CMS Releases Proposed Rule On Meaningful Use Stage 2

Posted February 23, 2012 by Elana Zana
Categories: HITECH, Incentive Payments, Meaningful Use, Medicare

CMS announced today its proposed rule (NPRM) on Stage 2 of the EHR Incentive Program Meaningful Use requirements.  These requirements apply to both eligible professionals and hospitals participating in the Medicare and Medicaid EHR Incentive Program.  As previously announced, and proposed within this NPRM, the onset of the Stage 2 meaningful use requirements will not begin until 2014.

The Stage 2 requirements include greater applicability to specialists, changes to the clinical quality measures, and modifications to the core and menu measures.  CMS has issued a fact sheet that briefly summarizes the Stage 2 requirements.

The NPRM will be published in the Federal Register on March 7, 2012.

For questions regarding the Stage 2 proposed requirements or for assistance related to the Medicare or Medicaid EHR Incentive Program please contact Elana Zana.

CMS Proposed Rule on Overpayments – A 10 Year Burden

Posted February 21, 2012 by Elana Zana
Categories: Anti-Kickback/Stark, Health Reform, Medicare, OIG, SRDP, Stark

CMS recently published its proposed rules on reporting and returning overpayments.  These rules are intended to implement the 60 day overpayment reporting requirement pursuant to the Affordable Care Act (the “ACA”).  The ACA created a new section 1128J(d) of the Social Security Act requiring a person who receives an overpayment to return and report the overpayment to HHS, the State, a carrier or a contractor and notify the recipient of the reason for the overpayment.  The statute requires that all  overpayments be refunded within 60 days after the date the overpayment was identified or the date of any corresponding cost report (as applicable), whichever is later.

The proposed regulations only relate to Medicare Parts A and B.  Medicaid, Medicare Advantage, Part D, and managed care organizations are not covered by the proposed rules; however, the 60 day shot clock noted in the statute still applies.

Reporting Overpayments

The proposed rules rename the current voluntary refund process the “self-reported overpayment refund process” (described more fully in the Medicare Financial Management Manual).  Providers will use voluntary refund forms currently on the websites of their Medicare contractors.  Reports of overpayments will require the inclusion of the following information:

1)      Name;

2)      TIN;

3)      How the error was discovered;

4)      The reason for the overpayment;

5)      The health insurance claim number, as appropriate;

6)      Date of service;

7)      Medicare claim control number, as appropriate;

8)      NPI;

9)      Description of the corrective action plan to ensure the error does not occur again;

10)   Whether the person has a corporate integrity plan with the OIG or is under the OIG Self-Disclosure Protocol;

11)   The timeframe and the total amount of the refund for the period during which the problem existed that caused the refund;

12)   If a statistical sample was used to determine the overpayment amount, a description of the statistically valid methodology used to determine the overpayment; and

13)   A refund in the amount of the overpayment.

Under the proposed rules, providers are required to report the overpayment within 60 days of identification and refund the overpayment within the same 60 day period.  Providers may request a refund extension through the extended repayment schedule.  A person has “identified” an overpayment if that person has actual knowledge of the existence of the overpayment or acts in reckless disregard or deliberate ignorance of the existence of the overpayment.  Providers who retain an overpayment after the 60 day deadline for reporting and returning the overpayment are liable under the False Claims Act.  Additionally, any person who knows of an overpayment and does not report and return the overpayment may be found liable for Civil Monetary Penalties and excluded from participation in federal health care programs.

Significantly, the proposed rules also set a lookback period of 10 years, meaning that if a provider identifies an overpayment within 10 years of the date the overpayment is received it will have to report and refund such overpayment.

SRDP and OIG Self-Disclosure Protocol

CMS attempts to reconcile these proposed regulations with the OIG Self-Disclosure Protocol and the new CMS Self-Referral Disclosure Protocol (“SRDP”) (which allows reports of Stark Law violations).  The reconciliation falls flat and creates confusion which will hopefully be remedied in the final rule.

The 60 day deadline for returning overpayments will be suspended if the OIG acknowledges receipt of submission to the OIG Self-Disclosure Protocol.  This suspension will last until a settlement agreement is entered, the person withdraws from the OIG Self-Disclosure Protocol, or the person is removed from the OIG Self-Disclosure Protocol.  Additionally, a person satisfies the reporting requirements listed above by making a disclosure under the OIG Self-Disclosure Protocol which results in a settlement agreement.

Similarly, the 60 day deadline for returning overpayments is suspended if CMS acknowledges receipt of a submission to the SRDP until such time as a settlement agreement is entered, a person withdraws from the SRDP, or the person is removed from the SRDP.  However, the reporting requirement described above is not tolled by submission to the SRDP.

Conclusion

Regardless of these proposed rules, providers must currently report and refund overpayments within 60 days per the ACA.  CMS has opened public comment on these proposed rules through April 16, 2012.  If you would like assistance on drafting comments or assistance with reporting an overpayment please contact Don Black or Elana Zana.

ICD-10 – Delayed

Posted February 17, 2012 by OMW Health Law
Categories: HIPAA

HHS announced yesterday its intent to delay the ICD-10 requirement.  Entities covered under HIPAA were required to comply with ICD-10 by October 1, 2013, HHS will now delay that date by a new compliance deadline yet to be announced.  To read the complete press release click here.

CMS Not Making Changes to Current EMTALA Policies or Regulations

Posted February 9, 2012 by Lee W. Kuo
Categories: EMTALA

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.

EHR Contracting Tip: Attestation for AIU

Posted January 28, 2012 by Elana Zana
Categories: Anti-Kickback/Stark, HITECH, Incentive Payments, Meaningful Use

Now that most states have their Medicaid EHR Incentive Program in full swing we have gotten a glimpse of what they are requiring for attesting to “adopt, implement and upgrade” aka “AIU”.  As described in the CMS rules themselves, practices need to show that they have some skin in the game and have actually invested in an EHR product.  Many states are asking that an EP (or group practice) upload the actual EHR software contract (or a redacted version).  Some states (such as California) are requesting a signed vendor statement in lieu of the full contract.  

If you are a practice in the process of negotiating an EHR contract, you may want to consider including a provision in the contract specific to the AIU attestation requirements of the state your practice is in.  For example, requiring in the contract itself that the software vendor execute any documents required by the state to attest to AIU or that the vendor provide a letter acknowledging the practice’s EHR license (if such a letter is acceptable in your state). Similar provisions are recommended in situations where the practice is involved with a Stark donation arrangement or other type of third party contract. 

Setting expectations up front and creating a contractual obligation will help ensure that the software vendor or other third party contractor does not stand in the way of your practice receiving EHR incentive dollars.

For assistance in drafting and negotiating EHR software contracts or the Medicaid EHR Incentive Program in general please contact Elana Zana or Dave Schoolcraft.            

OIG Launches Series on Provider Compliance

Posted January 10, 2012 by OMW Health Law
Categories: Anti-Kickback/Stark, OIG, Stark

In December, the Office of Inspector General (OIG) launched a webcast series on provider compliance. Currently there are six short (approximately five minutes) webcasts on topics such as fraud and abuse, the anti-kickback statutes and the physician self-referral law (aka the Stark law).    These webcasts provide a short overview of these important compliance laws.  The OIG also has sixteen webcast modules that go into further depth on fraud and abuse enforcement.  The OIG plans on posting additional webcasts on a weekly basis over the next few months.

To access the webcasts click here.  Slides and handouts are also available on the OIG compliance training website.

ACO Application Requirements and Procedures

Posted December 20, 2011 by Doug Albright
Categories: Accountable Care Organizations, Health Reform

The final ACO regulations outline the process and required content for ACO applicants to participate in the Shared Savings Program.  For the initial applications in 2012, the required term of the agreement will be either (i) April 1, 2012 through December 31, 2015, or (ii) July 1, 2012 through December 31, 2015.  Thereafter all agreements will commence on January 1 and have a three year term.  An ACO must submit an application on a form required by CMS that includes extensive information, disclosures and certificates.  Some (but not all) of the more significant requirements are that the ACO applicant must:

  • certify that the ACO, its participants, providers and suppliers have agreed to become accountable for the quality, cost, and overall care of the Medicare beneficiaries assigned to the ACO;
  • provide documents sufficient to describe the ACO’s participants and providers rights and obligations to receive shared savings and to adhere to the quality assurance and evidence based clinical guidelines, which, for example, include participation agreements, employment contracts, and operating policies;
  • include a description of how the ACO will implement the required patient-centeredness criteria, including the potential remedies and penalties, including expulsion;
  • provide materials documenting its organizational structure, including an organization chart, a list of committees with the names of the members, and key job descriptions;
  • either include a description or copy of a compliance plan;
  • list all ACO participating providers, along with their Medicare enrolled TINs;
  • describe (i) how the ACO plans to use shared savings payment, including the criteria for distributing the savings; (ii) how its plan will achieve the specific goals of the Shared Savings Program; and (iii) how the plan will achieve the general aims of better care for individuals, better health for populations, and lower growth in expenditures; and
  • include documentation that it is capable of repaying losses or other monies determined to be owed upon the first year reconciliation.

The detailed requirements for the application will make it imperative that ACO applicants comprehensively organize and document the ACO structure before applying.  Compliance with the extensive application requirements will require significant financial and other resources.

CMS will evaluate applications and provide a notice of determination to the applicant.  If the application is denied, the reasons will be provided.  If the application is approved, the ACO must sign the participation agreement, agreeing to comply with all provisions of the regulations.  Interestingly, ACOs that sign a three year agreement are still subject, with a few exceptions, to all statutory and regulatory changes that are effective during the term of the agreement.  The exceptions are limited to (i) eligibility requirements concerning the structure and governance of ACOs, (ii) calculation of the shared savings, and (iii) beneficiary assignment.  An ACO that fails to modify its processes as required by a change in the law or regulations will be placed on a corrective action plan, and if the ACO fails to comply with the corrective action plan it will be terminated.  It is likely that there will be material revisions to the ACO regulations to address issues identified as the first ACOs qualify and commence operation.  Therefore it will be important for ACOs to be structured in a manner that provides for effective governance and management as the rules change over time.

For more information regarding the ACO application or ACO’s in general, please contact Doug Albright.

ACO Final Rule – Drastically Reduces Quality Measure Requirements

Posted December 8, 2011 by Elana Zana
Categories: Accountable Care Organizations, Health Reform, Incentive Payments, Meaningful Use, Medicare

The Accountable Care Organization (“ACO”) final rules show that comments to CMS really do make a difference.  The public outcry against the 65 quality measures proposed in the spring led to CMS’ 50% cut of the number quality measures.  Along with the large cut, CMS explained its plan for allowing ACOs to meet the measure requirements by reporting on the measures in the first year and receiving “pay for performance” in the following years based on the weighted scores received in each quality measure.

Quality Measures

The revised list of quality measures are broken out into 33 different measures (predominately with NQF measure numbers) with four umbrella categories and five subcategories as follows:

  1. Patient/Caregiver Experience (7 measures)
  2. Care Coordination/Patient Safety (6 measures, includes the EHR Incentive Program)
  3. Preventative Health (8 measures)
  4. At Risk Population (12 measures)
    1. Diabetes (6 measures)
    2. Hypertension (1 measure)
    3. Ischemic vascular disease (2 measures)
    4. Heart failure (1 measure)
    5. Coronary Artery Disease (2 measures)

The tables provided in the final rule at pages 67889-90 are particularly helpful in visually identifying the measures, the method of data submission and whether the particular measure is pay for reporting or pay for performance.  The measures will be submitted to CMS through either surveys (for patient/caregiver experience measures), claims, the EHR Incentive Program, or the Group Practice Reporting Option (“GPRO”) Web Interface.  The surveys will be conducted using the Consumer Assessment of Healthcare Providers and System (“CAHPS”) surveys for 2012 and 2013, in future years, ACOs will have to select a CMS approved vendor to administer the surveys.

EHR Incentive Program

One of the significant changes to the quality measures was the expansion of the EHR incentive program related measure.  The quality measure no longer requires that 50% of the primary care providers to achieve meaningful use in order for the ACO to participate.  The EHR quality measure now recognizes those participating in the Medicaid EHR Incentive Program do not have to meet meaningful use requirements in their first year of participation.  As such, the new measure now includes primary care providers that successfully qualify for the EHR Incentive Program under either Medicare or Medicaid.  In addition, CMS cut previously proposed measures that were redundant with the EHR Incentive Program such as the measure concerning clinical decision support and electronic prescribing.

CMS still emphasizes the importance of the usage of the EHR technology by giving the EHR quality measure a higher weight.  Eligible professionals participating in ACOs are still eligible to separately participate in the EHR Incentive Programs or the e-prescribing incentive program.

Pay for Reporting vs. Pay for Performance

In the first year of participation, all of the quality measures may be satisfied by merely reporting on the quality measures.  For pay for reporting, ACOs will earn the maximum sharing rate for complete and accurate reporting of 100% of the required data, and no quality threshold must be met.  In the second year, 25 of the quality measures will be pay for performance, and eight will continue to be pay for reporting.  In the third year, all but one quality measure will be on a pay for performance basis.

In the pay for performance years, each domain will be given equal weight of 25% in the calculation of the ACOs overall quality performance score.  Each of the individual measures will be equally weighted within the domains, except for the EHR Incentive Program quality measure which is double weighted.  ACOs must minimally attain 30% (or be in the national 30th percentile) for that quality measure.  Subregulatory guidance will indicate the quality performance rates an ACO needs to achieve in order to earn the maximum quality points in a domain.

Recognizing that meeting all 33 measures in a given year may be difficult, CMS is requiring that ACOs achieve the quality performance standards on 70% of the measures in each domain.  Failure to achieve the 70% standard will result in a corrective action plan and re-evaluation in the final year.  However, if an ACO scores a zero for an entire measure, it will not be able to share in the savings generated.  Due to the double weight of the EHR measure, failure to meet the EHR measure in the Care Coordination domain would cause the ACO to miss the 70% cut-off.

Reporting Calendar & PQRS

ACOs are expected to report on the quality measures on a calendar year basis, beginning with the reporting period starting January 1, 2012 through December 31, 2012.  Even though a “performance year” in the regulations may begin in April or July of 2012 and end in December 2013, the quality performance for the first performance year will be based on reporting of the measures from January 1, 2013 through December 31, 2013.  Eligible professionals participating in an ACO that start the agreement in April or July of 2012 will also qualify for the 2012 PQRS incentive under the Shared Savings program by reporting the ACO GPRO measures for the full 2012 Physician Quality Reporting System (“PQRS”) calendar year reporting period.

Note that ACO participant entities that want to qualify for PQRS must participate as group practices and not separately participate or earn a PQRS incentive outside of the Shared Savings Program.  Individual ACO providers may not seek to qualify for the individual PQRS incentive under the traditional PQRS plans.  CMS also relaxed its requirements regarding the PQRS incentives.  If an ACO fails to meet the Shared Savings Program quality performance measures and therefore is not eligible for shared savings, the participating entities may still be eligible to receive the PQRS incentive under the Shared Savings Program.   

More Updates Coming

ACO participants should keep an eye out for subregulatory guidance which will detail the annual measure specifications.  CMS plans on releasing specifications in December and in the first quarter of 2012.

For more information regarding the ACO quality measures or ACOs in general, please contact Elana Zana.

Stage 2 Meaningful Use – Delayed to 2014

Posted November 30, 2011 by Elana Zana
Categories: HITECH, Incentive Payments, Meaningful Use

HHS announced today that eligible professionals (“EPs”) and hospitals who begin participating in the EHR Incentive Program in 2011 will not have to meet the Stage 2 Meaningful Use standards until 2014.  Therefore, those EPs and hospitals  participating in the Medicare EHR Incentive Program in 2011 will be able to show Stage 1 meaningful use in 2011, 2012, and 2013.  Those participating in the Medicaid EHR Incentive Program in 2011 will show Adopt, Implement or Upgrade in 2011, and Stage 1 meaningful use 2012 and 2013.

If you have questions on achieving meaningful use or the Medicare and Medicaid EHR Incentive Programs please contact Elana Zana.

The Nuts and Bolts of Determining Shared Savings and Losses for ACOs.

Posted November 28, 2011 by Carrie Soli
Categories: Accountable Care Organizations, Health Reform, Medicare

Under the final rules released by CMS on Accountable Care Organizations (“ACOs”), CMS offers ACOs the opportunity to participate in one of two models — a shared savings only model during the duration of the ACO’s first agreement period (Track 1), or a two-sided model in which there is a sharing of both savings and losses (Track 2).

Track 1 – Shared Savings Only Model

Citing the importance of attracting broad participation in the ACO program, including from small, rural, safety net and small and medium-sized physician groups, CMS created a shared savings only model for the duration of the ACO’s first three-year agreement period.  Under Track 1, which CMS deems a “gentler on ramp” into the ACO world, the ACO shares in the savings without the financial risk of sharing in the losses.  After the initial agreement period, the ACO must move to the two-sided model under Track 2.  Unlike in the Proposed Rule, ACOs who experience net losses under Track 1 in their first agreement period may renew their participation under Track 2.

Track 2 – Shared Savings/Losses Model

Track 2 is known as a two-sided model in which the ACO shares in both the savings and losses, with the opportunity for higher reward in exchange for performance-based risk.  Track 2 is available for ACOs during their first agreement period, and is the only option available for ACOs who have exhausted their first agreement period under Track 1.

Determining Shared Savings

In order to determine shared savings, CMS must take the following steps for each ACO:

Step 1.  Establish the expenditure benchmark.  The expenditure benchmark is a three-year benchmark (one year for each year in the agreement period).

Determining Patient Population for Whom the Benchmark is Calculated

 CMS’ methodology for establishing an ACO’s expenditure benchmark is based on the Medicare FFS Parts A and B expenditures of beneficiaries who would have been assigned to the ACO in any of the three years prior to the start of an ACO’s agreement period using the ACO participants’ TINs identified at the start of the agreement period.  CMS indicated, however, that it favors a benchmarking methodology based on an ACO’s actual  assigned population and intends to revisit whether it should adopt such a methodology in future rulemaking.

CMS calculates the benchmark expenditures by categorizing beneficiaries in the following cost categories:  ESRD, disabled, aged/dual eligible Medicare and Medicaid beneficiaries and aged/non-dual eligible Medicare and Medicaid beneficiaries.  CMS also finalized its proposal to truncate an assigned beneficiary’s total annual Parts A and B FFS per capita expenditures at the 99th percentile of the national Medicare FFS expenditures for each benchmark performance year, which has the advantage of excluding outlier payments from the expenditure benchmark calculations.  CMS adopted its proposed policy of weighting benchmark expenditures for each benchmark year as follows:  BY1 = 10%, BY2 = 30% and BY3 = 60%.

Benchmark Adjustments

 CMS adopted the CMS-HHC risk adjustment model that has been used under the Medicare Advantage program for adjusting the ACO’s benchmark expenditures. CMS will make additional risk adjustments for performance years to take into account changes in assigned beneficiaries.  For newly assigned beneficiaries, CMS will annually update the ACO’s CMS-HHC risk scores.  For continuously assigned beneficiaries, if there is no decline in the ACO’s CMS-HHC risk scores, CMS will use demographic factors to adjust for severity and case mix.  However, if the continuously assigned population shows a decline in its CMS-HHC risk scores, CMS will lower the risk score for that population.  An ACO’s updated benchmark will be restated in the appropriate performance year based on the health status of the ACO’s assigned beneficiaries.  In addition, CMS will make adjustments for  ESRD, disabled, aged/dual eligible Medicare and Medicaid beneficiaries and aged/non-dual eligible Medicare and Medicaid beneficiaries.

Trending Factors

CMS finalized its proposal to trend forward the most recent three years of per-beneficiary expenditures using growth rates in per beneficiary expenditures for Medicare Parts A and B services in order to estimate the benchmark for each ACO.  In addition, CMS will make calculations for separate cost categories for ESRD, disabled, aged/dual eligible Medicare and Medicaid beneficiaries and aged/non-dual eligible Medicare and Medicaid beneficiaries.  For initial expenditure determinations in the performance period, CMS finalized its proposed rule to use the national growth rate in expenditures for Part A and B services for FFS beneficiaries.  During the rest of the agreement period, CMS will update the benchmark by a flat amount, using the projected absolute amount of growth in national per capita Medicare Part A and B expenditures.

Step 2.  Determine per capita Medicare expenditures in each performance year of the agreement period.

Step 3.  Determine the appropriate minimum savings rate (MSR).

 CMS stated that the purpose of the MSR is to account for normal variation in expenditures.

Track 1 MSR Sliding Scale – Under Track 1, CMS adopted a sliding MSR scale to account for normal variation in expenditures based on the number of Medicare fee for service beneficiaries assigned to the ACO.  For Track 1 the sliding scale varies from a high of 3.6% – 3.9% for 5,000-5,999 assigned beneficiaries, to a low of 2% for 60,000+ assigned beneficiaries.

Track 2 – Flat 2% MSR.  Under Track 2, CMS will apply a flat two percent MSR to all ACOs.

Step 4.  Determine the appropriate sharing rate for ACOs meeting or exceeding the MSR.

 For those ACOs that have realized savings by meeting or exceeding the MSR, the following shared savings rate percentages will apply:

Track 1 – The ACO may earn up to 50% of the shared savings.

Track 2 – The ACO may  earn up to 60% of the shared savings.

Both Track 1 and Track 2 ACOs will share on a first dollar savings once the ACO achieves savings in excess of the MSR.

Step 5.  Determine the required sharing cap.

 CMS adopted the following payment limits, which are the maximum amounts of shared savings that can be realized by the ACO in any performance year and are intended to avoid creating incentives for excessive reductions in utilization.

Track 1 – 10% of the ACO’s updated expenditure benchmark for the performance year.

Track 2 – 15% of the ACO’s updated expenditure benchmark for the performance year.

Determining Shared Losses

 Just as shared savings must be calculated for ACOs, shared losses for Track 2 ACOs must also be determined.  The methodology for determining shared losses under Track 2 will mirror the methodology for determining shared savings, including a formula for calculating shared losses based on the final sharing rate, use of a MLR to protect against losses resulting from random variation and a loss sharing limit to provide a ceiling on the amount of losses an ACO will be required to repay.  To be responsible for sharing losses with the Medicare program, an ACO’s average per capita Medicare expenditures for the performance year must exceed its updated benchmark costs for the year by at least two percent.  Once losses meet or exceed the MLR (which is calculated as one minus the final sharing rate), an ACO would be responsible for paying the percentage of excess expenditures, on a first dollar basis, up to the proposed annual limit (60%) on shared losses.

For more information regarding the shared savings model or ACO’s in general, please contact Carrie Soli.


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