Wednesday, July 25, 2012

Should doctors use the proposed "administrative claims" PQRS option to avoid the 2015 pay cut?

  • On July 6, 2012, the Centers for Medicare and Medicaid Services (CMS) issued its proposed rule to update the Physician Fee Schedule (PFS), effective January 1, 2013.  This proposed rule can be found here.  CMS is accepting public comments until September 4, 2012, and the final rule is anticipated to be published in November 2012.
  • Physicians who do not report PQRS in 2013 will have their pay cut by 1.5% in 2015. If  providers don't report PQRS during 2014, they will have a 2% penalty during 2016. 
  • CMS is  making easier for provides to report PQRS - for example, physicians reporting PQRS Group Measures (like Asthma, Diabetes, CAD, Preventive Care, etc) will only need to report 20 patients during 2013 instead of the required 30 in 2012.
  • In the fall of 2013, Medicare plans to produce and disseminate Physician Feedback reports at the TIN level to all groups of physicians with 25 or more eligible professionals and to individual physicians that satisfactorily reported measures through PQRS in 2012 using any of the PQRS reporting mechanisms. These reports will include a “first look” at the methodologies that CMS is proposing in this rule for a value-based payment modifier.
  • These are the multiple ways to report PQRS: 

  1. Claims. Reporting the individual Physician Quality Reporting System quality measures or Physician Quality Reporting System measures groups to CMS on the eligible professional's Medicare Part B claims for covered professional services furnished during the applicable reporting period. Please note that as usual,  claims may not be reprocessed or reopened for the sole purpose or reporting on individual Physician Quality Reporting System measures or measures groups. If a physician forgets to add the PQRS quality code to a claim, there is no way to go back and correct the problem like in a registry.
  2. Qualified registry. Reporting the individual Physician Quality Reporting System quality measures or Physician Quality Reporting System measures groups to a qualified registry. The selected registry will submit information to CMS on the eligible professional's behalf.
  3. Direct EHR product. Reporting the individual Physician Quality Reporting System quality measures to CMS by extracting clinical data from a direct EHR product. The providers themselves submit the extracted files from their EHR and submit them to CMS (using the providers account at the QualityNet CMS Portal. I believe last year only 14 providers submitted PQRS data using this option.
  4. EHR data submission vendor. This new 2012 process is similar to the Direct EHR process, except that the vendor (instead of the provider) is responsible to submit the data to the QualityNet CMS Portal.
  5. GPRO web-interface. For a group practices that are comprised of 25 or more eligible professionals, reporting individual PQRS quality measures to CMS using a CMS web-interface. These group practices will need to register with  CMS in the beginning of 2013 in order to use this process during 2013
  6. Administrative claims. Providers will need to register with CMS to participate in this option. CMS then will use Medicare part B claims data to calculate certain PQRS measures. Unlike traditional PQRS, providers don't submit quality data to Medicare. They will give permission to Medicare to analyze claims data to determine whether a clinical quality action related to a quality measure was performed. Medicare wants to encourage providers to report quality using  the options above but a provider that didn't report PQRS using options 1 to 5 during 2013, can still avoid the 2015 PQRS penalty by registering for the "Administrative claims" before the end of January 2015. One of the measures for example is Breast Cancer Screening for Women ≤ 69 (Percentage of eligible women 40-69 who receive a mammogram in during the measurement year or in the year prior to the measurement year.). Usually with the claims and registry process, providers report to PQRS who are the women that got the mammogram. Using the administrative claims method, CMS checks for all the mammogram paid claims and calculates the measure for the provider.

The new "administrative claims" option sounds like an easier option for providers to report PQRS but providers will have limited amount of quality measures available to report. That will mean that a dermatologist that elects to report PQRS using the administrative claims option could be judged by the number of mammograms done on her/his patients, the number of eye exams on diabetes patients or the use of statins.

These are the CMS Proposed Measures for Eligible Professionals and Group Practices who report using Administrative Claims to avoid the 2015 and 2016 PQRS Payment Cut:

  • Bacterial Pneumonia.The number of admissions for bacterial pneumonia per 100,000 population.
  • UTI. The number of discharges for urinary tract infection per 100,000 population. Age 18 Years and Older in a one year time period
  • Dehydration. The number of admissions for dehydration per 100,000 population.
  • Uncontrolled diabetes. The number of discharges for uncontrolled diabetes per 100,000 population. Age 18 Years and Older in a one year time period.
  • Short Term Diabetes complications.The number of discharges for diabetes short-term complications per 100,000. Age 18 Years and Older population in a one year period.
  • Long term diabetes complications. he number of discharges for long-term diabetes complications per 100,000 population. Age 18 Years and in a one year time period.
  •  Lower extremity amputation for diabetes. The number of discharges for lower-extremity amputation among patients with diabetes per 100,000 population Age 18 Years in a one year time period.
  • COPD. The number of admissions for chronic obstructive pulmonary disease (COPD) per 100,000 population.
  • Heart Failure. Percent of the population with admissions for CHF.
  • All Cause Readmission. The rate of provider visits within 30 days of discharge from an acute care hospital per 1,000 discharges among eligible beneficiaries assigned.
  • 30 Day Post Discharge Visit. The rate of provider visits within 30 days of discharge from an acute care hospital per 1,000 discharges among eligible beneficiaries assigned.
  • Follow-Up After Hospitalization for Mental Illness. Percentage of discharges for patients who were hospitalized for treatment of selected mental health disorders and who had an outpatient visit, an intensive outpatient encounter, or partial hospitalization with a mental health practitioner
  • Annual Monitoring for Beneficiaries on Persistent Medications. Percentage of patients 18 years of age and older who received at least 180 treatment days of ambulatory medication therapy for a select therapeutic agent during the measurement year and at least one therapeutic monitoring event for the therapeutic agent in the measurement year.
  • Lack of Monthly INR Monitoring for Beneficiaries on Warfarin. Average percentage of 40-day intervals in which Part D beneficiaries with claims for warfarin do not receive an INR test during the measurement period.
  • Use of Spirometry Testing to Diagnose COPD. Percentage of patients at least 40 years old who have a new diagnosis or newly active chronic obstructive pulmonary disease (COPD) who received appropriate spirometry testing to confirm the diagnosis.
  • Pharmacotherapy Management of COPD Exacerbation. Percentage of chronic obstructive pulmonary disease (COPD) exacerbations for patients 40 years of age and older who had an acute inpatient discharge or ED encounter between January 1–November 30 of the measurement year and were dispensed appropriate medications
  • Statin Therapy for Beneficiaries with Coronary Artery Disease. Medication Possession Ratio (MPR) for statin therapy for individuals over 18 years of age with coronary artery disease.
  • Lipid Profile for Beneficiaries Who Started Lipid-Lowering Medications. Percentage of patients age 18 or older starting lipid-lowering medication during the measurement year who had a lipid panel checked within 3 months after starting drug therapy
  • Osteoporosis Management in Women ≥ 67 Who Had a Fracture. Percentage of women 67 years and older who suffered a fracture and who had either a bone mineral density (BMD) test or prescription for a drug to treat or prevent osteoporosis in the six months after the date of fracture.
  • Dilated Eye Exam for Beneficiaries ≤ 75 with Diabetes. Percentage of adult patients with diabetes aged 18-75 years who received a dilated eye exam by an ophthalmologist or optometrist during the measurement year, or had a negative retinal exam (no evidence of retinopathy) by an eye care professional in the year prior to the measurement year.
  • HbA1c Testing for Beneficiaries ≤ 75 with Diabetes. Percentage of adult patients with diabetes aged 18-75 years receiving one or more A1c test(s) per year.
  • Urine Protein Screening for Beneficiaries ≤ 75 with Diabetes. Percentage of adult diabetes patients aged 18-75 years with at least one test nephropathy screening test during the measurement year or who had evidence existing nephropathy (diagnosis of nephropathy or documentation of microalbuminuria or albuminuria).
  • Lipid Profile for Beneficiaries ≤ 75 with Diabetes. Percentage of adult patients with diabetes aged 18-75 who had an LDL-C test performed during the measurement year.
  • Lipid Profile for Beneficiaries with Ischemic Vascular Disease. Percentage of patients 18 years of age and older who were discharged alive for acute myocardial infarction (AMI), coronary artery bypass graft (CABG) or percutaneous coronary interventions (PCI) from January 1–November 1 of the year prior to the measurement year, or who had a diagnosis of ischemic vascular disease (IVD) during the measurement year and the year prior to measurement year, who had a complete lipid profile during the measurement year.
  • Antidepressant Treatment for Depression. Percentage of discharges for patients who were hospitalized for treatment of selected mental health disorders and who had an outpatient visit, an intensive outpatient encounter, or partial hospitalization with a mental health practitioner.
  • Breast Cancer Screening for Women ≤ 69. Percentage of eligible women 40-69 who receive a mammogram in during the measurement year or in the year prior to the measurement year

I think it would be better for providers to take a proactive approach in 2013 and choose to report PQRS measures connected with their specialty instead of waiting for 2015 and using "administrative claims" with measures that could be unrelated with their specialty.

Tuesday, July 24, 2012

PQRS Reporting for Pulmonologists

During 2012, there are three PQRS group measures that apply to pulmonologists:

  •  #64. Asthma: Asthma Assessment 
  • #53. Asthma: Pharmacologic Therapy 
  • #231. Asthma: Tobacco Use: Screening — Ambulatory Care Setting 
  • #232. Asthma: Tobacco Use: Intervention — Ambulatory Care Setting 
Community Acquired Pneumonia (CAP)
  •  #56. Vital Signs 
  •  #57. Assessment of Oxygen Saturation 
  •  #58. Assessment of Mental Status 
  •  #59. Empiric Antibiotic 
  •  #51. Chronic Obstructive Pulmonary Disease (COPD): Spirometry Evaluation 
  • #52. Chronic Obstructive Pulmonary Disease (COPD) Bronchodilator Therapy 
  • #110. Preventive Care and Screening: Influenza Immunization 
  • #111. Preventive Care and Screening: Pneumonia Vaccination for Patients 65 Years and Older 
  • #226. Preventive Care and Screening: Tobacco Use: Screening and Cessation Intervention 
PQRS Group measures are easier to report than the individual measures: There is a finite number of patients to report (30) on group measures, unlike PQRS individual measures where each provider needs to report at least 80% of the patients to whom the measure applies.
For example, if a pulmonary doctor sees 100 Medicare patients with COPD during the year, she/he will need to report at least 80 of those patients on the COPD measure #51 (Spirometry Evaluation).
However, it will need to report only 30 patients on the COPD Measures Group.

I would like to suggest that it is better to report the COPD Measures Group than the Asthma Measures Group because of the age restriction on the asthma group. The asthma group only applies to patients between the age of 5 and 50. The COPD group applies to anyone older than 18. Because most patients with Medicare are older than 65, it will be easier to get the necessary 30 patients with COPD.

These measures groups can be reported with claims or using a CMS qualified registry like MDinteractive. It is easier to report PQRS with a registry because the doctor always can go back and find the missing quality information and add it to the registry. Claims missing PQRS quality codes cannot be re-submitted to Medicare.

Monday, June 27, 2011

Accountable Care Organization (ACO) Accelerated Development Learning Program

I just came back from a conference organized by Medicare for Accountable Care Organizations (ACO) in Minneapolis.

These are some of the interesting ideas/thoughts/tips that I got there:
Don Berwick, MD, MPP, Administrator, Centers for Medicare & Medicaid Services:

- You don't need to lock patients to reach the Triple Aim of the ACO. Triple Aim is the business plan of the ACO.

- We need medical boards that celebrate when hospital beds are empty. We need to move away from an acute care system

- Medicare got 1200 comments on the Medicare ACO proposed rules.

- ACOs need to change health care delivery - this is not negotiable.

- Medicare is offering different options for ACOs with levels of experience. Using a skiing metaphor: Black diamond - Pioneer ACO. Blue Square - Track 2 Shared Savings ACO (takes risk on all 3 years). Green circle - Track 1 Shared Savings (takes risk only on third year).

- ACOs need to emulate best practices. For example, there are medical groups that have almost 0% complications on hip replacements and send most patients home after 2 days

James Rogers, MD, St. John’s Health System, Springfield, Missouri

Dr. Rogers has experience working with Medicare on a Medicare ACO Prototype — Medicare's Physician Group Practice Demonstration.

You can read more about this program at the New England Journal of Medicine

As you can see in this NEJM table, St. John's received no money on year 1 or 2, received $3,143,044 on year 3 and $8,185,757 on year 4.

One of the focus on this group was heart failure and nursing home transitions. Also putting nurse case manager on the ER was very important for their success during PGP. That prevented some hospital admissions related with "social" reasons.

There were able to decrease COPD admissions by vaccinating all COPD (they even send nurses to patients homes to give them shots) and worked on a smoke cessation program. An "emergency box" with prednisone and antibiotics was given to COPD patients. When the patient was short of breath, he could call the doctor and get permission to take the meds. Dr. Rogers found out that sending a prescription to the pharmacy of a patient with a COPD exacerbation would take an extra few hours and by then patient would be too short of breath and come to ER.

Dr. Rogers also found out that with direct phone calls between the hospitalists and the PCPs ("warm transfer"), the hospital readmissions drop significantly.

This group had experience already with the Medicare Advantage program and they translated some of this experience into the PGP demonstration program.

St. John's had no EHR initially and they used a homegrown registry to keep track of patients. Their initial billing system was IDX and they used it to track all the diagnosis and visits. The registry produced a "Visit Planner" with lists of all tests that patient is missing at the time a patient visits a doctor.

The PGP Medicare bonus was distributed the following way: Medicare got 20% savings and group got 80%. The group divided 50% to providers and 50% to system to pay for investment.

St John's managed 29000 medicare patients under the PGP. St. John Clinic changed job descriptions to some of their staff and it was able to only spend an extra $0.5m during first year and then $250-350k on the following years with infrastructure. St. John realized 3% savings on Medicare total costs.

There was a 30% change between year 3 and 4 on the Medicare population under PGP.

It is very important to keep track of the patient in almost real-time. Claims data sent from Medicare to St. John's was not used to track patients. St. John's used their own billing data. Around the 4th year, St. John's made a transition to an EHR and they lost some of the tracking abilities for a few months. For example, nurse care managers were not able to track CHF patients. That may affect their bonus payments for PGP year 5.

Barbara Walters, MD
Senior Medical director, Dartmouth-Hitchcock Medical Center

Dr. Walters also had experience with the PGP program at Dartmouth-Hitchcock Medical Center.

Dartmouth received no money on year 1, received $6,689,879 on year 2 and $3,570,173 on year 3 and $378,798 on year 4. They attribute the later decrease on the PGP bonus amount to a transition to an EHR.

Interesting, Marshfield Clinic, another PGP group (they didn't present their data on this meeting) made $4.5M on year 1, $5,8M on year 2, $13,8M on year 3 and $16,2M on year 4. This Wisconsin group already had an EHR before joining the PGP.

Dr. Walters thinks that another factor on the success under PGP is related with population size. It seems that no PGP group was able to get a bonus by managing Medicare populations below 15,000 patients. Dartmouth managed 32,000 patients and St. John's managed 29,000 patients.

Dartmouth also a focus on managing patients with CHF.
They selected high risk patient populations based on:
3 comorbidities, > 7 E&M visits, >10K on total Medical expenses or patients on 3 different classes of medications. They marked this patients as "Goldstar".

Dr. Walters had a practical way to define patients that are attributed to the Medicare ACO/PGP program- if >3 visits with the group doctors, they belong to the group.

Dartmouth also used commercial software to define high risk populations ("Episode Treatment Groups") and they got the same results by just asking medical offices about who were the high risk patients. Medical offices were advised to give same day appointments to anyone on the priority list (Goldstar patients) that called.


Craig Samitt, MD, Chief Executive Officer, Dean Health

Dr. Samitt talked about his experience of doing a transition from a volume based healthcare system to a value based system. He previously worked with Harvard Pilgrim and with Fallon Clinic in Massachusetts.

PCPs are essential on this transition. Interestingly, PCPs only earn 4% of total medical expenses (TME). Dean gave a 15% payment increase to PCPs (with a negligible effect on TME) and saved a lot of money.

Dean moved to a Value system by paying doctors based on Access/Growth (the doctor can choose new patient growth or appointment availability), patient satisfaction, quality (doctors can choose quality measures on the first year, then improve quality on second year) and achieving meaningful use.

They reward doctors with a blend of corporate performance (total cost of care), department level performance (quality) and individual performance (patient satisfaction).

They measure performance first then link to compensation. They offer a menu of options to make transition palatable.

Dean System made the incentive small initially (1-2% each) with low thresholds and then changed the metrics, increased the weights, decreased the options and raised the thresholds over time.

Received $18,000 check from Medicare for Meaningful Use Attestation with Care360 EHR

I submitted my Medicare EHR Incentive Attestation with Care360 EHR on April 18, 2011
I got a $18,000 Medicare check today:

"CMS FAQ on Payment for the Medicare EHR Incentive Program:

Question: I am an eligible professional (EP) who has successfully attested for the Medicare EHR Incentive Program, so why haven't I received my incentive payment yet?

Answer: For EPs, incentive payments for the Medicare EHR Incentive Program will be made approximately four to eight weeks after an EP successfully attests that they have demonstrated meaningful use of certified EHR technology. However, EPs will not receive incentive payments within that timeframe if they have not yet met the threshold for allowed charges for covered professional services furnished by the EP during the year.

The Medicare EHR incentive payments to EPs are based on 75% of the estimated allowed charges for covered professional services furnished by the EP during the entire payment year. Therefore, to receive the maximum incentive payment of $18,000 for the first year of participation in 2011 or 2012, the EP must accumulate $24,000 in allowed charges. If the EP has not met the $24,000 threshold in allowed charges at the time of attestation, CMS will hold the incentive payment until the EP meets the $24,000 threshold in order to maximize the amount of the EHR incentive payment the EP receives. If the EP still has not met the $24,000 threshold in allowed charges by the end of calendar year, CMS expects to issue an incentive payment for the EP in March 2012 (allowing 60 days after the end of the 2011 calendar year for all pending claims to be processed).

Payments to Medicare EPs will be made to the taxpayer identification number (TIN) selected at the time of registration, through the same channels their claims payments are made. The form of payment (electronic funds transfer or check) will be the same as claims payments.

Bonus payments for EPs who practice predominantly in a geographic Health Professional Shortage Area (HPSA) will be made as separate lump-sum payments no later than 120 days after the end of the calendar year for which the EP was eligible for the bonus payment.

Want more information about the EHR Incentive Programs?
Make sure to visit the CMS EHR Incentive Programs website for the latest news and updates on the EHR Incentive Programs."

Monday, April 18, 2011

Medicare EHR Incentive Attestation with Care360 EHR

I submitted my Medicare EHR Incentive Attestation with Care360 EHR today at 9.10am.
I was the 25th physician in the US to submit the attestation to Medicare.
I started the attestation process at 8.10am.

These are steps for the attestation using the "Medicare & Medicaid EHR Incentive Program Registration and Attestation System":

Saturday, April 2, 2011

Medicare ACO proposed rules: Highlights

The Medicare ACO proposed rules can be found at:

Medicare Program; Medicare Shared Savings Program: Accountable Care Organizations

These are some of the highlights of this 429 pages document:

"The following groups of providers of services and suppliers are eligible to participate:
• ACO professionals in group practice arrangements.
• Networks of individual practices of ACO professionals.
• Partnerships or joint venture arrangements between hospitals and ACO professionals.
• Hospitals employing ACO professionals.
• Such other groups of providers of services and suppliers as the Secretary determines appropriate.

The ACO shall enter into an agreement with the Secretary to participate in the program for not less than a 3-year period.

At a minimum, the ACO shall have at least 5,000 such beneficiaries assigned to it in order to be eligible to participate in the Shared Savings Program.

The ACO shall demonstrate to the Secretary that it meets patient-centeredness criteria specified by the Secretary, such as the use of patient and caregiver assessments or the use of individualized care plans.

ACO is eligible to receive payment for shared savings if the following occur:
• The ACO meets quality performance standards established by the Secretary;
• The ACO meets the requirements for realizing savings.

We will focus on achieving, as our highest-level goal, the three-part aim which consists of the following:

• Better care for individuals – as described by all six dimensions of quality in the Institute of Medicine report: safety, effectiveness, patient-centeredness, timeliness, efficiency, and equity;
• Better health for populations with respect to educating beneficiaries about the upstream causes of ill health – like poor nutrition, physical inactivity, substance abuse, economic disparities – as well as the importance of preventive services such as annual physicals and flu shots; and
• Lower growth in expenditures by eliminating waste and inefficiencies while not withholding any needed care that helps beneficiaries.

For purposes of this proposed rule, we propose definitions for the following
• Accountable care organization (ACO) means a legal entity that is recognized
and authorized under applicable State law, as identified by a Taxpayer Identification Number (TIN), and comprised of an eligible group (as discussed in section II.B. of this
proposed rule) of ACO participants that work together to manage and coordinate care for
Medicare FFS beneficiaries and have established a mechanism for shared governance that
provides all ACO participants with an appropriate proportionate control over the ACO's
decision making process,
• ACO participant means a Medicare-enrolled provider of services and/or a supplier, (as discussed in section II.B. of this proposed rule, as identified by a TIN).
• ACO provider/supplier means a provider of services and/or a supplier (as
discussed in section II.B. of this proposed rule) that bills for items and services it
furnishes to Medicare beneficiaries under a Medicare billing number assigned to the TIN
of an ACO participant in accordance with applicable Medicare rules and regulations.

We note that by proposing that the ACO be required to have a TIN, we are not
proposing to require that the ACO itself be enrolled in the Medicare program, in contrast to this requirement for each ACO participant.

We are not proposing to require that existing legal entities appropriately recognized under State law must form a separate new entity for the purpose of participating in the Shared Savings Program.

The Act requires that an ACO have a "mechanism for shared governance"

We believe that such a governance mechanism should allow for appropriate proportionate control for ACO participants, giving each ACO participant a voice in the
ACO's decision making process, and be sufficient to meet the statutory requirements
regarding clinical and administrative systems.

The governing body may be a board of directors, board of managers, or any other governing body that provides a mechanism for shared governance and decision-making for all ACO participants, and that has the authority to execute the statutory functions of an ACO, including for example, to "define processes to promote evidence-based medicine and patient engagement, report on quality and cost measures, and coordinate care,".

We propose that in order to be eligible for participation in the Shared Savings Program, the ACO participants must have at least 75 percent control of the ACO's governing body.

In addition, each of the ACO participants must choose an appropriate representative from within its organization to represent them on the governing body. This proposal ensures that ACOs remain provider-driven, but also leaves room for both non-providers and small provider groups to participate in the program.

We are proposing that ACOs meet the following criteria:
• The ACO's operations would be managed by an executive, officer, manager, or
general partner, whose appointment and removal are under control of the organization's
governing body and whose leadership team has demonstrated the ability to influence or
direct clinical practice to improve efficiency processes and outcomes.

Clinical management and oversight would be managed by a senior-level medical director who is a board-certified physician, licensed in the State in which the ACO operates, and physically present in that State.

• ACO participants and ACO providers/suppliers would have a meaningful commitment to the ACO's clinical integration program to ensure its likely success.
Meaningful commitment may include, for example, a meaningful financial investment in
the ACO, or a meaningful human investment (for example, time and effort) in the
ongoing operations of the ACO such that the potential loss or recoupment of the
investment is likely to motivate the participant to make the clinical integration program
• The ACO would have a physician-directed quality assurance and process improvement committee that would oversee an ongoing quality assurance and improvement program. The quality assurance program would establish internal performance standards for quality of care and services, cost effectiveness, and process and outcome improvements, and hold ACO providers/suppliers accountable for meeting the performance standards. The program would also have processes and procedures in place to identify and correct poor compliance with such standards and to promote continuous quality improvement.
• The ACO would develop and implement evidence-based medical practice or
clinical guidelines and processes for delivering care consistent with the goals of better care for individuals, better health for populations, lower growth in expenditures. The guidelines and care delivery processes would cover diagnoses with significant potential for the ACO to achieve quality and cost improvements, taking into account the circumstances of the individual beneficiary, and could be accomplished, for example, through an integrated electronic health record with clinical decision support. ACO participants and ACO providers/suppliers would have to agree to comply with these guidelines and processes and to be subject to performance evaluations and potential remedial actions.
• The ACO would have an infrastructure, such as information technology, that enables the ACO to collect and evaluate data and provide feedback to the ACO providers/suppliers across the entire organization, including providing information to influence care at the point of care via, for example, shared clinical decision support, feedback from patient experience of care surveys or other internal or external quality and utilization assessments.

It is our expectation that ACO participants and ACO providers/suppliers participating in the ACO would make a commitment to participate in the ACO for not less than 3 years.

In order to determine an ACO's compliance with these requirements, as part of the
application process, we are proposing that an ACO would submit all of the following:
• ACO documents (for example, participation agreements, employment contracts,
and operating policies) that describe the ACO participants' and ACO providers/suppliers' rights and obligations in the ACO, the shared savings that will encourage ACO participants and ACO providers /suppliers to adhere to the quality assurance and improvement program and the evidenced-based clinical guidelines;
• Documents that describe the scope and scale of the quality assurance and
clinical integration program, including documents that describe all relevant clinical
integration program systems and processes, such as the internal performance standards
and the processes for monitoring and evaluating performance;
• Supporting materials documenting the ACO's organization and management
structure, including an organizational chart, a list of committees (including names of
committee members) and their structures, and job descriptions for senior administrative
and clinical leaders; and
Evidence that the ACO has a board-certified physician as its medical director
who is licensed in the State in which the ACO resides and that a principal CMS liaison is identified in its leadership structure.
• Evidence that the governing body includes persons who represent the ACO
participants, and that these ACO participants hold at least 75 percent control of the
governing body.

If the ACO is approved for participation, we propose that an authorized representative -- specifically, an executive who has the ability to bind the ACO, must certify to the best of his or her knowledge, information, and belief that the ACO participants agree to the requirements set forth in the 3-year agreement between the ACO and us -- sign a 3-year participation agreement and submit the signed agreement to us.

Distribution of Savings

We propose to make any shared savings payments directly to the ACO as identified by its TIN.

This is part of the rationale for the payment withhold described in more detail in section II.

Therefore, we propose to require ACOs to provide a description in their application of the criteria they plan to employ for distributing shared savings among ACO participants and ACO providers/suppliers, and how any shared savings will be used to align with the aims of better care for individuals, better health for populations, and lower growth in expenditures.

Sufficient Number of Primary Care Providers and Beneficiaries

The Act requires participating ACOs to "include primary
care ACO professionals that are sufficient for the number of Medicare fee-for-service
beneficiaries assigned to the ACO …" and that at a minimum, "the ACO shall have at
least 5,000 such beneficiaries assigned to it"

We discuss our proposal to assign beneficiaries to an ACO on the basis of
primary care services rendered by physicians with primary care specializations in general practice, internal medicine, family practice, and geriatric medicine. We are proposing that this algorithm will also be used to assign beneficiaries during the baseline years in order to establish a historical per capita cost benchmark against which the ACO would be evaluated during each year of the agreement period.

An ACO would be determined to have a sufficient number of primary care ACO professionals to serve the number of Medicare beneficiaries assigned to it if the number of beneficiaries historically assigned over the three-year benchmarking period using the ACO participant TINs exceeds the 5,000 threshold for each year.

We are also proposing to require an ACO to maintain, update, and annually report to us the TINs of its ACO participants and the NPIs associated with the ACO providers/suppliers.

• Patient involvement in ACO governance. As discussed in more detail later in
the document, the ACO would be required to have a Medicare beneficiary on the governing board.

In order to safeguard against any conflicts of interest, any patient(s) included in an ACO's governing body, or an immediate family member, must not have any conflict of interest, and they may not be an ACO provider/supplier within the ACO's network.

We are proposing that all ACO marketing materials, communications, and activities related the ACO and its participation in the Shared Savings Program, such as mailings, telephone calls or community events, that are used to educate, solicit, notify, or contact Medicare beneficiaries or providers/suppliers regarding the ACO and its participation in the Shared Savings Program, be approved by us before use to protect beneficiaries and to ensure that they are not confusing or misleading. This requirement would also apply to any materials or activities used by ACO participants or ACO providers/suppliers on behalf of the ACO to communicate about the ACO's participation in the Shared Savings Program in any manner to Medicare beneficiaries. In addition, we would want to ensure that materials distributed to beneficiaries do not misrepresent Shared Savings Program policies or suggest that we endorse the ACO, its ACO participants, or its ACO providers/suppliers.

We do not believe that the following materials and activities would be subject to our approval:
Beneficiary communications that are informational materials, that are
customized or limited to a subset of beneficiaries;
and materials that do not include information about the ACO or providers in the ACO;
materials that cover beneficiary specific billing and claims issues or other specific individual health related issues; and
educational information on specific medical conditions, (for example, flu shot reminders), or referrals, for example, as discussed in section II. C. of this proposed rule, exceptions to the definition of "marketing" under the HIPAA Privacy Rule.

C. Establishing the 3-year Agreement with the Secretary
1. Options for Start Date of the Performance Year

We propose:
(1) to adopt the general requirement that ACO applications must be submitted by a deadline established by us;
(2) we will review the applications and approve applications from eligible organizations prior to the end of the calendar year;
(3) the requisite 3-year agreement period will begin on the January 1 following approval of an application; and
(4) the ACO's performance periods under the agreement will begin on January 1 of each respective year during the agreement period.

2. Timing and Process for Evaluating Shared Savings

Based upon historical trends, a 3-month run-out would result in a completion percentage of approximately 98.5 percent for physician services and 98 percent for Part A services.
A 6-month run-out of claims data results in a completion percentage of approximately 99.5 percent for physician services and 99 percent for Part A services.

We propose using a 6-month claims run-out to calculate the benchmark and per capita expenditures for the performance year.

3. Data Sharing

"We could provide data to ACOs in different forms with a focus on different levels
of information, for example, aggregated population level data or beneficiary identifiable data. These data could be combined with data collected within the ACO."

4. Sharing Aggregate Data

In the PGP demonstration, we provided several types of aggregate data to the
participating group practices. We generated an annual profile report that provided the
following information:
Financial performance including number of patients seen, number of patients assigned, per capita expenditures, risk score, benchmark, total assigned beneficiary expenditures, minimum savings amount, shareable savings, and annual performance payment.
Quality performance scores, including numerator, denominator, and rate for each measure along with the target benchmark for each measure.
• Aggregated metrics on the assigned beneficiary population, including a breakdown of the population into high risk score beneficiaries, beneficiaries with 1 or more hospitalizations, and chronic disease subpopulations such as patients with congestive heart failure, coronary artery disease, hypertension, chronic obstructive
pulmonary disease, and diabetes.
The number of patients overall and in each subpopulation with emergency department visits, hospital discharges, physician visits and their corresponding rate for the assigned population.

In general, by making similar types of aggregate, data available to ACOs
participating in the Shared Savings Program, we believe ACOs would have a more
complete picture of the services rendered to their assigned FFS beneficiaries

We further propose to include these data in conjunction with the yearly financial and quality performance reports. Additionally, we propose to provide quarterly aggregate data reports to ACOs based upon the most recent 12 months of data from potentially assigned beneficiaries.

5. Identification of Historically Assigned Beneficiaries

We propose to make certain limited beneficiary identifiable data available at the beginning of the first performance year.

Accordingly, we propose to disclose the name, date of birth (DOB), sex and Health Insurance Claim Number (HIC) of the historically assigned beneficiary population.

Therefore, at the beginning of the agreement period, at the request of the ACO,
we are proposing to provide the ACO with a list of beneficiary names, date of birth, sex, and HICN derived from the assignment algorithm used to generate the 3-year benchmark.
As discussed in section II.B. of this proposed rule, these are beneficiaries who received the plurality of primary care services from primary care physicians who are ACO participants.

6. Sharing Beneficiary-Identifiable Claims Data

For these reasons we believe sharing beneficiary identifiable claims data with ACOs will assist them in improving care for individuals, improving health of their population, and reducing the growth in expenditures for their assigned beneficiary population.

Additionally, when an ACO is accepted to participate in the Shared Savings
Program, we propose to require ACOs to enter into a Data Use Agreement (DUA) prior
to receipt of any beneficiary identifiable claims data. Under the DUA, the ACO would be prohibited from sharing the Medicare claims data that we provide through the Shared Savings Program with anyone outside the ACO.

(1) Sharing Data Related to Medicare Parts A and B

(2) Sharing Data Related to Medicare Part D

a. Beneficiary Opportunity to Opt-Out of Claims Data Sharing

Therefore, we propose affording beneficiaries the ability to opt-out of sharing their protected health information with the ACO. We believe this opportunity coupled with notification of how protected health information will be shared and used affords beneficiaries meaningful choice.

An example of the opt-out approach would be that when a beneficiary has a visit with their primary care physician, their physician would inform them at this visit that he or she is an ACO participant or ACO provider/supplier and that the ACO would like to be able to request claims information from us in order to better coordinate the beneficiary's care. If the beneficiary objects, we propose that the beneficiary would be given a form stating that they have been informed of their physician's participation in the ACO and explaining how to opt-out of having their personal data shared. The form could include a phone number and/or email address for beneficiaries to call and request that their data not be shared.

As noted previously, ACOs will only be allowed to request beneficiary identifiable claims data for beneficiaries who have
1) visited a primary care participating provider during the performance year, and
2) have not chosen to opt-out of claims data sharing.

7. New Program Standards Established During 3-Year Agreement Period

We propose that ACOs be subject to future changes in regulation with the
exception of the following program areas:
• Eligibility requirements concerning the structure and governance of ACOs;
• Calculation of sharing rate; and
• Beneficiary assignment.

For example, ACOs would be subject to changes in regulation related to the
quality performance standard. The language of the ACO agreement would be explicit to
ensure that ACOs understand the dynamic nature of this part of the program and what
specific programmatic changes would be incorporated into the agreement.

D. Assignment of Medicare Fee-for-Service Beneficiaries

However, assignment of beneficiaries to ACOs is to be determined only on the basis of primary care services provided by ACO professionals who are physicians.

The term "assignment" in this context refers only to an operational process by which Medicare will determine whether a beneficiary has chosen to receive a sufficient level of the requisite primary care services from physicians associated with a specific ACO so that the ACO may be appropriately designated as exercising basic responsibility
for that beneficiary's care.

It is important to note that the term "assignment" for purposes of this provision in no way implies any limits, restrictions, or diminishment of the rights of Medicare FFS beneficiaries to exercise complete freedom of choice in the physicians and other health care practitioners and suppliers from whom they receive their services.

Therefore, we are proposing to identify an ACO operationally as a collection of Medicare enrolled TINs.

In particular, NPI data will be useful to assess the quality of care furnished by an ACO. For example, NPI information will be necessary to determine what percent of physicians and other practitioners in the ACO are registered in the HITECH program
We are also proposing to require that organizations applying to be an ACO must provide not only their TINs but also a list of associated NPIs for all ACO professionals, including a list that separately identifies physicians that provide primary care.

2. Definition of Primary Care Services

In that section, "primary care services" are defined as a set of services
identified by these HCPCS codes: 99201 through 99215; 99304 through 99340; and
99341 through 99350. Additionally, we would consider the Welcome to Medicare visit
(G0402) and the annual wellness visits (G0438 and G0439) as primary care services for
purposes of the Shared Savings Program.

Assign beneficiaries with physicians designated as primary care providers (internal medicine, general practice, family practice, and geriatric medicine) who are providing the appropriate primary care services to beneficiaries.

3. Prospective vs. Retrospective Beneficiary Assignment to Calculate Eligibility for Shared Savings

We believe that the retrospective approach to beneficiary assignment for purposes of determining eligibility for shared savings is compelling.

Therefore, we are proposing the combined approach of retrospective beneficiary assignment for purposes of determining eligibility for shared savings balanced by the provision of aggregate beneficiary level data for the assigned population of Medicare beneficiaries during the benchmark period.

When the PGP data is modeled with the Shared Savings Program assignment methodology, the assigned patient population would vary by approximately 25 percent from year to year.

4. Majority vs. Plurality Rule for Beneficiary Assignment

Therefore, we are proposing to assign beneficiaries for purposes of the Shared Savings Program to an ACO if they receive a plurality of their primary care services from primary care physicians within that ACO.

E. Quality and Other Reporting Requirements

The collection of information should minimize the burden on providers to the
extent possible. As part of that effort, we have begun and will continuously seek to align Shared Savings Program measures with the methods and measures included in the Medicare and Medicaid EHR Incentive Programs to enable the collection and reporting of performance information to be a seamless part of care delivery and the meaningful use of certified EHR technology.

Align with other Medicare incentive programs such as the Physician Quality Reporting System ("PQRS"; formerly known as the Physician Quality Reporting
Initiative), Electronic Prescribing Incentive Program, Electronic Health Records (EHR)
Incentive Programs
, Hospital Inpatient Quality Reporting Program, and also Medicaid
and private sector initiatives that align with the three-part aim.

c. Proposed Quality Measures for Use in Establishing Quality Performance Standards that ACOs Must Meet for Shared Savings

Based upon the principles described, we are proposing 65 measures (see Table 1) for use in the calculation of the ACO Quality Performance Standard.

Specifically, for the first year of the program, we propose for the quality performance standard to be at the level of full and accurate measures reporting; for subsequent years, we propose the quality performance standard be based on a measures scale with a minimum attainment level as described in section II.E.4 of this proposed rule.
ACOs that do not meet the quality performance thresholds for all proposed measures would not be eligible for shared savings, regardless of how much per capita costs were reduced.

In an effort to provide focus to ACO quality improvement activity, we have
identified 5 key domains:
• Better Care for Individuals:
++ Patient/Caregiver Experience
++ Care Coordination
++ Patient Safety
• Better Health for Populations:
++ Preventive Health
++ At-Risk Population/Frail Elderly Health

As illustrated in the "Method of Data Submission" column of Table 1, we propose to
calculate results for the first program year measures via claims, the Group Practice Reporting Option (GPRO) data collection tool, as discussed in section II.E.4. of this proposed rule, and survey instruments. The ACO GPRO tool would be a new tool based on the data collection tool currently used in the Physician Quality Reporting System (formerly known as the Physician Quality Reporting Initiative) group practice reporting option (GPRO) and Physician Group Practice (PGP) demonstration.

Identical to the sampling method used in the 2011 Physician Quality Reporting System
GPRO I, we plan to require that the random sample for measures reported via ACO GPRO must consist of at least 411 assigned beneficiaries per measure set/domain. If the pool of eligible, GPRO assigned beneficiaries is less than 411 for any measure set/domain, then we plan to require the ACO to report on 100 percent, or all, of the assigned beneficiaries.

We propose aggregating the quality domain scores into a single overall ACO score which would be used to calculate the ACOs final sharing rate for purposes of determining shared savings or shared losses

(4) The Quality Performance Standard Level

That is, under the one-sided model, we propose that an ACO would receive 50 percent of shared savings based on 100 percent complete and accurate reporting on all quality measures.
Similarly, we propose that under the two-sided risk model, ACOs would receive 60 percent of shared savings based on 100 percent complete and accurate
reporting on all quality measures.

5. Incorporation of Other Reporting Requirements related to the Physician Quality Reporting System and Electronic Health Records Technology Under Section 1848 of the Act

We propose to incorporate a Physician Quality Reporting System group practice
reporting option (GPRO) under the Shared Savings Program and further propose that the eligible professionals that are ACO participant providers/suppliers would constitute a group practice for purposes of qualifying for a Physician Quality Reporting System incentive under the Shared Savings Program.

In addition, as a Shared Savings Program requirement separate from the quality measures reporting discussed previously, we propose requiring that at least 50 percent of an ACO's primary care physicians are determined to be "meaningful EHR users"

Such a requirement would be similar to the previous proposal for primary care physicians and would require 50 percent of eligible hospitals that are ACO providers/suppliers achieve meaningful use of certified EHR technology by the start of the second performance year in order for the ACO to continue participation in the Shared Savings Program.

6. Public Reporting

We propose that the following information regarding the ACO be publicly reported:
• Name and location.
• Primary contact.
• Organizational information including--
++ ACO participants;
++ Identification of ACO participants in joint ventures between ACO professionals and
++ Identification of the ACO participant representatives on its governing body; and
++ Associated committees and committee leadership.
• Shared savings information including--
++ Shared savings performance payment received by ACOs or shared losses payable to
us; and
++ Total proportion of shared savings invested in infrastructure, redesigned care
processes and other resources required to support the three-part aim goals of better health for populations, better care for individuals and lower growth in expenditures, including the proportion distributed among ACO participants.
• Quality performance standard scores.

F. Shared Savings Determination

Specifically, we are proposing that ACOs participating in the Shared Savings Program
will have an option between two tracks:

Track 1: Under Track 1, shared savings would be reconciled annually for the first 2 years of the 3-year agreement using a one-sided shared savings approach, with ACOs not being responsible for any portion of the losses above the expenditure target. However, for the third year of the 3-year agreement, an ACO would be required to agree to share any losses that may be generated as well as savings.

Track 2: More experienced ACOs that are ready to share in losses with greater opportunity for reward may elect to immediately enter the two-sided model.

"Benchmark for each agreement period using the most recent available 3 years of per-beneficiary expenditures for parts A and B services for Medicare fee-for-service beneficiaries assigned to the ACO."

Table 8: Shared Savings Program Overview

(e) Ensuring ACO Repayment of Shared Losses

As discussed in section II.F.of this proposed rule, we propose a flat 25 percent withholding rate will be applied annually to an ACO's earned performance payment.

We propose to require that an ACO establish a
self-executing method for repaying losses to the Medicare program by indicating that funds may be recouped from Medicare payments to the ACO's participants, obtaining reinsurance, placing funds in escrow, obtaining surety bonds, establishing a line of credit as evidenced by a letter of credit that the Medicare program can draw upon, or establishing another repayment mechanism, such as those previously discussed.

We propose that an ACO must demonstrate having established a repayment
mechanism, using one or more of the recoupment methods proposed previously, sufficient to ensure repayment of losses equal to at least 1 percent of per capita expenditures for its assigned beneficiaries from the most recent year available. (? $8000 per patient x 1% = $80 per patient x 5000 patients = $400,000 ?)

As a result, it is important to ensure that prior to entry into the Shared Savings Program, the ACO has an appropriate plan for how it will repay any losses incurred during the third year of its agreement when it is automatically transitioned to the two-sided model.

H. Monitoring and Termination of ACOs

In general, the methods we could use to monitor ACO performance may include, but are not limited to the following:

● Analysis of specific financial and quality data as well as aggregated annual and quarterly reports.
● Site visits.
● Assessment and following up investigation of beneficiary and provider complaints.
● Audits (including, for example, analysis of claims, chart review, beneficiary
surveys, coding audits).

1. Waivers of CMP, Anti-Kickback, and Physician Self-Referral Laws

We expect that the waivers applicable to ACOs participating in the Shared Savings
Program will be issued concurrently with our publication of the Shared Savings Program final rule.

For comments regarding the proposed rules see:

Saturday, February 12, 2011

How a physician can send a secure Direct message from Care360 EHR to a patient's Healthvault PHR account

As described by Sean and by Halamka with the Direct Project any medical Provider with an EHR that offers a Direct email account, can send secure email messages to a patient.

I am going to demo it with my Care360 EHR account:

First type a message to the patients Direct email or his regular email. When you don't know your patient Direct email on Healthvault you just send an email to with a subject line containing the patient's existing email account. I also attached to the message the patient's Continuity of Care Document (CCD).

The patient John Doe will get a regular email from you:

Then the patient will sign to his HealthVault account or create one

My patient John Doe can now see my Care360 EHR message and also his Continuity of Care Document (CCD).

Patient John Doe can decide or not to add the CCD to his HealthVault account

The CCD sent from Care360 EHR looks like this on HealthVault:

These are really very exciting times in healthcare :-)