of the payment adjustment exclusion criteria or the EP requests and CMS approves a hardship exemption.  An EP must qualify for one of the 2014 payment adjustment exclusion criteria or submit a hardship exemption request to CMS by June 30, 2013 to avoid the 2014 payment adjustment.

Medicare EHR Incentive Program

This program is intended to encourage Medicare EPs, hospitals and critical access hospitals to achieve “meaningful use” of certified EHR technology.  Payment adjustments for the Medicare EHR Incentive Program begin in 2015.  However, because of the two-year “look back” period adopted by CMS for the adjustments, EPs must demonstrate “meaningful use” in 2013 to avoid payment adjustment in 2015.  EPs who first demonstrate meaningful use in 2013 must demonstrate meaningful use for a 90-day reporting period in 2013 to avoid payment adjustments in 2015.  This means that October 3, 2013 is the last day for EPs who are demonstrating meaningful use for the first time to begin their 90-day reporting period.  EPs who first demonstrated meaningful use in 2011 or 2012 must demonstrate meaningful use for the full year in 2013 to avoid the 2015 payment adjustments.  The payment adjustment amount for 2015 is 1% of the EP’s PFS allowed charges for services furnished by the EP in 2015.

Summary of Key 2013 Dates:

June 30, 2013:

  • eRX: End of the 2013 six-month reporting period to avoid the 2014 payment adjustment
  • eRx: Last day for an EP to submit hardship exemption request to CMS to avoid the 2014 payment adjustment

October 3, 2013:

  • Medicare EHR: Last day for EPs to begin 90-day reporting period for Medicare EHR incentive (if 2013 is the EP’s first year of program participation)

October 15, 2013:

  • PQRS:  Deadline for group practices to submit self-nomination statement for group reporting option for PQRS program
  • PQRS:  Last day for EPs to elect the administrative claims option to avoid the 2015 PQRS payment adjustment

December 31, 2013:

  • PQRS:  End of period to avoid the 2015 PQRS payment adjustment
  • PQRS, eRx, Medicare EHR:  Participation year ends for all programs

In sum, Medicare providers should take note of the above dates related to the PQRS, eRx and Medicare EHR Incentive Programs, especially those dates associated with actions which they will need to take or achieve in order to avoid the applicable program payment adjustments beginning in 2015.

For more information about the Medicare incentive programs discussed above, please contact Lee Kuo.


Supervision Levels for Certain Hospital Outpatient Therapeutic Services

On September 24, 2012, CMS published its preliminary decisions regarding recommendations of the Hospital Outpatient Payment Panel (“Panel”) on supervision levels for certain hospital outpatient therapeutic services.  CMS’s review of the Panel’s recommendations stems from a process CMS created in the final Hospital Outpatient Prospective Payment System Rules for Calendar Year 2012 (“CY2012 OPPS Rule”) in which CMS charged the Panel with recommending to CMS the appropriate level of supervision (i.e., general, direct, or personal supervision) for individual hospital outpatient therapeutic services.  CMS directed the Panel to recommend supervision levels for particular services that will “ensure an appropriate level of quality and safety for delivery of a given services.”

In its first efforts since this process was put in place, the Panel recommended that CMS change the supervision level currently required for 28 hospital outpatient therapeutic services.  Of those, CMS accepted the Panel’s recommendation to change the requirements for 15 services from direct supervision to general supervision because those services do not typically require the immediate availability of the supervising physician (or other permitted non-physician practitioners).  CMS declined to accept the Panel’s recommendation to change the supervision level for the other 13 services, choosing to maintain their current requirement of direct supervision because the service either involves assessment by a physician, or there is a significant potential for patient complications or reactions which would require the supervising physician/non-physician practitioner to be immediately available.  CMS’s preliminary decisions and the specific services considered can be found here.

Pursuant to the process CMS established in the CY2012 Final Rule, CMS’s preliminary decisions are subject to a 30-day public review and comment period.  The deadline for submitting comments on these services is October 24, 2012.  After considering any additional comments, CMS will post its final decisions on the services which will be effective on January 1, 2013.  To ensure compliance with the supervision levels required for reimbursement, hospitals should review CMS’s preliminary decisions on the Panel’s recommendation, and then take note of CMS’ final decisions when those are published.

Recent CMS Guidance Allows Non-Medical Staff Practitioners To Order Hospital Outpatient Services


On February 17, 2011, the CMS Office of Clinical Standards and Quality/Survey & Certification Group issued letter memorandum S&C-12-17  regarding who may order hospital outpatient services (the “SCG Letter”).  The SCG Letter clarifies CMS’s interpretation of the Medicare Hospital Conditions of Participation (CoPs) for outpatient services set forth in 42 CFR 482.54.  The regulatory language of this CoP is silent on who may order outpatient services.

CMS issued the SCG Letter in response to industry concerns and confusion created by Transmittal 72 previously issued by CMS.  Transmittal 72 described CMS’s interpretation of the hospital CoPs related to ordering rehabilitation and respiratory care services, requiring these services to be ordered by practitioners who have hospital medical staff privileges. 

 CMS issued the SCG letter after receiving industry comments that Transmittal 72 was having the unintended effect of stating that all ordering practitioners had to hold medical staff privileges, even though CMS had intended the transmittal to expand the categories of practitioners who could order rehabilitation and respiratory services beyond just physicians.  The SCG Letter specifically rescinds those portions of Transmittal 72 which conflict with the letter.

The SCG letter clarified CMS’s interpretation of the hospital CoPs for outpatient services to be:  a practitioner who does not hold medical staff privileges at a hospital may order (or make referrals) for hospital outpatient services to the extent that the practitioner is permitted to do so under approved hospital policies for ordering outpatient services.  The SCG letter states that practitioners may order hospital outpatient services if the practitioners are: 

(1) responsible for the care of the patient;

(2) licensed in, or holds a license recognized in the jurisdiction where the practitioner sees the patient (which could be in a different state as the hospital to where the outpatient services are ordered or referred);

(3) acting within their scope of practice under state law; and

(4) authorized by the medical staff to order the outpatient services under a written hospital policy approved by the governing body. 

The SCG letter makes clear that ordering practitioners can include both practitioners who are on the hospital medical staff and who hold medical staff privileges that include ordering services, and other practitioners who are not on the hospital medical staff but who satisfy the hospital’s policies for ordering or referring patients for hospital outpatient services.  Hospital policies authorizing practitioners to order and refer patients for outpatient services should address how the hospital verifies that the referring practitioner is appropriately licensed and acting within his/her scope of practice.  The policies should also make clear whether the policies apply to all hospital outpatient services or whether there are specific services for which orders may only be accepted from practitioners with medical staff privileges.

Based on the SCG Letter, hospitals should adopt policies addressing who may order and refer hospital outpatient services.  The policies should include defining which outpatient services can be ordered by practitioners with hospital medical staff privileges, and which outpatient services can be ordered by practitioners who do not hold medical staff privileges.  Consistent with the requirements described in the SCG Letter, these policies must be approved by the hospital’s governing body.

If you have any questions about the SCG Letter or CMS hospital Conditions of Participation, please contact Lee Kuo.


CMS Not Making Changes to Current EMTALA Policies or Regulations

On February 2, 2012, CMS published a notice  of its policies and request for comments related to two issues regarding the applicability of the Emergency Medical Treatment and Labor Act (“EMTALA”) to hospital inpatients.  The first issue involves whether a hospital’s EMTALA obligations continue to exist even after the patient is admitted to the hospital as an inpatient, but is not stabilized upon or after such admission.  The second issue involves whether EMTALA should apply to situations where a hospital seeks to transfer an individual admitted as a hospital inpatient to a hospital with specialized capabilities because the admitted inpatient continues to have an unstabilized emergency medical condition (“EMC”) that requires specialized treatment not available at the admitting hospital.

CMS considered changes to its current policies in response to its advance notice of proposed rulemaking published in the Federal Register on December 23, 2010 which solicited comments regarding whether it should revisit policies established in 2003 and 2009 providing that a hospital’s EMTALA obligations end upon the good faith admission as an inpatient of an individual with an EMC (the “2010 ANPRM”).  After reviewing comments received in response to the 2010 ANPRM, CMS has decided not to make any changes to the policies or regulations at this time.  As such, the current CMS policies pertaining to the two issues remain as follows:

1.         If an individual comes to the hospital’s emergency department, and the hospital provides an appropriate medical screening examination and determines that an EMC exists, and then admits the individual in good faith in order to stabilize the EMC, the hospital has satisfied its EMTALA obligations towards that patient.

2.         If an individual comes to the hospital’s emergency department, is determined to have an EMC, is admitted as an inpatient, and continues to have an unstabilized EMC which requires the specialized capabilities of another hospital, the EMTALA obligation for the admitting hospital has ended.  Furthermore, a hospital with specialized capabilities does not have an EMTALA obligation towards that individual.

Although CMS is not changing its current policies at this time, it is soliciting comments on the second issue regarding the applicability of EMTALA to a hospital with specialized capabilities in order to determine whether it may be appropriate to reconsider the issue in the future.

If you have questions about the CMS notice or ETMALA, please contact Lee Kuo.

ACO Fraud and Abuse Law Waivers

In conjunction with the issuance of the final rules related for Accountable Care Organizations (“ACOs”) under the Medicare Shared Savings Program, the OIG published an interim final rule establishing waivers to fraud and abuse laws in connection with the Shared Savings Program.

The waivers were created to address industry concerns that restrictions in certain laws aimed at preventing fraud and abuse of federal health care programs, i.e., the Physician Self-Referral law (commonly known as the “Stark Law”), the federal anti-kickback statute (“AKS”), and the federal civil monetary penalties (“CMP”) law, would limit or otherwise impede development of innovative integrated care models envisioned by the Shared Savings Program.  The goal of the waivers is to effectively balance the need for ACO innovation and flexibility in the Shared Savings Program while protecting beneficiaries and the Medicare program.

The interim final rule establishes five waivers to the fraud and abuse laws which CMS and the OIG deemed necessary to carry out provisions of the Shared Savings Program.  Parties seeking to ensure that an arrangement is covered by a waiver for a particular law may look to any waiver that applies to that law.  An arrangement may meet the criteria of more than one waiver.

Key Points/General Overview:

  • To qualify for a waiver, the arrangement must meet all of the conditions set forth in the waiver.
  • A waiver of a specific fraud and abuse law is not needed for an arrangement to the extent that the arrangement: (1) does not implicate the specific fraud and abuse law, or (2) implicates the law, but either fits within an existing exception or safe harbor, as applicable, or does not otherwise violate the law.  Arrangements that do not fit a waiver have no special protection and must be evaluated on a case-by-case basis for compliance.  Failure to fit in a wavier is not, in and of itself, a violation of the fraud and abuse laws.
  • For purposes of the waivers, “reasonably related to the purposes of the Shared Savings Program” means the purposes of promoting accountability for the quality, cost, and overall care for a Medicare population; managing and coordinating care for Medicare fee-for-service beneficiaries through an ACO; and encouraging investment in infrastructure and redesigned care processes for high quality and efficient service delivery for patients, including Medicare beneficiaries.
  • CMS, OIG, and HHS will closely monitor ACOs entering into the program in 2012 through June 2013, and plan to narrow the waivers if they result in the unintended effect of shielding abusive arrangements.  The waivers could be narrowed by modifying the waivers to add or substitute conditions to the waivers; limiting ACO arrangements involving referral sources to those that are fair market value or commercially reasonably or involve services performed by the referral sources; preclude waiver protections for arrangements that involve individuals or entities that are not part of the ACO; or include a requirement that ACOs submit reports regarding their arrangement.  CMS and the OIG seek comments on these approaches to narrow the waivers.

Detailed summaries of the five waivers are provided below:

“ACO Pre-Participation” Waiver.  This waiver of the Stark Law, the AKS, and the gainsharing CMP applies to ACO-related start-up arrangements in anticipation of participation in the Shared Savings Program, but which pre-date an ACO’s participation agreement.

  • The parties must act with the good faith intent to develop an ACO that will participate in the Shared Savings Program starting in a particular year, must submit a completed application to participate in a Shared Savings Program for that year, and must be taking diligent steps to develop an ACO.
  • The ACO’s governing body must make a bona fide determination that the arrangement is reasonably related to the purposes of the Shared Savings Program.
  • Certain documentation of the arrangement must be maintained for at least 10 years following completion of the arrangement and made available to HHS upon request.
  • An ACO may use the pre-participation waiver (including any extensions granted) only one time.
  • As used in the waiver, “start-up arrangement” means any items, services, facilities, or goods (including non-medical items, services, facilities, or goods) used to create or develop an ACO that are provided by such ACO, ACO participants, or ACO providers/suppliers.  Commentary on the waiver provides a non-exhaustive list of examples of items, services, facilities and goods considered as start-up arrangements.
  • The start and end dates for when the waiver applies varies based on the ACO’s target year, whether an ACO’s participation application is accepted or denied, whether the ACO failed to submit an application for the target year, and whether the ACO was granted an extension of the waiver.
  • This pre-participation wavier does not cover arrangements involving drug and device manufacturers, distributors, DME suppliers, or home health suppliers.

“ACO Participation” Waiver.  This waiver of the Stark Law, the AKS, and the gainsharing CMP applies to ACO-related arrangements during the term of the ACO’s participation agreement under the Shared Savings Program and for a limited time thereafter.

  • The ACO must have entered into a participation agreement and remain in good standing under its participation agreement.
  • The ACO’s governing body must make a bona fide determination that the arrangement is reasonably related to the purposes of the Shared Savings Program.
  • Certain documentation of the arrangement must be maintained for at least 10 years following completion of the arrangement and made available to HHS upon request.
  • The waiver period starts on the start date of the participation agreement, and ends six (6) months following the earlier of the expiration of the participation agreement (including any renewals thereof) or the date on which the ACO has voluntarily terminated the participation agreement.  If CMS terminates the participation agreement, the waiver period ends on the date of the termination notice.

“Shared Savings Distribution” Waiver.  This waiver of the Stark Law, the AKS, and the gainsharing CMP applies to distributions and uses of shared savings payments earned under the Shared Savings Program.  The waiver permits shared savings to be distributed or used with the ACO in any form or manner, including “downstream” distributions or uses of shared savings funds between or among the ACO, its ACO participants, and its ACO providers/suppliers.

  • The ACO must have entered into a participation agreement and remain in good standing under its participation agreement.
  • The waiver applies to distributions and uses of shared savings earned during the term of the ACO’s participation agreement, even if the actual distribution or use of the shared savings occurs after expiration of the agreement.  The waiver also applies to individuals or entities that were ACO participants and ACO providers/suppliers at the time the shared savings were earned, even if they are not part of the ACO at the time of the actual distribution.
  • The waiver does not protect distributions of shared savings to referring physicians outside the ACO, unless those referring physicians are being compensation (using shared savings) for activities that are reasonably related to the purposes of the Shared Savings Program or were ACO participants or ACO providers/suppliers during the year in which the shared savings were earned by the ACO.
  • Under this waiver, payments of shared savings distributions made directly or indirectly from a hospital to a physician are not made knowingly to induce the physician to reduce or limit medically necessary items or services to patients to patients under the physician’s direct care.

“Compliance with the Physician Self-Referral Law” Waiver.  This waiver of the AKS and the gainsharing CMP applies to ACO arrangements that implicate the Stark Law but which meet an existing exception under the Stark Law.

  • The ACO must have entered into a participation agreement and remain in good standing under its participation agreement.
  • The financial relationship must be reasonably related to the purposes of the Shared Savings Program.
  • The financial relationship must fully comply with an exception under the Stark Law, as set forth at 42 CFR §411.255 through 411.357.
  • The waiver period begins on the start date of the participation agreement, and ends on the earlier of the expiration of the term of the participation agreement (including any renewals thereof) or the date on which the participation agreement has been terminated.

“Patient Incentive” Waiver.  This waiver of the beneficiary inducement CMP and the AKS applies to medically related incentives offered by ACOs under the Shared Savings Program to beneficiaries to encourage preventive care and compliance with treatment regimes.  More specifically, those fraud and abuse laws are waived with respect to items or services provided by an ACO, its ACO participants, or its ACO providers/suppliers to beneficiaries for free or below fair market value.

  • The ACO must have entered into a participation agreement and remain in good standing under its participation agreement.
  • There must be a reasonable connection between the items or services and the medical care of the beneficiary.
  • The items or services must be in-kind, and must be either preventive care items or services, or advance certain clinical goals (i.e., adherence to a treatment regime, drug regime or follow-up care plan, or management of a chronic disease or condition).
  • The waiver does not protect financial incentives to beneficiaries, such as waiving or reducing patient cost sharing amounts (i.e., co-payments or deductibles).  (Note that the Shared Savings Program itself prohibits ACO, ACO participants, and ACO providers/suppliers from providing gifts or other remuneration to beneficiaries as inducement from receiving items or services from, or remaining in, an ACO.)
  • The waiver also does not protect or the provision of free or below fair market value items or services by manufacturers or other vendors to beneficiaries, the ACO, ACO participants, or ACO providers/suppliers, including any discount arrangements between a manufacturer and an ACO.
  • The waiver period begins on the start date of the participation agreement, and ends on the earlier of the expiration of the term of the participation agreement (including any renewals thereof) or the date on which the participation agreement has been terminated.  However, a beneficiary may keep items received before the participation agreement expired or was terminated, and may receive the remainder of any service initiated before the participation agreement expired or was terminated.

For more information regarding the OIG’s fraud and abuse waiversor ACO’s in general contact Lee Kuo.

CMS Releases Proposed Rules for Accountable Care Organizations

On March 31, 2011, CMS released its proposed rules for public review and comment relating to Medicare payments for health care providers participating in Accountable Care Organizations (ACOs).  Under the proposed rules, health care providers participating in ACOs would be eligible to receive additional Medicare payments based on meeting certain specified quality and savings requirements in addition to receiving traditional Medicare fee-for-service payments under Medicare Parts A and B.

The proposed rules are available here and will be published in the Federal Register on April 7, 2011.  A fact sheet published by CMS which provides a summary of proposed rules is available here.  If you would like further information about ACOs, please contact Dave Schoolcraft or Elana Zana.