[Federal Register Volume 74, Number 226 (Wednesday, November 25, 2009)]
[Rules and Regulations]
[Pages 61738-62188]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-26502]
[[Page 61737]]
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Part II
Book 2 of 2 Books
Pages 61737-62206
Department of Health and Human Services
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Centers for Medicare & Medicaid Services
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42 CFR Parts 410, 411, 414 et al.
Medicare Program; Payment Policies Under the Physician Fee Schedule and
Other Revisions to Part B for CY 2010; Final Rule; Medicare Program;
Solicitation of Independent Accrediting Organizations To Participate in
the Advanced Diagnostic Imaging Supplier Accreditation Program; Notice
Federal Register / Vol. 74, No. 226 / Wednesday, November 25, 2009 /
Rules and Regulations
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
42 CFR Parts 410, 411, 414, 415, 485, and 498
[CMS-1413-FC]
RINs 0938-AP40
Medicare Program; Payment Policies Under the Physician Fee
Schedule and Other Revisions to Part B for CY 2010
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Final rule with comment period.
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SUMMARY: This final rule with comment period implements changes to the
physician fee schedule and other Medicare Part B payment policies to
ensure that our payment systems are updated to reflect changes in
medical practice and the relative value of services. It also implements
or discusses certain provisions of the Medicare Improvements for
Patients and Providers Act of 2008. (See the Table of Contents for a
listing of the specific issues addressed in this rule.)
This final rule with comment period also finalizes the calendar
year (CY) 2009 interim relative value units (RVUs) and issues interim
RVUs for new and revised codes for CY 2010. In addition, in accordance
with the statute, it announces that the update to the physician fee
schedule conversion factor is -21.2 percent for CY 2010, the
preliminary estimate for the sustainable growth rate for CY 2010 is -
8.8 percent, and the conversion factor (CF) for CY 2010 is $28.4061.
DATES: Effective Dates: With the exception of the provisions of Sec.
414.68 and Sec. 414.210(e)(5), this final rule is effective on January
1, 2010. The provisions of Sec. 414.68 are effective on October 30,
2009, and the provisions of Sec. 414.210(e)(5) are effective on July
1, 2010.
Comment Date: To be assured consideration, comments must be
received at one of the addresses provided below, no later than 5 p.m.
on December 29, 2009.
ADDRESSES: In commenting, please refer to file code CMS-1413-FC.
Because of staff and resource limitations, we cannot accept comments by
facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one
of the ways listed):
1. Electronically. You may submit electronic comments on this
regulation to http://www.regulations.gov. Follow the instructions under
the ``More Search Options'' tab.
2. By regular mail. You may mail written comments to the following
address ONLY: Centers for Medicare & Medicaid Services, Department of
Health and Human Services, Attention: CMS-1413-FC, P.O. Box 8013,
Baltimore, MD 21244-8013.
Please allow sufficient time for mailed comments to be received
before the close of the comment period.
3. By express or overnight mail. You may send written comments to
the following address ONLY: Centers for Medicare & Medicaid Services,
Department of Health and Human Services, Attention: CMS-1413-FC, Mail
Stop C4-26-05, 7500 Security Boulevard, Baltimore, MD 21244-1850.
4. By hand or courier. If you prefer, you may deliver (by hand or
courier) your written comments before the close of the comment period
to either of the following addresses:
a. For delivery in Washington, DC--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, Room 445-G, Hubert H. Humphrey Building, 200
Independence Avenue, SW., Washington, DC 20201.
(Because access to the interior of the Hubert H. Humphrey Building
is not readily available to persons without Federal government
identification, commenters are encouraged to leave their comments in
the CMS drop slots located in the main lobby of the building. A stamp-
in clock is available for persons wishing to retain a proof of filing
by stamping in and retaining an extra copy of the comments being
filed.)
b. For delivery in Baltimore, MD--
Centers for Medicare & Medicaid Services, Department of Health and
Human Services, 7500 Security Boulevard, Baltimore, MD 21244-1850.
If you intend to deliver your comments to the Baltimore address,
please call telephone number (410) 786-9994 in advance to schedule your
arrival with one of our staff members.
Comments mailed to the addresses indicated as appropriate for hand
or courier delivery may be delayed and received after the comment
period.
FOR FURTHER INFORMATION CONTACT: Rick Ensor, (410) 786-5617, for issues
related to practice expense methodology.
Craig Dobyski, (410) 786-4584, for issues related to geographic
practice cost indices and malpractice RVUs.
Ken Marsalek, (410) 786-4502, for issues related to the physician
practice information survey and the multiple procedure payment
reduction.
Regina Walker-Wren, (410) 786-9160, for issues related to the
phasing out of the outpatient mental health treatment limitation.
Diane Stern, (410) 786-1133, for issues related to the physician
quality reporting initiative and incentives for e-prescribing.
Lisa Grabert, (410) 786-6827, for issues related to the Physician
Resource Use Feedback Program.
Colleen Bruce, (410) 786-5529, for issues related to value-based
purchasing.
Sandra Bastinelli, (410) 786-3630, for issues related to the
implementation of accreditation standards.
Jim Menas, (410) 786-4507, for issues related to teaching
anesthesia services.
Sarah McClain, (410) 786-2994, for issues related to the coverage
of cardiac rehabilitation services.
Dorothy Shannon, (410) 786-3396, for issues related to payment for
cardiac and pulmonary rehabilitation services.
Roya Lotfi, (410) 786-4072, for issues related to the coverage of
pulmonary rehabilitation.
Jamie Hermansen, (410) 786-2064, for issues related to kidney
disease patient education programs.
Terri Harris, (410) 786-6830, for issues related to payment for
kidney disease patient education.
Brijet Burton, (410) 786-7364, for issues related to the compendia
for determination of medically-accepted indications for off-label uses
of drugs and biologicals in an anti-cancer chemotherapeutic regimen.
Henry Richter, (410) 786-4562, or Lisa Hubbard, (410) 786-5472, for
issues related to renal dialysis provisions and payments for end-stage
renal disease facilities.
Cheryl Gilbreath, (410) 786-5919, for issues related to payment for
covered outpatient drugs and biologicals.
Edmund Kasaitis, (410) 786-0477, or Bonny Dahm, (410) 786-4006, for
issues related to the Competitive Acquisition Program (CAP) for Part B
drugs.
Pauline Lapin, (410) 786-6883, for issues related to the
chiropractic services demonstration BN issue.
Monique Howard, (410) 786-3869, for issues related to CORF
conditions of coverage.
Roechel Kujawa, (410) 786-9111, for issues related to ambulance
services.
Anne Tayloe Hauswald, (410) 786-4546, for clinical laboratory
issues.
Troy Barsky, (410) 786-8873, or Roy Albert, (410) 786-1872, for
issues related to physician self-referral.
Christopher Molling, (410) 786-6399, or Anita Greenberg, (410) 786-
4601, for issues related to the repeal of transfer of title for oxygen
equipment.
[[Page 61739]]
Michelle Peterman, (410) 786-2591, or Iffat Fatima, (410) 786-6709
for issues related to the grandfathering provisions of the durable
medical equipment, prosthetics, orthotics, and supplies (DMEPOS)
Competitive Acquisition Program.
Ralph Goldberg, (410) 786-4870, or Heidi Edmunds, (410) 786-1781,
for issues related to the damages process caused by the termination of
contracts awarded in 2008 under the DMEPOS Competitive Bidding program.
Diane Milstead, (410) 786-3355, or Gaysha Brooks, (410) 786-9649,
for all other issues.
SUPPLEMENTARY INFORMATION:
Submitting Comments: We welcome comments from the public on the
following issues: interim relative value units (RVUs) for selected
codes identified in Addendum C; the physician self-referral designated
health services (DHS) codes listed in Tables 31 and 32; services for
consideration for the Five-Year Review of work RVUs for services as
discussed in section II.P., and information concerning services
provided under arrangement as discussed in section II.N.2.
Inspection of Public Comments: All comments received before the
close of the comment period are available for viewing by the public,
including any personally identifiable or confidential business
information that is included in a comment. We post all comments
received before the close of the comment period on the following Web
site as soon as possible after they have been received: http://www.regulations.gov. Follow the search instructions on that Web site to
view public comments.
Comments received timely will also be available for public
inspection as they are received, generally beginning approximately 3
weeks after publication of a document, at the headquarters of the
Centers for Medicare & Medicaid Services, 7500 Security Boulevard,
Baltimore, Maryland 21244, Monday through Friday of each week from 8:30
a.m. to 4 p.m. To schedule an appointment to view public comments,
phone 1-800-743-3951.
Table of Contents
To assist readers in referencing sections contained in this
preamble, we are providing a table of contents. Some of the issues
discussed in this preamble affect the payment policies, but do not
require changes to the regulations in the Code of Federal Regulations
(CFR). Information on the regulation's impact appears throughout the
preamble, and therefore, is not discussed exclusively in section XIII.
of this final rule with comment period.
I. Background
A. Development of the Relative Value System
1. Work RVUs
2. Practice Expense Relative Value Units (PE RVUs)
3. Resource-Based Malpractice (MP) RVUs
4. Refinements to the RVUs
5. Adjustments to RVUs Are Budget Neutral
B. Components of the Fee Schedule Payment Amounts
C. Most Recent Changes to the Fee Schedule
II. Provisions of the Final Regulation and Analysis of the Public
Comments
A. Resource-Based Practice Expense (PE) Relative Value Units
(RVUs)
1. Practice Expense Methodology
a. Data Sources for Calculating Practice Expense
b. Allocation of PE to Services
c. Facility and Non-Facility Costs
d. Services With Technical Components (TCs) and Professional
Components (PCs)
e. Transition Period
f. PE RVU Methodology
2. PE Revisions for CY 2010
a. SMS and Supplemental Survey Background
b. Physician Practice Information Survey (PPIS)
c. Equipment Utilization Rate
d. Miscellaneous PE Issues
e. AMA RUC PE Recommendations for Direct PE Inputs
f. Practice Expense for Intranasal Vaccine Administration Codes
(CPT Codes 90467, 90468, 90473, and 90474)
B. Geographic Practice Cost Indices (GPCIs): Locality Discussion
1. Update--Expiration of 1.0 Work GPCI Floor
2. Payment Localities
C. Malpractice Relative Value Units (RVUs)
1. Background
2. Methodology for the Revision of Resource-Based Malpractice
RVUs
D. Medicare Telehealth Services
1. Requests for Adding Services to the List of Medicare
Telehealth Services
2. Submitted Requests for Addition to the List of Telehealth
Services
a. Health and Behavior Assessment and Intervention (HBAI)
b. Nursing Facility Services
c. Critical Care Services
d. Other Requests
e. Summary: Result of Evaluation of 2010 Requests
3. Other Issues
E. Specific Coding Issues Related to the Physician Fee Schedule
1. Canalith Repositioning
2. Payment for an Initial Preventive Physical Examination (IPPE)
3. Audiology Codes: Policy Clarification of Existing CPT Codes
4. Consultation Services
F. Potentially Misvalued Codes Under the Physician Fee Schedule
1. Valuing Services Under the Physician Fee Schedule
2. High Cost Supplies
3. Review of Services Often Billed Together and the Possibility
of Expanding the Multiple Procedure Payment Reduction (MPPR) to
Additional Nonsurgical Services
4. AMA RUC Review of Potentially Misvalued Services
a. Site of Service
b. ``23-Hour'' Stay
c. AMA RUC Review of Potentially Misvalued Codes for CY 2010
5. PE Issues--Arthoscopy
6. Establishing Appropriate Relative Values for Physician Fee
Schedule Services
G. Issues Related to the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA)
1. Section 102: Elimination of Discriminatory Copayment Rates
for Medicare Outpatient Psychiatric Services
2. Section 131(b): Physician Payment, Efficiency, and Quality
Improvements--Physician Quality Reporting Initiative (PQRI)
3. Section 131(c): Physician Resource Use Measurement and
Reporting Program
4. Section 131(d): Plan for Transition to Value-Based Purchasing
Program for Physicians and Other Practitioners
5. Section 132: Incentives for Electronic Prescribing (E-
Prescribing)--The E-Prescibing Incentive Program
6. Section 135: Implementation of Accreditation Standards for
Suppliers Furnishing the Technical Component (TC) of Advanced
Diagnostic Imaging Services
7. Section 139: Improvements for Medicare Anesthesia Teaching
Programs
8. Section 144(a): Payment and Coverage Improvements for
Patients With Chronic Obstructive Pulmonary Disease and Other
Conditions--Cardiac Rehabilitation Services
9. Section 144(a): Payment and Coverage Improvements for
Patients With Chronic Obstructive Pulmonary Disease and Other
Conditions--Pulmonary Rehabilitation Services
10. Section 144(b): Repeal of Transfer of Title for Oxygen
Equipment
11. Section 152(b): Coverage of Kidney Disease Patient Education
Services
12. Section 153: Renal Dialysis Provisions
13. Section 182(b): Revision of Definition of Medically-Accepted
Indication for Drugs; Compendia for Determination of Medically-
Accepted Indications for Off-Label Uses of Drugs and Biologicals in
an Anti-Cancer Chemotherapeutic Regimen
H. Part B Drug Payment
1. Average Sales Price (ASP) Issues
2. Competitive Acquisition Program (CAP) Issues
I. Provisions Related to Payment for Renal Dialysis Services
Furnished by End-Stage Renal Disease (ESRD) Facilities
J. Discussion of Chiropractic Services Demonstration
1. Background
2. Analysis of Demonstration
3. Payment Adjustment
K. Comprehensive Outpatient Rehabilitation Facilities (CORF) and
Rehabilitation Agency Issues
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L. Ambulance Fee Schedule: Technical Correction to the Rural
Adjustment Factor Regulations (Sec. 414.610)
M. Clinical Laboratory Fee Schedule: Signature on Requisition
N. Physician Self-Referral
1. General Background
2. Physician Stand in the Shoes
3. Services Provided ``Under Arrangements'' (Services Performed
by an Entity Other Than the Entity That Submits the Claim):
Solicitation of Comments
O. Durable Medical Equipment-Related Issues
1. Damages to Suppliers Awarded a Contract Under the Acquisition
of Certain Durable Medical Equipment, Prosthetics, Orthotics, and
Supplies (Medicare DMEPOS Competitive Bidding Program) Caused by the
Delay of the Program
2. Notification to Beneficiaries for Suppliers Regarding
Grandfathering
P. Five-Year Refinement of Relative Value Units
Q. Other Issues--Therapy Caps
III. Refinement of Relative Value Units for Calendar Year 2010 and
Response to Public Comments on Interim Relative Value Units for 2009
A. Summary of Issues Discussed Related to the Adjustment of
Relative Value Units
B. Process for Establishing Work Relative Value Units for the
Physician Fee Schedule
C. Work Relative Value Unit Refinements of Interim Relative
Value Units
D. Interim 2009 Codes
E. Establishment of Interim Work Relative Value Units for New
and Revised Physician's Current Procedural Terminology (CPT) Codes
and New Healthcare Common Procedure Coding System Codes (HCPCS) for
2010 (Includes Table Titled ``AMA RUC Recommendations and CMS'
Decisions for New and Revised 2010 CPT Codes'')
F. Discussion of Codes and AMA RUC Recommendations
G. Additional Coding Issues
H. Establishment of Interim PE RVUs for New and Revised
Physician's Current Procedural Terminology (CPT) Codes and New
Healthcare Common Procedure Coding System (HCPCS) Codes for 2010
IV. Physician Self-Referral Prohibition: Annual Update to the List
of CPT/HCPCS Codes
A. General
B. Annual Update to the Code List
V. Physician Fee Schedule Update for CY 2010
A. Physician Fee Schedule Update
B. The Percentage Change in the Medicare Economic Index (MEI)
C. The Update Adjustment Factor (UAF)
VI. Allowed Expenditures for Physicians' Services and the
Sustainable Growth Rate (SGR)
A. Medicare Sustainable Growth Rate
B. Physicians' Services
C. Preliminary Estimate of the SGR for 2010
D. Revised Sustainable Growth Rate for 2009
E. Final Sustainable Growth Rate for 2008
F. Calculation of 2010, 2009, and 2008 Sustainable Growth Rates
VII. Anesthesia and Physician Fee Schedule Conversion Factors for CY
2010
A. Physician Fee Schedule Conversion Factor
B. Anesthesia Conversion Factor
VIII. Telehealth Originating Site Facility Fee Payment Amount Update
IX. Provisions of the Final Rule
X. Waiver of Proposed Rulemaking and Delay in Effective Date
XI. Collection of Information Requirements
XII. Response to Comments
XIII. Regulatory Impact Analysis
Regulation Text
Addendum A--Explanation and Use of Addendum B
Addendum B--Relative Value Units and Related Information Used in
Determining Medicare Payments for CY 2010
Addendum C--Codes With Interim RVUs
Addendum D--2010 Geographic Adjustment Factors (GAFs)
Addendum E--2010 Geographic Practice Cost Indices (GPCIs) by State
and Medicare Locality
Addendum F--CY 2010 ESRD Wage Index for Non-Urban Areas Based on
CBSA Labor Market Areas
Addendum G--CY 2010 ESRD Wage Index for Urban Areas Based on CBSA
Labor Market Areas
Addendum H--CPT/HCPCS Imaging Codes Defined by Section 5102(b) of
the DRA
Addendum I--List of CPT/HCPCS Codes Used To Define Certain
Designated Health Services Under Section 1877 of the Social Security
Act
Acronyms
In addition, because of the many organizations and terms to which
we refer by acronym in this final rule with comment period, we are
listing these acronyms and their corresponding terms in alphabetical
order below:
AA Anesthesiologist assistant
AACVPR American Association of Cardiovascular and Pulmonary
Rehabilitation
AANA American Association of Nurse Anesthetists
ABMS American Board of Medical Specialties
ABN Advanced Beneficiary Notice
ACC American College of Cardiology
ACGME Accreditation Council on Graduate Medical Education
ACLS Advanced cardiac life support
ACR American College of Radiology
AED Automated external defibrillator
AFROC Association of Freestanding Radiation Oncology Centers
AHA American Heart Association
AHFS-DI American Hospital Formulary Service--Drug Information
AHRQ [HHS'] Agency for Healthcare Research and Quality
AMA American Medical Association
AMA-DE American Medical Association Drug Evaluations
AMP Average manufacturer price
AO Accreditation organization
AOA American Osteopathic Association
APA American Psychological Association
APTA American Physical Therapy Association
ARRA American Recovery and Reinvestment Act (Pub. L. 111-5)
ASC Ambulatory surgical center
ASP Average sales price
ASRT American Society of Radiologic Technologists
ASTRO American Society for Therapeutic Radiology and Oncology
ATA American Telemedicine Association
AWP Average wholesale price
BBA Balanced Budget Act of 1997 (Pub. L. 105-33)
BBRA [Medicare, Medicaid and State Child Health Insurance Program]
Balanced Budget Refinement Act of 1999 (Pub. L. 106-113)
BIPA Medicare, Medicaid, and SCHIP Benefits Improvement Protection
Act of 2000 (Pub. L. 106-554)
BLS Basic Life support
BN Budget neutrality
BPM Benefit Policy Manual
CABG Coronary artery bypass graft
CAD Coronary artery disease
CAH Critical access hospital
CAHEA Committee on Allied Health Education and Accreditation
CAP Competitive acquisition program
CBIC Competitive Bidding Implementation Contractor
CBP Competitive Bidding Program
CBSA Core-Based Statistical Area
CF Conversion factor
CfC Conditions for Coverage
CFR Code of Federal Regulations
CKD Chronic kidney disease
CLFS Clinical laboratory fee schedule
CMA California Medical Association
CMHC Community mental health center
CMP Civil money penalty
CMS Centers for Medicare & Medicaid Services
CNS Clinical nurse specialist
CoP Condition of participation
COPD Chronic obstructive pulmonary disease
CORF Comprehensive Outpatient Rehabilitation Facility
COS Cost of service
CPEP Clinical Practice Expert Panel
CPI Consumer Price Index
CPI-U Consumer price index for urban customers
CPR Cardiopulmonary resuscitation
CPT [Physicians'] Current Procedural Terminology (4th Edition, 2002,
copyrighted by the American Medical Association)
CR Cardiac rehabilitation
CRNA Certified registered nurse anesthetist
CRP Canalith repositioning
CRT Certified respiratory therapist
CSW Clinical social worker
CY Calendar year
DEA Drug Enforcement Agency
DHS Designated health services
DME Durable medical equipment
DMEPOS Durable medical equipment, prosthetics, orthotics, and
supplies
DOQ Doctor's Office Quality
DOS Date of service
DRA Deficit Reduction Act of 2005 (Pub. L. 109-171)
[[Page 61741]]
DSMT Diabetes self-management training
E/M Evaluation and management
EDI Electronic data interchange
EEG Electroencephalogram
EHR Electronic health record
EKG Electrocardiogram
EMG Electromyogram
EMTALA Emergency Medical Treatment and Active Labor Act
EOG Electro-oculogram
EPO Erythopoeitin
ESRD End-stage renal disease
FAX Facsimile
FDA Food and Drug Administration (HHS)
FFS Fee-for-service
FR Federal Register
GAF Geographic adjustment factor
GAO General Accounting Office
GEM Generating Medicare [Physician Quality Performance Measurement
Results]
GFR Glomerular filtration rate
GPO Group purchasing organization
GPCI Geographic practice cost index
HAC Hospital-acquired conditions
HBAI Health and behavior assessment and intervention
HCPAC Health Care Professional Advisory Committee
HCPCS Healthcare Common Procedure Coding System
HCRIS Healthcare Cost Report Information System
HDRT High dose radiation therapy
HH PPS Home Health Prospective Payment System
HHA Home health agency
HHRG Home health resource group
HHS [Department of] Health and Human Services
HIPAA Health Insurance Portability and Accountability Act of 1996
(Pub. L. 104-191)
HIT Health information technology
HITECH Health Information Technology for Economic and Clinical
Health Act (Title IV of Division B of the Recovery Act, together
with Title XIII of Division A of the Recovery Act)
HITSP Healthcare Information Technology Standards Panel
HIV Human immunodeficiency virus
HOPD Hospital outpatient department
HPSA Health Professional Shortage Area
HRSA Health Resources Services Administration (HHS)
IACS Individuals Access to CMS Systems
ICD International Classification of Diseases
ICF Intermediate care facilities
ICR Intensive cardiac rehabilitation
ICR Information collection requirement
IDTF Independent diagnostic testing facility
IFC Interim final rule with comment period
IMRT Intensity-Modulated Radiation Therapy
IPPE Initial preventive physical examination
IPPS Inpatient prospective payment system
IRS Internal Revenue Service
ISO Insurance services office
IVD Ischemic Vascular Disease
IVIG Intravenous immune globulin
IWPUT Intra-service work per unit of time
JRCERT Joint Review Committee on Education in Radiologic Technology
KDE Kidney disease education
LCD Local coverage determination
MA Medicare Advantage
MA-PD Medicare Advantage--Prescription Drug Plans
MAV Measure Applicability Validation
MCMP Medicare Care Management Performance
MDRD Modification of Diet in Renal Disease
MedCAC Medicare Evidence Development and Coverage Advisory Committee
(formerly the Medicare Coverage Advisory Committee (MCAC))
MedPAC Medicare Payment Advisory Commission
MEI Medicare Economic Index
MIEA-TRHCA Medicare Improvements and Extension Act of 2006 (that is,
Division B of the Tax Relief and Health Care Act of 2006 (TRHCA)
(Pub. L. 109-432)
MIPPA Medicare Improvements for Patients and Providers Act of 2008
(Pub. L. 110-275)
MMA Medicare Prescription Drug, Improvement, and Modernization Act
of 2003 (Pub. L. 108-173)
MMSEA Medicare, Medicaid, and SCHIP Extension Act of 2007 (Pub. L.
110-173)
MNT Medical nutrition therapy
MOC Maintenance of certification
MP Malpractice
MPPR Multiple procedure payment reduction
MQSA Mammography Quality Standards Act of 1992 (Pub. L. 102-539)
MRA Magnetic resonance angiography
MRI Magnetic resonance imaging
MSA Metropolitan statistical area
NBRC National Board for Respiratory Care
NCD National Coverage Determination
NCQDIS National Coalition of Quality Diagnostic Imaging Services
NDC National drug code
NF Nursing facility
NISTA National Institute of Standards and Technology Act
NP Nurse practitioner
NPI National Provider Identifier
NPP Nonphysician practitioner
NQF National Quality Forum
NRC Nuclear Regulatory Commission
OACT [CMS'] Office of the Actuary
OBRA Omnibus Budget Reconciliation Act
ODF Open door forum
OGPE Oxygen generating portable equipment
OIG Office of Inspector General
OMB Office of Management and Budget
ONC [HHS'] Office of the National Coordinator for Health IT
OPPS Outpatient prospective payment system
OSCAR Online Survey and Certification and Reporting
PA Physician assistant
PAT Performance assessment tool
PC Professional component
PCI Percutaneous coronary intervention
PDP Prescription drug plan
PE Practice expense
PE/HR Practice expense per hour
PEAC Practice Expense Advisory Committee
PERC Practice Expense Review Committee
PFS Physician Fee Schedule
PGP [Medicare] Physician Group Practice
PHI Protected health information
PHP Partial hospitalization program
PIM [Medicare] Program Integrity Manual
PLI Professional liability insurance
POA Present on admission
POC Plan of care
PPI Producer price index
PPIS Physician Practice Information Survey
PPS Prospective payment system
PPTA Plasma Protein Therapeutics Association
PQRI Physician Quality Reporting Initiative
PR Pulmonary rehabilitation
PRA Paperwork Reduction Act
PSA Physician scarcity areas
PT Physical therapy
PTCA Percutaneous transluminal coronary angioplasty
PVBP Physician and Other Health Professional Value-Based Purchasing
Workgroup
RA Radiology assistant
RBMA Radiology Business Management Association
RFA Regulatory Flexibility Act
RHC Rural health clinic
RIA Regulatory impact analysis
RN Registered nurse
RNAC Reasonable net acquisition cost
RPA Radiology practitioner assistant
RRT Registered respiratory therapist
RUC [AMA's Specialty Society] Relative (Value) Update Committee
RVU Relative value unit
SBA Small Business Administration
SGR Sustainable growth rate
SLP Speech-language pathology
SMS [AMA's] Socioeconomic Monitoring System
SNF Skilled nursing facility
SOR System of record
SRS Stereotactic radiosurgery
STARS Services Tracking and Reporting System
TC Technical Component
TIN Tax identification number
TRHCA Tax Relief and Health Care Act of 2006 (Pub. L. 109-432)
TTO Transtracheal oxygen
UPMC University of Pittsburgh Medical Center
USDE United States Department of Education
USP-DI United States Pharmacopoeia--Drug Information
VBP Value-based purchasing
WAMP Widely available market price
I. Background
Since January 1, 1992, Medicare has paid for physicians' services
under section 1848 of the Social Security Act (the Act), ``Payment for
Physicians' Services.'' The Act requires that payments under the
physician fee schedule (PFS) are based on national uniform relative
value units (RVUs) based on the relative resources used in furnishing a
service. Section 1848(c) of the Act requires that national RVUs be
established for physician work, practice expense (PE), and malpractice
expense. Before the establishment of the resource-based relative value
system, Medicare payment for physicians'
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services was based on reasonable charges.
A. Development of the Relative Value System
1. Work RVUs
The concepts and methodology underlying the PFS were enacted as
part of the Omnibus Budget Reconciliation Act (OBRA) of 1989 (Pub. L.
101-239), and OBRA 1990, (Pub. L. 101-508). The final rule, published
on November 25, 1991 (56 FR 59502), set forth the fee schedule for
payment for physicians' services beginning January 1, 1992. Initially,
only the physician work RVUs were resource-based, and the PE and
malpractice RVUs were based on average allowable charges.
The physician work RVUs established for the implementation of the
fee schedule in January 1992 were developed with extensive input from
the physician community. A research team at the Harvard School of
Public Health developed the original physician work RVUs for most codes
in a cooperative agreement with the Department of Health and Human
Services (DHHS). In constructing the code-specific vignettes for the
original physician work RVUs, Harvard worked with panels of experts,
both inside and outside the Federal government, and obtained input from
numerous physician specialty groups.
Section 1848(b)(2)(B) of the Act specifies that the RVUs for
anesthesia services are based on RVUs from a uniform relative value
guide, with appropriate adjustment of the conversion factor (CF), in a
manner to assure that fee schedule amounts for anesthesia services are
consistent with those for other services of comparable value. We
established a separate CF for anesthesia services, and we continue to
utilize time units as a factor in determining payment for these
services. As a result, there is a separate payment methodology for
anesthesia services.
We establish physician work RVUs for new and revised codes based on
our review of recommendations received from the American Medical
Association's (AMA) Specialty Society Relative Value Update Committee
(RUC).
2. Practice Expense Relative Value Units (PE RVUs)
Section 121 of the Social Security Act Amendments of 1994 (Pub. L.
103-432), enacted on October 31, 1994, amended section
1848(c)(2)(C)(ii) of the Act and required us to develop resource-based
PE RVUs for each physician's service beginning in 1998. We were to
consider general categories of expenses (such as office rent and wages
of personnel, but excluding malpractice expenses) comprising PEs.
Section 4505(a) of the Balanced Budget Act of 1997 (BBA) (Pub. L.
105-33), amended section 1848(c)(2)(C)(ii) of the Act to delay
implementation of the resource-based PE RVU system until January 1,
1999. In addition, section 4505(b) of the BBA provided for a 4-year
transition period from charge-based PE RVUs to resource-based RVUs.
We established the resource-based PE RVUs for each physicians'
service in a final rule, published November 2, 1998 (63 FR 58814),
effective for services furnished in 1999. Based on the requirement to
transition to a resource-based system for PE over a 4-year period,
resource-based PE RVUs did not become fully effective until 2002.
This resource-based system was based on two significant sources of
actual PE data: the Clinical Practice Expert Panel (CPEP) data; and the
AMA's Socioeconomic Monitoring System (SMS) data. The CPEP data were
collected from panels of physicians, practice administrators, and
nonphysicians (for example, registered nurses (RNs)) nominated by
physician specialty societies and other groups. The CPEP panels
identified the direct inputs required for each physician's service in
both the office setting and out-of-office setting. We have since
refined and revised these inputs based on recommendations from the RUC.
The AMA's SMS data provided aggregate specialty-specific information on
hours worked and PEs.
Separate PE RVUs are established for procedures that can be
performed in both a nonfacility setting, such as a physician's office,
and a facility setting, such as a hospital outpatient department. The
difference between the facility and nonfacility RVUs reflects the fact
that a facility typically receives separate payment from Medicare for
its costs of providing the service, apart from payment under the PFS.
The nonfacility RVUs reflect all of the direct and indirect PEs of
providing a particular service.
Section 212 of the Balanced Budget Refinement Act of 1999 (BBRA)
(Pub. L. 106-113) directed the Secretary of Health and Human Services
(the Secretary) to establish a process under which we accept and use,
to the maximum extent practicable and consistent with sound data
practices, data collected or developed by entities and organizations to
supplement the data we normally collect in determining the PE
component. On May 3, 2000, we published the interim final rule (65 FR
25664) that set forth the criteria for the submission of these
supplemental PE survey data. The criteria were modified in response to
comments received, and published in the Federal Register (65 FR 65376)
as part of a November 1, 2000 final rule. The PFS final rules published
in 2001 and 2003, respectively, (66 FR 55246 and 68 FR 63196) extended
the period during which we would accept these supplemental data through
March 1, 2005.
In the Calendar Year (CY) 2007 PFS final rule with comment period
(71 FR 69624), we revised the methodology for calculating PE RVUs
beginning in CY 2007 and provided for a 4-year transition for the new
PE RVUs under this new methodology.
3. Resource-Based Malpractice (MP) RVUs
Section 4505(f) of the BBA amended section 1848(c) of the Act
requiring us to implement resource-based malpractice (MP) RVUs for
services furnished on or after 2000. The resource-based MP RVUs were
implemented in the PFS final rule published November 2, 1999 (64 FR
59380). The MP RVUs were based on malpractice insurance premium data
collected from commercial and physician-owned insurers from all the
States, the District of Columbia, and Puerto Rico.
4. Refinements to the RVUs
Section 1848(c)(2)(B)(i) of the Act requires that we review all
RVUs no less often than every 5 years. The first Five-Year Review of
the physician work RVUs was published on November 22, 1996 (61 FR
59489) and was effective in 1997. The second Five-Year Review was
published in the CY 2002 PFS final rule with comment period (66 FR
55246) and was effective in 2002. The third Five-Year Review of
physician work RVUs was published in the CY 2007 PFS final rule with
comment period (71 FR 69624) and was effective on January 1, 2007.
(Note: Additional codes relating to the third Five-Year Review of
physician work RVUs were addressed in the CY 2008 PFS final rule with
comment period (72 FR 66360).)
In 1999, the AMA's RUC established the Practice Expense Advisory
Committee (PEAC) for the purpose of refining the direct PE inputs.
Through March 2004, the PEAC provided recommendations to CMS for over
7,600 codes (all but a few hundred of the codes currently listed in the
AMA's Current Procedural Terminology (CPT) codes). As part of the CY
2007 PFS final rule with comment period (71 FR 69624), we implemented a
new
[[Page 61743]]
methodology for determining resource-based PE RVUs and are
transitioning it over a 4-year period.
In the CY 2005 PFS final rule with comment period (69 FR 66236), we
implemented the first Five-Year Review of the MP RVUs (69 FR 66263).
5. Adjustments to RVUs Are Budget Neutral
Section 1848(c)(2)(B)(ii)(II) of the Act provides that adjustments
in RVUs for a year may not cause total PFS payments to differ by more
than $20 million from what they would have been if the adjustments were
not made. In accordance with section 1848(c)(2)(B)(ii)(II) of the Act,
if revisions to the RVUs cause expenditures to change by more than $20
million, we make adjustments to ensure that expenditures do not
increase or decrease by more than $20 million.
As explained in the CY 2009 PFS final rule with comment period
(73FR 69730), as required by section 133(b) of the Medicare
Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L.
110-275), the separate budget neutrality (BN) adjustor resulting from
the third Five-Year Review of physician work RVUs is being applied to
the CF beginning with CY 2009 rather than the work RVUs.
B. Components of the Fee Schedule Payment Amounts
To calculate the payment for every physicians' service, the
components of the fee schedule (physician work, PE, and MP RVUs) are
adjusted by a geographic practice cost index (GPCI). The GPCIs reflect
the relative costs of physician work, PE, and malpractice expense in an
area compared to the national average costs for each component.
RVUs are converted to dollar amounts through the application of a
CF, which is calculated by CMS' Office of the Actuary (OACT).
The formula for calculating the Medicare fee schedule payment
amount for a given service and fee schedule area can be expressed as:
Payment = [(RVU work x GPCI work) + (RVU PE x GPCI PE) + (RVU
malpractice x GPCI malpractice)] x CF.
C. Most Recent Changes to the Fee Schedule
The CY 2009 PFS final rule with comment period (73 FR 69726)
implemented changes to the PFS and other Medicare Part B payment
policies. It also finalized the CY 2008 interim RVUs and implemented
interim RVUs for new and revised codes for CY 2009 to ensure that our
payment systems are updated to reflect changes in medical practice and
the relative value of services. The CY 2009 PFS final rule with comment
period also addressed other policies, as well as certain provisions of
the MIPPA.
As required by the statute, and based on section 131 of the MIPPA,
the CY 2009 PFS final rule with comment period also announced the
following for CY 2009: the PFS update of 1.1 percent, the initial
estimate for the sustainable growth rate of 7.4 percent, and the
conversion factor (CF) of $36.0666.
II. Provisions of the Final Regulation
In response to the CY 2010 PFS proposed rule (74 FR 33520) we
received approximately 16,500 timely public comments. These included
comments from concerned citizens, individual physicians, health care
workers, professional associations and societies, manufacturers and
Congressmen. The majority of the comments addressed proposals related
to the MIPPA provisions concerning teaching anesthesiology and cardiac
and pulmonary rehabilitation, the physician practice information survey
(PPIS), and the impact of the proposed rule on specific specialties. To
the extent that comments were outside the scope of the proposed rule,
they are not addressed in this final rule with comment period.
A. Resource-Based Practice Expense (PE) Relative Value Units (RVUs)
Practice expense (PE) is the portion of the resources used in
furnishing the service that reflects the general categories of
physician and practitioner expenses, such as office rent and personnel
wages but excluding malpractice expenses, as specified in section
1848(c)(1)(B) of the Act.
Section 121 of the Social Security Amendments of 1994 (Pub. L. 103-
432), enacted on October 31, 1994, required CMS to develop a
methodology for a resource-based system for determining PE RVUs for
each physician's service. Until that time, PE RVUs were based on
historical allowed charges. This legislation stated that the revised PE
methodology must consider the staff, equipment, and supplies used in
the provision of a variety of medical and surgical services in various
settings beginning in 1998. The Secretary has interpreted this to mean
that Medicare payments for each service would be based on the relative
PE resources typically involved with furnishing the service.
The initial implementation of resource-based PE RVUs was delayed
from January 1, 1998, until January 1, 1999, by section 4505(a) of the
BBA. In addition, section 4505(b) of the BBA required that the new
payment methodology be phased in over 4 years, effective for services
furnished in CY 1999, and fully effective in CY 2002. The first step
toward implementation of the statute was to adjust the PE values for
certain services for CY 1998. Section 4505(d) of the BBA required that,
in developing the resource-based PE RVUs, the Secretary must--
Use, to the maximum extent possible, generally-accepted
cost accounting principles that recognize all staff, equipment,
supplies, and expenses, not solely those that can be linked to specific
procedures and actual data on equipment utilization.
Develop a refinement method to be used during the
transition.
Consider, in the course of notice and comment rulemaking,
impact projections that compare new proposed payment amounts to data on
actual physician PE.
In CY 1999, we began the 4-year transition to resource-based PE
RVUs utilizing a ``top-down'' methodology whereby we allocated
aggregate specialty[dash]specific practice costs to individual
procedures. The specialty[dash]specific PEs were derived from the
American Medical Association's (AMA's) Socioeconomic Monitoring Survey
(SMS). In addition, under section 212 of the BBRA, we established a
process extending through March 2005 to supplement the SMS data with
data submitted by a specialty. The aggregate PEs for a given specialty
were then allocated to the services furnished by that specialty on the
basis of the direct input data (that is, the staff time, equipment, and
supplies) and work RVUs assigned to each CPT code.
For CY 2007, we implemented a new methodology for calculating PE
RVUs. Under this new methodology, we use the same data sources for
calculating PE, but instead of using the ``top-down'' approach to
calculate the direct PE RVUs, under which the aggregate direct and
indirect costs for each specialty are allocated to each individual
service, we now utilize a ``bottom-up'' approach to calculate the
direct costs. Under the ``bottom up'' approach, we determine the direct
PE by adding the costs of the resources (that is, the clinical staff,
equipment, and supplies) typically required to provide each service.
The costs of the resources are calculated using the refined direct PE
inputs assigned to each CPT code in our PE database, which are based on
our review of recommendations received from the AMA's Relative Value
Update Committee (RUC). For a more detailed
[[Page 61744]]
explanation of the PE methodology, see the Five-Year Review of Work
Relative Value Units Under the PFS and Proposed Changes to the Practice
Expense Methodology proposed notice (71 FR 37242) and the CY 2007 PFS
final rule with comment period (71 FR 69629).
Note: In section II.A.1 of this final rule with comment period
rule, we discuss the current methodology used for calculating PE. In
section II.A.2. of this final rule with comment period, which
contains PE proposals for CY 2010, we summarize and respond to
comments on our proposal to use data from the AMA Physician Practice
Information Survey (PPIS) in place of the AMA's SMS survey data and
supplemental survey data that is currently used in the PE
methodology, as well as our proposal concerning equipment
utilization assumptions.
1. Practice Expense Methodology
a. Data Sources for Calculating Practice Expense
The AMA's SMS survey data and supplemental survey data from the
specialties of cardiothoracic surgery, vascular surgery, physical and
occupational therapy, independent laboratories, allergy/immunology,
cardiology, dermatology, gastroenterology, radiology, independent
diagnostic testing facilities (IDTFs), radiation oncology, and urology
are currently used to develop the PE per hour (PE/HR) for each
specialty. For those specialties for which we do not have PE/HR, the
appropriate PE/HR is obtained from a crosswalk to a similar specialty.
The AMA developed the SMS survey in 1981 and discontinued it in
1999. Beginning in 2002, we incorporated the 1999 SMS survey data into
our calculation of the PE RVUs, using a 5-year average of SMS survey
data. (See the CY 2002 PFS final rule with comment period (66 FR
55246).) The SMS PE survey data are adjusted to a common year, 2005.
The SMS data provide the following six categories of PE costs:
Clinical payroll expenses, which are payroll expenses
(including fringe benefits) for nonphysician clinical personnel.
Administrative payroll expenses, which are payroll
expenses (including fringe benefits) for nonphysician personnel
involved in administrative, secretarial, or clerical activities.
Office expenses, which include expenses for rent, mortgage
interest, depreciation on medical buildings, utilities, and telephones.
Medical material and supply expenses, which include
expenses for drugs, x-ray films, and disposable medical products.
Medical equipment expenses, which include depreciation,
leases, and rent of medical equipment used in the diagnosis or
treatment of patients.
All other expenses, which include expenses for legal
services, accounting, office management, professional association
memberships, and any professional expenses not previously mentioned in
this section.
In accordance with section 212 of the BBRA, we established a
process to supplement the SMS data for a specialty with data collected
by entities and organizations other than the AMA (that is, those
entities and organizations representing the specialty itself). (See the
Criteria for Submitting Supplemental Practice Expense Survey Data
interim final rule with comment period (65 FR 25664).) Originally, the
deadline to submit supplementary survey data was through August 1,
2001. In the CY 2002 PFS final rule (66 FR 55246), the deadline was
extended through August 1, 2003. To ensure maximum opportunity for
specialties to submit supplementary survey data, we extended the
deadline to submit surveys until March 1, 2005 in the Revisions to
Payment Policies Under the Physician Fee Schedule for CY 2004 final
rule with comment period (68 FR 63196) (hereinafter referred to as CY
2004 PFS final rule with comment period).
The direct cost data for individual services were originally
developed by the Clinical Practice Expert Panels (CPEP). The CPEP data
include the supplies, equipment, and staff times specific to each
procedure. The CPEPs consisted of panels of physicians, practice
administrators, and nonphysicians (for example, RNs) who were nominated
by physician specialty societies and other groups. There were 15 CPEPs
consisting of 180 members from more than 61 specialties and
subspecialties. Approximately 50 percent of the panelists were
physicians.
The CPEPs identified specific inputs involved in each physician's
service provided in an office or facility setting. The inputs
identified were the quantity and type of nonphysician labor, medical
supplies, and medical equipment. The CPEP data has been regularly
updated by various RUC committees on PE.
b. Allocation of PE to Services
Currently, the aggregate level specialty-specific PEs are derived
from the AMA's SMS survey and supplementary survey data. For CY 2010,
we discuss in section II.A.2. of this final rule with comment period
how a new data source, PPIS, will be used. To establish PE RVUs for
specific services, it is necessary to establish the direct and indirect
PE associated with each service.
(i) Direct costs. The direct costs are determined by adding the
costs of the resources (that is, the clinical staff, equipment, and
supplies) typically required to provide the service. The costs of these
resources are calculated from the refined direct PE inputs in our PE
database. These direct inputs are then scaled to the current aggregate
pool of direct PE RVUs. The aggregate pool of direct PE RVUs can be
derived using the following formula: (PE RVUs x physician CF) x
(average direct percentage from survey PE/HR data)).
(ii) Indirect costs. Currently, the SMS and supplementary survey
data are the sources for the specialty-specific aggregate indirect
costs used in our PE calculations. For CY 2010, we discuss in section
II.A.2. of this final rule with comment period how a new data source,
PPIS, will be used. We then allocate the indirect costs to the code
level on the basis of the direct costs specifically associated with a
code and the greater of either the clinical labor costs or the
physician work RVUs. For calculation of the 2010 PE RVUs, we use the
2008 procedure-specific utilization data crosswalked to 2010 services.
To arrive at the indirect PE costs--
We apply a specialty-specific indirect percentage factor
to the direct expenses to recognize the varying proportion that
indirect costs represent of total costs by specialty. For a given
service, the specific indirect percentage factor to apply to the direct
costs for the purpose of the indirect allocation is calculated as the
weighted average of the ratio of the indirect to direct costs (based on
the survey data) for the specialties that furnish the service. For
example, if a service is furnished by a single specialty with indirect
PEs that were 75 percent of total PEs, the indirect percentage factor
to apply to the direct costs for the purposes of the indirect
allocation would be (0.75/0.25) = 3.0. The indirect percentage factor
is then applied to the service level adjusted indirect PE allocators.
We currently use the specialty-specific PE/HR from the SMS
survey data, as well as the supplemental surveys for cardiothoracic
surgery, vascular surgery, physical and occupational therapy,
independent laboratories, allergy/immunology, cardiology, dermatology,
radiology, gastroenterology, IDTFs, radiation oncology, and urology.
(Note: For radiation oncology, the data represent the combined survey
data from the
[[Page 61745]]
American Society for Therapeutic Radiology and Oncology (ASTRO) and the
Association of Freestanding Radiation Oncology Centers (AFROC)). As
discussed in the CY 2008 PFS final rule with comment period (72 FR
66233), the PE/HR survey data for radiology is weighted by practice
size. For CY 2010, we discuss in section II.A.2. of this final rule
with comment period how a new data source, PPIS, will be used. We
incorporate this PE/HR into the calculation of indirect costs using an
index which reflects the relationship between each specialty's indirect
scaling factor and the overall indirect scaling factor for the entire
PFS. For example, if a specialty had an indirect practice cost index of
2.00, this specialty would have an indirect scaling factor that was
twice the overall average indirect scaling factor. If a specialty had
an indirect practice cost index of 0.50, this specialty would have an
indirect scaling factor that was half the overall average indirect
scaling factor.
When the clinical labor portion of the direct PE RVU is
greater than the physician work RVU for a particular service, the
indirect costs are allocated based upon the direct costs and the
clinical labor costs. For example, if a service has no physician work
and 1.10 direct PE RVUs, and the clinical labor portion of the direct
PE RVUs is 0.65 RVUs, we would use the 1.10 direct PE RVUs and the 0.65
clinical labor portions of the direct PE RVUs to allocate the indirect
PE for that service.
c. Facility and Non-Facility Costs
Procedures that can be furnished in a physician's office, as well
as in a hospital or facility setting have two PE RVUs: facility and
non-facility. The non-facility setting includes physicians' offices,
patients' homes, freestanding imaging centers, and independent
pathology labs. Facility settings include hospitals, ambulatory
surgical centers (ASCs), and skilled nursing facilities (SNFs). The
methodology for calculating PE RVUs is the same for both facility and
non-facility RVUs, but is applied independently to yield two separate
PE RVUs. Because the PEs for services provided in a facility setting
are generally included in the payment to the facility (rather than the
payment to the physician under the PFS), the PE RVUs are generally
lower for services provided in the facility setting.
d. Services With Technical Components (TCs) and Professional Components
(PCs)
Diagnostic services are generally comprised of two components: a
professional component (PC) and a technical component (TC), both of
which may be performed independently or by different providers. When
services have TCs, PCs, and global components that can be billed
separately, the payment for the global component equals the sum of the
payment for the TC and PC. This is a result of using a weighted average
of the ratio of indirect to direct costs across all the specialties
that furnish the global components, TCs, and PCs; that is, we apply the
same weighted average indirect percentage factor to allocate indirect
expenses to the global components, PCs, and TCs for a service. (The
direct PE RVUs for the TC and PC sum to the global under the bottom-up
methodology.)
e. Transition Period
As discussed in the CY 2007 PFS final rule with comment period (71
FR 69674), the change to the PE methodology was implemented over a 4-
year period. In CY 2010, the transition period for the change to the PE
methodology is complete and PE RVUs will be calculated based entirely
on the current methodology.
f. PE RVU Methodology
The following is a description of the PE RVU methodology. While
there are some changes to the data sources, the methodology remains the
same.
(i) Setup File
First, we create a setup file for the PE methodology. The setup
file contains the direct cost inputs, the utilization for each
procedure code at the specialty and facility/non-facility place of
service level, and the specialty-specific survey PE per physician hour
data.
(ii) Calculate the Direct Cost PE RVUs
Sum the costs of each direct input.
Step 1: Sum the direct costs of the inputs for each service. The
direct costs consist of the costs of the direct inputs for clinical
labor, medical supplies, and medical equipment. The clinical labor cost
is the sum of the cost of all the staff types associated with the
service; it is the product of the time for each staff type and the wage
rate for that staff type. The medical supplies cost is the sum of the
supplies associated with the service; it is the product of the quantity
of each supply and the cost of the supply. The medical equipment cost
is the sum of the cost of the equipment associated with the service; it
is the product of the number of minutes each piece of equipment is used
in the service and the equipment cost per minute. The equipment cost
per minute is calculated as described at the end of this section.
Apply a BN adjustment to the direct inputs.
Step 2: Calculate the current aggregate pool of direct PE costs. To
do this, multiply the current aggregate pool of total direct and
indirect PE costs (that is, the current aggregate PE RVUs multiplied by
the CF) by the average direct PE percentage from the SMS and
supplementary specialty survey data. For CY 2010, we discuss in section
II.A.2. of this final rule with comment period how a new data source,
PPIS, will be used.
Step 3: Calculate the aggregate pool of direct costs. To do this,
for all PFS services, sum the product of the direct costs for each
service from Step 1 and the utilization data for that service.
Step 4: Using the results of Step 2 and Step 3 calculate a direct
PE BN adjustment so that the aggregate direct cost pool does not exceed
the current aggregate direct cost pool and apply it to the direct costs
from Step 1 for each service.
Step 5: Convert the results of Step 4 to an RVU scale for each
service. To do this, divide the results of Step 4 by the Medicare PFS
CF.
(iii) Create the Indirect PE RVUs
Create indirect allocators.
Step 6: Based on the SMS and supplementary specialty survey data,
calculate direct and indirect PE percentages for each physician
specialty. For CY 2010, we discuss in section II.A.2. of this final
rule with comment period how a new data source, PPIS, will be used.
Step 7: Calculate direct and indirect PE percentages at the service
level by taking a weighted average of the results of Step 6 for the
specialties that furnish the service. Note that for services with TCs
and PCs, we are calculating the direct and indirect percentages across
the global components, PCs, and TCs. That is, the direct and indirect
percentages for a given service (for example, echocardiogram) do not
vary by the PC, TC and global component.
Step 8: Calculate the service level allocators for the indirect PEs
based on the percentages calculated in Step 7. The indirect PEs are
allocated based on the three components: the direct PE RVU, the
clinical PE RVU, and the work RVU.
For most services the indirect allocator is:
indirect percentage * (direct PE RVU/direct percentage) + work RVU.
There are two situations where this formula is modified:
If the service is a global service (that is, a service
with global, professional, and technical components), then the
[[Page 61746]]
indirect allocator is: indirect percentage * (direct PE RVU/direct
percentage) + clinical PE RVU + work RVU.
If the clinical labor PE RVU exceeds the work RVU (and the
service is not a global service), then the indirect allocator is:
indirect percentage * (direct PE RVU/direct percentage) + clinical PE
RVU.
Note: For global services, the indirect allocator is based on
both the work RVU and the clinical labor PE RVU. We do this to
recognize that, for the professional service, indirect PEs will be
allocated using the work RVUs, and for the TC service, indirect PEs
will be allocated using the direct PE RVU and the clinical labor PE
RVU. This also allows the global component RVUs to equal the sum of
the PC and TC RVUs.
For presentation purposes in the examples in the Table 1, the
formulas were divided into two parts for each service. The first part
does not vary by service and is the indirect percentage * (direct PE
RVU/direct percentage). The second part is either the work RVU,
clinical PE RVU, or both depending on whether the service is a global
service and whether the clinical PE RVU exceeds the work RVU (as
described earlier in this step.)
Apply a BN adjustment to the indirect allocators.
Step 9: Calculate the current aggregate pool of indirect PE RVUs by
multiplying the current aggregate pool of PE RVUs by the average
indirect PE percentage from the physician specialty survey data. This
is similar to the Step 2 calculation for the direct PE RVUs.
Step 10: Calculate an aggregate pool of indirect PE RVUs for all
PFS services by adding the product of the indirect PE allocators for a
service from Step 8 and the utilization data for that service. This is
similar to the Step 3 calculation for the direct PE RVUs.
Step 11: Using the results of Step 9 and Step 10, calculate an
indirect PE adjustment so that the aggregate indirect allocation does
not exceed the available aggregate indirect PE RVUs and apply it to
indirect allocators calculated in Step 8. This is similar to the Step 4
calculation for the direct PE RVUs.
Calculate the Indirect Practice Cost Index.
Step 12: Using the results of Step 11, calculate aggregate pools of
specialty-specific adjusted indirect PE allocators for all PFS services
for a specialty by adding the product of the adjusted indirect PE
allocator for each service and the utilization data for that service.
Step 13: Using the specialty-specific indirect PE/HR data,
calculate specialty-specific aggregate pools of indirect PE for all PFS
services for that specialty by adding the product of the indirect PE/HR
for the specialty, the physician time for the service, and the
specialty's utilization for the service.
Step 14: Using the results of Step 12 and Step 13, calculate the
specialty-specific indirect PE scaling factors as under the current
methodology.
Step 15: Using the results of Step 14, calculate an indirect
practice cost index at the specialty level by dividing each specialty-
specific indirect scaling factor by the average indirect scaling factor
for the entire PFS.
Step 16: Calculate the indirect practice cost index at the service
level to ensure the capture of all indirect costs. Calculate a weighted
average of the practice cost index values for the specialties that
furnish the service. (Note: For services with TCs and PCs, we calculate
the indirect practice cost index across the global components, PCs, and
TCs. Under this method, the indirect practice cost index for a given
service (for example, echocardiogram) does not vary by the PC, TC and
global component.)
Step 17: Apply the service level indirect practice cost index
calculated in Step 16 to the service level adjusted indirect allocators
calculated in Step 11 to get the indirect PE RVU.
(iv) Calculate the Final PE RVUs.
Step 18: Add the direct PE RVUs from Step 6 to the indirect PE RVUs
from Step 17.
Step 19: Calculate and apply the final PE BN adjustment by
comparing the results of Step 18 to the current pool of PE RVUs. This
final BN adjustment is required primarily because certain specialties
are excluded from the PE RVU calculation for ratesetting purposes, but
all specialties are included for purposes of calculating the final BN
adjustment. (See ``Specialties excluded from ratesetting calculation''
below in this section.)
(v) Setup File Information
Specialties excluded from ratesetting calculation: For the
purposes of calculating the PE RVUs, we exclude certain specialties
such as midlevel practitioners paid at a percentage of the PFS,
audiology, and low volume specialties from the calculation. These
specialties are included for the purposes of calculating the BN
adjustment.
Crosswalk certain low volume physician specialties:
Crosswalk the utilization of certain specialties with relatively low
PFS utilization to the associated specialties.
Physical therapy utilization: Crosswalk the utilization
associated with all physical therapy services to the specialty of
physical therapy.
Identify professional and technical services not
identified under the usual TC and 26 modifiers: Flag the services that
are PC and TC services, but do not use TC and 26 modifiers (for
example, electrocardiograms). This flag associates the PC and TC with
the associated global code for use in creating the indirect PE RVU. For
example, the professional service code 93010 is associated with the
global code 93000.
Payment modifiers: Payment modifiers are accounted for in
the creation of the file. For example, services billed with the
assistant at surgery modifier are paid 16 percent of the PFS amount for
that service; therefore, the utilization file is modified to only
account for 16 percent of any service that contains the assistant at
surgery modifier.
Work RVUs: The setup file contains the work RVUs from this
proposed rule.
(vi) Equipment cost per minute
The equipment cost per minute is calculated as:
(1/(minutes per year * usage)) * price * ((interest rate/(1-(1/((1
+ interest rate) ** life of equipment)))) + maintenance)
Where:
minutes per year = maximum minutes per year if usage were continuous
(that is, usage = 1); 150,000 minutes.
usage = equipment utilization assumption; 0.9 for certain expensive
diagnostic equipment (see section II.A.2. of this final rule with
comment period rule) and 0.5 for others.
price = price of the particular piece of equipment.
interest rate = 0.11.
life of equipment = useful life of the particular piece of
equipment.
maintenance = factor for maintenance; 0.05.
Note: To illustrate the PE calculation, in Table 1 we have used
the conversion factor (CF) of $28.3769 which is the CF effective
January 1, 2010 as published in this final rule with comment period.
BILLING CODE 4120-01-P
[[Page 61747]]
[GRAPHIC] [TIFF OMITTED] TR25NO09.173
[[Page 61748]]
[GRAPHIC] [TIFF OMITTED] TR25NO09.174
BILLING CODE 4120-01-C
[[Page 61749]]
2. PE Revisions for CY 2010
a. SMS and Supplemental Survey Background
Currently, we use PE/HR obtained from the SMS surveys from 1995
through 1999. For several specialties that collected additional PE/HR
data through a more recent supplemental survey, we accepted and
incorporated these data in developing current PE/HR values.
While the SMS survey was not specifically designed for the purpose
of establishing PE RVUs, we found these data to be the best available
at the time. The SMS was a multi-specialty survey effort conducted
using a consistent survey instrument and method across specialties. The
survey sample was randomly drawn from the AMA Physician Masterfile to
ensure national representativeness. The AMA discontinued the SMS survey
in 1999.
As required by the BBRA, we also established a process by which
specialty groups could submit supplemental PE data. In the May 3, 2000
interim final rule entitled, Medicare Program; Criteria for Submitting
Supplemental Practice Expense Survey Data, (65 FR 25664), we
established criteria for acceptance of supplemental data. The criteria
were modified in the CY 2001 and CY 2003 PFS final rules with comment
period (65 FR 65380 and 67 FR 79971, respectively). We currently use
supplemental survey data for the following specialties: cardiology;
dermatology; gastroenterology; radiology; cardiothoracic surgery;
vascular surgery; physical and occupational therapy; independent
laboratories; allergy/immunology; independent diagnostic testing
facilities (IDTFs); radiation oncology; medical oncology; and urology.
Because the SMS data and the supplemental survey data are from
different time periods, we have historically inflated them by the MEI
to help put them on as comparable a time basis as we can when
calculating the PE RVUs. This MEI proxy has been necessary in the past
due to the lack of contemporaneous, consistently collected, and
comprehensive multispecialty survey data.
b. Physician Practice Information Survey (PPIS)
The AMA has conducted a new survey, the PPIS, which was expanded
(relative to the SMS) to include nonphysician practitioners (NPPs) paid
under the PFS. The PPIS, administered in CY 2007 and CY 2008, was
designed to update the specialty-specific PE/HR data used to develop PE
RVUs.
The AMA and our contractor, The Lewin Group (Lewin), analyzed the
PPIS data and calculated the PE/HR for physician and nonphysician
specialties, respectively. The AMA's summary worksheets and Lewin's
final report are available on the CMS Web site at http://www.cms.gov/PhysicianFeeSched/. (See AMA PPIS Worksheets 1-3 and Lewin Group Final
Report PPIS.) We also included a table in the proposed rule showing the
current indirect PE/HR based on SMS and supplemental surveys, the PPIS
indirect PE/HR, and the indirect cost percentages of total costs (74 FR
33530 through 33531).
The PPIS is a multispecialty, nationally representative, PE survey
of both physicians and NPPs using a consistent survey instrument and
methods highly consistent with those used for the SMS and the
supplemental surveys. The PPIS has gathered information from 3,656
respondents across 51 physician specialty and health care professional
groups. We believe the PPIS is the most comprehensive source of PE
survey information available to date.
As noted, the BBRA required us to establish criteria for accepting
supplemental survey data. Since the supplemental surveys were specific
to individual specialties and not part of a comprehensive
multispecialty survey, we had required that certain precision levels be
met in order to ensure that the supplemental data was sufficiently
valid, and acceptable for use in the development of the PE RVUs.
Because the PPIS is a contemporaneous, consistently collected, and
comprehensive multispecialty survey, we do not believe similar
precision requirements are necessary and we did not propose to
establish them for the use of the PPIS data.
For physician specialties, the PPIS responses were adjusted for
non-response bias. Non-response bias is the bias that results when the
characteristics of survey respondents differ in meaningful ways, such
as in the mix of practice sizes, from the general population. The non-
response adjustment was developed based on a comparison of practice
size and other characteristic information between the PPIS survey
respondents and data from the AMA Masterfile (for physician
specialties) or information from specialty societies (for non-physician
specialties). For six specialties (chiropractors, clinical social
workers, nuclear medicine, osteopathic manipulative therapy, physical
therapy, and registered dietitians) such an adjustment was not possible
due to a lack of available characteristic data. The AMA and Lewin have
indicated that the non-response weighting has only a small impact on
PE/HR values.
Under our current policy, various specialties without SMS or
supplemental survey data have been crosswalked to other similar
specialties to obtain a proxy PE/HR. For specialties that were part of
the PPIS for which we currently use a crosswalked PE/HR, we proposed
instead to use the PPIS-based PE/HR. We also proposed to continue
current crosswalks for specialties that did not participate in PPIS.
Supplemental survey data on independent labs, from the College of
American Pathologists, was implemented for payments in CY 2005.
Supplemental survey data from the National Coalition of Quality
Diagnostic Imaging Services (NCQDIS), representing IDTFs, was blended
with supplementary survey data from the American College of Radiology
(ACR) and implemented for payments in CY 2007. Neither IDTFs, nor
Independent Labs, participated in the PPIS. Therefore, we proposed to
continue using the current PE/HR that was developed using their
supplemental survey data.
We did not propose to use the PPIS data for reproductive
endocrinology, sleep medicine, and spine surgery since these
specialties are not separately recognized by Medicare and we do not
know how to blend this data with Medicare recognized specialty data. We
sought comment on this issue.
We did not propose changes to the manner in which the PE/HR data
are used in the current PE RVU methodology. We proposed to update the
PE/HR data itself based on the new survey. We proposed to utilize the
PE/HR developed using PPIS data for all Medicare recognized specialties
that participated in the survey for payments effective January 1, 2010.
The impact of using the new PPIS-based PE/HR is discussed in the
Regulatory Impact Analysis in section XIII. of this final rule with
comment period.
The following is a summary of the public comments received on the
PPIS survey and our responses.
Comment: MedPAC was generally supportive of the use of the PPIS
survey data, stating:
Ensuring the accuracy of PE payments is important given that
close to half of all payments under the physician fee schedule are
associated with practice expense. The Commission has repeatedly
raised concerns that the specialty-specific cost data that CMS uses
to derive PE RVUs are not current for most specialties, which might
lead to payments becoming inaccurate over time.
[[Page 61750]]
Compared with the multiple data sources that CMS currently relies on
for practice cost information, the PPIS is a step forward because:
(1) It reflects current practice patterns and costs; (2) it measures
costs of nearly all physician and nonphysician specialties; and (3)
it uses a standard protocol for all specialty groups that was
designed to derive PE RVUs. However, CMS should provide more
information about the PPIS's response rate and representativeness.
We are also concerned that CMS has not laid out options for ensuring
the accuracy of PE RVUs in the long term. As a future step, CMS
should consider alternatives for collecting specialty-specific cost
data or options to decrease the reliance on such data.
Response: We agree with MedPAC that the PPIS is a step forward
compared to the data sources currently used in the development of the
PE RVUs.
With respect to additional information on the PPIS survey, the AMA
has continued to respond to requests from the individual specialty
societies for additional data analysis as they have done since the PPIS
results were first released. We have also performed further analyses in
response to comments received on the proposed rule. The results of
these analyses are available on our Web site (described later in this
section) and have not changed our conclusion that the PPIS is the most
comprehensive, multi-specialty, contemporaneous, consistently collected
PE data source available.
We also agree with MedPAC that it is appropriate to consider the
future of the PE RVUs moving forward. We did not propose any changes to
the methodology in conjunction with the use of the PPIS data. However,
we seek comments from other stakeholders on the issues raised by MedPAC
for the future. In particular, we seek comments regarding MedPAC's
suggestion that we consider alternatives for collecting specialty-
specific cost data or options to decrease the reliance on such data.
For example, MedPAC stated that ``CMS should consider if Medicare or
provider groups should sponsor future data collection efforts, if
participation should be voluntary (such as surveys) or mandatory (such
as cost reports), and whether a nationally representative sample of
practitioners would be sufficient for either a survey or cost
reports.'' MedPAC also stated that one option for decreasing the
reliance on specialty-specific cost data would be the elimination of
specialty-specific cost pools from the method used to derive indirect
PE RVUs. We would address any changes through future rulemaking.
Comment: In addition to MedPAC, numerous specialty groups and
individual physicians and practitioners supported utilizing the PPIS
data. The commenters included family practice, general practice,
geriatrics, pediatrics, internal medicine, obstetrics and gynecology,
general surgery, infectious disease, emergency medicine, psychiatry,
anesthesiology, colorectal surgery, dermatology, endocrinology,
gastroenterology, neurology, neurosurgery, ophthalmology, optometry,
orthopedic surgery, osteopathic physicians, otolaryngology, pathology,
physical medicine and rehabilitation, physical and occupational
therapy, plastic surgery, podiatry, pulmonary disease, spine surgery,
thoracic surgery, transplant surgery, and vascular surgery.
Those in favor of using the PPIS data made one or more of the
following points:
PPIS was a nationally representative survey providing the
most up-to-date and comprehensive data available from 51 specialties.
It was a highly scientific and controlled undertaking, using a survey
instrument that the AMA took great care to design, test, and implement.
Seventy organizations contributed to the costs of the
survey and agreed to take responsibility for communicating and
publicizing the effort in order to enhance response rates. All groups
had ample time to review and provide input and received monthly updates
on response rates for their group.
PPIS followed the exacting criteria that CMS has
established for gathering this type of data and for producing results
that are acceptable for submission. The AMA worked with CMS's
contractor to ensure that all data met these criteria and were analyzed
consistently across the various physicians and practitioner
specialties. Any data that did not meet the criteria such as response
outliers were excluded.
The vast majority of the data currently used are
completely outdated. MedPAC and GAO have been calling on CMS to update
PE payments. The annual update of such data is inadequate to capture
the true changes in practice costs that physicians have experienced
over the years.
Supplemental survey data from a limited number of
specialties have caused significant distortions and misallocations of
PE payments, and provided an unfair advantage to some specialties. Many
organizations were unable to submit supplemental survey data due to the
high cost of gathering the data.
Concurrently and uniformly collected data will correct
payment imbalances caused by the supplemental surveys. Due to BN, this
leads to a shift in payment to some specialties at the expense of
others. The new data will reduce the payment gap between primary care
and other specialties.
Blending PPIS data with existing data would preserve
distortions and continue utilization of data that are more than 10
years old for some groups.
Response: We appreciate the support of this broad-based and diverse
mix of primary care, surgical, and other nonsurgical specialties for
our proposal. We agree with the commenters that the PPIS is the most
comprehensive, multi-specialty, contemporaneous, consistently collected
PE data source available.
Comment: There were also many specialty groups and individual
physicians and practitioners strongly opposed to the use of the PPIS
data. The commenters included representatives of the specialties of
cardiology, radiation oncology, medical oncology, interventional
radiology, hematology, nuclear medicine, urology, rheumatology, and
dieticians. Those opposed to using the PPIS data made one or more of
the following points:
Some commenters stated that data were not collected in a
contemporaneous, consistent, and comprehensive way;
Some commenters stated that the PPIS should be subject to
the same level of analysis as the supplemental surveys to assess
accuracy and precision. The commenters also indicated that the survey
did not meet the target goal for useable responses. The commenters
stated that the low response rates, for some specialties, means that
the data are not representative of the specialties' PEs. The commenters
also stated that specialty societies should be given the names of the
survey respondents, especially those that failed to fully complete the
survey, so they could be contacted;
Some commenters stated that there was not adequate
transparency in the PPIS survey process and that there was insufficient
information provided about the survey methodology and process;
Some commenters stated that CMS should withdraw the
proposal and take the time necessary to adequately examine the data
submitted by AMA, consider changes to the PE methodology, and solicit
public input on the validity of the data and the most appropriate way
to integrate this data into the PFS; and
Some commenters stated that if PPIS data is used, it
should be blended with supplemental survey data and/or phased in over a
number of years.
[[Page 61751]]
Response: The PPIS uses a consistent survey instrument and
methodology across all specialty and health care professional groups.
The sample was drawn from the AMA's Physician Masterfile, which is a
listing of all member and non-member physicians in the United States.
The survey was conducted in conjunction with national medical specialty
societies and other health care professionals, representing 51
specialties and health professions in order to maximize the overall
response rate. Respondents could submit information through multiple
modalities, including telephone, fax, and Web-based reporting.
The survey was conducted by external contractors. In 2007 the PPIS
project was contracted to the Gallup Organization. In late 2007 the AMA
transitioned the survey effort to dmrkynetec, formally Doane Marketing
Research, to complete the project. Dmrkynetec conducted the majority of
the specialty level surveys that were previously implemented by CMS.
Dmrkynetec used the same survey instruments as did the Gallup
Organization in order that survey data collected by Gallup could be
appropriately merged in the dmrkynetec data collection.
The survey methodology was highly consistent with the prior SMS
methodology because only small deviations were allowed to accommodate
practice style differences across the various groups surveyed. The PPIS
was conducted in accordance with known conventions governing PE
collection activities. One hundred completed surveys for each specialty
was set as a goal for the PPIS, but was not a minimum requirement. More
than 7,000 surveys were collected for 51 physicians, non MD/DO
specialties, and health professions. For the majority of specialties,
at least 100 surveys were collected.
The AMA provided specialty groups with information on the survey
throughout the survey process. Monthly progress reports were issued on
response rates. Due to confidentiality agreements with the AMA and
participating specialty groups, raw survey data was not distributed to
CMS or the specialty groups. However, this does not mean that analysis
was not performed on the PPIS data.
In conjunction with publication of the proposed rule, we posted
information on our Web site on physician response rates, precision and
PE/HR. In addition, we posted Lewin's report entitled, ``Physician
Practice Information Survey (PPIS) Data Submitted for 2010: Non-MD/DO
and Health Professionals Practice Information'' (June 19, 2009). This
report includes information on the PPIS survey process as well as the
methodology for determining the PE/HR.
As noted earlier in our response to the MedPAC comment, the AMA has
continued to respond to requests from the individual specialty
societies for additional data analysis, as they have done since the
PPIS results were first released. In response to comments received on
the proposed rule, we have also performed additional analyses of
summary data supplied by the AMA, the supplemental survey, and
cardiology, urology, and radiology groups. This additional analysis
indicates that while the PE/HR for these specialties differs between
the data sources reviewed for certain practice sizes, these differences
do not validate the commenters' conclusion that the PPIS data is
invalid. We continue to believe that the PPIS is the most appropriate
data source available for the development of resource-based PE RVUs. To
view this analysis, please see our Web site at http://www.cms.hhs.gov/PhysicianFeeSched/. (At this Web site, Go to ``PFS Federal Regulation
Notices'' tab, and then chose ``CMS-1413-P.'' Lewin's original report
is listed under the CY 2010 PFS proposed rule page. The additional AMA
information and analysis of the PPIS is available at http://www.ama-assn.org/go/ppisurvey.
We disagree with some commenters that the same precision
requirements that applied to the individual specialty supplemental
surveys should apply to the broad multispecialty contemporaneous PPIS.
Each individual specialty supplemental survey was being used alongside
the multispecialty contemporaneous SMS survey data for all the other
specialties. This is not the case for the PPIS data. We proposed to use
the PPIS data in its entirety for all Medicare recognized specialties,
with the exception of two supplier specialties that did not participate
in the PPIS. Precision requirements were appropriate, and required by
the BBRA, in the context of the selective acceptance of individual
supplemental surveys, but are not necessary in the context of the much
broader adoption of the PPIS data.
We also disagree that we should blend the supplemental survey data
with the PPIS data. One of the advantages of the PPIS data is precisely
that it is contemporaneous and collected in a consistent, broad multi-
specialty manner. Blending this data with the supplemental survey data
weakens the advantage of using the PPIS data, as was pointed out by
commenters who favored its use.
However, we do recognize that some specialties experience
significant payment reductions with the use of the PPIS data. Given the
magnitude of these payment reductions for some specialties, we agree
with commenters who suggested a transition to the new PE RVUs developed
using the PPIS data. Historically, we have provided for 4-year
transitions when we have significantly altered the PE methodology.
While we did not propose any changes to the methodology in the proposed
rule, we are persuaded by commenters that the use of the new PPIS data
has a sufficiently significant impact to warrant the use of such a
transition. In light of the comments received and our past practice, we
are finalizing a 4-year transition (75/25, 50/50, 25/75, 0/100) from
the current PE RVUs to the PE RVUs developed using the new PPIS data.
Comment: Some commenters that supported the use of the PPIS data
and some who opposed its use claimed that Medicare pays only 51 percent
of direct costs. Commenters maintained that the PE methodology results
in the underpayment of procedures with high direct costs, and will
shift procedures from the office to the higher cost hospital setting.
Response: The purpose of the resource-based PE methodology is to
develop RVUs within the overall PFS BN requirements. We are unaware of
any independent analysis that indicates that Medicare pays 51 percent
of direct costs as a result of these BN requirements. In the PE
methodology, there is a scaling factor applied in the development of
the direct PE portion of the PE RVUs and there is a scaling factor
applied in the development of the indirect PE portion. We believe that
commenters may be misinterpreting the scaling factor applied in the
development of the direct cost portion of the PE RVUs.
The PPIS data indicated a significant decrease in the percentage of
PEs that are attributable to direct PEs and a corresponding increase in
the percentage that are attributable to indirect PEs. The incorporation
of the PPIS data, therefore, results in a decrease in the scaling
factor applied in the development of the direct cost portion of the PE
methodology from its current value of 0.63 to its new value of 0.51 and
a corresponding increase in the scaling factor applied in development
of the indirect cost portion. As stated earlier, the PPIS is the most
comprehensive, multi-specialty, contemporaneous, consistently
[[Page 61752]]
collected source of PE data. The PPIS data indicates that direct costs
are a smaller proportion of total PE costs for almost every single
specialty surveyed (see Table 2). We are incorporating this result into
our methodology and disagree with commenters that this empirically
based decrease in the scaling factor for the direct cost portion of the
PE RVU using the PPIS survey data is inappropriate.
Comment: The American Society of Clinical Oncology (ASCO) noted
that section 303 of the Medicare Prescription Drug, Improvement, and
Modernization Act of 2003 (Pub. L. 108-173) (MMA) added section
1848(c)(2)(H) of the Act, which requires us to use their supplemental
survey submitted in 2003 for oncology drug administration services.
Response: We have reviewed the MMA provision and agree that, as
amended, section 1848(c)(2)(H)(i) of the Act requires that we continue
to use the supplemental survey data for oncology. We have revised the
PE/HR for medical oncology, hematology, and hematology/oncology to
reflect the continued use of these supplemental survey data.
Comment: Several commenters indicated that PPIS data for
reproductive endocrinology, sleep medicine, and spine surgery should
not be used because they are not separately recognized specialties by
Medicare and it is difficult to blend this data with data from
specialties that are recognized. Other commenters disagreed and
recommended weights we could use to blend the PPIS data with the data
from the recognized specialties for certain services.
Some commenters encouraged us to make these Medicare-recognized
specialties because they perform work that is separate and apart from
their parent specialty, require additional training, and have separate
liability issues. Other commenters opposed the recognition of separate
specialties for these groups, indicating that they are not markedly
different from their parent specialties.
Response: We did not specifically solicit comments on whether
reproductive endocrinology, sleep medicine, and spine surgery should be
separately recognized Medicare specialties, nor did we make such a
proposal. Specialties seeking such recognition must make a formal
request using our existing process. (See the CMS Internet-Only Medicare
Claims Processing Manual, Pub. L. 100-04, Chapter 26, Section 10.8,
Requirements for Specialty Codes.)
We did consider the comments on blending in the PPIS data for the
above physician groups as suggested by some commenters. However, we are
more persuaded by the commenters who indicated that determining the
correct blend would be difficult. We are reluctant to assign
utilization weights to the mix of specialties that perform these
services in the absence of actual claims data. We suggest that the
commenters who wish us to use the PPIS data for these groups apply for
a specialty code using our normal process. If approved, the claims data
associated with the new specialty code could be used to incorporate the
PPIS survey data for that specialty.
Comment: A group of commenters indicated that they were precluded
from participating in the PPIS. Some commenters representing portable
x-ray suppliers indicated that an inability to participate in the PPIS
resulted in an inappropriately low crosswalk for their specialty to
radiology.
Response: We did not exclude any specialty from participating in
PPIS. Individual specialties made the decision whether to participate.
However, we agree with the commenters representing portable x-ray
suppliers that radiology may not be the most appropriate crosswalk for
their specialty given the relatively low amount of physician time in
the services performed by the specialty. In light of these comments, we
are changing the PE/HR crosswalk for portable x-ray suppliers to IDTF,
a specialty similar with respect to the physician time issue.
Comment: As noted earlier, commenters representing freestanding
radiation oncology centers are opposed to the use of the PPIS data.
However, if CMS were to use the PPIS data, these commenters requested
that CMS adjust the PE/HR used for freestanding radiation oncology
centers by eliminating the weighting of the data and by eliminating 21
survey responses whose physician hour information was missing from the
data and imputed. The commenters also requested that we update the
weights used to blend the hospital-based and freestanding radiation
oncology center survey data based on more recent claims data.
Response: We agree with the commenters that it would be more
consistent with the methodology used for other specialties to remove
the 21 survey responses whose physician hour information was missing
from the data and imputed. We also agree it is more appropriate to
update the weights used to blend the hospital-based and freestanding
radiation oncology center survey data based on more recent claims data.
However, we disagree that it is appropriate to eliminate the weighting
of the survey data, especially with the 21 observations with imputed
physician practice hours removed from the survey sample respondent mix.
Consistent with the weighting methodology for other physician
specialties, we applied the AMA Masterfile weights to the data. More
details on our analysis of this comment can be found on our Web site.
Comment: Some commenters indicated that since, by statute,
registered dieticians are paid 85 percent of what a physician would be
paid for providing medical nutrition therapy services, the PPIS survey
data for registered dieticians should not be used in calculation of PE
RVUs; and that we should, therefore, base the RVUs for these services
only on the physician specialties that provide the service.
Response: We agree with commenters that, under the current PE
methodology, the PPIS survey data for registered dieticians should not
be used in the calculation of PE RVUs since they are paid 85 percent of
what a physician would be paid for providing the service. To include
them in the PE calculation would influence the rate setting to include
what the services would be paid if performed by registered dieticians
and not strictly on what the payment rate would be if provided by
physicians. We will crosswalk the specialty of registered dietician to
the ``all physician'' PE/HR rate.
In summary, based on the decisions described above, Table 2 shows
the indirect PE/HR for the specialties that have PPIS survey data that
we are adopting to calculate the PE RVUs. Also shown for these
specialties is the previous indirect PE/HR used to calculate the PE
RVUs. Note that for oncology, clinical laboratories, and IDTFs we are
continuing to use the supplemental survey data as described above.
Consistent with our past practice, the previous indirect PE/HRs for
these specialties have been updated to CY 2006 using the MEI to put
them on a comparable basis with the PPIS survey data.
[[Page 61753]]
Table 2--Indirect PE/HR for the Specialties That Have PPIS Survey Data
----------------------------------------------------------------------------------------------------------------
Previous Final rule
Specialty indirect indirect Previous Final rule
PE/HR PE/HR indirect % indirect %
----------------------------------------------------------------------------------------------------------------
All Physicians.............................................. $59.04 86.36 67 74
Allergy and Immunology...................................... 153.29 162.68 62 67
Anesthesiology.............................................. 19.76 29.36 56 82
Audiology................................................... 59.04 72.17 67 85
Cardiology.................................................. 131.02 88.04 56 65
Cardiothoracic Surgery...................................... 61.75 67.83 68 83
Chiropractor................................................ 49.60 65.33 69 86
Clinical Laboratory (Billing Independently)................. 66.46 68.32 37 37
Clinical Psychology......................................... 29.07 20.07 90 93
Clinical Social Work........................................ 29.07 17.80 90 97
Colon & Rectal Surgery...................................... 53.93 90.84 77 80
Dermatology................................................. 158.49 184.62 70 70
Emergency Medicine.......................................... 36.85 38.36 88 94
Endocrinology............................................... 49.60 84.39 69 73
Family Medicine............................................. 52.79 90.15 62 76
Gastroenterology............................................ 101.30 96.78 70 75
General Practice............................................ 52.79 78.59 62 69
General Surgery............................................. 53.93 82.73 77 82
Geriatrics.................................................. 49.60 54.14 69 74
Hand Surgery................................................ 98.56 148.78 72 77
Independent Diagnostic Testing Facilities................... 466.16 501.45 50 51
Internal Medicine........................................... 49.60 84.02 69 76
Interventional Pain Medicine................................ 59.04 156.79 67 70
Interventional Radiology.................................... 118.48 82.56 58 81
Medical Oncology............................................ 141.84 145.81 59 59
Nephrology.................................................. 49.60 66.00 69 80
Neurology................................................... 66.05 110.39 74 87
Neurosurgery................................................ 89.64 115.76 86 87
Nuclear Medicine............................................ 118.48 39.80 58 77
Obstetrics/Gynecology....................................... 69.74 99.32 67 67
Ophthalmology............................................... 103.28 170.07 65 70
Optometry................................................... 59.04 88.02 67 77
Oral Surgery (Dentist only)................................. 96.01 173.19 71 65
Orthopaedic Surgery......................................... 98.56 131.40 72 81
Osteopathic Manipulative Therapy............................ 59.04 53.93 67 93
Otolaryngology.............................................. 96.01 141.54 71 75
Pain Medicine............................................... 59.04 122.42 67 70
Pathology................................................... 59.80 74.98 70 74
Pediatrics.................................................. 51.52 76.27 62 69
Physical Medicine and Rehabilitation........................ 84.92 110.13 71 84
Physical Therapy............................................ 35.17 57.26 65 84
Plastic Surgery............................................. 99.32 134.81 67 74
Podiatry.................................................... 59.04 74.76 67 82
Psychiatry.................................................. 29.07 30.10 90 94
Pulmonary Disease........................................... 44.63 55.26 76 74
Radiation Oncology (Hospital Based & Freestanding).......... 114.00 165.10 50 57
Radiology................................................... 118.48 95.60 58 71
Rheumatology................................................ 84.92 98.08 71 67
Urology..................................................... 119.57 97.01 69 73
Vascular Surgery............................................ 60.10 83.98 63 73
----------------------------------------------------------------------------------------------------------------
c. Equipment Utilization Rate
As part of the PE methodology associated with the allocation of
equipment costs for calculating PE RVUs, we currently perform these
calculations with an equipment usage assumption of 50 percent. In the
CY 2008 PFS proposed rule (72 FR 38132), we noted that if the assumed
equipment usage percentage is set too high, the result would be an
insufficient allowance at the service level for the practice costs
associated with equipment. If the assumed equipment usage percentage is
set too low, the result would be an excessive allowance for the
practice costs of equipment at the service level. We acknowledged that
the current 50 percent usage assumption does not capture the actual
usage rates for all equipment, but stated that we did not believe that
we had strong empirical evidence to justify any alternative approaches.
In the CY 2008 PFS final rule with comment period, we summarized
comments received on this issue. Commenters' recommendations about
making adjustments to the 50 percent utilization rate assumption
varied. Some commenters recommended that we do nothing until stronger
empirical evidence is available. Other commenters recommended a
decrease in the utilization assumption while others recommended an
increase in the utilization assumption. We agreed with the commenters
that the equipment utilization rate should continue to be examined for
accuracy. We indicated that we would continue to monitor the
appropriateness of the equipment utilization assumption, and evaluate
whether changes should be proposed in light of the data available.
[[Page 61754]]
In the CY 2010 PFS proposed rule (74 FR 33532), we acknowledged
that since the publication of the CY 2008 PFS final rule with comment
period, MedPAC addressed this issue in its March 2009 Report to
Congress (see http://www.medpac.gov/documents/Mar09_EntireReport.pdf).
In part of its discussion, MedPAC stated:
In 2006, the Commission sponsored a survey by NORC of imaging
providers in six markets, which found that MRI and CT machines are
used much more than the 25 hours per week that CMS assumes (Table
2B-6). According to data from this survey, MRI scanners are used 52
hours per week, on average (median of 46 hours), and CT machines are
operated 42 hours per week, on average (median of 40 hours) (NORC
2006). Although the survey results are not nationally
representative, they are representative of imaging providers in the
six markets included in the survey. We also analyzed data from a
2007 survey of CT providers by IMV, a market research firm (IMV
Medical Information Division 2008). IMV data are widely used in the
industry and have also appeared in published studies (Baker et al.
2008, Baker and Atlas 2004). Using IMV's data on 803 nonhospital CT
providers (imaging centers, clinics, and physician offices), we
calculated that the average provider uses its CT scanner 50 hours
per week, which is twice the number CMS assumes. The IMV survey also
found that nonhospital providers increased the average number of
procedures per CT machine by 31 percent from 2003 to 2007, which
indicates that providers either used their machines more hours per
day or performed more scans per hour (IMV Medical Information
Division 2008) (p. 108).
In the proposed rule, we stated that the studies cited by MedPAC
indicated that the current equipment usage rate assumption is
significantly understated, especially with respect to the types of high
cost equipment that were the subject of the studies. The current 50
percent utilization rate translates into about 25 hours per week out of
a 50-hour work week. The median value of 46 hours for Magnetic
Resonance Imaging equipment from the first study cited by MedPAC is
equivalent to a utilization rate of 92 percent on a 50-hour week. For
Computed Tomography scanners, averaging the value from the first study
of 40 hours per week and the value from the second study of 50 hours
per week yields 45 hours and is equivalent to a 90 percent utilization
rate on a 50-hour work week. Therefore, in the CY 2010 PFS proposed
rule, we proposed to increase the equipment usage rate to 90 percent
for all services containing equipment that cost in excess of $1 million
dollars. We stated that the studies cited by MedPAC suggested that
physicians and suppliers would not typically make huge capital
investments in equipment that would only be utilized 50 percent of the
time. We stated that we would continue to explore data sources
regarding the utilization rates of equipment priced at less than $1
million dollars, but we did not propose a change in the usage rate for
this less expensive equipment.
The following is a summary of the public comments received and our
responses.
Comment: We received comments supporting our proposal to apply a 90
percent equipment utilization rate to expensive equipment priced at
more than $1 million and comments opposing our proposal. MedPAC stated:
``The Commission supports CMS's proposal as it applies to
diagnostic imaging machines that cost more than $1 million, and we
encourage CMS to explore increasing the equipment use factor for
diagnostic imaging machines that cost less than $1 million. MedPAC
did not contemplate applying the policy to radiation therapy
machines.''
Commenters supporting our proposal cited the MedPAC studies and the
rationale we provided in the proposed rule.
Commenters opposing our proposal stated that the Balanced Budget
Act of 1997 (BBA) directed CMS to ``utilize, to the maximum extent
practicable, generally accepted cost accounting principles which: (1)
Recognize all staff, equipment, supplies and expense, not just those
which can be tied to specific procedures; and (2) use actual data on
equipment utilization and other key assumptions.'' The commenters
stated that the equipment usage proposal violates this provision of the
BBA since we lacked sufficient empirical justification for the change.
The commenters indicated that the National Opinion Research Center
survey data, which was one data source used by MedPAC, was not
nationally representative, and was never intended to determine
equipment usage rates.
Some commenters referenced information submitted by the Radiology
Benefit Management Association (RBMA) based on a survey of its members.
The commenters stated that the information supported maintaining a 50
percent utilization usage rate assumption for diagnostic imaging
equipment. The commenters also stated that the information indicated
differences in utilization rates between rural and urban areas and that
our proposal would create access issues, especially in rural areas.
In MedPAC's comment letter, it agreed with CMS that ``decreasing PE
RVUs for expensive diagnostic imaging services should not affect access
to care in rural areas.''
The AMA submitted summary equipment utilization data from the PPIS
survey on MRI, CT, angiography, IMRT, and gamma camera. It stated that
although there was a relatively small sample size, the survey responses
suggest that equipment utilization varies depending on the type of
equipment involved. The AMA requested that we allow specialty societies
to provide data supporting lower utilization rates, if appropriate. It
stated that this would allow for varying equipment utilization rate
assumptions depending on the type of equipment being used, rather than
a single utilization assumption.
Some commenters indicated that even if the available data did
indicate a higher utilization rate for certain types of diagnostic
equipment, we should not apply the change to all types of expensive
diagnostic equipment. For example, we should not apply the usage rate
to new imaging technology.
Some commenters requested that we not change the equipment usage
rate assumption to 90 percent for any equipment until additional data
sources can be identified. The commenters suggested that the equipment
usage rate policy should not be limited to increasing usage rate
assumptions but should also include potentially decreasing equipment
usage rate assumptions when appropriate.
If we were to implement a higher utilization rate, some commenters
suggested that the change be phased in over a number of years.
Response: We appreciate all of the comments received on this issue.
At the time that we published the proposed rule, we had the data on MRI
and CT from the MedPAC analysis. We indicated that the MedPAC studies
suggested that physicians and suppliers would not typically make
significant capital investments in equipment that would only be
utilized 50 percent of the time. Commenters opposed to our proposal
have questioned both the validity of the MedPAC analysis for CT and MRI
and extrapolation of this data to all expensive equipment, particularly
therapeutic equipment. While we are persuaded by PPIS data on
angiography, IMRT, and Gamma Camera that the extrapolation of the MRI
and CT data to all expensive equipment may be inappropriate, we
disagree with commenters who indicated that we do not have an empirical
basis for applying a 90 percent usage rate to MRIs and CTs.
As described earlier, the MedPAC analysis was performed on two data
sources for different types of equipment. The first data source was the
survey done by NORC for MRIs and CTs. The second data source was the
IMV data for
[[Page 61755]]
CT scans. With respect to MRIs and CTs, we have now also received
summary information from the RBMA and summary PPIS survey data from the
AMA. The PPIS survey data results for MRIs (n=97) and CTs (n=86) are
consistent with the findings from the MedPAC studies on MRIs and CTs.
However, the data from the RBMA (17 members submitted a total of 46
center surveys) indicates a lower utilization rate for CT and MRI.
As we have described in section II.A.2.b. of this final rule with
comment, the PPIS is the best available data source currently available
on PEs. Given the corroboration of the MedPAC analysis by the PPIS
data, we are confident that we are using the best data currently
available on the utilization of MRIs and CTs (90 percent), consistent
with the BBA requirement that we use actual data on equipment
utilization.
We are open to receiving more comprehensive data than the responses
of 16 RBMA members on this issue from the RBMA or other members of the
public. We will evaluate any data submitted for consideration in future
rulemaking.
We continue to agree with the MedPAC analysis and comment
indicating that decreasing the PE payments for expensive diagnostic
imaging services should not affect access to care in rural areas.
We also agree with commenters that it would be appropriate to
transition the new PE RVUs developed using the higher 90 percent
utilization rate for MRIs and CTs. As discussed elsewhere in this final
rule, we are providing for a 4-year transition (25/75, 50/50, 75/25,
100/0) to the new PE RVUs.
As indicated above, we are not finalizing our proposal to increase
the utilization rate assumption for expensive equipment other than MRIs
and CTs, including therapeutic equipment. We are finalizing our
proposal to increase the utilization rate to 90 percent for expensive
diagnostic equipment priced at more than $1 million.
d. Miscellaneous PE Issues
As we have discussed in the past rulemaking (see the CY 2007 and CY
2008 PFS final rules with comment period (71 FR 69647 and 72 FR 66236,
respectively), we continue to have concerns about the issue of PE RVUs
for services which are utilized 24 hours a day/7 days a week, such as
certain monitoring systems. For example, the PE equipment methodology
was not developed with this type of 24/7 equipment in mind. As stated
in the CY 2010 PFS proposed rule (74 FR 33532), we are continuing to
analyze the issue of PEs for services, which are utilized 24 hours a
day/7 days a week to identify any modifications to our methodology that
would address the specific ``constant use'' issues associated with
these services. Services that are currently contractor priced in CY
2009 would remain contractor priced in CY 2010. We also indicated that
any proposed changes will be communicated through future rulemaking.
Comments: We received three comments regarding the proposal to
continue to contractor price these services. All three commenters
supported the establishment of a national price for cardiac outpatient
telemetry. The commenters also indicated that they believe they were
the only ones that should be billing these codes.
Response: We will finalize our proposal to continue to contractor
price these services in 2010 so that we may conduct further analysis.
Any proposed changes will be communicated through future rulemaking.
As discussed in the proposed rule, (74 FR 33532) we received
comments regarding the PE direct cost inputs (for example, supply costs
and the useful life of the renewable sources) related to the high dose
radiation therapy (HDRT) and placement CPT codes (CPT codes 77785,
Remote afterloading high dose rate radionuclide brachytherapy; 1
channel, 77786, Remote afterloading high dose rate radionuclide
brachytherapy; 2-12 channels, 77787, Remote afterloading high dose rate
radionuclide brachytherapy; over 12 channels). Based on our review of
these codes and comments received, we requested that the AMA RUC
consider these CPT codes for additional review.
Comment: The AMA RUC reviewed these CPT codes based on our request
and recommended revisions to the clinical labor staff type, supplies,
and equipment. The AMA RUC also recommended further discussion between
the specialty and CMS regarding a resolution regarding the useful life
of Iridium-192 source. The AMA RUC and other commenters stated that the
useful life of the Iridium-192 source is 70 to 90 days. However, many
commenters stated that physician offices enter into 1 year contracts
for its replacement.
Several commenters supported the AMA RUC's recommended changes to
the practice expense inputs for these codes. The commenters agreed that
certain direct PE inputs were previously omitted.
Response: We accept the AMA RUC's recommendations regarding the
direct PE inputs for these CPT codes. Based on the comments received
and further analysis, we are changing the useful life of the Iridium-
192 source from 5 years to 1 year and it will be considered as
equipment. We are also revising the direct PE inputs for clinical labor
staff type, supplies, and equipment.
e. AMA RUC Recommendations for Direct PE Inputs
The AMA RUC provided recommendations for PE inputs for the codes
listed in Table 3 (74 FR 33532).
Table 3--Codes With AMA RUC PE Recommendations
------------------------------------------------------------------------
CPT \1\ code Description
------------------------------------------------------------------------
37183.................................. Remove hepatic shunt (tips).
47382.................................. Percut ablate liver rf.
50200.................................. Biopsy of kidney.
55873.................................. Cryoablate prostate.
93025.................................. Microvolt t-wave assess.
------------------------------------------------------------------------
\1\ CPT codes and descriptions are Copyright 2009 American Medical
Association.
In the proposed rule, we stated that we were in agreement with the
AMA RUC recommendations for the direct PE inputs for the codes listed
in Table 3 and proposed to adopt these for CY 2010.
Comment: Several commenters stated that it did not appear that we
had adopted the AMA RUC recommendations for these codes. Commenters
requested that we review their direct PE inputs to determine if we had
adopted the RUC's recommendations.
Response: We have reviewed the direct PE inputs for these codes and
it appears that some were omitted in error. We have now updated the PE
inputs for these codes consistent with the RUC recommendation.
f. Practice Expense for Intranasal Vaccine Administration Codes (CPT
Codes 90467, 90468, 90473, and 90474)
Comment: We received a comment from a manufacturer that the payment
for the intranasal vaccine administration codes (represented by CPT
codes 90467, 90468, 90473, and 90474) is approximately half the rate of
the injected vaccine administration codes (represented by CPT codes
90465, 90466, 90471, and 90472). The commenter stated that the apparent
source of the difference is the clinical staff time inputs of the PE
component of the RVUs for these codes. The commenter noted that these
codes are used to administer the intranasal form
[[Page 61756]]
of the influenza vaccine to healthy individuals between 2 to 49 years
of age.
Response: We responded to a similar comment in the CY 2008 PFS
final rule with comment period (72 FR 66242). At that time, we stated
that a manufacturer had expressed concern that the PE RVUs for
intranasal administration of vaccines (CPT codes 90467/8 and 90473/4)
are inappropriately low and should be equalized to the injectable
immunization administration PE RVUs. The commenter stated that when the
codes were re-evaluated in 2004 there was not enough experience in the
office to fully understand the time associated with providing an
intranasal vaccine. The commenter stated that specialty organizations
have indicated that this issue is worth reexamining and indicated that
they had been encouraged to communicate with the AMA RUC in support of
equalizing payment for the codes. In our response we stated that we
appreciated the commenter's concerns about the disparity in the PE RVUs
for the intranasal and injectable immunization administration
procedures. To the extent that these concerns related to the direct PE
inputs, we encouraged the commenters to work with the specialty
organizations to determine if it was appropriate to bring these codes
forward for further AMA RUC review.
The AMA RUC reviewed the immunization administration services (CPT
codes 90465 through 90474) in February 2008. It recommended similar PE
inputs for the intramuscular and intranasal immunization administration
codes. In the CY 2009 PFS final rule with comment period (73 FR 38512),
we stated that we accepted all of the AMA RUC recommendations, except
for inclusion of the clinical staff time related to quality activities
for the codes. In the CY 2009 PFS final rule with comment period (73 FR
69736), we stated that we had reexamined the issue and that there was
evidence to support the inclusion of QA time in this case. We revised
the PE database to reflect QA time for these codes.
B. Geographic Practice Cost Indices (GPCIs): Locality Discussion
1. Update--Expiration of 1.0 Work GPCI Floor
Section 1848(e)(1)(A) of the Act requires us to develop separate
Geographic Practice Cost Indices (GPCIs) to measure resource cost
differences among localities compared to the national average for each
of the three fee schedule components (that is, work, PE and
malpractice). While requiring that the PE and malpractice GPCIs reflect
the full relative cost differences, section 1848(e)(1)(A)(iii) of the
Act requires that the physician work GPCIs reflect only one-quarter of
the relative cost differences compared to the national average.
Section 1848(e)(1)(C) of the Act requires us to review and, if
necessary, adjust the GPCIs at least every 3 years. This section also
specifies that if more than 1 year has elapsed since the last GPCI
revision, we must phase in the adjustment over 2 years, applying only
one-half of any adjustment in each year. As discussed in the CY 2009
PFS final rule with comment period (73 FR 69740), the CY 2009
adjustment to the GPCIs reflected the fully implemented fifth
comprehensive GPCI update. We noted that a 1.0 work GPCI floor was
enacted and implemented for CY 2006, and was set to expire on June 30,
2008. We also noted that section 134 of the MIPPA extended the 1.0 work
GPCI floor from July 1, 2008, through December 31, 2009. Additionally,
section 1848(e)(1)(G) of the Act, as amended by section 134(b) of the
MIPPA, set a permanent 1.5 work GPCI floor in Alaska for services
furnished beginning January 1, 2009. Therefore, as required by the
MIPPA, beginning on January 1, 2010, the 1.0 work GPCI floor will be
removed. However, the 1.5 work GPCI floor for Alaska will remain in
place. See Addenda D and E of this final rule for the GPCIs and
summarized geographic adjustment factors (GAFs), respectively.
Comment: A few commenters urged us to make the 1.0 work GPCI floor
permanent.
Response: With regard to the 1.0 work GPCI floor, we do not have
the authority to extend this provision beyond December 31, 2009. As
explained in the CY 2010 PFS proposed rule (74 FR 33533), section 134
of the MIPPA only extended the 1.0 work GPCI floor from July 1, 2008,
through December 31, 2009.
2. Payment Localities
a. Background
As stated above in this section, section 1848(e)(1)(A) of the Act
requires us to develop separate GPCIs to measure resource cost
differences among localities compared to the national average for each
of the three fee schedule components (this is, work, PE, and
malpractice). Payments under the PFS are based on the relative
resources involved in furnishing physicians' services, and are adjusted
for differences in relative resource costs among payment localities
using the GPCIs. As a result, PFS payments vary between localities.
The current PFS locality structure was developed and implemented in
1997. There are currently 89 localities including 37 higher-cost areas;
16 Rest of State areas (comprising the remaining counties not located
in a higher-cost area within a State); 34 Statewide areas; and Puerto
Rico and the Virgin Islands which are designated as ``territory-wide''
localities. The development of the current locality structure is
described in detail in the CY 1997 PFS proposed rule (61 FR 34615) and
the subsequent final rule (61 FR 59494).
As we have frequently noted, any changes to the locality
configuration must be made in a budget neutral manner within a State
and can lead to significant redistributions in payments. For many
years, we have not considered making changes to localities without the
support of a State medical association in order to demonstrate
consensus for the change among the professionals whose payments would
be affected (with some increasing and some decreasing). However, we
have recognized that, over time, changes in demographics or local
economic conditions may lead us to conduct a more comprehensive
examination of existing payment localities.
Payment Locality Approaches Discussed in the CY 2008 PFS Proposed Rule
For the past several years, we have been involved in discussions
with California physicians and their representatives about recent
shifts in relative demographics and economic conditions among a number
of counties within the current California payment locality structure.
In the CY 2008 PFS proposed and final rules with comment period, we
described three potential options for changing the payment localities
in California (72 FR 38139 and 72 FR 66245, respectively).
After reviewing the comments on these options, we decided not to
proceed with implementing any of them at that time. We explained that
there was no consensus among the California medical community as to
which, if any, of the options would be most acceptable. We also
received suggestions from the Medicare Payment Advisory Commission
(MedPAC) for developing changes in payment localities for the entire
country and other States expressed interest in having their payment
localities reconfigured as well. In addition, other commenters wanted
us to consider a national reconfiguration of localities rather than
just making changes one State at a time. Because of the divergent views
[[Page 61757]]
expressed in comments, we explained in the CY 2008 PFS final rule with
comment period that we intended to conduct a thorough analysis of
potential approaches to reconfiguring localities and would address this
issue again in future rulemaking.
Interim Study of Alternative Payment Localities Under the PFS
As a follow-up to the CY 2008 PFS final rule with comment period,
we contracted with Acumen, LLC (Acumen), to conduct a preliminary study
of several options for revising the payment localities on a nationwide
basis. The contractor's interim report was posted on the CMS Web site
on August 21, 2008, and we requested comments from the public. The
report entitled, ``Review of Alternative GPCI Payment Locality
Structures,'' is still accessible from the CMS PFS Web page under the
heading ``Interim Study of Alternative Payment Localities under the
PFS.'' The report may also be accessed directly from the following
link: http://www.cms.hhs.gov/PhysicianFeeSched/10_Interim_Study.asp#TopOfPage. We accepted comments on the interim report through
November 3, 2008. The alternative locality configurations discussed in
the report are described briefly below in this section.
Option 1: CMS Core Based Statistical Area (CBSA) Payment Locality
Configuration
This option uses the Office of Management and Budget (OMB's)
Metropolitan Statistical Area (MSA) designations for the payment
locality configuration. MSAs would be considered as urban CBSAs.
Micropolitan Areas (as defined by OMB) and rural areas would be
considered as non-urban (rest of State) CBSAs. This approach would be
consistent with the inpatient hospital prospective payment system
(IPPS) pre-reclassification CBSA assignments and with the geographic
payment adjustments used in other Medicare payment systems. This option
would increase the number of localities from 89 to 439.
Option 2: Separate High Cost Counties From Existing Localities
(Separate Counties)
Under this approach, higher cost counties are removed from their
existing locality structure and they would each be placed into their
own locality. This option would increase the number of localities from
89 to 214 using a 5 percent GAF differential to separate high cost
counties.
Option 3: Separate MSAs From Statewide Localities (Separate MSAs)
This option begins with Statewide localities and creates separate
localities for higher cost MSAs (rather than removing higher cost
counties from their existing locality as described in option 2). This
option would increase the number of localities from 89 to 130 using a 5
percent GAF differential to separate high cost MSAs.
Option 4: Group Counties Within a State Into Locality Tiers Based on
Costs (Statewide Tiers)
This option creates tiers of counties (within each State) that may
or may not be contiguous but share similar practice costs. This option
would increase the number of localities from 89 to 140 using a 5
percent GAF differential to group similar counties into Statewide
tiers.
Additionally, as discussed in the interim locality study report,
our contractor, Acumen, applied a ``smoothing'' adjustment to the
current PFS locality structure, as well as to each of the alternative
locality configurations (except option 4: Statewide Tiers). The
``smoothing'' adjustment was applied to mitigate large payment
differences (or payment ``cliffs'') between adjacent counties. Since
large payment differences between adjacent counties could influence a
physician's decision on a practice location (and possibly impact access
to care), the ``smoothing'' adjustment was applied to ensure that GAF
differences between adjacent counties do not exceed 10 percent. (For
more information on the ``smoothing'' adjustment see the interim
locality study report on the PFS Web page via the link provided above).
b. Summary of Public Comments on Interim Locality Study Report
In the CY 2009 PFS proposed rule (73 FR 38514), we encouraged
interested parties to submit comments on the options presented both in
the proposed rule and in the interim report posted on our Web site. We
also requested comments and suggestions on other potential alternative
locality configurations (in addition to the options described in the
report). Additionally, we requested comments on the administrative and
operational issues associated with the various options under
consideration. We also emphasized that we would not be proposing any
changes to the current PFS locality structure for CY 2009 and that we
would provide extensive opportunities for public comment before
proposing any change.
In the CY 2010 PFS proposed rule (74 FR 33533), we noted that
approximately 200 industry comments were submitted on the alternative
locality options discussed in the CY 2009 PFS proposed rule and on the
interim locality study report. Comments were submitted from various
specialty groups, medical societies, state medical associations,
individual practitioners, and beneficiaries. Commenters generally
commended us for acknowledging the need to reconfigure PFS payment
localities and expressed support for our study of alternative locality
configurations. Some urged us to expedite any changes while other
commenters requested that we take a cautious approach.
Several commenters who supported the adoption of an MSA-based PFS
locality structure suggested that option 3 could be used as a
transition to the CMS CBSA locality configuration (option 1). Many
commenters from the State of California supported option 3 (Separate
High Cost MSAs) because the commenters believe it would improve payment
accuracy (over the current locality configuration) and mitigate
possible payment reductions to rural areas as compared to option 1 (CMS
CBSA) and option 4 (Statewide Tiers. Because of the payment reductions
to rural areas, most commenters did not support option 4 (Statewide
Tiers).
Many commenters also acknowledged the significant redistribution of
payments that would occur under each option and requested that we
minimize the payment discrepancy between urban and rural areas to
ensure continued access to services. One medical association stated
that ``budget neutral redistributions would only exacerbate an already
flawed and under-funded Medicare PFS'' and suggested that States with a
Statewide locality be given the option of remaining a Statewide
locality. The commenter also requested that we continue our policy of
allowing any State the option of converting to a Statewide locality.
For a more detailed discussion of the comments submitted on the
interim locality study, see the CY 2010 PFS proposed rule (74 FR
33534).
We did not make a specific proposal for changing the PFS locality
structure in the CY 2010 PFS proposed rule. As noted by the commenters
and reflected in the report, significant payment redistribution would
occur if a nationwide change in the PFS locality configuration were
undertaken. All four of the potential alternative payment locality
configurations reviewed in the report would increase the number of
localities and separate higher cost,
[[Page 61758]]
typically urban areas from lower cost, typically rural ``Rest of
State'' areas. In general, payments to urban areas would increase while
rural areas would see a decrease in payment under each of the options
studied because they would no longer be grouped with higher cost
``urbanized'' areas. We intend to continue our review of the
suggestions made by the commenters and consider the impact of each of
the potential alternative locality configurations.
Comment: We received some comments on the locality discussion from
various specialty groups and medical societies. A few commenters
expressed support for our decision to defer proposing changes to the
PFS locality reconfiguration and recommended that we continue pursuing
a cautious approach. One State Medical Association stated that it is
hopeful that the Congress will provide a method to update all payment
localities in a manner that prevents cuts to payments in lower-cost
counties. However, in the event the Congress does not provide
additional funding to hold lower cost counties harmless, the commenter
supports a PFS locality configuration based on MSAs. Another commenter
noted that the redistribution of payments could have a negative impact
on access to care. The commenter stated that geographic location should
not be a detriment as to whether a physician can provide care to a
Medicare beneficiary. One specialty group stated that changes in
localities should only be made to improve the relative accuracy of
Medicare payment. In the event we make a proposal to change the PFS
locality structure, the commenter urged us to provide sufficient data
for the public to ascertain the impact on specific geographic areas.
Response: We agree that a nationwide locality reconfiguration
requires a cautious approach and will carefully consider the
commenter's suggestion regarding an MSA-based locality configuration.
We would also like to thank the public again for the many thoughtful
comments on the interim locality study report entitled, ``Review of
Alternative GPCI Payment Locality Structures''. A final report will be
posted to the CMS Web site after further review of the studied
alternative locality approaches. As explained in the CY 2010 PFS
proposed rule, we are not proposing changes in the PFS locality
structure at this time. In the event we decide to make a specific
proposal for changing the locality configuration, we would provide data
on the impact of the changes. We would also provide extensive
opportunities for public input (for example, Town Hall meetings or Open
Door Forums, as well as opportunities for public comments afforded by
the rulemaking process).
C. Malpractice Relative Value Units (RVUs)
1. Background
Section 1848(c) of the Act requires that each service paid under
the PFS be comprised of three components: Work, PE, and malpractice.
From 1992 to 1999, malpractice RVUs were charge-based, using weighted
specialty-specific malpractice expense percentages and 1991 average
allowed charges. Malpractice RVUs for new codes after 1991 were
extrapolated from similar existing codes or as a percentage of the
corresponding work RVU. Section 4505(f) of the BBA required us to
implement resource-based malpractice RVUs for services furnished
beginning in 2000. Initial implementation of resource-based malpractice
RVUs occurred in 2000. The statute also requires that we review, and if
necessary adjust, RVUs no less often than every 5 years. The first
review and update of resource based malpractice RVUs was addressed in
the CY 2005 PFS final rule (69 FR 66263). Minor modifications to the
methodology were addressed in the CY 2006 PFS final rule (70 FR 70153).
In the CY 2010 PFS proposed rule, we proposed to implement the second
review and update of malpractice RVUs.
2. Methodology for the Revision of Resource-Based Malpractice RVUs
The proposed malpractice RVUs were developed by Acumen, LLC
(Acumen) under contract to us (74 FR 33537).
The methodology used in calculating the proposed second review and
update of resource-based malpractice RVUs largely parallels the process
used in the CY 2005 update. The calculation requires information on
malpractice premiums, linked to the physician work conducted by
different specialties that furnish Medicare services. Because
malpractice costs vary by State and specialty, the malpractice premium
information must be weighted geographically and across specialties.
Accordingly, the malpractice expense RVUs that we proposed are based
upon three data sources:
Actual CY 2006 and CY 2007 malpractice premium data.
CY 2008 Medicare payment data on allowed services and
charges.
CY 2008 Geographic adjustment data for malpractice
premiums.
Similar to the previous update of the resource-based malpractice
expense RVUs, we proposed to revise the RVUs using specialty-specific
malpractice premium data because they represent the actual malpractice
expense to the physician. In addition, malpractice premium data are
widely available through State Departments of Insurance. We proposed to
use actual CY 2006 and CY 2007 malpractice premium data because they
are the most current data available (CY 2008 malpractice premium data
were not consistently available during the data collection process).
Accounting for market share, three fourths of all included rate filings
were implemented in CY 2006 and CY 2007. The remaining rate filings
were implemented in CY 2003 through CY 2005 but still effective in CY
2006 and CY 2007. Carriers submit rate filings to their State
Departments of Insurance listing the premiums and other features of
their coverage. The rate filings include an effective date, which is
the date the premiums go into effect. Some States require premium
changes to be approved before their effective date; others just require
the rate filings to be submitted. We attempted to capture at least 2
companies and at least 50 percent of the market share, starting with
the largest carriers in a State.
The primary determinants of malpractice liability costs continue to
be physician specialty, level of surgical involvement, and the
physician's malpractice history. We collected malpractice premium data
from 49 States and the District of Columbia for all physician
specialties represented by major insurance providers. Rate filings were
not available through Departments of Insurance in Mississippi or Puerto
Rico. Premiums were for $1 million/$3 million, mature, claims-made
policies (policies covering claims made, rather than services furnished
during the policy term). A $1 million/$3 million liability limit policy
means that the most that would be paid on any claim is $1 million and
that the most that the policy would pay for several claims over the
timeframe of the policy is $3 million. We collected data from
commercial and physician-owned insurers and from joint underwriting
associations (JUAs). A JUA is a State government-administered risk
pooling insurance arrangement in areas where commercial insurers have
left the market. Adjustments were made to reflect mandatory surcharges
for patient compensation funds (PCFs) (funds to pay for any claim
beyond the statutory amount, thereby limiting an individual physician's
liability in cases of a large suit) in States where PCF participation
is mandatory. We sought to collect premium data representing at least
50
[[Page 61759]]
percent of physician malpractice premiums paid in each State as
identified by State Departments of Insurance and by the National
Association of Insurance Commissioners (NAIC).
Rather than select the top 20 physician specialties as we did when
the malpractice RVU were originally established and updated, we
included premium information for all physician and surgeon specialties,
and risk classifications available in the collected rate filings. Most
insurance companies provided crosswalks from insurance service office
(ISO) codes to named specialties; we matched these crosswalks to CMS
specialty codes. We also preserved information obtained regarding
surgery classes, which are categorizations that affect premium rates.
For example, many insurance companies grouped general practice
physicians into nonsurgical, minor-surgical and major-surgical classes,
each with different malpractice premiums. Some companies provided
additional surgical subclasses; for example, distinguishing general
practice physicians that conducted obstetric procedures, which further
impacted malpractice rates. We standardized this information to CMS
specialty codes.
We proposed a resource based methodology for developing malpractice
RVUs for technical component (TC) services (for example diagnostic
tests). Currently, the MP RVUs for TC services and the TC portion of
global services are based on historical allowed charges and have not
been made resource based due to a lack of available malpractice premium
data for nonphysician suppliers. Over the last few years, we have
requested malpractice premium data for nonphysician suppliers, but had
not received any data prior to last year. In response to our request in
last year's rulemaking cycle, one commenter did provide information on
one of the largest insurance companies that provides liability
insurance for medical physicists employed by imaging facilities. After
our contractor, Acumen, verified the medical physicist premium
information submitted in response to last year's proposed rule, we
proposed to use the medical physicist premium data as a proxy for the
malpractice premiums paid by all entities providing TC services;
primarily independent diagnostic testing facilities (IDTFs).
Other than the change in methodology for developing malpractice
RVUs for TC services, our proposed methodology for updating malpractice
RVUs conceptually followed the same approach, with some minor
refinements, used to originally develop the resource based malpractice
RVUs in CY 2000 and used in the CY 2005 update. These refinements
included an expansion in the malpractice premium data collection to
include additional specialties, a distinction between major and minor
surgical risk factors, and a proposal to use the malpractice risk
factor of the specialty that performs a given service the most
(dominant specialty) for services with less than 100 occurrences. We
solicited comments on our proposed methodology for updating the
malpractice RVUs and posted the Acumen report, ``Interim Report on
Malpractice RVUs for the CY 2010 Medicare Physician Fee Schedule
Proposed Rule'' on the CMS Web site. The interim report on Malpractice
RVUs for the CY 2010 PFS proposed rule and Malpractice premium amounts
and risk factors by specialty, which was produced by Acumen, LLC under
contract to CMS, is accessible from the CMS PFS Web page under the
heading ``Interim Report on Malpractice RVUs for the CY 2010 Medicare
PFS Proposed rule.'' The report and malpractice premiums may also be
accessed directly on the CMS Web site at http://www.cms.hhs.gov/PhysicianFeeSched/05_Malpractice_Report.asp#TopOfPage.
A more detailed explanation of our proposed malpractice RVU update
can be found in the CY 2010 PFS proposed rule (74 FR 33537).
We received over 250 industry comments on the CY 2010 proposed
malpractice RVU update.
Comment: Many commenters commended us for employing an expanded
data collection that included premium information for all physician
specialties, rather than just the top 20 Medicare physician
specialties. Commenters also applauded our use of the most current PLI
premium data available from State filings.
Response: We agree with the commenters that the use of the most
current PLI data and the expanded data collection is appropriate.
Comment: Some commenters supported the use of medical physicist
data as a proxy for developing malpractice RVUs for TC services. The
commenters expressed their belief that using medical physicist data
provide a better reflection of PLI premiums paid by entities furnishing
TC services than the current charge-based approach or cross-walking to
physician specialties. Many commenters did not support the proposed
change to resource-based MP RVUs for TC services because premium
amounts paid by medical physicists were used as a proxy for all
entities furnishing TC services. The commenters objected to our
proposed use of medical physicist data, stating that the use of this
data will result in inappropriately low MP RVUs for the affected
services. The commenters indicated that we should use premium data from
the suppliers of these TC services, such as IDTFs and audiologists.
Some commenters requested that we work with the Radiology Business
Management Association (RBMA) to obtain PLI premium information for
IDTFs. Other suppliers of TC services, including suppliers of imaging
services and remote cardiac monitoring services, also submitted
liability policy information. Several commenters requested that we use
the current charge-based malpractice RVUs until data from TC suppliers
can be collected.
Response: We appreciate all the comments received on this issue.
While we agree with the commenters who stated that the medical
physicist data provide a better reflection of PLI premiums paid by
entities furnishing TC services than the current charge-based approach
or crosswalking to physician specialties, we also agree with the
commenters who indicated that we should use premium data from the
suppliers of these services, if the data are available and meet the
same standards as the other premium data collected for use in the
development of the malpractice RVUs. As noted earlier, we have
repeatedly requested PLI data sources for suppliers of TC services. Our
proposal for TC services was based on the first verifiable data source
provided to us. In the comment period, alternative PLI sources were
recommended for use with the TC services. In some circumstances, the
information submitted by the commenters included insurance coverage
beyond the scope of the malpractice RVUs (for example, property
liability, errors and omissions liability) and/or coverage limits
beyond the $1 million/$3 million coverage malpractice premium
collection parameters used for professional services. However, these
same commenters also submitted the names of several insurance companies
who provide malpractice insurance for IDTFs. We contacted these
insurance companies in an attempt to collect premium data for the
suppliers of TC services. We were able to verify the premium
information for IDTFs consistent with the information collected for
physician specialties. Therefore, we are using this verified premium
data in the calculation of the malpractice RVUs for TC services.
Comment: Many commenters stated that all services have some level
of malpractice risk and that it was
[[Page 61760]]
inappropriate for CMS to allow rounding to result in zero malpractice
RVUs for some services.
Response: After considering the comments on this issue, we agree
that it would be inappropriate for services to receive zero payment for
malpractice due to rounding. These services will be assigned 0.01
malpractice RVUs for CY 2010.
Comment: One commenter did not support the use of work RVUs to
account for differences in risk-of-service for drug administration
services and that these services were being inappropriately penalized
in the malpractice risk allocation.
Response: When developing the current resource-based PE RVU
methodology, we received similar comments since the work RVUs are also
a component of the indirect PE allocation. In response to those
comments, we modified the resource-based PE methodology to allow the
allocation to be done using the greater of the clinical labor involved
in the service or the work RVUs. In light of similar comments on this
issue in the malpractice allocation, we will make a similar
modification. Specifically, we will use the greater of the clinical
labor involved in the service or the work RVUs in the malpractice
allocation.
Comment: The AMA RUC and other commenters requested that we use the
generally lower malpractice survey data from the Physician Practice
Information Survey (PPIS) for NPPs instead of crosswalking NPPs to the
lowest physician specialty (allergy/immunology). One commenter also
noted that the average premiums collected for diagnostic radiology were
lower than the average reported premium from the AMA PPIS data.
Response: The resource-based malpractice RVUs are based on
verifiable PLI premium data. We do not believe it would be appropriate
to base the malpractice RVUs for nonphysician specialties or selected
specialties on survey data and use premium data for all other
specialties. Therefore, we do not agree with the commenters who
suggested the use of survey data for NPPs or selected specialties.
Comment: The AMA RUC and two other commenters requested that we
crosswalk gynecologic oncology to general surgery and surgical oncology
(instead of crosswalking it to medical oncology) because gynecologic
oncologists are predominantly cancer surgeons.
Response: We agree with the commenters and will crosswalk
gynecologic oncology to general surgery premium data.
Comment: Some commenters raised questions about our proposal to
crosswalk maxillofacial surgery and oral surgery to allergy/immunology.
The commenters suggested that we use PLI data collected from the
American Association of Maxillofacial Surgery (AAOMS) or the PPIS data
instead of crosswalking to the lowest physician specialty.
Response: As noted earlier, the resource-based malpractice RVUs are
based on verifiable premium data. We do not agree with the commenters
who suggested the use of unverified maxillofacial surgery and oral
surgery PLI information. However, we do agree that it would be more
appropriate to use a surgical specialty's premium data rather than
allergy/immunology premium data for surgical specialties. Therefore, we
will crosswalk these specialties to the similar specialty of plastic
surgery.
Comment: Some commenters did not support using the global surgery
indicator for assigning the major or minor risk factor to surgical
procedures. The commenters stated that using this methodology for
determining the surgical class will not adequately address all the
instances in which a surgical procedure should be classified as major.
The commenters requested that we work with PLI insurance companies and
the AMA RUC to determine a more comprehensive definition of major and
minor surgical classifications. One commenter requested that we assign
the surgical risk factor to injection procedures performed during
cardiac catheterization as described by CPT codes 93501 through 93572.
Response: For the original implementation of resource-based MP RVUs
(CY 2000), we assigned one of two risk factors to each service based on
code range: surgery and nonsurgery (the surgery risk factor did not
distinguish between major and minor). This methodology of assigning
risk factors to specific services was also used in the first Five-Year
Review. For the second malpractice RVU update, we proposed to assign
each service code to one of the following three risk factors:
Nonsurgical; minor surgical; and major surgical (74 FR 33539). Risk
factor classes for each service were assigned based on procedure code
ranges and whether or not the service had a 90-day global period. The
90-day global period was used to assign surgical codes to major
surgery.
After consideration of the comments, we will not finalize our
proposal but will continue to use our current approach for assigning
risk factors to individual services while we study this issue further.
We will consider the request to assign the surgical risk factor to
injection procedures as part of our further study and would propose any
changes through future rulemaking.
As is done under the current methodology, we will continue to
assign each service to either a nonsurgical or surgical risk factor
based on CPT code ranges: Surgery (CPT code range 10000 through 69999;
92980 through 92998; 93501 through 93536; 92973 through 92974; 93501
through 93533; 93580 through 93581; 93600 through 93613; 93650 through
93652; 92975; 92980 through 92998; 93617 through 93641); and nonsurgery
(all other CPT codes). Consistent with current practice, the surgery
risk factor would not distinguish between major and minor.
Comment: While commenters agreed with most of our proposed claims
based dominant specialty designations for codes with less than 100
allowed services, the commenters disagreed with our proposal for some
services. The commenters believe that the claims have been miscoded,
resulting in erroneous specialty designations.
Response: Service specific malpractice RVUs are determined based on
the weighted average risk factor(s) of the specialties that furnish the
service. For rarely-billed Medicare services (that is, when allowed
services are less than 100), we proposed to use the risk factor of the
dominant specialty as reflected in our claims data. In the past, we had
used all the specialties performing these low volume services as
reflected in our claims data. Approximately 2,000 services met the
criteria for ``low volume.'' The dominant specialty for each `low
volume' service was determined from CY 2008 Medicare claims data.
By using the dominant specialty from our claims data to assign the
specialty for these low volume services, we attempted to strike a
balance between our preference for the empirical, objective use of all
of our claims data in the development of the malpractice RVUs and the
desire of commenters to override our claims data for these low volume
services using less objective criteria. After careful consideration of
the comments, we continue to believe that a more balanced approach
between the complete reliance on all of the specialties in our claims
data and the subjective review of each low volume service is the most
appropriate way of approaching the development of malpractice RVUs for
these low volume services. We disagree with the commenters that we
should override the dominant specialty from the claims data
[[Page 61761]]
with the recommended specialty. Therefore, we will finalize our
proposal to use Medicare claims data to assign a dominant specialty to
low volume services.
D. Medicare Telehealth Services
1. Requests for Adding Services to the List of Medicare Telehealth
Services
Section 1834(m)(4)(F) of the Act defines telehealth services as
professional consultations, office visits, and office psychiatry
services, and any additional service specified by the Secretary. In
addition, the statute requires us to establish a process for adding
services to or deleting services from the list of telehealth services
on an annual basis.
In the December 31, 2002 Federal Register (67 FR 79988), we
established a process for adding services to or deleting services from
the list of Medicare telehealth services. This process provides the
public with an ongoing opportunity to submit requests for adding
services. We assign any request to make additions to the list of
Medicare telehealth services to one of the following categories:
Category #1: Services that are similar to professional
consultations, office visits, and office psychiatry services. In
reviewing these requests, we look for similarities between the
requested and existing telehealth services for the roles of, and
interactions among, the beneficiary, the physician (or other
practitioner) at the distant site and, if necessary, the telepresenter.
We also look for similarities in the telecommunications system used to
deliver the proposed service, for example, the use of interactive audio
and video equipment.
Category #2: Services that are not similar to the current
list of telehealth services. Our review of these requests includes an
assessment of whether the use of a telecommunications system to deliver
the service produces similar diagnostic findings or therapeutic
interventions as compared with the face-to-face ``hands on'' delivery
of the same service. Requestors should submit evidence showing that the
use of a telecommunications system does not affect the diagnosis or
treatment plan as compared to a face-to-face delivery of the requested
service.
Since establishing the process, we have added the following to the
list of Medicare telehealth services: psychiatric diagnostic interview
examination; ESRD services with two to three visits per month and four
or more visits per month (although we require at least one visit a
month to be furnished in-person ``hands on'', by a physician, clinical
nurse specialist (CNS), nurse practitioner (NP), or physician assistant
(PA) to examine the vascular access site); individual medical nutrition
therapy; neurobehavioral status exam; and follow-up inpatient
telehealth consultations.
Requests to add services to the list of Medicare telehealth
services must be submitted and received no later than December 31 of
each calendar year to be considered for the next rulemaking cycle. For
example, requests submitted before the end of CY 2009 are considered
for the CY 2011 proposed rule. Each request for adding a service to the
list of Medicare telehealth services must include any supporting
documentation you wish us to consider as we review the request. Because
we use the annual PFS rulemaking process as a vehicle for making
changes to the list of Medicare telehealth services, requestors should
be advised that any information submitted is subject to disclosure for
this purpose. For more information on submitting a request for an
addition to the list of Medicare telehealth services, including where
to mail these requests, visit our Web site at http://www.cms.hhs.gov/telehealth/.
2. Submitted Requests for Addition to the List of Telehealth Services
We received requests in CY 2008 to add the following services as
Medicare telehealth services effective for CY 2010: (1) Health and
behavior assessment and intervention (HBAI) procedures; and (2) nursing
facility services. In addition, we received a number of requests to add
services that we did not approve as Medicare telehealth services in
previous PFS rules. These requested services include critical care
services; initial and subsequent hospital care; group medical nutrition
therapy; diabetes self-management training; speech and language
pathology services; and physical and occupational therapy services.
In the CY 2010 PFS proposed rule (74 FR 33543), we responded to
these requests. We proposed to add individual HBAI services to the list
of Medicare telehealth services, and we proposed to revise our
regulations at Sec. 410.78 and Sec. 414.65 accordingly. We proposed
to revise Sec. 410.78 to restrict physicians and practitioners from
using telehealth to furnish the physician visits required under Sec.
483.40(c). We proposed to revise Sec. 410.78 to specify that the G-
codes for follow-up inpatient telehealth consultations (as described by
HPCPCS codes G0406 through G0408) include follow-up telehealth
consultations furnished to beneficiaries in hospitals and SNFs. We did
not propose to add group HBAI, family-with-patient HBAI, nursing
facility services, critical care services, or any of the other
requested services to the list of Medicare telehealth services. The
following is a summary of the discussion from the proposed rule, a
summary of comments we received, and our responses.
a. Health and Behavior Assessment and Intervention (HBAI)
The American Psychological Association (APA) submitted a request to
add HBAI services (as described by HCPCS codes 96150 through 96154) to
the list of approved telehealth services. The APA asked us to evaluate
and approve HBAI services as a Category 1 service because they
are comparable to the psychotherapy services currently approved for
telehealth.
As discussed in the CY 2010 PFS proposed rule (74 FR 33543),
clinical psychologists furnish HBAI services to beneficiaries to help
them manage or improve their behavior in response to physical problems.
Elements of HBAI services typically include interviewing, observing,
and counseling beneficiaries to help them modify their behavior. These
elements are also common to the office psychiatry services currently
approved for telehealth. In the proposed rule, we stated that we
believe the interaction between a practitioner and a beneficiary
receiving individual HBAI services (as described by HCPCS codes 96150
through 96152) is similar to the assessment and counseling elements of
the individual office psychiatry services currently approved for
telehealth. Therefore, we proposed to revise Sec. 410.78 and Sec.
414.65 to include individual HBAI services as Medicare telehealth
services.
With regard to group HBAI (as described by HCPCS code 96153) or
family-with-patient HBAI (as described by HCPCS code 96154), we noted
that group services are not currently approved as Medicare telehealth
services. Group counseling services have a different interactive
dynamic between the physician or practitioner and his or her patients
as compared to individual services. Since the interactive dynamic for
group HBAI services is not similar to that for individual HBAI services
or any other approved telehealth services, we stated that we do not
believe that group HBAI or family-with-patient HBAI services should be
considered as Category 1 requests. To be considered as a
Category 1 request, a service must be similar to the current
list of Medicare telehealth services. (See 70 FR 45787 and 70157, and
73 FR 38516 and 69743). Instead,
[[Page 61762]]
we believe that group HBAI and family-with-patient HBAI must be
evaluated as Category 2 services. Accordingly, we need to
evaluate whether these are services for which telehealth can be an
adequate substitute for a face-to-face encounter. The requestor did not
submit evidence suggesting that the use of a telecommunications system
to deliver these services would produce similar diagnostic findings or
therapeutic interventions as compared to the face-to-face delivery of
these services. Therefore, we did not propose to add group HBAI (as
described by HCPCS code 96153) or family-with-patient HBAI (as
described by HCPCS code 96154) to the list of approved Medicare
telehealth services.
Comment: The APA stated that it was pleased that we proposed to add
individual HBAI to the list of approved telehealth services and that it
may wish to resume the discussion of adding other HBAI services in the
future. Other commenters were also pleased that we proposed to add
individual HBAI to the list of approved telehealth services. However,
they disagreed with our proposal not to add the other HBAI services to
the list of approved Medicare telehealth services. The commenters noted
that CMS has no evidence that it is not appropriate to furnish group
services via telehealth. In addition, the commenters believe that the
involvement of family members in patient counseling can often be
critical in developing an appropriate plan of care.
Response: Office psychiatry services currently approved for
telehealth are individual rather than group services. There are no
group services approved for telehealth. In order to add services for
Medicare telehealth that are not similar to the existing list of
Medicare telehealth services, we evaluate comparative studies to assess
whether the use of an interactive audio and video telecommunications
system is an adequate substitute for the in-person (face-to-face)
delivery of the requested service. Requestors did not submit sufficient
comparative analyses showing that the use of a telecommunications
system is an adequate substitute for group counseling services
furnished in person.
b. Nursing Facility Services
Section 149 of the MIPPA added SNFs as telehealth originating sites
effective for services furnished on or after January 1, 2009. We
received a request from the American Telemedicine Association (ATA) to
add subsequent nursing facility care; nursing facility discharge
services; and other nursing facility services to the list of approved
telehealth services. The Center for Telehealth and e-Health Law
submitted a request to add the same nursing facility services and
indicated its support of ATA's request. We also received a request from
the Marshfield Clinic to add the same services requested by the ATA,
plus the initial nursing facility care services.
The procedure codes included in these requests are used to report
evaluation and management (E/M) services furnished onsite to patients
in SNFs. The requestors drew analogies to the E/M services currently
approved for Medicare telehealth, and they provided evidence in support
of their belief that the use of telehealth could be a reasonable
surrogate for the face-to-face delivery of this type of care.
As discussed in the CY 2010 PFS proposed rule (74 FR 33543), the
long-term care regulations at Sec. 483.40 require that residents of
SNFs receive initial and periodic personal visits. These regulations
insure that at least a minimal degree of personal contact between a
physician or a qualified NPP and a resident is maintained, both at the
point of admission to the facility and periodically during the course
of the resident's stay. We believe that these Federally-mandated visits
should be conducted in-person, and not as Medicare telehealth services.
We proposed to revise Sec. 410.78 to restrict physicians and
practitioners from using telehealth to furnish the physician visits
required under Sec. 483.40(c).
We reviewed the use of telehealth for each of the subcategories of
nursing facility services included in these requests. We identified the
E/M services that fulfill Federal requirements for personal visits
under Sec. 483.40 and we did not propose to add any procedure codes
that are used exclusively to describe these Federally-mandated visits.
Initial Nursing Facility Care
The initial nursing facility care procedure codes (as described by
HCPCS codes 99304 through 99306) are used to report the initial E/M
visit in a SNF or NF that fulfills Federally-mandated requirements
under Sec. 483.40(c). We did not propose to add the initial nursing
facility care services (as described by HCPCS codes 99304 through
99306) to the list of approved Medicare telehealth services because
these procedure codes are used exclusively to describe E/M services
that fulfill Federal requirements for personal visits under Sec.
483.40.
Subsequent Nursing Facility Care
The subsequent nursing facility care procedure codes (as described
by HCPCS codes 99307 through 99310) are used to report either a
Federally-mandated periodic visit under Sec. 483.40(c), or any E/M
visit, prior to and after the initial physician visit, that is
reasonable and medically necessary to meet the medical needs of the
individual resident. In the past, we have not added hospital E/M visits
to the list of approved Medicare telehealth services because of our
concern regarding the use of telehealth for the ongoing E/M of a high-
acuity hospital inpatient. (See 69 FR 47511, 69 FR 66276, 72 FR 38144,
72 FR 66250, 73 FR 38517, and 73 FR 69745.) Many residents of SNFs also
require medically complex care, and we have similar concerns about
allowing physicians or NPPs to furnish E/M visits via telehealth to
residents of SNFs.
The complexity of care required by many residents of SNFs may be
significantly greater than the complexity of care generally associated
with patients receiving the office visits approved for telehealth.
Accordingly, we do not consider E/M visits furnished to residents of
SNFs similar to the office visits on the current list of Medicare
telehealth services. Therefore, we believe the use of subsequent
nursing facility care for medically necessary E/M visits that are in
addition to Federally-mandated periodic personal visits must be
evaluated as a Category 2 service.
We evaluated whether these are services for which telehealth can be
an adequate substitute for a face-to-face encounter. The requestors
submitted supporting documentation to demonstrate that the use of
telehealth could be a reasonable surrogate for the face-to-face
delivery of this type of care. However, we did not receive sufficient
comparative analysis or other compelling evidence to demonstrate that
furnishing E/M visits via telehealth to residents of SNFs is an
adequate substitute for the face-to-face encounter between the
practitioner and the resident, especially in cases where the resident
requires medically complex care. We were also concerned that one study
demonstrated that services provided via telehealth do not elicit
adequate participation in informed medical decision-making from
residents with low to moderate illness when compared to face-to-face
encounters. We determined that telehealth is not an adequate substitute
for the face-to-face delivery of E/M visits to residents of SNFs.
Therefore, we did not propose to
[[Page 61763]]
add subsequent nursing facility care services to the list of approved
Medicare telehealth services.
Nursing Facility Discharge Day Management
The nursing facility discharge day management codes (as described
by HCPCS codes 99315 and 99316) are used to report an E/M visit that
prepares a resident for discharge from a nursing facility. We note that
there is no Medicare Part B requirement to furnish and bill an E/M
visit in preparation for a resident's discharge from a SNF. However, if
a physician or qualified NPP bills a Nursing Facility Discharge
Services code, we believe that a face-to-face encounter will better
insure that the resident is prepared for discharge. We do not have
evidence that nursing facility discharge services furnished via
telehealth are equivalent to face-to-face provision of this service. We
did not propose to add the nursing facility discharge day management
services to the list of approved Medicare telehealth services.
Other Nursing Facility Service
In 2006, CPT added a procedure code for Other Nursing Facility
Service (CPT code 99318) to describe an annual nursing facility
assessment. An annual assessment is not one of the required visits
under the long-term care regulations at Sec. 483.40. For Medicare
purposes, this code can be used in lieu of a Subsequent Nursing
Facility Care code to report a Federally-mandated periodic personal
visit furnished under Sec. 483.40(c). An annual assessment visit
billed using CPT code 99318 does not represent a distinct benefit
service for Medicare Part B physician services, and it cannot be billed
in addition to the required number of Federally-mandated periodic
personal visits. Under Medicare Part B, we cover this procedure code if
the visit fully meets the CPT code 99318 requirements for an annual
nursing facility assessment. In order to cover and pay for this
service, we also require that this annual assessment falls on the 60-
day mandated visit cycle. We did not propose to add the other nursing
facility care services described by this code to the list of approved
Medicare telehealth services because this code is payable by Medicare
only if the visit is substituted for a Federally-mandated visit under
Sec. 483.40(c). We believe all of the Federally-mandated periodic
visits must be conducted in person.
Follow-up Inpatient Consultations
Prior to 2006, follow-up inpatient consultations (as described by
CPT codes 99261 through 99263) were approved telehealth services. In
2006, the CPT Editorial Panel of the American Medical Association (AMA)
deleted the codes for follow-up inpatient consultations. In the
hospital setting, the AMA advised practitioners to bill for services
that would previously have been billed as follow-up inpatient
consultations using the procedure codes for subsequent hospital care
(as described by CPT codes 99231 through 99233). In the nursing
facility setting, the AMA advised practitioners to bill for these
services using the procedure codes for subsequent nursing facility care
(as described by CPT codes 99307 through 99310).
In the CY 2009 PFS final rule with comment period (73 FR 69745), we
created follow-up inpatient telehealth consultation codes (as described
by HCPCS codes G0406 through G0408) to furnish care to hospital
inpatients, and we added these G-codes to the list of Medicare
telehealth services. These HCPCS codes are limited to the range of
services included in the scope of the previous CPT codes for follow-up
inpatient consultations, and the descriptions limit the use of such
services for telehealth.
In the CY 2010 PFS proposed rule (74 FR 33547), we stated that if
the former codes for follow-up consultations (as described by CPT codes
99261 through 99263) still existed, these procedure codes would also be
available to practitioners providing follow-up consultations via
telehealth to SNF patients. Although we did not receive a public
request to add follow-up inpatient consultations for SNF patients to
the list of approved Medicare telehealth services, we stated that we
also recognized a need to establish a method for practitioners to
provide these services. For CY 2010, we proposed to revise Sec. 410.78
to specify that the G-codes for follow-up inpatient telehealth
consultations (as described by HCPCS codes G0406 through G0408) include
follow-up inpatient telehealth consultations furnished to beneficiaries
in SNFs, as well as in hospitals. The HCPCS codes clearly designate
these services as follow-up consultations provided via telehealth, and
not as subsequent care used for E/M visits. Utilization of these codes
for patients in SNFs will facilitate payment for these services, as
well as enable us to monitor whether the codes are used appropriately.
(See the CMS Internet-Only Medicare Claims Processing Manual, Pub. 100-
04, Chapter 12, Section 190, for the definition of follow-up inpatient
telehealth consultations.)
The following is a summary of the comments we received regarding
our proposed decisions on Nursing Facility Services.
Comment: Commenters supported our proposal to restrict physicians
and practitioners from using telehealth to furnish the physician visits
required under Sec. 483.40(c). Commenters also supported our proposal
to expand the definition of Follow-Up Inpatient Telehealth
Consultations (as described by HCPCS codes G0406-G0408) to allow their
use for residents of SNFs. Commenters noted that this change would be a
positive step towards increasing access to care for Medicare
beneficiaries in rural areas.
Some commenters disagreed with our proposal not to add Nursing
Facility Services to the list of approved Medicare telehealth services.
Commenters acknowledged Congressional intent expressed in section 413
of the MMA that the use of telehealth should not be a substitute for
the Federally-mandated periodic personal visits required under Sec.
483.40(c). All commenters agreed with our proposal not to add any
procedure codes that are used exclusively to describe these Federally-
mandated visits. Commenters stated that they believed that the Congress
intended to allow the use of telehealth to furnish E/M medically
necessary visits onsite to residents of SNFs that are in addition to
Federally-mandated periodic personal visits. Some commenters also noted
that due to health professional shortages in rural areas, many SNFs
lack essential onsite services. Some commenters believe adding nursing
facility visits to the list of approved telehealth services will
improve the quality of care furnished to residents of SNFs. Commenters
also noted that not adding nursing facility visits to the list of
approved Medicare telehealth services will not prevent the use of
telehealth to furnish services to residents of SNFs, including those
residents requiring medically complex care. These same residents could
be transported to physicians' offices or hospitals where they could
receive similar E/M visits via telehealth.
Response: We did not receive sufficient comparative analysis or
other compelling evidence to demonstrate that furnishing E/M visits via
telehealth to residents of SNFs is an adequate substitute for the face-
to-face encounter between the practitioner and the resident, especially
in cases where the resident requires medically complex care. We are
further concerned that the use of telehealth may not elicit adequate
participation from residents of SNFs in
[[Page 61764]]
making informed medical decisions with their clinicians when compared
to face-to-face encounters.
We agree with the commenters who noted that expanding the
definition of Follow-Up Inpatient Telehealth Consultations (G0406-
G0408) to allow their use for residents of SNFs will increase access to
care for Medicare beneficiaries in rural areas. We believe the
availability of inpatient consultations to furnish care via telehealth
to residents of SNFs is consistent with the addition of SNFs as
approved telehealth originating sites. Physicians and NPPs who furnish
inpatient consultations via telehealth complement the care provided by
the SNF and furnished onsite by the attending physician or physician of
record.
c. Critical Care Services
In the CY 2009 PFS final rule with comment period (73 FR 69744), we
did not add critical care services to the list of approved Medicare
telehealth services. In 2009, Philips Healthcare submitted an expanded
request to add critical care services to the list of approved Medicare
telehealth services. It stated that critical care services can be
approved as a Category 1 service based on their similarity to
the inpatient consultation services currently approved for Medicare
telehealth. The requestor also stated that many of the components of
critical care are similar to a high-level inpatient consultation
service, which is currently approved for Medicare telehealth. Common
components include obtaining a patient history, conducting an
examination, and engaging in complex medical decision-making for
patients who may be severely ill. Because we classified critical care
as a Category 2 service last year, the requestor also
submitted evidence to support its belief that the use of telehealth
could be a reasonable surrogate for the face-to-face delivery of this
type of care.
In the CY 2010 PFS proposed rule (74 FR 33548), we stated that
remote critical care services are different than the telehealth
delivery of critical care (as described by HCPCS codes 99291 and
99292). We did not propose adding critical care services (as described
by HCPCS codes 99291 and 99292) to the list of approved Medicare
telehealth services. We reiterated that our decision not to add
critical care services to the list of approved telehealth services does
not preclude physicians from furnishing telehealth consultations to
critically ill patients.
Comment: A commenter disagreed with our proposal not to add
critical care services to the list of approved Medicare telehealth
services. The commenter submitted a new study to support its belief
that these services are comparable to critical care furnished in-
person. The commenter asserted that the role of the intensivist,
whether in-person or remotely, is to provide the required expertise and
ability to direct onsite clinical staff to perform any necessary hands-
on intervention, not necessarily to effectuate them personally. To
support this, the commenter submitted a vignette describing critical
care services, including an analysis detailing the types of services
furnished when critical care (as described by HCPCS codes 99291 and
99292) was billed by a sample of intensivists. The commenter noted that
the critical care services included in this sample did not require
hands-on intervention.
Another commenter who submitted the CY 2009 request submitted
descriptions of telestroke technology to support the assertion that the
elements of a stroke-related neurological assessment performed by a
neurologist are effectively the same whether furnished in-person or via
telehealth. The commenter acknowledges that some telestroke services
satisfy the criteria for billing consultations via telehealth, but
noted that the payment is less than the same neurological assessment
furnished in-person and billed as a critical care service. The
commenter requested that we consider adding critical care services to
the list of approved Medicare telehealth services when the underlying
diagnosis is stroke-related.
Response: We continue to believe that remote critical care services
are different from the telehealth delivery of critical care services
(as described by HCPCS codes 99291 and 99292). The AMA created remote
critical care tracking codes. Such codes track utilization of a
service, facilitating data collection on, and assessment of, new
services and procedures. We believe that the data collected for these
tracking codes will help provide useful information on how to best
categorize and value remote critical care services in the future.
We did not find the studies submitted during the comment period
persuasive that telehealth can be an adequate substitute for the face-
to-face delivery of critical care services (as described by HCPCS codes
99291 and 99292). As described in these studies, the role of the
physician furnishing remote critical care services includes monitoring
patients and directing on-site staff to intervene, as necessary. Within
the current standards of practice, we believe that critical care
services (as described by HCPCS codes 99291 and 99292) require the
physical presence of a physician who is available to furnish any hands-
on intervention. We continue to believe that remote critical care
services are different services than the telehealth delivery of
critical care (as described by HCPCS codes 99291 and 99292). As noted
above, we believe that the data collected for the remote critical care
tracking codes will help provide useful information on how to best
categorize and value remote critical care services in the future.
d. Other Requests
We received a number of requests to add services that we reviewed
and did not accept in previous PFS Rules. The following are brief
summaries of our discussions from the proposed rule, summaries of
comments received, and our responses.
Initial and Subsequent Hospital Care
We received a request to add initial hospital care (as described by
HCPCS codes 99221 through 99223) and subsequent hospital care (as
described by HCPCS codes 99231 through 99233) to the list of approved
Medicare telehealth services. In response to previous requests, we did
not add initial or subsequent hospital care to the list of approved
telehealth services because of our concern regarding the use of
telehealth for the ongoing E/M of a high-acuity hospital inpatient.
(See 69 FR 47510 and 66276, 72 FR 38144 and 66250, and 73 FR 38517 and
69745.) We did not receive any new information with this request that
would alter our previous decision. Therefore, we did not propose adding
initial hospital care or subsequent hospital care to the list of
approved Medicare telehealth services. We did not receive any comments
on this proposal.
Group Medical Nutrition Therapy Services
We received a request to add group medical nutrition therapy (MNT)
services (as described by HCPCS codes G0271 and 97804) to the list of
approved Medicare telehealth services. In response to a previous
request, we did not add group MNT to the list of approved telehealth
services because we believe that group services are not appropriately
delivered through telehealth. (See 70 FR 45787 and 70157.) We did not
receive any new information with this request that would alter our
previous decision. Therefore, we did not propose adding group MNT to
the list of approved Medicare telehealth services. We did
[[Page 61765]]
not receive any comments on this proposal.
Diabetes Self-Management Training (DSMT)
We received a request to add diabetes self-management training
(DSMT) (as described by HCPCS codes G0108 and G0109) to the list of
approved telehealth services. In response to previous requests, we did
not add DSMT to the list of approved telehealth services because of the
statutory requirement that DSMT include teaching beneficiaries to self-
administer injectable drugs. Furthermore, DSMT is often performed in
group settings and we believe that group services are not appropriately
delivered through telehealth. (See 70 FR 45787 and 70157, and 73 FR
38516 and 69743.) We did not receive any new information with this
request that would alter our previous decision. Therefore, we did not
propose to add DSMT to the list of approved Medicare telehealth
services.
Comment: We received two comments opposing our proposal not to add
DSMT to the list of approved Medicare telehealth services. The American
Association of Diabetes Educators (AADE) agrees that telehealth is not
an appropriate venue for initial DSMT when it includes teaching
beneficiaries to self-administer injectable drugs. One commenter
submitted studies to support its belief that the use of a
telecommunications system was equivalent to the face-to-face delivery
of follow-up DSMT.
Response: We believe that skill-based training, such as teaching
patients how to inject insulin, would be difficult to accomplish
effectively without the physical presence of the teaching practitioner.
We disagree that this training element should be carved out of
individual DSMT for purposes of providing Medicare telehealth services.
The training involved in teaching beneficiaries the skills necessary
for the self-administration of injectable drugs is a key component of
this statutorily described benefit (and therefore inherent in the codes
that describe DSMT). We continue to believe that it would not be
appropriate to add individual follow-up DSMT to the list of approved
Medicare telehealth services.
Speech and Language Pathology Services
We received a request to add various speech and language pathology
services to the list of approved telehealth services. Speech-language
pathologists are not permitted under current law to furnish and receive
payment for Medicare telehealth services. Therefore, we did not propose
to add any speech and language pathology services to the list of
approved Medicare telehealth services. (For further discussion, see 69
FR 47512 and 66276, and 71 FR 48995 and 69657.)
Comment: The American Speech-Language Hearing Association (ASHA)
commented that telehealth has been successfully applied to speech-
language pathology and audiology services. ASHA requested that CMS
support expansion of Medicare telehealth coverage for speech-language
pathologists in communications with Congress. The American Academy of
Audiology commented on the shortage of audiologists in rural areas. The
group requested that we use our administrative authority to add
audiology services to the list of approved Medicare telehealth
services.
Response: It is not within our administrative authority to pay
speech-language pathologists and audiologists for services furnished
via telehealth. The statute authorizes the Secretary to pay only for
telehealth services furnished by a physician or a practitioner as those
terms are defined in the statute.
Physical and Occupational Therapy Services
We received a request to add various physical and occupational
therapy services to the list of approved Medicare telehealth services.
The statute does not authorize Medicare payment to physical and
occupational therapists for Medicare telehealth services. Therefore, we
did not propose to add any physical and occupational therapy services
to the list of approved Medicare telehealth services. (For further
discussion, see 71 FR 48995 and 69657.)
e. Summary: Result of Evaluation of 2010 Requests
We will finalize our proposal to add the individual HBAI services
(as described by HCPCS codes 96150 through 96152) and not to add group
HBAI (as described by HCPCS code 96153) or family-with-patient HBAI (as
described by HCPCS code 96154) to the list of approved Medicare
telehealth services. We will also finalize our proposal to add
individual HBAI services to the list of approved Medicare telehealth
services at Sec. 410.78 and Sec. 414.65.
We will finalize our proposal to revise Sec. 410.78 to restrict
physicians and practitioners from using telehealth to furnish the
physician visits required under Sec. 483.40(c). We will finalize our
proposal not to add Nursing Facility Services (as described by HCPCS
codes 99304 through 99318) to the list of approved Medicare telehealth
services. We will also finalize our proposal to revise Sec. 410.78 to
specify that the G-codes for follow-up inpatient telehealth
consultations (as described by HPCPCS codes G0406 through G0408)
include follow-up telehealth consultations furnished to beneficiaries
in hospitals and SNFs.
We will finalize our proposals not to add critical care services
(as described by HCPCS codes 99291 and 99292) or any of the other
requested services to the list of approved Medicare telehealth
services.
3. Other Issues
We received other comments on matters related to Medicare
telehealth services that were not the subject of proposals in the CY
2010 PFS proposed rule. We thank the commenters for sharing their views
and suggestions. Because we did not make any proposals regarding these
matters, we do not generally summarize or respond to such comments in
this final rule. However, we have chosen to summarize and respond to
the following comments in order to furnish more information.
Comment: The American Society of Nephrology requested clarification
on whether Medicare would pay for kidney disease patient education
furnished via telehealth. Other commenters specifically requested that
we add kidney disease patient education services to the list of
approved telehealth services.
Response: Kidney disease patient education services are not
approved Medicare telehealth services. Any interested parties may
submit requests to add services to the list of Medicare telehealth
services. Requests submitted before the end of CY 2009 will be
considered for the CY 2011 PFS proposed rule. Requestors should be
advised that each request to add a service to the list of Medicare
telehealth services must include any supporting documentation the
requestor wishes us to consider as we review the request. For more
information on submitting a request for an addition to the list of
Medicare telehealth services, including where to directly mail these
requests, visit our Web site at http://www.cms.hhs.gov/telehealth.
Comment: We received a few comments that questioned our criteria
and process for reviewing requests to add to the list of approved
Medicare telehealth services. The commenters stated that our standards
interfere with appropriate physician medical judgment under section
1801 of the Act. One commenter noted that since the
[[Page 61766]]
standards are not specified in regulation text, we can change them
without formal rulemaking.
Response: Our established criteria and process for reviewing
requests to add to the list of approved Medicare telehealth services
were subject to full notice and comment procedures in the CY 2003 PFS
proposed and final rules. Since we did not make any proposals relating
to the criteria or process, any potential revisions to the process for
adding or deleting services from the list of approved Medicare
telehealth services are outside the scope of this final rule.
Comment: We received a request to provide a list of physician
services that can be furnished without an in-person examination.
Response: General guidance regarding physician services that can be
furnished by visualizing some aspect of the patient's condition without
an in-person examination is provided in the CMS Internet-Only Medicare
Benefits Policy Manual, Pub. 100-02, Chapter 15, Sec. 30.
E. Specific Coding Issues Related to the Physician Fee Schedule
1. Canalith Repositioning
In 2008, the CPT Editorial Panel created a new code for canalith
repositioning (CRP). This procedure is a treatment for vertigo which
involves therapeutic maneuvering of the patient's body and head in
order to use the force of gravity to redeposit the calcium crystal
debris in the semicircular canal system.
In the CY 2009 PFS final rule with comment period (73 FR 69896),
new CPT code 95992, Canalith repositioning procedure(s) (e.g., Epley
maneuver, Semont maneuver), per day, was assigned the bundled status
indicator (B). We explained that this procedure previously was billed
as part of an evaluation and management (E/M) service or under a number
of CPT codes, including CPT code 97112, Therapeutic procedure, one or
more areas, each 15 minutes; neuromuscular reeducation of movement,
balance, coordination, kinesthetic sense, posture, and/or
proprioception for sitting and/or standing activities. We also
explained that because neurologists and therapists are the predominant
providers of this service to Medicare patients (each at 22 percent), it
was assigned as a ``sometimes therapy'' service under the therapy code
abstract file.
After publication of the CY 2009 PFS final rule with comment
period, we received comments on this issue from an organization
representing physical therapists, as well as others expressing
opposition to our decision to bundle the new code. Commenters stated
that they believe that our decision to bundle CPT code 95992 was flawed
since physical therapists are unable to bill E/M services. One
commenter also stated that therapists would be precluded from using
another code for billing for this service because CPT correct coding
instructions require that the provider/supplier select the procedure
that most accurately defines the service provided.
Based upon the commenters' feedback, we realized that we had failed
to address how therapists would bill for the service since they cannot
bill E/M services. In order to address this situation so that access to
this service would not be impacted we released a MedLearn article
informing PTs to continue using one of the more generally defined
``always therapy'' CPT codes (97112) as a temporary measure. See http://www.cms.hhs.gov/transmittals/downloads/R1691CP.pdf and http://www.cms.hhs.gov/MLNMattersArticles/downloads/MM6397.pdf.
In response to the concerns raised and upon additional review of
this issue in the CY 2010 PFS proposed rule, we proposed to change the
status indicator for this code from B (Bundled) to I (Not valid for
Medicare purposes). We proposed that physicians would continue to be
paid for CRP as a part of an E/M service. Physical therapists would
continue to use one of the more generally defined ``always therapy''
CPT codes (97112). We stated that we believe that this will enable
beneficiaries to continue to receive this service while at the same
time it will address our concerns about the potential for duplicate
billing for this service to the extent that this service is paid as a
part of an E/M service. As a result of this proposal, CPT code 95992
would be removed as a ``sometimes'' therapy code from the therapy code
list.
The following is a summary of the comments we received regarding
the canalith repositioning proposal.
Comment: Some commenters stated that the canalith repositioning
treatment requires 20 minutes of intraservice time as valued by the AMA
RUC and that the pre-time was specifically removed because the service
is typically performed with an E/M code. The commenters also stated
that they believe we expected physicians to forgo payment for CRP and
asked that we pay it separately from an E/M service. The commenters
requested that CMS recognize the service as separate and distinct from
an E/M service.
Response: As we stated in the CY PFS final rule (73 FR 69896)
canalith repositioning has been billed using E/M codes and therapy
service codes in the past and we believe it should continue to be
billed this way. Physicians will continue to be paid for the work
performed when CRP is billed using E/M codes.
Comment: Some commenters opposed designating CPT code 95992 as not
valid for Medicare purposes. The commenters stated that the code was
developed to describe and value CRP and that it should be utilized.
Another commenter stated that it is not consistent with CPT coding
principles to direct therapists to use a less specific code.
Response: As stated in the CY 2010 PFS proposed rule we initially
decided to bundle this code, but upon further review proposed to change
the status indicator to ``I'' (not valid for Medicare purposes).
Physicians will continue to be paid for CRP as part of an E/M service.
Physical therapists will continue to use an ``always therapy'' CPT code
as they have in the past. The code will be removed from the
``sometimes'' therapy list. This change will address our concerns about
the potential for duplicate billing of this service while still
allowing physicians and therapists to perform the service.
Comment: Some commenters are concerned that audiologists have no
way to bill for CRP. They requested that CMS reconsider allowing
payment to audiologists for this treatment.
Response: Audiological tests are covered under the benefit category
for other diagnostic tests. There is no statutory authority to allow
audiologists to bill Medicare for treatment services, such as CRP. CRP
may be covered under the benefit category for physician services or
physical therapy services. If covered as a physician service, it may be
furnished incident to a physician's service by any qualified staff.
We will finalize our proposal to designate CPT code 95992 as ``I'',
not valid for Medicare purposes. We will also remove it from the
``sometimes'' therapy code list in order to allow therapists to bill
appropriately for the service, using one of the more generally defined
``always therapy'' codes.
2. Payment for an Initial Preventive Physical Examination (IPPE)
In the CY 2010 PFS proposed rule, we proposed to increase the
payment for an initial preventive physical examination (IPPE) furnished
face-to-face with the patient and billed with HCPCS code G0402, Initial
preventive physical examination; face-to-face visit, services limited
to new beneficiary during the first 12 months of Medicare enrollment
beginning January 1, 2010. The IPPE service includes a broad array of
[[Page 61767]]
components and focuses on primary care, health promotion, and disease
prevention.
Section 101(b) of the MIPPA changed the IPPE benefit by adding to
the IPPE visit the measurement of an individual's body mass index and,
upon an individual's consent, end-of-life planning. Section 101(b) of
the MIPPA also removed the screening electrocardiogram (EKG) as a
mandatory service of the IPPE.
In order to implement this MIPPA provision, in the CY 2009 PFS
final rule with comment period (73 FR 69870), we created HCPCS code
G0402 as a new HCPCS code and retained, on an interim basis, the work
RVUs of 1.34 assigned to HCPCS code G0344, the code that was previously
used to bill for the IPPE. While we did not believe the revisions to
the IPPE required by MIPPA impacted the work RVUs associated with this
service, we solicited public comments on this issue, as well as
suggested valuations of this service to reflect resources involved in
furnishing the service. (For a summary of the comments received on the
CY 2009 PFS final rule with comment period, see the CY 2010 PFS
proposed rule (74 FR 33549)).
Based on a review of the comments received on the CY 2009 PFS final
rule with comment period and upon further evaluation of the component
services of the IPPE, we stated in the CY 2010 PFS proposed rule that
we believe the services, in the context of work and intensity,
contained in HCPCS code G0402 are most equivalent to those services
contained in CPT code 99204, Evaluation and management new patient,
office or other outpatient visit, and proposed increasing the work RVUs
for HCPCS code G0402 to 2.30 effective for services furnished beginning
on January 1, 2010.
The following is a summary of the comments we received regarding
the proposed increase to the payment for the IPPE billed with HCPCS
code G0402.
Comment: All commenters strongly supported CMS' proposal to
increase the payment for the IPPE. Commenters believe that the CY 2010
payment will fairly account for the services rendered.
Response: We are finalizing our proposal to increase the work RVUs
for the IPPE to 2.30 effective for services furnished beginning January
1, 2010.
3. Audiology Codes: Policy Clarification of Existing CPT Codes
In the CY 2009 PFS final rule with comment period (73 FR 69890), we
noted that the AMA RUC reviewed and recommended work RVUs for 6
audiology codes with which we agreed (that is, CPT codes 92620, 92621,
92625, 92626, 92627, and 92640). We also noted that in the Medicare
program, audiology services are covered under the diagnostic test
benefit and that some of the work descriptors for these services
include ``counseling,'' ``potential for remediation,'' and
``establishment of interventional goals.''
Since audiology services fall under the diagnostic test benefit,
aspects of services that are therapeutic or management activities are
not payable to audiologists. This distinction is of particular
importance since CPT codes 92620, 92621, 92626, 92627, and 92640 are
``timed'' codes. These codes are billed based on the actual time spent
furnishing the service.
We noted that we do not believe these aspects fit within the
diagnostic test benefit. We solicited comments on this issue. For a
summary of the comments received and our responses to those comments,
see the CY 2010 PFS proposed rule (74 FR 33550).
The following is summary of the comments we received regarding the
policy clarification of existing CPT codes for audiology services.
Comment: We received additional comments reiterating the comments
to which we had responded previously in the proposed rule that
``counseling,'' ``potential for remediation,'' and ``establishment of
interventional goals'' were part of the diagnostic test and were not
therapeutic or management activities. Other commenters agreed with the
clarification as it was presented in the proposed rule.
Response: After a careful consideration of all the comments, we are
finalizing the clarification of audiology services with respect to CPT
codes 92620, 92621, 92625, 92626, 92627, 92640, and other audiologist
services as discussed in the proposed rule. Although we understand that
test results are sometimes appropriately and briefly conveyed to the
patient at the time of the diagnostic test, any therapeutic activities
or activities that should be billed as E/M services associated with
these audiology codes are not payable to audiologists because they do
not fall within the benefit category under which these tests are
covered.
4. Consultation Services
a. Background
The current physician visit and consultation codes were developed
by the American Medical Association (AMA) Current Procedural
Terminology (CPT) Editorial Panel in November 1990. A consultation
service is an evaluation and management (E/M) service furnished to
evaluate and possibly treat a patient's problem(s). It can involve an
opinion, advice, recommendation, suggestion, direction, or counsel from
a physician or qualified NPP at the request of another physician or
appropriate source. (See the Internet-Only Medicare Claims Processing
Manual, Pub. 100-04, chapter 12, Sec. 30.6.10 A for more information.)
A consultation service must be documented and a written report given to
the requesting professional. Currently, consultation services are
predominantly billed by specialty physicians. Primary care physicians
infrequently furnish these services.
The required documentation supports the accuracy and medical
necessity of a consultation service that is requested and provided.
Medicare pays for a consultation service when the request and report
are documented as a consultation service, regardless of whether
treatment is initiated during the consultation evaluation service. (See
the Internet-Only Medicare Claims Processing Manual, Pub. 100-04,
chapter 12, Sec. 30.6.10 B.) A consultation request between
professionals may be done orally by telephone, face-to-face, or by
written prescription brought from one professional to another by the
patient. The request must be documented in the medical record.
In the Physician Fee Schedule Final Rule issued June 5, 1991, (56
FR 25828) we stated that the agency's goal for the development of the
new visit and consultation codes was that they meet two criteria: (1)
They should be used reliably and consistently by all physicians and
carriers; that is, the same service should be coded the same way by
different physicians; and (2) they should be defined in a way that
enables us to properly crosswalk the new codes to the relative values
for the Harvard vignettes so valid RVUs for work are assigned to the
new codes.
Based on requests from the physician community to clarify our
consultation payment policy and to provide consultation examples, we
convened an internal workgroup of medical officers within CMS (then
called the Health Care Financing Administration, or HCFA) and revised
the payment policy instructions in August 1999 in the Medicare Claims
Processing Manual (at Sec. 30.6.10 as cited above). We provided
examples of consultation services and examples of clinical scenarios
that did not satisfy Medicare criteria for consultation services.
Without explicit instructions for every possible clinical scenario
outlined in national policy
[[Page 61768]]
instructions or in AMA coding definitions or coding instructions, the
local policy interpretations by Medicare contractors were not
universally equivalent or acceptable to the physician community and
resulted in denials in different localities. Some Medicare contractors
would consider a consultation service with treatment to be an initial
visit rather than a consultation thus resulting in a denial for the
billed consultation. We clarified in the 1999 revision that Medicare
would pay for a consultation whether treatment was initiated at the
consultation visit or not. The physician community has stated that
terms such as referral, transfer and consultation, used interchangeably
by physicians in clinical settings, confuse the actual meaning of a
consultation service and that interpretation of these words varies
greatly among members of that community as some label a transfer as a
referral and others label a consultation as a referral. Although we
clarified the terms referral and consultation in the 1999 revision,
there was disagreement with our policy by physicians in the health care
community and by AMA CPT staff. We provided our documentation guidance
so physicians would be in compliance with our payment policy. The
consultation definition in the AMA CPT simply stated that the
consultant's opinion or other information must be communicated to the
requesting physician.
Additional manual revisions in both January and September 2001 (at
Sec. 30.6.10 as cited above) clarified that NPPs can both request and
furnish consultation services within their scope of practice and
licensure requirements. We continued to explain our documentation
requirements to the physician community through our Medicare
contractors and in our discussions with the AMA CPT staff. Under our
current policy and in the AMA CPT definition, a consultation service
must have a request from another physician or other professional and be
followed by a report to the requesting professional. The AMA CPT
definition does not state that the request must be written in the
requesting physician's medical record. However, we require the request
to be documented in the requesting physician's plan of care in the
medical record as a condition for Medicare payment. The E/M
documentation guidelines which apply to all E/M visits or consultations
(http://www.cms.hhs.gov/MLNEdWebGuide/25_EMDOC.asp) clearly state that
when referrals are made, consultations are requested, or advice is
sought, the medical record should indicate to whom and where the
referral or consultation is made or from whom the advice is requested.
Our Medicare contractors are responsible for reviewing and paying
consultation claims when submitted. When there is a question that
triggers a review of a consultation service, our Medicare contractors
will look at both the requesting physician's medical record (where the
request should be noted) and the consultant's medical record where the
consultation is reported and at the report generated for the requesting
physician. Medicare contractors do not look for evidence of
documentation on every claim, only when there is a concern raised
during random sampling or during a specific audit performed by a
contractor. The AMA CPT coding manual, which is not a payment manual,
does not specify these requirements, and, therefore, as we understand
it, many physicians do not agree with the CMS policy.
In March 2006, the Office of the Inspector General (OIG) published
a report entitled, ``Consultations in Medicare: Coding and
Reimbursement'' (OEI-09-02-00030). The stated purpose of the report was
to assess whether Medicare's payments for consultation services were
appropriate. While the OIG study was being conducted, we continued our
ongoing discussions with the AMA CPT staff for potential changes to the
consultation definition and guidance in CPT. The findings in the OIG
report (based on claims paid by Medicare in 2001) indicated that
Medicare allowed approximately $1.1 billion more in 2001 than it should
have for services that were billed as consultations. Approximately 75
percent of services paid as consultations did not meet all applicable
program requirements (per the Medicare instructions) resulting in
improper payments. The majority of these errors (47 percent of the
claims reviewed) were billed as the wrong type or level of
consultation. The second most frequent error was for services that did
not meet the definition of a consultation (19 percent of the claims
reviewed). The third category of improperly paid claims was a lack of
appropriate documentation (9 percent of the claims reviewed). The OIG
recommended that CMS, through our Medicare contractors, should educate
physicians and other health care practitioners about Medicare criteria
and proper billing for all types and levels of consultations with
emphasis on the highest levels and follow-up inpatient consultation
services.
We agreed with the OIG findings that additional education would
help physicians understand the differences in the requirements for a
consultation service from those for other E/M services. With each
additional revision from 1999 until the OIG study began, we continually
educated physicians through the guidance provided by our Medicare
contractors. However, there remained discrepancies with unclear and
ambiguous terms and instructions in the AMA CPT definition of a
consultation, transfer of care and documentation, and the feedback from
the physician community that indicated they disagreed with Medicare
guidance.
Prior to the official publication of the OIG report, we issued a
Medlearn Matters article, effective January 2006, to educate the
physician community about requirements and proper billing for all types
and levels of consultation services as requested by the OIG in their
report. The Medlearn Matters article reflected the manual changes we
made in 2006 and the AMA CPT coding changes as noted below. (This
article and related documents can be accessed at http://www.cms.hhs.gov/MLNMattersArticles/2005MMA/itemdetail.asp?filterType=none&filterByDID=-99&sortByDID=7&sortOrder=ascending&itemID=CMS053630&intNumPerPage=2000.)
Our consultation policy revisions continued as a work-in-progress
over several years as disagreements were raised by the physician
community. We continued to work with AMA CPT coding staff in an attempt
to have improved guidance for consultation services in the CPT coding
definition. In looking at physician claims data (for example, the low
usage of confirmatory consultation services) and in response to
concerns from the physician community regarding how to correctly use
the follow-up consultation codes, the AMA CPT Editorial Panel chose to
delete some of the consultation codes for 2006. The Follow-Up Inpatient
Consultation codes (CPT codes 99261 through 99263) and the Confirmatory
Consultation codes (CPT codes 99271 through 99275) were deleted. During
our ongoing discussions, the AMA CPT staff maintained that physicians
did not fully understand the use of these codes and historically
submitted them inappropriately for payment as was reflected in the OIG
study.
We issued a manual revision in the Medicare Claims Processing
Manual (at Sec. 30.6.10 as cited above) simultaneously with the
publication of AMA CPT 2006
[[Page 61769]]
coding changes removing the follow-up consultation codes, and
instructed physicians to use the existing subsequent hospital care
code(s) and subsequent nursing facility care codes for visits following
a consultation service. The confirmatory consultation codes (which were
typically used for second opinions) were also removed and we instructed
physicians to use the existing E/M codes for a second opinion service.
We further clarified the documentation requirements by making it easier
to document a request for a consultation service from another physician
and to submit a consultation report to the requesting professional.
Again, physicians stated that a consultant has no control over what a
requesting or referring physician writes in a medical record, and that
they should not be penalized for the behavior of others. However, our
consultation policy instructions apply to all physicians, whether they
request a consultation or furnish a consultation. As noted above,
documentation by both the requesting physician and the physician who
furnishes the consultation is required under the E/M documentation
guidelines. The E/M documentation guidelines have been in use since
1995. In our discussions with the AMA CPT staff and physician groups,
and national physician open door conference calls, we have emphasized
that the requesting physician medical record is not reviewed unless
there is a specific audit or random sampling performed. The physician
furnishing the consultation service should document in the medical
record from whom a request is received.
We continue to hear from the AMA and from specific national
physician specialty representatives that physicians are dissatisfied
with Medicare documentation requirements and guidance that distinguish
a consultation service from other E/M services such as transfer of
care. CPT has not clarified transfer of care. Many physician groups
disagree with our requirements for documentation of transfer of care.
Interpretation differs from one physician to another as to whether
transfer of care should be reported as an initial E/M service or as a
consultation service.
Despite our efforts, the physician community disagrees with
Medicare interpretation and guidance for documentation of transfer of
care and consultation. The existing consultation coding definition in
the AMA CPT definition has been ambiguous and confusing for certain
clinical scenarios and without a clear definition of transfer of care.
The CPT consultation codes are used by physicians and qualified NPPs to
identify their services for Medicare payment. There has been an absence
of any guidance in the AMA CPT consultation coding definition that
distinguishes a transfer of care service (when a new patient visit is
billed) from a consultation service (when a consultation service is
billed). Although Medicare has provided guidance, there has continued
to be disagreement with our policy from AMA CPT staff and some members
of the physician community. Because of the disparity between AMA coding
guidance and Medicare policy, some physicians have stated that they
have difficulty in choosing the appropriate code to bill. The payment
for both inpatient consultation and office/outpatient consultation
services is higher than for initial hospital care and new patient
office/outpatient visits. However, the associated physician work is
clinically similar. Many physicians contend that there is more work
involved with a new patient visit than a consultation service because
of the post work involvement with a new patient. The payment for a
consultation service has been set higher than for initial visits
because a written report must be made to the requesting professional.
However, all medically necessary Medicare services require
documentation in some form in a patient's medical record. Over the past
several years, some physicians have asked CMS to recognize the
provision of the consultation report via a different form of
communication in lieu of a written letter report to the requesting
physician so as to lessen any paperwork burden on physicians. We have
eased the consultation reporting requirements by lessening the required
level of formality and permitting the report to be made in any written
form of communication, (including submission of a copy of the
evaluation examination taken directly from the medical record and
submitted without a letter format) as long as the identity of the
physician who furnished the consultation is evident. Although
preparation and submission of the consultant's report is no longer the
major defining aspect of consultation services, the higher payment has
remained. (See the Internet-Only Medicare Claims Processing Manual,
Pub. 100-04, chapter 12, Sec. 30.6.10 F.)
Both AMA CPT coding rules and Medicare Part B payment policy have
always required that there is only one admitting physician of record
for a particular patient in the hospital or nursing facility setting.
(AMA CPT 2009, Hospital Inpatient Services, Initial Hospital Care,
p.12) This physician has been the only one permitted to bill the
initial hospital care codes or initial nursing facility codes. All
other physicians must bill either the subsequent hospital care codes,
subsequent nursing facility care codes or consultation codes. (See the
Internet-Only Medicare Claims Processing Manual, Pub. 100-04, chapter
12, Sec. 30.6.9.1 G.)
Beginning January 1, 2008, we ceased to recognize office/outpatient
consultation CPT codes for payment of hospital outpatient visits (72 FR
66790 through 66795). Instead, we instructed hospitals to bill a new or
established patient visit CPT code, as appropriate to the particular
patient, for all hospital outpatient visits. Regardless of all of our
efforts to educate physicians on Medicare guidance for documentation,
transfer of care, and consultation policy, disagreement in the
physician community prevails.
b. Summary of CY 2010 Proposal
In the CY 2010 PFS proposed rule (74 FR 33551), we proposed,
beginning January 1, 2010, to budget neutrally eliminate the use of all
consultation codes (inpatient and office/outpatient codes for various
places of service except for telehealth consultation G-codes) by
increasing the work RVUs for new and established office visits,
increasing the work RVUs for initial hospital and initial nursing
facility visits, and incorporating the increased use of these visits
into our PE and malpractice RVU calculations.
We noted that section 1834(m) of the Act includes ``professional
consultations'' (including the initial inpatient consultation codes
``as subsequently modified by the Secretary'') in the definition of
telehealth services. We recognize that consultations furnished via
telehealth can facilitate the provision of certain services and/or
medical expertise that might not otherwise be available to a patient
located at an originating site. Therefore, for CY 2010, we proposed to
create HCPCS codes specific to the telehealth delivery of initial
inpatient consultations. The purpose of these codes would be solely to
preserve the ability for practitioners to provide and bill for initial
inpatient consultations delivered via telehealth. These codes are
intended for use by practitioners when furnishing services that meet
Medicare requirements relating to coverage and payment for telehealth
services. Practitioners would use these codes to submit claims to their
Medicare contractors for payment of initial inpatient consultations
provided via
[[Page 61770]]
telehealth. The proposed HCPCS codes would be limited to the range of
services included in the scope of the CPT codes for initial inpatient
consultations, and the descriptions would be modified to limit the use
of such services for telehealth. The HCPCS codes would clearly
designate these as initial inpatient consultations provided via
telehealth, and not initial hospital care or initial nursing facility
care used for inpatient visits. Utilization of these codes would allow
us to provide payment for these services, as well as enable us to
monitor whether the codes are used appropriately.
We also stated that, if we create HCPCS G-codes specific to the
telehealth delivery of initial inpatient consultations, then we would
crosswalk the RVUs for these services from the RVUs for initial
hospital care (as described by CPT codes 99221 through 99223). We
believed this is appropriate because a physician or practitioner
furnishing a telehealth service is paid an amount equal to the amount
that would have been paid if the service had been furnished without the
use of a telecommunication system. Since physicians and practitioners
furnishing initial inpatient consultations in a face-to-face encounter
to hospital inpatients must continue to utilize initial hospital care
codes (as described by CPT codes 99221 through 99223), we believe it is
appropriate to set the RVUs for the proposed inpatient telehealth
consultation G-codes at the same level as for the initial hospital care
codes.
We considered creating separate G-codes to enable practitioners to
bill initial inpatient telehealth consultations when furnished to
residents of SNFs and crosswalking the RVUs to initial nursing facility
care (as described by CPT codes 99304 through 99306). For the sake of
administrative simplicity, if we create HCPCS G-codes specific to the
telehealth delivery of initial inpatient consultations, they will be
defined in Sec. 410.78 and in our manuals as appropriate for use to
deliver care to beneficiaries in hospitals or skilled nursing
facilities.
We stated in the CY 2010 PFS proposed rule that if we adopt this
proposal, we would then make corresponding changes to our regulations
at Sec. 410.78 and Sec. 414.65. In addition, we would add the
definition of these codes to the CMS Internet-Only Medicare Benefit
Policy Manual, Pub. 100-02, Chapter 15, Medicare Claims Processing
Manual, Pub. 100-04, Chapter 12, Section 190.
Outside the context of telehealth services, physicians will bill an
initial hospital care or initial nursing facility care code for their
first visit during a patient's admission to the hospital or nursing
facility in lieu of the consultation codes these physicians may have
previously reported. The initial visit in a skilled nursing facility
and nursing facility must be furnished by a physician except as
otherwise permitted as specified in Sec. 483.40(c)(4). In the nursing
facility setting, an NPP who is enrolled in the Medicare program, and
who is not employed by the facility, may perform the initial visit when
the State law permits this. (See this exception in the Internet-Only
Medicare Claims Processing Manual, Pub. 100-04, chapter 12, Sec.
30.6.13 A). An NPP, who is enrolled in the Medicare program, is
permitted to report the initial hospital care visit or new patient
office visit, as appropriate, under current Medicare policy.
Because of an existing CPT coding rule and current Medicare payment
policy regarding the admitting physician, we will create a modifier to
identify the admitting physician of record for hospital inpatient and
nursing facility admissions. For operational purposes, this modifier
will distinguish the admitting physician of record who oversees the
patient's care from other physicians who may be furnishing specialty
care. The admitting physician of record will be required to append the
specific modifier to the initial hospital care or initial nursing
facility care code which will identify him or her as the admitting
physician of record who is overseeing the patient's care. Subsequent
care visits by all physicians and qualified NPPs will be reported as
subsequent hospital care codes and subsequent nursing facility care
codes.
We believe that the rationale for a differential payment for a
consultation service is no longer supported because documentation
requirements are now similar across all E/M services. To be consistent
with OPPS policy, as noted above, we will pay only new and established
office or other clinic visits under the PFS.
We proposed that this change would be implemented in a budget
neutral manner, meaning it would not increase or decrease PFS
expenditures. We proposed to make this change budget neutral for the
work RVUs by increasing the work RVUs for new and established office
visits by approximately 6 percent to reflect the elimination of the
office consultation codes and the work RVUs for initial hospital and
facility visits by approximately 2 percent to reflect the elimination
of the facility consultation codes. We crosswalked the utilization for
the office consultation codes into the office visits and the
utilization of the hospital and facility consultation codes into the
initial hospital and facility visits. We proposed that this change
would be made budget neutral in the PE and malpractice RVU
methodologies through the use of the new work RVUs and the crosswalked
utilization.
We solicited comments on the proposal to eliminate payment for all
consultation services codes under the PFS and to allow all physicians
to bill, in lieu of a consultation service code, an initial hospital
care visit or initial nursing facility care visit for their first visit
during a patient's admission to the hospital or nursing facility.
Additionally, we solicited comments on the proposal to create HCPCS G-
codes to identify the telehealth delivery of initial inpatient
consultations.
We received many comments on our proposal. MedPAC also commented on
our proposal. The following is a summary of the comments we received
regarding the discussion of the proposed changes to consultation
services and our responses.
Comment: One commenter noted that ``there may be both advantages
and disadvantages to this proposal,'' but urged that we refrain from
finalizing it for January 1, 2010. The commenter expressed concerns
about whether there would be sufficient time to educate physicians who
currently employ the consultation codes in order to avoid ``a flood of
claim denials and appeals.'' Other commenters raised similar concerns
about whether there would be adequate time to educate physicians and
billing personnel about the change and to assess the effects of the
proposal.
Response: We agree that adoption of this proposal would call for
appropriate measures to educate physicians and billing personnel about
the change. However, we do not believe that the requisite educational
efforts are extensive and complex enough as to warrant delaying
implementation of the proposal. Essentially, the proposal would require
physicians to cease submitting the consultation codes on their Medicare
claims, and to employ the appropriate visit codes in their place. The
determination of the appropriate visit code would be made solely on the
basis of the existing rules and guidelines for the use of these codes,
without any reference to the guidelines that have been employed for the
use of the consultation codes. The guidelines for use of the visit
codes are well established and well known and used by nearly all
physicians. It is not necessary to develop any complicated coding
crosswalk or guidelines for translating the consultation code
[[Page 61771]]
requirements for purposes of applying the visit codes. The major
effects of the provision may actually simplify coding because
physicians will use the office and hospital visit codes in place of
consultations and will not have to determine whether the requirements
to bill a consult are met. For these reasons, we believe the proposal
should be implemented beginning January 1, 2010.
Comment: Some commenters urged delay or deferral of the proposal in
order to allow time to determine whether the new CPT definition of
``transfer of care'' that goes into effect for 2010 would address
concerns about the use of consultation codes. Other commenters stated
more generally that the proposed change is not the appropriate way to
resolve the confusion about using consultation codes versus patient
visits.
Response: As we discussed in presenting our proposal, the confusion
and disagreement about the proper use of the consultation codes have
persisted for a long time. We discussed in detail our efforts over a
period of years to clarify the guidelines and to resolve the persistent
disagreements. As a result of this experience, we are skeptical that
any further changes in guidelines or definitions would resolve these
issues. We appreciate the efforts by the CPT committee to develop a new
definition of transfer of care. However, we do not believe that this
new definition will clarify all the ambiguities and resolve all the
differences about the appropriate use of these codes.
As we stated when we implemented the PFS in 1992, one of our goals
for the development of new visit and consultation codes was that they
should be used reliably and consistently by all physicians and
carriers, that is, that the same service should be coded the same way
by different physicians. In addition, as we discussed in the CY 2010
PFS proposed rule, we believe that the confusion and disagreement about
the use of the consultation codes have produced a situation in which
that goal is far from being met.
As we also discussed in the proposed rule, we believe that a good
deal of this confusion and disagreement arises from the use of terms
such as referral, transfer, and consultation which are used sometimes
interchangeably and sometimes inconsistently, by physicians in clinical
settings.
The divergent interpretations and uses of these terms have served
to confuse the meaning of a consultation service, as some label a
transfer as a referral while others label a consultation as a referral.
Even with the new definition of ``transfer of care,'' we foresee many
clinical situations in which two physicians may not agree as to whether
the referral was for consultation or transfer of care, and it may be
difficult to resolve the issue based upon the conflicting
interpretations reflected in the two physicians' medical records.
Comment: A number of commenters recommended a delay in order to
develop alternative approaches on this issue. The commenters
recommended that we revise the consultation codes or provide additional
payments to physicians who provide thorough consultation reports to
referring physicians.
Response: As we discussed in the proposed rule, we have considered
numerous approaches to the issues posed by the use of the consultation
codes over a period of years, and we have adopted some measures in an
attempt to resolve those issues. We believe that, if there any other
realistic and reasonable resolution to the issues surrounding the
consultation codes, it would have emerged by now during the discussions
that we have recounted above. The specific proposal mentioned by the
commenter would have us pay more to physicians that provide thorough
consultation reports to the referring physicians. However, we
previously have tried to resolve the issues surrounding consultations
in part by revising the documentation requirements, with the result
that the documentation requirements for consultation codes have been
reduced to the point where there is no longer a sufficient difference
between the requirements for consultations and those for visits to
justify a payment differential. The commenter's idea would have us
return to increasing documentation requirements to receive higher
payment for providing a thorough consultation report. We believe that
any attempt to increase documentation requirements again to justify a
payment differential will lead to objections from some physicians, and
that it would be very difficult or impossible to define the
requirements for a ``detailed report'' with sufficient precision to
justify the provision of an additional payment.
Comment: Other commenters disagreed with our assessment that there
is no substantial difference in work between consultations and visits.
The commenters observed that consultations necessarily involve more
complex cases that the referring physician is unable to treat.
Furthermore, the commenters stated that these services require greater
cognitive work and more complex medical decision making. Several
commenters emphasized that consultation services required greater
knowledge and expertise, acquired through additional training and
experience, than is required for initial hospital and office visits.
The preparation of a written report to the referring physician also
requires additional time, regardless of the format in which the report
is provided. One commenter expressed disagreement with our statement
that ``the higher work value for consultations is entirely related to
the provision of a written report to the requesting physicians.''
However, other commenters agreed with our assessment that there is no
substantial difference in work between consultations and visits.
Response: To some degree, greater complexity and cognitive effort
may be relative to the training and specialization of the physician. A
case that presents clinical complexity and complex medical decision-
making for one physician may be relatively simple and straightforward
to another physician because of their repeated experience evaluating
the same or similar problems. Evaluation and management services,
although similar in the types of activities that occur during the
encounter, may vary widely in the types of conditions being evaluated.
The major difference between the work of a hospital or office visit and
a consultation is that the patient has been referred to the consultant
to obtain a specialized opinion. However, with the requirements
lessened upon the consultant, the actual work done during the encounter
with a patient for a consultation or an office or hospital visit has
become harder to distinguish in terms of clinical complexity and
medical decisionmaking. Further, many physicians contend that a new
patient office visit may actually require more work than a consultation
service because of the post work involvement with a new patient. As we
discussed in the proposed rule, the documentation requirements for
consultation services have been reduced to the point where it is
difficult to justify a payment differential between consultations and
new visits. Therefore, for these reasons, we support the view of those
commenters who contend that in most cases, there is no substantial
difference in work between consultations and visits.
Comment: Several commenters objected to the proposal on the grounds
that it constitutes an unprecedented elimination of a set of CPT codes
widely used by large numbers of physicians. Some commenters also stated
that the proposal circumvents the CPT and AMA RUC processes.
[[Page 61772]]
Response: We do not agree that discontinuing the use of these codes
for Medicare purposes is unprecedented. On the contrary, our proposal
follows existing program precedent. As we noted in the proposed rule,
beginning January 1, 2008, we ceased to recognize office/outpatient
consultation CPT codes for payment of hospital outpatient visits (72 FR
66790 through 66795). Instead, we instructed hospitals to bill a new or
established patient visit CPT code, as appropriate to the particular
patient, for all hospital outpatient visits. We also do not believe
that we have in any way circumvented the existing CPT and AMA RUC
processes. We described in the CY 2010 PFS proposed rule the numerous
attempts that we have made to resolve the relevant issues with AMA CPT
staff. Despite all of our efforts to devise and implement relevant
guidance, and educate physicians regarding documentation, transfer of
care, and consultation policy, there is still substantial disagreement
and inconsistency within the physician community regarding these
issues.
Comment: Some commenters stated that the overall payment decreases
that various specialists would face as a result of the proposed change
are unwarranted.
Response: In making the proposal to eliminate use of the
consultation codes under the PFS, it has not been our intention to
increase or to decrease overall payments for any group or groups of
physicians. Rather, our intent has been to provide for correct and
consistent coding for services provided by physicians, as well as to
provide for appropriate payment for the specific services that have
been billed using the consultation codes, specifically, as well as the
evaluation and management codes. It is in the nature of any budget
neutral payment system for changes such as this to have a somewhat
differential impact on various groups of providers and/or
practitioners. In this particular case, we do not believe that these
impacts are disproportionate to the goals we have sought to achieve in
making and finalizing this proposal. It is important to keep in mind
that, while elimination of the differential payment for consultation
services will have a greater negative impact on some physician
specialties than on others, all physicians will benefit from the budget
neutral increase in the payment levels for the visit codes.
For more information on the impact of the changes in this rule, see
section XIII. of this final rule with comment period.
Comment: Some commenters objected to our failure to increase the
bundled payments for post-operative visits occurring over a 10-day or
90-day global period. For example, one major specialty society
recommended extending the incremental work RVU increase to the E/M
codes that are built into the 10-day and 90-day global codes.
``Arbitrarily changing the work RVUs for some E/M codes without
adjusting the E/M components of other procedural codes undermines the
relative value scale on which physician payment is based.'' The
commenters otherwise supported the proposal, but strongly recommended
that the global codes be increased for the sake of consistency.
However, some other commenters who supported the proposal urged us to
maintain this position in the final rule on the grounds that these
services, by their very nature, were never billed as consultations.
Response: Payment for major surgeries includes bundled payment for
the related post-operative visits occurring over a 10-day or 90-day
global period. Historically, when payments for new and established
office visits were increased after the third Five-Year Review, we also
increased the bundled payments for these post-operative visits in the
global period. However, we did not propose to increase the payments for
the major surgeries to reflect the increase in the visits. We agree
with those commenters who contended that consistency requires that we
increase the bundled payments for these services proportionately in
order to account for the increase in the visits that are incorporated
into these bundles. We have accordingly increased the payments for
those services in conjunction with finalizing our proposal to eliminate
use of the consultation codes in the PFS. However, the increases in the
payments for these services due specifically to this change are quite
small because visits are a relatively small proportion of the total
global payment amount.
Comment: A few commenters objected that we did not make available
the crosswalk we used to relate the consultation codes to visit codes
for purposes of ensuring BN. Other commenters expressed concerns about
the assumptions we used in crosswalking the consultation codes to
existing E/M codes. For example, one commenter stated that, for E/M
services, a physician must consider three elements (extent of history
obtained, extent of examination performed, and complexity of medical
decision making) in determining the appropriate code level. However,
for subsequent hospital care or hospital outpatient E/M services, only
two of these three elements are necessary. In contrast, all three
elements must be considered in determining the appropriate coding level
for consultation services, both initial and follow-up consultations.
There is no established patient visit code or subsequent hospital care
code that adequately describes the work of consultation codes (CPT
codes 99245 and 99255) when a patient is seen for follow-up
consultation. One of these commenters noted that while there are five
consultation codes, there are only three initial visit codes, and
expressed concern that it would be difficult for physicians to
accurately employ the visit codes for the services previously billed
under the consultation codes. Another commenter observed that none of
the E/M codes reflect the face-to-face times reflected in the highest
level consultation codes (for example, 80 minutes for CPT code 99245
and 110 minutes for CPT code 99255). Still other commenters took issue
with some elements of the destination mapping in our crosswalk, for
example, the assumption that 50 percent of the cases represented as
office consultation code (CPT code 99245) would be coded as a new
patient office visit code (CPT code 99205), and 50 percent as an
established patient office visit code (CPT code 99215).
Response: We made the relevant crosswalk available on our Web site
at http://www.cms.hhs.gov/PhysicianFeeSched/PFSFRN/itemdetail.asp?filterType=none&filterByDID=-99&sortByDID=4&sortOrder=descending&itemID=CMS1223902&intNumPerPage=10.
As we have noted above, we did not develop that crosswalk for
purposes of providing any guidelines or principles for using the visit
codes in place of the consultation codes that physicians have employed
prior to the implementation of this proposal. Rather, the crosswalk was
developed solely for purposes of making the requisite BN calculations.
For purposes of coding specific cases, adoption of this proposal will
essentially require physicians to cease submitting the consultation
codes on their Medicare claims, and to employ the appropriate visit
codes in their place. The determination of the appropriate visit code
should be made solely on the basis of the existing rules and guidelines
for the use of the relevant visit codes (for example, office visit or
inpatient visit), without any reference to the guidelines that have
been employed for the use of the consultation codes. The guidelines for
use of the visit codes are well established and well understood.
Therefore, we do not believe that it is necessary to provide any coding
[[Page 61773]]
crosswalk or guidelines for translating the consultation code
requirements into the appropriate visit codes. Commenters are correct
that while there are five consultation codes, there are only three
initial visit codes, that none of the E/M codes reflect the face-to-
face times reflected in the highest level consultation codes, and
various other differences between the two sets of codes. Nevertheless,
it remains possible to determine the appropriate visit code for the
services in question by applying the appropriate guidelines and
requirements for using those codes. There are, for example, legitimate
coding measures to take into account face-to-face times over and above
the times specified in the relevant visit codes. Since we ordinarily
refrain from providing coding advice in this context, we recommend that
physicians, coders, and billing personnel consult the appropriate
manuals and coding authorities about how to make the appropriate coding
determinations for services previously coded under the consultation
codes.
In crosswalking the codes for purposes of making the requisite BN
calculations, we employed the same estimating techniques that we
normally employ in such calculations. In the absence of concrete data
on certain factors in the calculation, we also employed standard
assumptions that are appropriate in a system based on averages. For
example, office consultation CPT code 99245 was employed to report
consultations provided to new or established patients in a physician's
office or other ambulatory setting. For purposes of making the BN
calculations, it was necessary to apportion the utilization of that
code between the separate office visit codes for new patients (CPT code
99205) and established patients (CPT code 99215). In the absence of
concrete data on the number of new and established patients reported
under CPT 99245, we employed the standard technique of assuming that
half the patients were new patients, and half the patients were
established patients. Such an assumption minimizes the range of
potential error and negative impacts in a system based of averages.
Similarly, with respect to the new or established patient initial
inpatient consultation codes such as CPT code 99251, it was necessary
to apportion the utilization estimates between inpatient visits in a
hospital setting and in nursing homes. In this case, we believe that
there would be far fewer consultation visits in nursing homes than in
the inpatient hospital setting. Therefore, we adopted a standard
assumption that 70 percent of the cases would be in inpatient hospitals
(CPT initial hospital inpatient visit code 99221) and 30 percent in
nursing homes (CPT initial nursing care facility visit code 99304). We
employed similar assumptions throughout the crosswalk.
Comment: Several commenters maintained that we had not adequately
responded to the OIG report about the use of consultation codes prior
to developing this proposal. These commenters noted that the majority
of the billing errors detected by the OIG were created by lack of
documentation and/or services that did not meet the definition of
consultation, and that the OIG recommended education and outreach to
physicians to reduce such errors. The commenters recommended that we
not proceed with the proposal until we can demonstrate that education
and outreach efforts cannot improve the situation.
Response: Prior to the official publication of the OIG report, we
issued a Medlearn Matters article, effective January 2006, to educate
the physician community about requirements and proper billing for all
types and levels of consultation services as requested by the OIG in
their report. The Medlearn Matters article reflected the manual changes
we made in 2006 and the AMA CPT coding changes as noted below. We have
also answered numerous questions and inquiries regarding the use of
these codes at open door forums and other settings.
With each additional revision from 1999 until the OIG study began,
we made repeated efforts to educate physicians through the guidance
provided by, and through, our Medicare contractors. However, there were
continued discrepancies with unclear and ambiguous terms and
instructions in the AMA CPT consultation coding definition, transfer of
care and documentation, and the feedback from the physician community
indicated they disagreed with Medicare guidance. Despite our best,
these disagreements and misunderstandings among the physician community
with Medicare interpretations and guidance relating to documentation of
transfer of care and consultation have continued.
Comment: A number of commenters expressed concern about the effects
of this proposal on coordination of payment between CMS and other
payers. The commenters believe that if other payers continue to
recognize consultation codes, the result could be confusion, erroneous
billings, and serious delays or even denials of payment.
Response: We do not have the authority to determine which services
will be recognized and paid by other third party payers. Some payers
may choose to adopt this policy subsequent to this final rule. In cases
where other payers do not adopt this policy, physicians and their
billing personnel will need to take into consideration that Medicare
will no longer recognize consultation codes submitted on bills, whether
those bills are for primary or secondary payment. In those cases where
Medicare is the primary payer, physicians must submit claims with the
appropriate visit code in order to receive payment from Medicare for
these services. In these cases, physicians should consult with the
secondary payers in order to determine how to bill those services in
order to receive secondary payment. In those cases where Medicare is
the secondary payer, physicians and billing personnel will first need
to determine whether the primary payer continues to recognize the
consultation codes. If the primary payer does continue to recognize
those codes, the physician will need to decide whether to bill the
primary payer using visit codes, which will preserve the possibility of
receiving a secondary Medicare payment, or to bill the primary payer
with the consultation codes, which will result in a denial of payment
for invalid codes.
Comment: One commenter stated that we had not responded to several
letters over the last few years requesting clarification of the
confusion over consultation and transfer of care, and providing
suggested language to clarify the confusion. In addition, the commenter
stated that the agency has never responded to a request that the
contractors suspend audits of consultation services pending resolution
of the confusion.
Response: We have received many similar requests and suggestions
regarding the confusion over consultation and transfer of care over
many years. We have continuously discussed these issues in the
appropriate forums, including proposed and final rules, manual
instructions, Medlearn matters articles, and meetings of the AMA CPT
Committee. We recounted this extensive history in the proposed rule. As
for the status of audits of consultation services, we generally do not
discuss the specific audit measures and priorities that we are
currently pursuing. In general, the goal of medical review is to
identify, through analysis of data and evaluation of other information,
program vulnerabilities concerning coverage and coding made by
individual providers and to take the
[[Page 61774]]
necessary action to prevent or address the identified vulnerabilities.
Comment: A few commenters stated that it was inconsistent to
continue separate payment for consultation services under the
telehealth benefit, but to discontinue them in other contexts in which
physician services are provided. Some commenters also stated that
discontinuing the consultation codes may be contrary to the statute.
Specifically, section 1845(c)(5) of the Act, states:
Coding.--The Secretary shall establish a uniform coding system
for the coding of all physician services. The Secretary shall
provide for an appropriate coding structure for visits and
consultations. The Secretary may incorporate the use of time in the
coding for visits and consultations. The Secretary, in establishing
such coding system, shall consult with the Physician Payment Review
Commission and other organizations representing physicians.
Response: We note that section 1845(c)(5) of the Act calls for the
Secretary to provide for ``an appropriate coding structure for visits
and consultations.'' We believe the use of the adjective
``appropriate'' indicates that the statute is granting the Secretary
discretion to determine the structure of coding for these services. For
the reasons given above and in our proposed rule, we believe that we
are creating an appropriate coding structure for visits and
consultations by employing a set of codes that accurately describes,
and permits appropriate payment for, those services. We also note that
discontinuing the use of the consultation codes does not imply
discontinuing payment for consultation services, but only discontinuing
the payment differential between consultations and visits. These
services will continue to be reported, coded, and paid under the PFS.
On the other hand, as we noted previously, section 1834(m) of the Act
merely states that the definition of telehealth services includes
``professional consultations,'' and points to the initial inpatient
consultation codes (``as subsequently modified by the Secretary'') as
part of the coding structure for such services. We believe it is more
consistent with legislative intent, as expressed in this provision, to
retain the separate recognition of consultation services in the context
of telehealth services. We believe that we have appropriately exercised
the Secretary's discretion under section 1845(c)(5) of the Act in
eliminating the consultation codes under the PFS, while at the same
time respecting the legislative intent underlying section 1834(m) of
the Act for separate recognition of consultation services in the
context of telehealth.
Comment: MedPAC commented that the proposed change ``seems an
appropriate policy response'' to the relaxation of documentation
requirements. However, the Commission noted that:
* * * reduced consultation documentation may not sufficiently
meet the needs of the requesting physician, and thus not help
achieve the goals and benefits of well-coordinated care. While CMS'
proposed payment policy for consultation may be appropriate in the
light of current practice, in the future, the agency may wish to
consider whether to increase the requirements for consultations in
order to better coordinate care and increase consultation payments
commensurately.
Other commenters expressed similar concerns that the elimination of
the consultation codes might financially discourage coordination of
care and communication among physicians.
Response: We appreciate MedPAC's evaluation that our proposal has
merit as a response to the reduction in the documentation requirements
for consultation services. We also agree with MedPAC that promoting
effective coordination of care must be an essential goal of our payment
systems. However, we are not aware of any evidence that the reduced
consultation documentation requirements are currently failing to
sufficiently meet the needs of referring physicians, or that the
benefits of effective coordination of care are otherwise not being
realized as result of these reduced requirements. If we become aware of
such evidence in the future, we would certainly consider whether there
is an appropriate policy response to promote more effective
coordination of care. It is, however, premature to consider what the
appropriate responses might be until and unless specific evidence of an
issue comes to our attention. Nevertheless, we will certainly be
attentive to any concerns that develop about the effects of this policy
on the goal of promoting effective coordination of care.
Comment: Many other commenters supported the proposal. The
commenters agreed with us that the documentation requirements are now
generally similar among consultation services, office visits, and
hospital and facility visits. The commenters also agreed that the
proposed change would simplify documentation and resolve the confusion
surrounding the billing of consultation codes, ``transfer of care,''
and other matters.
Response: We appreciate the support of the commenters, and we
continue to believe that the approach we proposed is the most
appropriate policy response to the confusion, disagreement, and
problems that have beset the use of the consultation codes under the
PFS. Accordingly, we are adopting our proposal in this final rule.
Specifically, beginning January 1, 2010, we will eliminate the use
of all consultation codes (inpatient and office/outpatient codes for
various places of service except for telehealth consultation G-codes)
on a budget neutral basis by increasing the work RVUs for new and
established office visits, increasing the work RVUs for initial
hospital and initial nursing facility visits, and incorporating the
increased use of these visits into our PE and malpractice RVU
calculations.
Since section 1834(m) of the Act includes ``professional
consultations'' (including the initial inpatient consultation codes
``as subsequently modified by the Secretary'') in the definition of
telehealth services, we will not eliminate the use of these codes in
the telehealth context. Therefore, for CY 2010, we will create HCPCS
codes specific to the telehealth delivery of initial inpatient
consultations. Specifically, we are establishing the following HCPCS
codes to describe initial inpatient consultations approved for
telehealth:
G0425, Initial inpatient telehealth consultation,
typically 30 minutes communicating with the patient via telehealth.
G0426, Initial inpatient telehealth consultation,
typically 50 minutes communicating with the patient via telehealth.
G0427, Initial inpatient telehealth consultation,
typically 70 minutes or more communicating with the patient via
telehealth.
The purpose of these codes is solely to preserve the ability for
practitioners to provide and bill for initial inpatient consultations
delivered via telehealth. These codes are intended for use by
practitioners when furnishing services that meet Medicare requirements
relating to coverage and payment for telehealth services. Practitioners
will use these codes to submit claims to their Medicare contractors for
payment of initial inpatient consultations provided via telehealth. The
new HCPCS codes will be limited to the range of services included in
the scope of the CPT codes for initial inpatient consultations, and the
descriptions will limit the use of such services for telehealth.
Utilization of these codes will allow us to provide payment for these
services, as well as enable us to monitor whether the codes are used
appropriately.
[[Page 61775]]
As we also stated in the CY 2010 PFS proposed rule, we will
crosswalk the RVUs for these services from the RVUs for initial
hospital care (as described by CPT codes 99221 through 99223). We
believed this is appropriate because a physician or practitioner
furnishing a telehealth service is paid an amount equal to the amount
that would have been paid if the service had been furnished without the
use of a telecommunication system. Since physicians and practitioners
furnishing initial inpatient consultations in a face-to-face encounter
to hospital inpatients must continue to utilize initial hospital care
codes (as described by CPT codes 99221 through 99223), we believe it is
appropriate to set the RVUs for the proposed inpatient telehealth
consultation G-codes at the same level as for the initial hospital care
codes. As we stated in the CY 2010 PFS proposed rule, we also will make
corresponding changes to our regulations at Sec. 410.78 and Sec.
414.65. In addition, we will add the definition of these codes to the
CMS Internet-Medicare Claims Processing Manual, Pub. 100-04, Chapter
12, Section 190.
Outside the context of telehealth services, physicians will bill an
initial hospital care or initial nursing facility care code for their
first visit during a patient's admission to the hospital or nursing
facility in lieu of the consultation codes these physicians may have
previously reported. The initial visit in a skilled nursing facility
and nursing facility must be furnished by a physician except as
otherwise permitted as specified in Sec. 483.40(c)(4). In the nursing
facility setting, an NPP who is enrolled in the Medicare program, and
who is not employed by the facility, may perform the initial visit when
the State law permits this. (See this exception in the Internet-Only
Medicare Claims Processing Manual, Pub. 100-04, chapter 12, Sec.
30.6.13 A). An NPP, who is enrolled in the Medicare program is
permitted to report the initial hospital care visit or new patient
office visit, as appropriate, under current Medicare policy. Because of
an existing CPT coding rule and current Medicare payment policy
regarding the admitting physician, we will create a modifier to
identify the admitting physician of record for hospital inpatient and
nursing facility admissions. For operational purposes, this modifier
will distinguish the admitting physician of record who oversees the
patient's care from other physicians who may be furnishing specialty
care. The admitting physician of record will be required to append the
specific modifier to the initial hospital care or initial nursing
facility care code which will identify him or her as the admitting
physician of record who is overseeing the patient's care. Subsequent
care visits by all physicians and qualified NPPs will be reported as
subsequent hospital care codes and subsequent nursing facility care
codes.
As proposed, this change will be implemented in a budget neutral
manner, meaning that it will not increase or decrease aggregate PFS
expenditures. We will make this change budget neutral for the work RVUs
by increasing the work RVUs for new and established office visits by
approximately 6 percent to reflect the elimination of the office
consultation codes and the work RVUs for initial hospital and facility
visits by approximately 0.3 percent to reflect the elimination of the
facility consultation codes. As discussed above, in this final rule we
are also increasing the incremental work RVUs for the E/M codes that
are built into the 10-day and 90-day global surgical codes. As we did
for the CY 2010 PFS proposed rule, we have crosswalked the utilization
for the office consultation codes into the office visits and the
utilization of the hospital and facility consultation codes into the
initial hospital and facility visits. And, as we proposed, this change
will be made budget neutral in the PE and malpractice RVU methodologies
through the use of the new work RVUs and the crosswalked utilization.
F. Potentially Misvalued Services Under the Physician Fee Schedule
1. Valuing Services Under the Physician Fee Schedule
As explained in the CY 2010 PFS proposed rule (74 FR 33554), the
American Medical Association's (AMA) Relative Value System Update
Committee (RUC) provides recommendations to CMS for the valuation of
new and revised codes, as well as codes identified as misvalued. On an
ongoing basis, the AMA RUC's Practice Expense (PE) Subcommittee reviews
direct PE (clinical staff, medical supplies, medical equipment) for
individual services and examines the many broad and methodological
issues relating to the development of PE relative value units (RVUs).
To address concerns expressed by stakeholders with regard to the
process we use to price services paid under the PFS, the AMA RUC
created the Five-Year Review Identification Workgroup. As we stated in
the CY 2009 PFS proposed rule (73 FR 38582), the workgroup identified
some potentially misvalued codes through several vehicles. It focused
on codes for which there have been shifts in the site of service (site
of service anomalies), codes with a high intra-service work per unit of
time (IWPUT), high volume codes, new technology designation, and shifts
from practice expense to work. We also identified other methods that
the AMA RUC could undertake to assist in identifying potentially
misvalued services including reviewing the fastest growing procedures,
Harvard-valued codes, and practice expense RVUs. There were 204
potentially misvalued services identified in 2008.
We believe that there are additional steps we can take to address
the issue of potentially misvalued services. In the CY 2009 PFS
proposed rule, we identified approaches to address this issue including
reviewing services often billed together and the possibility of
expanding the multiple procedure payment reduction (MPPR) to additional
nonsurgical procedures and the update of high cost supplies.
Comment: We received several comments concerning the misvalued code
initiative. One commenter, representing a physician specialty
organization, expressed concern about the ongoing misuse of
intraservice work per unit of time (IWPUT) as a means to determine
appropriate work values. The commenter states that IWPUT was never
intended to compare intensity or work across specialties and was to be
used only as a measure of relativity between codes or in families of
codes. Commenters also expressed concern about the need for
transparency concerning the development of values for codes, including
the review of PE inputs; the need for CMS to consider the underlying
reasons why utilization for certain services may increase; and the
economic and public health implications of appropriate valuation of
services. A commenter also recommended that the agency become more
proactive in identifying problematic trends in utilization and in re-
evaluating new technology. The commenter recognized that additional
resources would be needed and acknowledged that the Congress may need
to ensure adequate resources are available but believes that such an
investment could result in lower overall costs in the system over the
long-term.
Response: We thank the commenters for sharing their concerns and
will consider them as we continue examining the valuation of services
under the misvalued code initiative.
We also share some the concerns expressed by the commenter with
regards to IWPUT, which is a
[[Page 61776]]
calculation that was used as the primary tool to value physician
services for some codes during the third Five-Year Review. This
calculation poorly assesses intensity for services that are short in
time duration and also services that are short in time duration and of
high intensity. The IWPUT has also been used to align procedures within
a family of codes. It has value in some instances, such as in
validating the RVUs for a given procedure using the building block
methodology. However, the IWPUT has not proven to be a valuable tool in
evaluating or validating cognitive services. The building block
methodology is the accepted methodology used by the AMA RUC and CMS for
valuing all physician procedures and services. We believe that the
building block methodology should be consistently used when the AMA RUC
considers valuation of physician services for its recommendations.
2. High Cost Supplies
In the CY 2010 PFS proposed rule (74 33554), we referenced our CY
2009 PFS proposal concerning updating prices for high cost supplies (73
FR 38582) and (73 FR 69882), and stated that we are continuing to
examine alternatives on the best way to obtain accurate pricing
information and will propose a revised process in future rulemaking.
The following is a summary of the comments received to date
regarding high cost supplies and our response.
Comment: Several commenters expressed support for this initiative.
A few commenters were disappointed that we did not propose any new
methodologies in the CY 2010 PFS proposed rule.
Commenters were in agreement that we must ensure accurate pricing
of supplies, as the cost of supplies plays an important role in the
payment calculation for services under the PFS.
Commenters also offered the following suggestions for pricing high
cost supplies including:
Identify high cost disposable supplies (that is, over
$200) with separate HCPCS codes;
Use the supply pricing methodology used by the Veterans
Administration;
Work with specialty societies to obtain invoices for high
priced items from a designated group of physicians that are
geographically representative; and
Work with the industry or physicians directly to get
current pricing information.
MedPAC stated it is important for us to update the prices of higher
priced supplies on a regular basis as inaccurate prices can distort PE
RVUs over time. MedPAC believes that prices drop over time as items
diffuse through the market and as other companies begin to produce
them, and encouraged us to regularly update information.
A few commenters also recommended that any pricing proposal should
be available for public comment through future rulemaking, possibly on
an annual basis. This would enable stakeholders to evaluate and provide
feedback to the agency on pricing accuracy as well as practical
availability of the item itself.
Response: We want to thank the commenters for sharing their
suggestions and will take these comments into consideration as we
explore the best way to address this issue.
3. Review of Services Often Billed Together and the Possibility of
Expanding the Multiple Procedure Payment Reduction (MPPR) to Additional
Nonsurgical Procedures
In the CY 2009 PFS final rule with comment period (73 FR 69882), we
stated that we planned to perform a data analysis of nonsurgical CPT
codes that are often billed together. We stated that we would identify
whether there are inequities in PFS payments that are a result of
variations between services in the comprehensiveness of the codes used
to report the services or in the payment policies applied to each (for
example, global surgery and MPPRs). The rationale for the MPPR is that
certain clinical labor activities, supplies, and equipment are not
performed or furnished twice when multiple procedures are performed.
The MPPR currently applies to certain diagnostic and surgical
procedures (73 FR 38586). We stated that we would consider developing a
proposal either to bundle more services or expand application of the
MPPR to additional procedures. Additionally, the Medicare Payment
Advisory Committee (MedPAC) requested that we consider duplicative
physician work and PE in any expansion of the MPPR.
In the CY 2010 PFS proposed rule (74 FR 33554), we stated that we
planned to analyze codes furnished together more than 75 percent of the
time, excluding E/M codes. We also stated that we planned to analyze
both physician work and PE inputs. If duplications are found, we said
that we would consider whether to propose to implement an MPPR or to
bundle the services involved. We stated that we would propose any
changes through future rulemaking.
Comment: Several commenters did not support the analysis of codes
furnished together more than 75 percent of the time. The commenters
stated that limiting the review to codes performed together 90 to 95
percent of the time was more appropriate. A few commenters suggested
that 75 percent should not be the only criterion we use when
considering whether to implement an MPPR or bundle services. Some
commenters requested that we postpone our review of services that are
often billed together and rely on the work that is being done in this
area by the AMA RUC. The commenters believe that the work the AMA RUC
is doing will be informative regarding which services should be
considered in the future in determining whether to propose to expand
the MPPR or to bundle services. The AMA RUC stated that it wants to
work with CMS to accurately assess these services.
A few commenters generally supported the analysis of codes
furnished together more than 75 percent of the time. One commenter
stated that almost all imaging procedures and equipment have become
more efficient in recent years allowing more procedures in a given
time.
Most commenters were in agreement that this policy should not be
expanded until CMS has additional data and there is an opportunity for
public comment through future rulemaking.
Response: We appreciate the comments received and will consider
these comments as we explore the best way to address this issue. We
also look forward to working with the AMA RUC to accurately assess
these services.
4. AMA RUC Review of Potentially Misvalued Codes
a. Site of Service
In the CY 2009 PFS final rule with comment period (73 FR 69883), we
said that although we would accept the AMA RUC valuation for these site
of service anomaly codes for 2009, we indicated that we had concerns
about the methodology used by the AMA RUC to review these services
because they may have resulted in removal of hospital days and deletion
or reallocation of office visits without extraction of the associated
RVUs from the valuation of the code. We also stated that we would
continue to examine these codes and would consider whether it would be
appropriate to propose additional changes in future rulemaking.
In the CY 2010 PFS proposed rule (74 FR 33554), we proposed work
RVU changes to several of the codes where the valuation had been
adjusted to
[[Page 61777]]
reflect changes in the site of service but the RVUs had not been
extracted by the AMA RUC. The proposed work RVUs were recalculated
based upon the AMA RUC-recommended inputs (that is, changes in pre-
service and post-service times and associated E/M services). The
proposed work RVUs for each CPT code were recalculated using the pre-
AMA RUC review work RVUs as a starting point, and adjusted for the
addition or extraction of pre-service and post-service times, inpatient
hospital days, discharge day management services and outpatient visits
as recommended by the AMA RUC.
In addition to the proposed revisions to the AMA RUC-recommended
RVUs, we encouraged the AMA RUC to utilize the building block
methodology as described in the CY 2007 PFS proposed rule (71 FR 37172)
in the future when revaluing codes with site of service anomalies. We
recognized that the AMA RUC looks at families of codes and may assign
RVUs based on a particular code ranking within the family. However, we
stated that we believed that the relative value scale requires each
service to be valued based on the resources used in furnishing the
service.
We also sought public comment on alternative methodologies that
could be used to establish work RVUs for codes that would have a
negative valuation under the methodology we utilized to develop
proposed revisions to the AMA RUC-recommended values described above.
The following is summary of the comments we received regarding the
proposed revisions to the codes with site of service anomalies.
Comment: Some commenters supported CMS' attempt to account for
recognized changes in physician work for certain procedures in which
the typical site of service has changed. However, other commenters
opposed the proposed work RVUs and found the methodology unclear and
problematic since some cases resulted in negative work values. Many
commenters recommended the acceptance of the AMA RUC recommended values
and encouraged CMS to work with them to develop a clearer methodology.
Response: As a result of the comments, we are not finalizing our
proposal to change the work RVUs for codes with site of service
anomalies that were included in Table 8 of the CY 2010 proposed rule
(74 FR 33555). Although we still have concerns about the methodology
used by the AMA RUC to review the services, we are accepting the AMA
RUC-recommended work RVUs in the interim and request that the AMA RUC
utilize the building block methodology to revalue the services listed
in Table 4.
TABLE 4--CY 2010 CMS Interim Work RVUs for Site of Service Anomalies Reviewed by the AMA RUC in CY 2009
----------------------------------------------------------------------------------------------------------------
2009 AMA RUC 2010 CMS
CPT code \1\ Descriptor recommended CMS decision interim work
work RVU RVU \2\
----------------------------------------------------------------------------------------------------------------
21025............................ Excision of bone, lower 9.87 Agree.............. 10.03
jaw.
23415............................ Release of shoulder 9.07 Agree.............. 9.23
ligament.
25116............................ Remove wrist/forearm 7.38 Agree.............. 7.56
lesion.
42440............................ Excise submaxillary 7.05 Agree.............. 7.13
gland.
52341............................ Cysto w/ureter stricture 5.35 Agree.............. 5.35
tx.
52342............................ Cysto w/up stricture tx. 5.85 Agree.............. 5.85
52343............................ Cysto w/renal stricture 6.55 Agree.............. 6.55
tx.
52344............................ Cysto/uretero, stricture 7.05 Agree.............. 7.05
tx.
52345............................ Cysto/uretero w/up 7.55 Agree.............. 7.55
stricture.
52346............................ Cystouretero w/renal 8.58 Agree.............. 8.58
strict.
52400............................ Cystouretero w/congen 8.66 Agree.............. 8.69
repr.
52500............................ Revision of bladder neck 7.99 Agree.............. 8.14
52640............................ Relieve bladder 4.73 Agree.............. 4.79
contracture.
53445............................ Insert uro/ves nck 15.21 Agree.............. 15.39
sphincter.
54410............................ Remove/replace penis 15.00 Agree.............. 15.18
prosth.
54530............................ Removal of testis....... 8.35 Agree.............. 8.46
57287............................ Revise/remove sling 10.97 Agree.............. 11.15
repair.
62263............................ Epidural lysis mult 6.41 Agree.............. 6.54
sessions.
62350............................ Implant spinal canal 6.00 Agree.............. 6.05
cath.
63650............................ Implant neuroelectrodes. 7.15 Agree.............. 7.20
63685............................ Insrt/redo spine n 6.00 Agree.............. 6.05
generator.
64708............................ Revise arm/leg nerve.... 6.22 Agree.............. 6.36
64831............................ Repair of digit nerve... 9.00 Agree.............. 9.16
65285............................ Repair of eye wound..... 14.43 Agree.............. 14.71
----------------------------------------------------------------------------------------------------------------
\1\ All CPT codes copyright 2009 American Medical Association.
\2\ 2010 CMS Interim Work RVUs may differ from AMA RUC-recommended work RVU due to work increases in 10 and 90
day global codes as a result of the elimination of the consultation codes.
b. ``23-Hour'' Stay
Services that are performed in the hospital outpatient setting and
require a stay of less than 24 hours are considered outpatient
services. We received recommendations from the AMA RUC for inclusion of
inpatient services for services that are typically performed in an
outpatient setting.
In the 2010 PFS proposed rule (74 FR 33556), we stated that we
believed the use of E/M codes for services rendered in the post-service
period for procedures requiring less than a 24-hour hospital stay would
result in overpayment for pre- and post-service work that would not be
provided. Therefore, we stated that we would not allow an additional E/
M service to be billed for care furnished during the post procedure
period when care is furnished for an outpatient service requiring less
than a 24-hour hospital stay.
The following is summary of the comments we received regarding the
proposed revisions to the ``23-Hour'' stay.
Comment: The majority of commenters disagreed with CMS'
[[Page 61778]]
proposal because they believed it would result in surgeons not being
paid for the work they perform. Commenters urged CMS to engage in a
discussion at CPT and/or the AMA RUC regarding alternative E/M coding
solutions.
Response: As a result of the comments, we are not finalizing our
proposal and will work with CPT and the AMA RUC regarding alternative
E/M coding solutions to address our concerns about using inpatient
hospital visit codes as a proxy for the work being performed.
c. AMA RUC Review of Potentially Misvalued Codes for CY 2010
We are addressing the AMA RUC's recommendations from the February
and April 2009 meetings for potentially misvalued codes in this final
rule with comment period in a manner consistent with the way we address
other AMA RUC recommendations. Specifically, we completed our own
review of the AMA RUC recommendations and we describe the AMA RUC's
recommendations, indicate whether or not we accept them, and provide a
rationale for our decision in this final rule with comment period. The
values for these services are interim values for the next calendar
year.
The AMA RUC continued its review of potentially misvalued codes
using various screens, including codes with site of anomalies, high
IWPUT, high volume, fastest growing procedures, and other CMS requests.
For CY 2010, the AMA RUC submitted recommendations for 113 codes. Of
those codes 1 was recommended for a reduction in valuation; 7 were
recommended for an increase in valuation; 11 were recommended to
maintain the same valuation; 45 were referred to CPT for further code
clarification, 33 were recommended for PE changes and 16 were
recommended for clinical labor revisions.
We have agreed to accept the valuation for these codes for CY 2010
as interim, including the conforming changes to the PE inputs for these
codes, as applicable with the exception of CPT 92597, Evaluation for
use and/or fitting of voice prosthetic device to supplement oral
speech. With the enactment of the MIPPA, speech-language pathologists
were able to bill the Medicare program independently as private
practitioners effective July 1, 2009. In response, speech-language
pathologists requested that the AMA RUC value the work of certain
codes. Previously, the work of the speech-language pathologists had
been accounted for and paid under the PE component for these codes. CPT
code 92597 was evaluated by the AMA RUC, after which the AMA RUC
recommended a work RVU of 1.48 based upon a survey that included
speech-language pathologists and otolaryngologists, the most frequent
providers of the service. The work description for CPT code 92597
includes initial fitting of a prosthesis. The code descriptor for CPT
code 31611, Construction of tracheoesophageal fistula and subsequent
insertion of an alaryngeal speech prosthesis (eg, voice button, Blom-
Singer prosthesis), with a work RVU of 5.92 also includes insertion or
fitting of a speech prosthesis. Otolaryngologists perform this service
a majority of the time. It appears that both codes include fitting a
prosthesis and that there is an overlap of work between CPT codes 92597
and 31611. To account for the overlap of work between these two codes,
for CPT code 92597 we have assigned a work RVU value at the 25th
percentile, 1.26 work RVUs. We note that the work RVU for CPT code
31611 may not have been reviewed by the RUC since 1995. We invite the
RUC to review these two codes and any others for which work may
overlap.
We continue to have concerns about the methodology used by the AMA
RUC to review services with site of service anomalies. We request that
the AMA RUC utilize the building block methodology to revalue these
services.
The AMA RUC also recommended that we review claims data for CPT
codes 76970, Ultrasound study follow-up (specify), 94450, Breathing
response to hypoxia (hypoxia response curve), 94014, Patient-initiated
spirometric recording per 30-day period of time; includes reinforced
education, transmission of spirometric tracing, data capture, analysis
of transmitted data, periodic recalibration and physician review and
interpretation, 94015, Patient-initiated spirometric recording per 30-
day period of time; recording (includes hook-up, reinforced education,
data transmission, data capture, trend analysis, and periodic
recalibration) and 94016, Patient-initiated spirometric recording per
30-day period of time; physician review and interpretation only. We
will take the AMA RUC's suggestions under consideration and further
investigate these claims.
5. PE Issues--Arthoscopy
Previously, the AMA RUC recommended that an arthoscopic procedure
(CPT code 29870, Arthroscopy, knee, diagnostic, with or without
synovial biopsy (separate procedure)) not be valued in the non-facility
setting because they believed the procedure was unsafe to perform
outside of the facility setting. In the CY 2008 PFS final rule (72 FR
66238), we deferred proposing non-facility inputs for these types of
procedures. We stated that the physicians performing arthroscopic
services in the non-facility setting should be given the opportunity to
have a multi-specialty review by the AMA RUC.
Comment: We have received many inquiries about why CPT code 29870
was not valued in the non-facility setting. For CY 2010, in response to
a request from CMS, the AMA RUC has recommended PE inputs for CPT code
29870.
Response: We accept the AMA RUC's recommended PE inputs for this
procedure and are valuing this code in the non-facility setting.
BILLING CODE 4120-01-P
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BILLING CODE 4120-01-C
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6. Establishing Appropriate Relative Values for Physician Fee Schedule
Services
In MedPAC's March 2006 Report to Congress, MedPAC made a number of
recommendations to improve the review of the relative values for PFS
services. Since that time, we have taken significant actions to improve
the accuracy of the RVUs. As MedPAC noted in its recent March 2009
Report to Congress, ``CMS and the AMA RUC have taken several steps to
improve the review process'' in the intervening years since those
initial recommendations. Many of our efforts to improve the accuracy of
RVUs have also resulted in substantial increases in the payments for
primary care services.
The original March 2006 recommendation was summarized in the March
2008 Report to Congress:
We also recommended that CMS establish a group of experts,
separate from the AMA RUC, to help the agency conduct these and
other activities. This recommendation was intended not to supplant
the AMA RUC but to augment it. To that end, the panel should include
members who do not directly benefit from changes to Medicare's
payment rates, such as experts in medical economics and technology
diffusion and physicians who are employed by managed care
organizations and academic medical centers.
The idea of a group of experts separate from the AMA RUC, to help
the agency improve the review of relative values, raises a number of
issues. In the proposed rule, we solicited input on specific points
concerning the creation of such a group, including:
How could input from a group of experts best be
incorporated into existing processes of rulemaking and agency receipt
of AMA RUC recommendations?
What specifically would be the roles of a group of experts
(for example, identify potentially misvalued services, provide
recommendations on valuation of specified services, review AMA RUC
recommendations selected by the Secretary, etc.)?
What should be the composition of a group of experts? How
could such a group provide expertise on services that clinician group
members do not furnish?
How would such a group relate to the AMA RUC and existing
Secretarial advisory panels such as the Practicing Physician Advisory
Committee?
We also requested comments on the resources required to establish
and maintain such a group. We stated that we would consider these
comments as we consider the establishment of a group of experts to
assist us in our ongoing reviews of the PFS RVUs.
Comments: We received comments from many organizations, specialty
societies, and groups, including the AMA, the AMA RUC, and MedPAC
concerning the creation of a group of experts.
Some commenters expressed support of such a panel. The commenters
offered suggestions concerning its establishment and operations. The
commenters stated that adequate resources and funding would be needed.
The commenters viewed the panel as a vehicle to independently assess
the AMA RUC recommendations. Several commenters stressed the importance
of including consumers or purchasing representatives on such a panel
and that the current process is too narrowly focused on resource costs.
Commenters stated there is a need to restructure the payment system so
that it appropriately values coordinated care delivery, encourages
appropriate use of services, and rewards value and not volume.
Other commenters opposed creation of such a panel. The commenters
stated that the current process has been successful, is transparent,
and the rulemaking process provides additional oversight of the AMA
RUC's recommendations. The commenters also stated that the AMA RUC has
the technical knowledge and objective judgment to assist CMS in
maintenance of the RVUs and that a superimposed panel would lack its
insight. Commenters also stated that the addition of a separate group
would increase demands on CMS; create coordination problems; and would
be fiscally unsound and imprudent. Commenters noted that CMS and the
AMA RUC have made strides in the misvalued codes initiative. Some of
the commenters suggested that we consider enhancing the existing
refinement panel process used to address the comments received on
interim work RVUs (see section III for additional information on this
process). Some commenters expressed concern that the refinement panels
have not been adequately developed and that there is a lack of
transparency.
MedPAC stated there are valid reasons that a panel should be
established. It stated that CMS needs a regular source of expertise
available to assist in valuing services and that such expertise is not
solely the domain of the AMA RUC.
Response: We appreciate all of the comments and suggestions
provided regarding the creation of a group of experts. We will take
these comments into consideration as we continue to explore this issue.
We also appreciate the comments raised concerning the existing
refinement panel process. Any revisions to this process would be
discussed in future rulemaking.
G. Issues Related to the Medicare Improvements for Patients and
Providers Act of 2008 (MIPPA)
This section addresses certain provisions of the Medicare
Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L.
110-275). We proposed to revise our policies and regulations as
described below in order to conform them to the statutory amendments.
1. Section 102: Elimination of Discriminatory Copayment Rates for
Medicare Outpatient Psychiatric Services
Prior to the enactment of the MIPPA, section 1833(c) of the Act
provided that for expenses incurred in any calendar year in connection
with the treatment of mental, psychoneurotic, and personality disorders
of an individual who is not an inpatient of a hospital, only 62[frac12]
percent of such expenses are considered to be incurred under Medicare
Part B when determining the amount of payment and application of the
Part B deductible in any calendar year. This provision is known as the
outpatient mental health treatment limitation (the limitation), and has
resulted in Medicare paying only 50 percent of the approved amount for
outpatient mental health treatment, rather than the 80 percent that is
paid for most other outpatient services.
Section 102 of the MIPPA amends the statute to phase out the
limitation on recognition of expenses incurred for outpatient mental
health treatment, which will result in an increase in the Medicare Part
B payment for outpatient mental health services to 80 percent by CY
2014. When this section is fully implemented in 2014, Medicare will pay
for outpatient mental health services at the same level as other Part B
services. For CY 2010, section 102 of the MIPPA provides that Medicare
will recognize 68[frac34] percent of expenses incurred for outpatient
mental health treatment, which translates to a payment of 55 percent of
the Medicare-approved amount. Section 102 of the MIPPA specifies that
the phase out of the limitation will be implemented as shown in Table 6
provided that the patient has satisfied his or her deductible.
[[Page 61787]]
Table 6--Implementation of Section 102 of the MIPPA
----------------------------------------------------------------------------------------------------------------
Recognized
Calendar year incurred Patient pays Medicare pays
expenses
----------------------------------------------------------------------------------------------------------------
CY 2009 and prior calendar years................................ 62.50% 50% 50%
CY 2010 and CY 2011............................................. 68.75% 45% 55%
CY 2012......................................................... 75.00% 40% 60%
CY 2013......................................................... 81.25% 35% 65%
CY 2014......................................................... 100.00% 20% 80%
----------------------------------------------------------------------------------------------------------------
At present, Sec. 410.155(c) of the regulations includes examples
to illustrate application of the current limitation. We proposed to
remove these examples from the regulations and, instead, provided
examples in the CY 2010 PFS proposed rule (74 FR 33521), in our manual,
and under provider education materials as needed. (See the CY 2010 PFS
proposed rule (74 FR 33557) for the examples illustrating the
application of the limitation in various circumstances as it is
gradually reduced under section 102 of the MIPPA.) Section 102 of the
MIPPA did not make any other changes to the outpatient mental health
treatment limitation. Therefore, other aspects of the limitation will
remain unchanged during the transition period between CYs 2010 and
2014. The limitation will continue to be applied as it has been in
accordance with our regulation at Sec. 410.155(b) which specifies that
the limitation applies to outpatient treatment of a mental,
psychoneurotic, or personality disorder, identified under the
International Classification of Diseases (ICD) diagnosis code range
290-319. We use this ICD diagnosis code range, place of service code,
and the procedure code to identify services to which the limitation
applies.
Additionally, we proposed to make technical corrections to Sec.
410.155(b)(2) in order to update and clarify the services already under
these regulations to which the limitation does not apply. We proposed
the following technical changes:
Under Sec. 410.155(b)(2)(ii), revise the regulation to
specify the HCPCS code, M0064 (or any successor code), that represents
the statutory exception to the limitation for brief office visits for
the sole purpose of monitoring or changing drug prescriptions used in
mental health treatment.
At Sec. 410.155(b)(2)(iv), we proposed to revise the
regulation to add neuropsychological tests and diagnostic psychological
tests to the examples of diagnostic services that are not subject to
the limitation when performed to establish a diagnosis.
Under Sec. 410.155(b)(2)(v), we proposed to revise the
regulation to specify the CPT code 90862 (or any successor code) that
represents pharmacologic management services to which the limitation
does not apply when furnished to treat a patient who is diagnosed with
Alzheimer's disease or a related disorder.
Finally, we proposed to add a new paragraph (c) to Sec. 410.155
that provides a basic formula for computing the limitation during the
phase-out period from CY 2010 through CY 2013, as well as after the
limitation is fully removed from CY 2014 onward.
The following is a summary of the comments we received regarding
the proposed implementation of section 102 of the MIPPA.
Comment: All of the comments on section 102 of the MIPPA support
the enactment by the Congress and implementation by CMS of this
provision that will eventually achieve parity in payment for outpatient
mental health services under the Medicare Part B program with the
program's payment for other outpatient services. Most of the commenters
describe the limitation as discriminatory and inequitable, and believe
that it should have been eliminated a long time ago. The majority of
the commenters believe that the elimination of the limitation will
increase access to outpatient mental health services in the Medicare
population. Therefore, elimination of the limitation will have a
positive impact on Medicare beneficiaries because they will have to pay
less out-of-pocket. Also, commenters believe that physicians and other
providers of outpatient mental health care will be ``held harmless''
with respect to this change because, although they will collect less
from the patient, they will ultimately be able to collect from the
program the full Medicare approved amount for outpatient mental health
services. The commenters that embrace our proposal to implement section
102 of the MIPPA, request that we maintain our proposal in the final
rule, and encourage CMS to finalize section 102 of the MIPPA in a
timely fashion.
Response: We appreciate the supportive comments received on our
proposal to implement section 102 of the MIPPA and the encouragement to
finalize our proposal. Also, we are grateful for the offerings made by
a few commenters to assist in educating the provider community about
section 102 of the MIPPA.
Comment: One commenter opposed two of our technical corrections to
current regulations on the limitation at Sec. 410.155(b)(2) and
provided suggested changes. Specifically, under Sec.
410.155(b)(2)(iv), we proposed to insert neuropsychological tests along
with diagnostic tests that are performed to establish a diagnosis as
diagnostic services that are not subject to the limitation. While this
commenter has no issue with including neuropsychological tests, the
commenter believes that a complete list of services would include
outpatient consultation codes, all outpatient new patient and initial
visit evaluation and management (E/M) codes, and the psychiatric
diagnostic and evaluation interview codes (90801 and 90802).
Accordingly, the commenter believes that if we expand the list of
identified services not subject to the limitation by inserting
neuropsychological tests only, without including the complete listing
of services, we could be subjecting services inappropriately to the
limitation.
On this particular technical correction, another commenter
suggested that we should consider including a definition of
``diagnostic services'' to provide further guidance to the field on
this issue.
The other technical correction that the commenter opposed is the
provision under Sec. 410.155(b)(2)(v) that lists medical management
services billed under CPT code 90862 (or its successor code), as
opposed to psychotherapy, as not being subject to the limitation when
furnished to treat a patient who is diagnosed with Alzheimer's disease
or a related disorder. The commenter believes that medical management
services are not limited to those billed under CPT code 90862, but also
[[Page 61788]]
includes E/M of a patient with a mental illness using the outpatient E/
M codes (CPT codes 99211 through 99215), and in a nursing facility, the
subsequent nursing facility care E/M CPT codes (CPT codes 99307 through
99310). Hence, this commenter suggests that the proposed technical
correction would unnecessarily and improperly limit the exception to
only those instances when CPT code 90862 is billed. This commenter
urged that the exception to the limitation for the treatment of a
patient who is diagnosed with Alzheimer's disease or a related disorder
should continue to include all non-psychotherapy services. Accordingly,
this commenter suggested that the current language under regulations
should be retained or that new language clarify that any outpatient
service including CPT code 90862, E/M codes, and any other non-
psychotherapy service provided to a patient with Alzheimer's disease or
a related condition is not subject to the limitation.
One commenter who supports our implementation of the MIPPA
provision commented that it is appropriate to update the list of
services to which the limitation does not apply by specifying HCPCS
code M0064, neuropsychological tests and diagnostic psychological
tests, as well as CPT code 90862 when reporting services provided to a
patient with Alzheimer's disease or a related disorder.
Response: The intent of our technical corrections to Sec. 410.155
was to clarify, not to expand, our current policy. We intended to amend
the existing regulations in a way that would update and clarify the
already stated policy. Diagnostic psychological and neuropsychological
tests are diagnostic services that are excluded from the limitation
when performed to establish a diagnosis. The neuropsychological test
codes were established years after the CPT codes for diagnostic
psychological tests and that is why the reference to neuropsychological
tests had not been included under current regulations. Additionally, in
the context of psychiatric mental health services, the specific
diagnostic services for which we have national policy regarding the
limitation are the psychiatric diagnostic services under CPT codes
90801 and 90802, and, the CPT codes for diagnostic psychological and
neuropsychological testing. In the absence of national policy
concerning application of the limitation to diagnostic services billed
under the outpatient consultation codes or the outpatient new patient
and initial visit E/M codes, contractors use their discretion in making
decisions about whether the limitation should be applied to such
services under a variety of circumstances. To list these additional
outpatient consultation and E/M codes as suggested by the commenter
would represent an expansion of the current regulatory exception at
Sec. 410.155(b)(2)(iv).
However, we believe that if we revise the wording under Sec.
410.155(b)(2)(iv) to specify that psychiatric diagnostic services
billed under CPT codes 90801 and 90802 (or successor codes) and
diagnostic psychological and neuropsychological tests billed under CPT
code range 96101 through 96125 (or any successor code range) that are
performed to establish a diagnosis are not subject to the limitation,
we will address the commenter's concerns. Also, such a change will
provide the field with specific guidance on our definition of
``diagnostic services'' in terms of mental health services.
We agree with the commenter that our technical correction to Sec.
410.155(b)(2)(v) might have been read to restrict application of the
exception to CPT code 90862. We will refrain from addressing
specifically in the regulation outpatient E/M codes or nursing facility
E/M codes. Rather, we will continue to leave in the hands of our
contractors decisions as to whether the exception applies for these
codes under particular circumstances. We have provided policy guidance
to our contractors that medical management services furnished under CPT
code 90862 to treat a patient diagnosed with Alzheimer's disease or a
related disorder are not subject to the limitation. Therefore, we
believe it is consistent with current national policy to amend the
regulatory exception under Sec. 410.155(b)(2)(v) to read, ``medical
management such as that furnished under CPT code 90862 (or its
successor code), as opposed to psychotherapy, furnished to a patient
diagnosed with Alzheimer's disease or a related disorder.''
We received comments on issues that are outside the scope of our
proposals for section 102 of MIPPA. These comments are not addressed in
this final rule with comment.
2. Section 131: Physician Payment, Efficiency, and Quality
Improvements--Physician Quality Reporting Initiative (PQRI)
a. Program Background and Statutory Authority
The Physician Quality Reporting Initiative (PQRI) is a voluntary
reporting program that provides an incentive payment to eligible
professionals who satisfactorily report data on quality measures for
covered professional services during a specified reporting period.
Under section 1848(k)(3)(B) of the Act, the term ``eligible
professional'' means any of the following a: (1) physician; (2)
practitioner described in section 1842(b)(18)(C); (3) physical or
occupational therapist or a qualified speech-language pathologist; or
(4) qualified audiologist. The PQRI was first implemented in 2007 as a
result of section 101 of Division B of the Tax Relief and Health Care
Act of 2006--the Medicare Improvements and Extension Act of 2006 (Pub.
L. 109-432) (MIEA-TRHCA), which was enacted on December 20, 2006. The
PQRI was extended and further enhanced as a result of the Medicare,
Medicaid, and SCHIP Extension Act of 2007 (Pub. L. 110-173) (MMSEA),
which was enacted on December 29, 2007, and the MIPPA, which was
enacted on July 15, 2008. Changes to the PQRI as a result of these
laws, as well as information about the PQRI in 2007, 2008, and 2009,
are discussed in detail in the CY 2008 PFS proposed rule (72 FR 38196
through 38204), CY 2008 PFS final rule with comment period (72 FR 66336
through 66353), CY 2009 PFS proposed rule (73 FR 38558 through 38575),
and CY 2009 PFS final rule with comment period (73 FR 69817 through
69847). In addition, detailed information about the PQRI is available
on the CMS Web site at http://www.cms.hhs.gov/PQRI.
We received several comments from the public on the CY 2010 PFS
proposed rule related to the PQRI. General comments about the PQRI are
addressed immediately below.
Comment: Many commenters supported proposed program changes for
2010, in particular those that make reporting flexible and less
burdensome such as changes to the criteria for satisfactory reporting
of measures groups (specifically, the removal of the requirement to
report on consecutive patients), the proposed electronic health record-
based (EHR-based) reporting mechanism, and the group practice reporting
option.
Response: We appreciate the commenters' support of the changes
proposed for the 2010 PQRI, many of which are finalized herein. We
agree with commenters that many of the changes that we are finalizing
for the 2010 PQRI, including the ones listed above, provide eligible
professionals with greater flexibility and make reporting less
burdensome.
Comment: Several commenters suggested that we consider and
recommend to the Congress a modified version of the proposed option
[[Page 61789]]
presented by the Senate Finance Committee in the April 29, 2009,
``Description of Policy Options, Transforming the Health Care Delivery
System: Proposals to Improve Patient Care and Reduce Health Care
Costs'' to add a new participation option allowing eligible
professionals to receive PQRI incentive payments for 3 successive years
if, on a triennial (every 3 year) basis, the eligible professional: (1)
participates in a qualified American Board of Medical Specialties
(ABMS) certification known as the Maintenance of Certification (MOC),
or equivalent programs; and (2) completes a qualified MOC practice
assessment. Such practice assessments typically consist of the use of
performance measures to evaluate practice activities, which includes
documentation of evidence of practice changes to improve quality, and
re-evaluation to determine the effect of a change in the practice
process or structure of care.
Response: Section 1848(m)(1) of the Act specifies the PQRI
incentive amount for each program year and how the incentive payment
amount is to be calculated for each reporting period during the program
year. We do not have the authority to change how the incentive payment
amount is determined and, therefore, cannot continue payments beyond
the authorized program year.
With respect to the commenters' suggestion to provide PQRI
incentive payments to eligible professionals who participate in an ABMS
MOC program and complete a qualified MOC practice assessment, section
1848(m)(3)(A) of the Act dictates the criteria that eligible
professionals must meet in order to be treated as satisfactorily
submitting data on quality measures. These criteria include the
reporting, by eligible professionals, of quality data on a standardized
set of national consensus-based measures. For years after 2009, section
1848(m)(3)(D) of the Act gives us the discretion to revise the criteria
for satisfactorily submitting data on quality measures. The proposed
criteria for 2010, which did not explicitly include the option
suggested by the commenters, were discussed in the CY 2010 PFS proposed
rule (74 FR 33565 through 33569). We believe that basing criteria for
satisfactory reporting solely on participation in an ABMS MOC and
completion of a qualified MOC practice assessment without the
submission of PQRI measures results would defeat the ability of CMS to
analyze and compare eligible professional performance based on a
standardized set of measures. PQRI is not based upon such
qualifications, but rather on the submission of data on quality
measures to measure eligible professional performance.
However, to the extent that ABMS member certification boards
collect information on PQRI quality measures from eligible
professionals, the ABMS member boards may qualify as registries under
the PQRI and report such information to CMS on behalf of eligible
professionals. Currently, one of the ABMS member boards has qualified
as a CMS PQRI registry and successfully submitted data on PQRI measures
on behalf of eligible professionals. This would allow eligible
professionals to concurrently participate in an ABMS MOC and PQRI.
Comment: Several commenters suggested that we expand our education
and outreach efforts so that professionals can gain a better
understanding of the program, coding, and how to participate
satisfactorily. Specifically, commenters suggested that we:
Publish a list of professions that have participated in
PQRI.
Communicate potential incentive amounts that could be
earned by an individual participant.
Work with the AMA and other national stakeholder
organizations to increase education and outreach for professionals
about the requirements for satisfactorily reporting under various
options.
Use provider-neutral language, such as ``clinician'' or
``provider'' in describing the array of eligible professionals.
Response: We value the input received from stakeholders and
participants who have provided constructive feedback and have
collaborated with us to disseminate educational PQRI materials to
eligible professionals in the health care community. We will continue
to work with national and regional stakeholder organizations to educate
their members on program requirements for satisfactory reporting.
We also plan to continue to host monthly national provider calls in
which we expect to provide guidance on specific topics, including
having our PQRI subject matter experts available to answer questions on
the PQRI. Information about upcoming calls can be obtained from the CMS
Sponsored Calls page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/04_CMSSponsoredCalls.asp#TopOfPage. We will
continue to make PQRI educational materials and other resources
available on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI as well. Updated educational materials and
resources for the 2010 PQRI will be made available as soon as possible
following publication of this final rule with comment period. Where
appropriate, we will consistently use inclusive terminology such as
``eligible professionals'' rather than ``physicians'' in PQRI
educational resources and related documents. We encourage eligible
professionals to visit this Web site and to review the frequently asked
questions (FAQs) found on this Web site. Eligible professionals are
also encouraged to join the physician listserv to obtain periodic
updates about the PQRI. Instructions for joining the listserv can be
found at https://list.nih.gov/archives/physicians-1.html.
Finally, we anticipate conducting and publishing an evaluation of
the 2008 PQRI similar to the ``PQRI 2007 Reporting Experience'' posted
on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/Downloads/PQRI2007ReportFinal12032008CSG.pdf. Although we have not yet
finalized the operational details of our evaluation strategy, we expect
the report to include participation rates by specialty/profession,
associated trends in clinical performance and beneficiary outcomes, and
other observable impacts on participants, the Medicare program, and
beneficiaries.
Comment: Several commenters requested that we provide more detailed
educational resources well in advance of the 2010 PQRI start date and
provide enough lead time so that electronic systems may be updated to
allow data capture for new or revised 2010 PQRI measures.
Response: We agree with the commenters that it is desirable to
provide final measure specifications and other educational resources
sufficiently in advance of the start of a new program year to allow
reasonable time for professionals to analyze new or revised reporting
options and measures, and implement any needed changes in their office
workflows so that they may accurately capture and satisfactorily submit
data on a selection of measures applicable to their practice. We are
aware that such lead time would also help the eligible professionals'
specialty or professional societies to prepare to support the
professionals' selection of relevant measures. Having detailed
information on measures available in advance also enhances the ability
of vendors (such as practice-management software, billing services, and
electronic health record vendors) to support professionals' successful
implementation of revised data capture processes for the measures. We
are
[[Page 61790]]
targeting finalization and publication of the detailed specifications
for all 2010 PQRI measures on the CMS Web site, by November 15, 2009,
but no later than December 31, 2009. The detailed specifications
include instructions for reporting and identifying the circumstances in
which each measure is applicable. The specifications for measures in
the final listing for the 2010 PQRI, including a measure's title,
remain potentially subject to corrections until the start of the 2010
reporting period. We are also committed to making other educational
resources for the 2010 PQRI available on the PQRI section of the CMS
Web site at http://www.cms.hhs.gov/PQRI as quickly as possible after
publication of this final rule with comment period.
As discussed below, to assist eligible professionals who may need
additional time to make updates to their electronic systems or practice
workflows, we also are finalizing a 6-month reporting period beginning
July 1, 2010, for claims-based reporting of individual measures. Thus,
the 6-month reporting period will be available for both those who wish
to report individual measures, as well as measures groups through
claims or a qualified registry.
Comment: Some commenters requested that we provide detailed data
used to determine that a professional failed to report on 80 percent of
eligible cases and to inform them about what they need to do to rectify
errors.
Response: We considered recommendations about PQRI participant
feedback reports as part of an ongoing dialogue with the stakeholder
and participant community. We convened a multi-specialty focus group
and have revised the design and content of the 2008 PQRI feedback
reports, which were recently released. These revised feedback reports
include more detailed information at the individual eligible
professional level than was provided in the 2007 PQRI feedback reports.
Comment: Several commenters stated that the 2007 feedback reports
were too difficult to obtain, did not provide sufficient detailed
information to allow correction, and were not available on an interim
basis to prevent eligible professionals from making the same errors in
the following program year.
Response: To address concerns expressed about our secure method
used to obtain the feedback reports (which requires eligible
professionals to register and obtain an Individuals Authorized Access
to CMS Computer Services, or IACS, account), we identified an
alternative feedback report request process for individual eligible
professionals requesting NPI level reports, which allows an individual
participant to obtain his or her own feedback report through their
carrier or MAC after providing appropriate identification. Information
about this new process is available on the PQRI section of the CMS Web
site and was discussed on the October 15, 2009, PQRI national provider
call.
We have assessed the feasibility of providing some type of interim
feedback report to participants. We have determined, however, detailed,
accurate, participant-level interim feedback reports cannot be provided
in an appropriately secure access environment. However, given that the
most prevalent underlying reasons for failure to meet incentive
eligibility are due to (1) failure by the professional to identify and
report on at least 80 percent of denominator-eligible cases for the
measures selected, and (2) quality data code errors due to incorrect or
insufficient coding, we have determined that an aggregate-level quality
data submission error report could be published on a quarterly basis on
the PQRI section of the CMS Web site, to provide information on the
types of submission errors found for each measure. Following the
posting of the ``PQRI 2007 Reporting Experience'' report, we have
continued to post updated error reports on a quarterly basis on the
PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI.
Comment: Several commenters who participated in the 2008 PQRI have
commented on the lack of timely feedback reports and incentive
payments.
Response: For claims-based reporting, PQRI analysis of individual
professionals' claims begins after the conclusion of the program year
when all claims have been processed. Conducting individual-level
analysis on a portion of a professional's claims during the program
year would result in inaccurate data and presents a significant expense
to CMS. We acknowledge participating professionals' need for interim
information on the accuracy of their quality reporting through claims.
Therefore, we have posted aggregate-level information on the PQRI
section of the CMS Web site on a quarterly basis describing quality-
data code submission errors that we observe on claims for each PQRI
measure and anticipate continuing to do so in the future.
In addition, many registries provide interim feedback to their
clients. Therefore, eligible professionals who participate in PQRI
through a qualified registry may be able to receive interim feedback
from the registry and have the opportunity to correct those errors
prior to the program year data submission deadline.
Comment: Several commenters requested that we establish a formal
appeals process for those professionals who participate in PQRI but do
not qualify for the incentive payment.
Response: Section 1848(m)(5)(e) of the Act provides that with
respect to the PQRI there shall be no administrative or judicial review
under section 1869, section 1879, or otherwise of (1) The determination
of measures applicable to services furnished by eligible professionals;
(2) the determination of satisfactory reporting; and (3) the
determination of any incentive payment. Since 2007, we have addressed
inquiries about the PQRI through the question-and-answer sessions held
during monthly PQRI national provider calls and open door forums. More
recently, a dedicated Help Desk has been implemented to respond to
participants' inquiries related to all aspects of the PQRI, including
assisting eligible professionals in understanding why they did not
receive a PQRI incentive payment. The Help Desk is available from 7
a.m. to 7 p.m. CT and can be reached by phone at (866) 288-8912 or via
e-mail at [email protected].
Comment: Several commenters expressed the need to evaluate the
impact of PQRI and make evaluation results available to stakeholders.
Some commenters stated that an evaluation of outcomes achieved is
needed before deciding whether to expand the program, impose penalties,
or make participation mandatory. One commenter noted that such an
evaluation is needed to restore confidence in the PQRI since the
program's validity within the eligible professional community has been
compromised due to the PQRI being rushed. Other commenters urged us to
provide medical specialty organizations with the PQRI data files so
that they may perform an independent analysis to assist CMS to improve
the clinical appropriateness of physician quality measures and better
understand or correct potential barriers to satisfactory reporting.
Response: We have conducted and published an evaluation of the 2007
PQRI and have posted the ``PQRI 2007 Reporting Experience'' on the PQRI
section of the CMS Web site at http://www.cms.hhs.gov/PQRI/Downloads/PQRI2007ReportFinal12032008CSG.pdf. We anticipate conducting a similar
evaluation of the 2008 PQRI and expect to include participation rates
by
[[Page 61791]]
specialty/profession, associated trends in clinical performance and
beneficiary outcomes, and other observable impacts on participants, the
Medicare program, and beneficiaries. Although we have not yet finalized
the operational details of our evaluation strategy for the 2008 PQRI
and beyond, we do anticipate making the results of the evaluation, at
the national level, available to the public. We also may make publicly
available the results of such analyses aggregated at other meaningful
levels (for example, State, specialty, or profession). We do not at
this time plan to make results publicly available in a format or with
content that would enable identification of individual professionals or
specific practices' reporting or performance results.
Comment: Several commenters urged CMS to expand PQRI in a manner
that would allow participation by therapy professionals who practice in
institutional settings such as hospitals, rehabilitation facilities,
and skilled nursing facilities and submit their individual National
Provider Identifier (NPI) either through claims or through registry-
based reporting.
Response: As we stated in the CY 2008 PFS final rule with comment
period (74 FR 69820 through 69821), we agree with the goal of offering
the opportunity to participate in PQRI to as many eligible
professionals as feasible and practical, consistent with the statutory
requirements. Except for group practices participating in the group
practice reporting option, which begins in 2010, the determination of
satisfactory reporting and the calculation of any earned incentive
payment amount must be determined at the individual professional level,
regardless of the method of reporting quality data. For therapy
professionals who practice in institutional settings, we cannot make
the determination of satisfactory reporting and calculate earned
incentive payment amounts at the individual eligible professional level
without extensive modifications to the claims processing systems of CMS
and providers, which would represent a material administrative burden
to us and to providers. It would also require modifications to the
industry standard claims formats, which would require substantial time
to effect through established processes and structures that we do not
maintain or control. We have also found that most institutions that
employ therapists do not tie the individual therapist to the service
rendered to an individual patient. Instead, therapists are hired for a
fixed number of hours per day per week. In this case, there are no
provider identifiers available to use in processing these claims.
Comment: Several commenters indicated that we should convert PQRI
from a pay-for-reporting program to a pay-for performance program,
stating that reporting on quality measures is not sufficient and that
consumers need performance data for informed choice based on quality
and value.
Response: Our plans for a report to Congress on transitioning to a
physician value-based purchasing program are discussed in section
II.G.4. of this final rule with comment period.
Comment: Some commenters expressed concern that the impact analysis
of the estimated costs for participation by professionals for claims-
based, registry-based, and EHR-based reporting contained in the CY 2010
PFS proposed rule (74 FR 33664 through 33665) are too low or inaccurate
and should be rectified in the final rule. One commenter noted that one
estimate of the cost for a practice to participate in PQRI ranges from
$55,000 to $1.3 million. Other commenters cited an example from a
practice with 1 full-time eligible professional and 1 part-time
eligible professional where it was determined that the cost for claims-
based reporting in PQRI was $1,780 per year, or $1,186 per eligible
professional. Some commenters suggested that we conduct a survey of
successful PQRI participants and/or data submission vendors to
determine all participation costs and publish survey results in future
rules.
Response: As stated in the CY 2010 PFS proposed rule (74 FR 33664),
individual eligible professionals and group practices may have
different processes for integrating the PQRI into their practices' work
flows. Therefore, it is difficult for us to accurately quantify the
cost burden because it would vary with each eligible professional by
the number of measures applicable to the eligible professional, the
number of measures on which an eligible professional chooses to report,
the complexity of the measure(s) chosen by the eligible professional,
the eligible professional's patient population and how frequently the
professional's selected measure(s) apply to the professional's patient
population, the eligible professional's familiarity, understanding, and
experience with the PQRI, and the reporting option selected by the
eligible professional. To be able to provide any cost estimates we had
to use certain assumptions with respect to the number of measures
reported on and the number of reporting instances per eligible
professional. Given that practices vary in size and patient population,
these assumptions will not hold true for every practice participating
in PQRI and some practices' costs associated with PQRI participation
will exceed the estimates provided in our cost estimates while other
practices will have costs below our estimates. We cannot assess the
examples offered by commenters without additional information on the
number of measures reported by each eligible professional in the
practice and the number of reporting instances per eligible
professional. We will consider, however, the commenters' suggestions
for future years but believe that it would be unlikely that we would be
able to obtain a representative sample of survey respondents given the
many variables that impact participation costs.
Comment: A specific concern cited by commenters with respect to the
impact analysis was that reliance on historical data from the Physician
Voluntary Reporting Program (PVRP) is inappropriate and does not take
into consideration the development and maintenance of new workflows
necessary to participate in PQRI and the new measure, measure
specification changes and reporting option changes that occur on an
annual basis.
Response: Information from the PVRP was used solely for developing
cost estimates for participation in PQRI through the claims-based
reporting mechanism; not through other reporting mechanisms. To develop
our cost estimates for claims-based reporting, we applied information
from PVRP on how much time it takes one eligible professional, in a
median practice, to report one measure one time through claims to our
assumptions. We recognize that the PVRP cost estimates are historical,
but we do not believe that the process for reporting measures through
claims has changed significantly from PVRP to PQRI in a way to
considerably change the amount of time it takes one eligible
professional to report one measure one time through claims. However,
for our impact analysis, we did use a higher average practice labor
cost than what was indicated in the information from the PVRP (that is,
we used $55 per hour instead of $50 per hour) to account for increases
in labor costs over time (74 FR 33655).
Comment: Other commenters had specific concerns about the estimates
provided for participation in PQRI via registries. Some commenters
offered anecdotal information that the annual cost to one practice of
participating in a specific registry is approximately $3,000. Another
commenter believed that more than 5 minutes is needed for
[[Page 61792]]
an eligible professional to authorize a registry to submit quality
measure results and numerator and denominator data on their behalf.
Other commenters were concerned that our estimate of $1,500 to $5,000
to purchase an EHR product was too low. One commenter noted that EHR
systems have capital costs of over $1 million per year. Another
commenter noted that researchers recently found that it would cost
about $124,000 for a single doctor or small practice to upgrade to EHRs
over 5 years.
Response: We appreciate the input from commenters and have taken
the additional information provided by commenters into consideration to
revise the estimates associated with registry and EHR reporting where
appropriate in sections XIII.E.2 and XI. of this final rule with
comment period.
For registry reporting, however, we note that many registries offer
additional services beyond what is required to participate in PQRI. In
the example provided by commenters, it is not clear whether those costs
that are not related to reporting PQRI quality measure results and
numerator and denominator data on PQRI measures have been taken into
consideration and excluded. Our impact analysis is limited to the
incremental cost of participating in PQRI.
b. Incentive Payments for the 2010 PQRI
For 2010, section 1848(m)(1)(B) of the Act authorizes the Secretary
to provide an incentive payment equal to 2.0 percent of the estimated
total Medicare Part B PFS allowed charges (based on claims submitted
not later than 2 months after the end of the reporting period) for all
covered professional services furnished during the reporting period for
2010. Although PQRI incentive payments are only authorized through 2010
under section 1848(m)(1)(A) of the Act, section 1848(k)(2)(C) of the
Act provides for the use of consensus-based quality measures for the
PQRI for 2010 and subsequent years.
The PQRI incentive payment amount is calculated using estimated
Medicare Part B PFS allowed charges for all covered professional
services, not just those charges associated with the reported quality
measures. ``Allowed charges'' refers to total charges, including the
beneficiary deductible and coinsurance, and is not limited to the 80
percent paid by Medicare or the portion covered by Medicare where
Medicare is secondary payer. Amounts billed above the PFS amounts for
assigned and non-assigned claims will not be included in the
calculation of the incentive payment amount. In addition, since, by
definition under section 1848(k)(3)(A) of the Act, ``covered
professional services'' are limited to services for which payment is
made under, or is based on, the PFS and which are furnished by an
eligible professional, other Part B services and items that may be
billed by eligible professionals but are not paid under or based upon
the Medicare Part B PFS are not included in the calculation of the
incentive payment amount.
Under section 1848(m)(6)(C) of the Act, the ``reporting period''
for the 2008 through 2011 PQRI is defined to be the entire year, but
the Secretary is authorized to revise the reporting period for years
after 2009 if the Secretary determines such ``revision is appropriate,
produces valid results on measures reported, and is consistent with the
goals of maximizing scientific validity and reducing administrative
burden.''
We are also required by section 1848(m)(5)(F) of the Act to
establish alternative criteria for satisfactorily reporting and
alternative reporting periods for registry-based reporting and for
reporting measures groups. Therefore, eligible professionals who meet
the alternative criteria for satisfactorily reporting for registry-
based reporting and for reporting measures groups for the 2010
alternative reporting periods for registry-based reporting and for
reporting measures groups will also be eligible to earn an incentive
payment equal to 2.0 percent of the estimated total Medicare Part B PFS
allowed charges for all covered professional services furnished by the
eligible professional during the alternative reporting periods for 2010
PQRI registry-based reporting or for reporting measures groups.
Prior to 2010, the PQRI was an incentive program in which
determination of whether an eligible professional satisfactorily
reported quality data was made only at the individual professional
level, based on the NPI. Although the incentive payments were made to
the practice(s) represented by the Tax Identification Number (TIN) to
which payments are made for the individual professional's services,
there were no incentive payments made to the group practice based on a
determination that the group practice, as a whole, satisfactorily
reported PQRI quality measures data. To the extent individuals (based
on the individuals' NPIs) satisfactorily reported data on PQRI quality
measures that were associated with more than one practice or TIN, the
determination of whether an eligible professional satisfactorily
reported PQRI quality measures data was made for each unique TIN/NPI
combination. Therefore, the incentive payment amount was calculated for
each unique TIN/NPI combination and payment was made to the holder of
the applicable TIN.
However, section 1848(m)(3)(C)(i) of the Act requires that by
January 1, 2010, the Secretary establish and have in place a process
under which eligible professionals in a group practice (as defined by
the Secretary) shall be treated as satisfactorily submitting data on
quality measures for the PQRI for covered professional services for a
reporting period, if, in lieu of reporting measures under subsection
(k)(2)(C), the group practice reports measures determined appropriate
by the Secretary, such as measures that target high-cost chronic
conditions and preventive care, in a form and manner, and at a time,
specified by the Secretary. Therefore, beginning with the 2010 PQRI,
group practices that satisfactorily submit data on quality measures
also would be eligible to earn an incentive payment equal to 2.0
percent of the estimated total Medicare Part B PFS allowed charges for
all covered professional services furnished by the group practice
during the applicable reporting period. As required by section
1848(m)(3)(C)(iii) of the Act, payments to a group practice by reason
of the process described above would be in lieu of the PQRI incentive
payments that would otherwise be made to eligible professionals in the
group practice for satisfactorily submitting data on quality measures.
Therefore, an individual eligible professional who is participating in
the group practice reporting option as a member of a group practice
would not be able to separately earn a PQRI incentive payment as an
individual eligible professional under that same TIN (that is, for the
same TIN/NPI combination).
The following is summary of the comments we received regarding the
2010 PQRI incentive payment amount.
Comment: One commenter expressed support of the proposed extension
of the PQRI incentive related to the group practice reporting option.
Response: We appreciate the commenter's support of the extension of
the PQRI incentive to group practices.
Commenter: One commenter expressed a concern that the PQRI
incentive payment is calculated as a percentage of the total Medicare
billing of the individual eligible professional. The commenter
expressed concern that for an equal amount of relative value unit work,
eligible professionals in lower GPCI localities will receive as
[[Page 61793]]
much as 38 percent less PQRI payment for the same work, time, and
effort used in providing quality care than eligible professionals in
higher GPCI localities. The commenter suggested that PQRI incentive
payment calculations should not be geographically adjusted and
recommended that we change the basis of the incentive to RVUs rather
than dollars billed to Medicare.
Response: While we acknowledge the effect of the GPCI on the
calculation of the PQRI incentive amount, we do not have authority to
change the basis for the calculation of the incentive amount, which is
defined by section 1848(m)(1) of the Act.
Comment: A commenter requested clarification on whether
radiopharmaceuticals are included in the PQRI and electronic
prescribing incentive payments (see section II.G.5. of this final rule
with comment period for further discussion of the E-Prescribing
Incentive Program).
Response: Medicare Part B PFS allowed charges for
radiopharmaceuticals have been included for determining the PQRI and
electronic prescribing incentive payments. Radiopharmaceuticals are
included as part of section 1861(s)(4) of the Act, which is
incorporated into the list of PFS services cited in section 1848(j)(3)
of the Act, and therefore, are part of the PQRI and electronic
prescribing incentive calculations.
The relevant radiopharmaceutical codes are paid on the basis of
invoices submitted by physicians. Such invoices are considered similar
to contractor priced items or services. In addition,
radiopharmaceuticals are classified as A codes (A9500-A9699) which
inadvertently have not previously been included in Addendum B.
Commencing with CY 2010, radiopharmaceuticals will be included in
Addendum B as MPFSDB covered charges.
Furthermore, FAQ 8545, which can be accessed via the PQRI section
of the CMS Web site, states that for ``PQRI participants who report
satisfactorily, radiopharmaceuticals furnished as part of a covered
professional service will be included in the basis of total Medicare
Part B PFS allowed charges on which the incentive is calculated.''
No changes in radiopharmaceutical payment will be necessary.
Payment will continue to be contractor-priced on the basis of invoices
under the physician fee schedule.
c. 2010 Reporting Periods for Individual Eligible Professionals
As we indicated above, section 1848(m)(6)(C) of the Act defines
``reporting period'' for 2010 to be the entire year. Section
1848(m)(6)(C)(ii) of the Act, however, authorizes the Secretary to
revise the reporting period for years after 2009, if the Secretary
determines such revision is appropriate, produces valid results on
measures reported, and is consistent with the goals of maximizing
scientific validity and reducing administrative burden. In addition,
section 1848(m)(5)(F) of the Act requires, for 2008 and subsequent
years, the Secretary to establish alternative reporting periods for
reporting groups of measures and for registry-based reporting.
In the CY 2010 PFS proposed rule (74 FR 33560), we proposed that
the 2010 PQRI reporting period for the reporting of individual PQRI
quality measures through claims or a qualified EHR would be the entire
year (that is, January 1, 2010 through December 31, 2010). We also
proposed to retain the 2 alternative reporting periods from the 2008
and 2009 PQRI for reporting measures groups and for registry-based
reporting: (1) the entire year; and (2) a 6-month reporting period
beginning July 1.
We solicited comments on these proposals and the decision not to
propose a 6-month reporting period for claims-based reporting of
individual PQRI quality measures. The following is a summary of the
comments received regarding the proposed reporting periods.
Comment: Although a majority of the commenters supported the
proposed reporting periods, we received several comments requesting
that CMS retain or add a 6-month reporting period for claims-based
reporting of individual measures. Many commenters requested this
additional reporting period because they believe that doing so would
encourage PQRI participation by allowing more time for eligible
professionals to implement PQRI into their practice workflows and
providing an opportunity for those who are hesitant to continue
participating in PQRI until they receive feedback from the previous
year to do so as well. Many commenters noted that reporting measures
groups or reporting through a registry is not an option for them. Other
commenters suggested that we maintain the 6-month reporting period for
claims-based reporting of individual measures to maintain flexibility
and uniformity in reporting periods for all PQRI reporting options to
reduce confusion since many eligible professionals already believe that
they can start claims-based reporting of individual measures in July.
Some commenters also requested that we have a 6-month reporting
period for claims-based reporting of individual measures for situations
in which an eligible professional who was planning to report through an
alternative reporting mechanism may have to revert to claims-based
reporting during the year, such as when an eligible professional's EHR
system requires re-installation or significant maintenance or upgrades
or when it takes longer for a practice to acquire a new EHR system than
anticipated.
Response: Although many commenters requested that we ``retain'' the
6-month reporting period for claims-based reporting of individual
measures, we would like to clarify there was no 6-month reporting
period for claims-based reporting of individual quality measures
available for either the 2008 or 2009 PQRI. In the 2008 and 2009 PQRI,
the 6-month reporting period beginning July 1 was only available to
eligible professionals who chose to report on measures groups or chose
registry-based reporting (of either individual measures or measures
groups). Prior to 2010 we did not have the authority to change the
reporting period for claims-based reporting of individual measures,
which is defined by section 1848(m)(6)(C)(i)(II) of the Act to be the
entire year for 2008, 2009, 2010, and 2011. The only program year in
which the reporting period was defined by statute to be the 6-month
period beginning July 1 was the 2007 PQRI.
However, as a result of the compelling arguments presented by
commenters, we will exercise our authority under section
1848(m)(6)(C)(ii) of the Act to revise the reporting period for the
2010 PQRI. Thus, in addition to the 12-month reporting period beginning
January 1, 2010, we are finalizing a 6-month reporting period beginning
July 1, 2010, available for claims-based reporting of individual
measures for the 2010 PQRI.
Comment: One commenter supported not adding a 6-month reporting
period for claims-based reporting of individual measures based on the
assumption that we would eliminate claims-based reporting after 2010.
Response: As we stated in the CY 2010 PFS proposed rule (74 FR
33561), our ability to reduce or eliminate our reliance on claims-based
reporting is contingent on there being an adequate number and variety
of registries available and/or EHR reporting options. Since it is
unlikely that there will be an adequate number of measures available
for EHR reporting in 2011 for us to solely rely on registry and EHR
reporting, we anticipate continuing to offer claims-based reporting
options for the PQRI beyond 2010. Therefore, for the reasons discussed
above, we believe that a 6-month reporting period for claims-based
reporting of individual
[[Page 61794]]
measures should be available to the extent that claims-based reporting
of individual measures continues to be an available option for eligible
professionals.
Comment: One commenter requested that we provide a ``clarifying
definition of the term `qualified' '' with respect to the proposed 2010
PQRI reporting periods. The commenter noted that there is a similar
term in industry use and a definition would help to avoid confusion.
Response: We are unclear as to how the term ``qualified'' relates
to the PQRI reporting periods and believe that the commenter may be
referring to our use of the term ``qualified'' with respect to registry
and EHR reporting. As proposed for the 2010 PQRI (74 FR 33563 through
33565), for purposes of the PQRI, a ``qualified'' registry is one that
has self-nominated to be able to submit PQRI quality measures results
and numerator and denominator data on PQRI quality measures or measures
groups on behalf of eligible professionals and that has been vetted by
CMS to ensure the registry's meets certain technical and other
requirements. Similarly, a ``qualified'' EHR vendor is one that has
self-nominated to have one or more of its EHR products vetted by CMS to
ensure that the product(s) meets certain technical and other
requirements. Eligible professionals who wish to submit PQRI measures
via an EHR may only use qualified EHR products to do so.
For the reasons discussed above and based on the comments, for
2010, we will retain a 12-month reporting period beginning January 1,
2010, which will be available for all reporting mechanisms and
regardless of whether an individual eligible professional chooses to
report on 2010 PQRI individual measures or measures groups. In
addition, we are adopting a 6-month reporting beginning July 1, 2010,
for claims-based and registry-based reporting of 2010 PQRI individual
measures or measures groups. This 6-month reporting period will not be
available for EHR-based reporting in 2010. Once we have additional
experience with EHR reporting in PQRI we may consider including a 6-
month reporting period for EHR reporting in future years.
In addition, an eligible professional who satisfactorily reports
2010 PQRI measures or measures groups through claims or a qualified
registry for the 6-month reporting period will qualify to earn a PQRI
incentive payment equal to 2.0 percent of his or her total estimated
Medicare Part B PFS allowed charges for covered professional services
furnished between July 1, 2010 and December 31, 2010 only. As required
by section 1848(m)(1)(A) of the Act, the incentive payment will be
calculated based on the eligible professional's charges for covered
professional services furnished during the applicable reporting period
only.
d. 2010 PQRI Reporting Mechanisms for Individual Eligible Professionals
When the PQRI was first implemented in 2007, there was only 1
reporting mechanism available to submit data on PQRI quality measures.
For the 2007 PQRI, the only way that eligible professionals could
submit data on PQRI quality measures was by reporting the appropriate
quality data codes on their Medicare Part B claims (claims-based
reporting). For the 2008 PQRI, we added a second reporting mechanism as
required by section 1848(k)(4) of the Act, so that eligible
professionals could submit data on PQRI quality measures to a qualified
PQRI registry and request the registry to submit PQRI quality measures
results and numerator and denominator data on the 2008 PQRI quality
measures or measures groups on their behalf (registry-based reporting).
For the 2009 PQRI, we retained the 2 reporting mechanisms used in the
2008 PQRI (that is, claims-based reporting and registry-based
reporting) for reporting individual PQRI quality measures and for
reporting measures groups.
To promote the adoption of EHRs, we also conducted limited testing
of a third reporting mechanism for the 2008 and 2009 PQRI, which was
the submission of clinical quality data extracted from an EHR, or the
EHR-based reporting mechanism. No incentive payment was available to
those eligible professionals who participated in testing the EHR-based
reporting mechanism.
For the 2010 PQRI, we proposed to retain the claims-based reporting
mechanism and the registry-based reporting mechanism. In addition, we
proposed to accept PQRI quality measure data extracted from a qualified
EHR product (that is, an EHR successfully completing the 2009 EHR
Testing Program) for a limited subset of the proposed 2010 PQRI quality
measures, as identified in Table 20 of the CY 2010 PFS proposed rule,
contingent upon the successful completion of our 2009 EHR data
submission testing process and a determination based on that testing
process that accepting data from EHRs on quality measures for the 2010
PQRI is practical and feasible. We solicited comments on the proposed
reporting mechanisms for the 2010 PQRI, including the proposal to add
an EHR-based reporting mechanism to the 2010 PQRI, contingent upon the
successful completion of our 2009 EHR data submission testing process
and a determination that accepting data from EHRs on quality measures
for the 2010 PQRI is practical and feasible.
We also discussed in the CY 2010 PFS proposed rule how we may
consider significantly limiting the claims-based mechanism of reporting
clinical quality measures for the PQRI after 2010. We solicited
comments on our intent to lessen our reliance on the claims-based
reporting mechanism for the PQRI beyond 2010.
The following is a summary of the comments received with regard to
the proposed 2010 PQRI reporting mechanisms and our intent to lessen
reliance on the claims-based reporting mechanism for the PQRI beyond
2010.
Comment: A majority of the commenters agreed with our reasons for
lessening our reliance of claims-based reporting, supported alternative
reporting mechanisms, or agreed that we should eventually transition
away from claims-based reporting. At the same time, however, many of
these same commenters urged us to reconsider limiting or eliminating
claims-based reporting in 2011. Many commenters noted that claims-based
reporting is currently the only option available for many eligible
professionals and is the only reporting mechanism that is available to
all eligible professionals. Other commenters cited claims-based
reporting as the most convenient and cost-effective reporting mechanism
available to eligible professionals, particularly solo practitioners
and those in small practices. Also, the commenters noted that the EHR-
based reporting mechanism initially will only be available on a limited
basis so we should wait until EHR-based reporting becomes well
established before transitioning away from claims-based reporting.
Response: We acknowledge the commenters' concerns that prematurely
eliminating the claims-based reporting mechanism could create barriers
to participation. While our goal continues to be to eventually phase-
out claims-based reporting, our ability to reduce or eliminate our
reliance on claims-based reporting is contingent on there being an
adequate number and variety of registries available and/or EHR
reporting options. As we stated previously, since it is unlikely that
there will be an adequate number of measures available for EHR
reporting in 2011 for us to completely eliminate the claims-based
reporting mechanism, we
[[Page 61795]]
anticipate continuing to offer claims-based reporting options for the
PQRI beyond 2010. We may, however, avoid introducing new claims-based
measures and increasingly limit the circumstances in which claims-based
reporting is an available reporting mechanism in order to encourage
wider adoption of registry or EHR-based reporting.
Comment: One commenter recommended that, as we move towards
reducing reliance on claims-based reporting for PQRI and increase
registry-based and EHR-based options, we require registries and EHR
vendors to seek and obtain a license to use the measures from the
measure developers.
Response: PQRI measure specifications are developed in consultation
with the measure developers and are made available to the public via
posting on the PQRI section of the CMS Web site. Registries must use
the PQRI measure specifications posted on the PQRI section of the CMS
Web site to calculate reporting or performance unless otherwise stated.
Similarly, eligible professionals who choose to participate in PQRI via
the EHR-based reporting mechanism must use PQRI measure specifications
to do so. We believe use of these measure specifications, regardless of
the method by which quality data is submitted to PQRI for analysis,
ensures consistent use and reporting of the measures.
Comment: One commenter expressed concern that registry and EHR-
based reporting may not account for changes in patient condition over
the course of the reporting period, and suggested reporting options be
restructured so that results submitted using any method for a given
patient population and a specific time period are identical.
Response: Regardless of the reporting mechanism an eligible
professional selects to participate in PQRI, measure specifications and
instructions for reporting a measure are consistent across mechanisms.
If the measure specifications are analyzed properly by a registry or
EHR vendor, the results should be very close or identical to the
results for claims-based reporting, as the commenter requested.
Comment: Several commenters recommended uniform data submission
deadlines be established across all reporting mechanisms. The commenter
noted specifically that the proposed deadline for submission of data on
PQRI quality measures for EHR-based reporting and for registry
reporting was March 31, 2011 while the proposed deadline for submission
of data on PQRI quality measures for other reporting mechanisms was
February 28, 2011.
Response: We agree that the deadline for submission of data on PQRI
quality measures for EHR-based reporting should be consistent with the
deadline for submission of data on PQRI quality measures for claims-
based reporting. Therefore, eligible professionals participating in the
2010 PQRI via EHR reporting or claims reporting will be required to
submit all data on 2010 PQRI quality measures by no later than February
28, 2011 in order for the data to be included in the 2010 PQRI data
analysis. Whereas CMS receives the raw data elements from eligible
professionals for EHR and claims-based reporting and calculates the
eligible professionals' reporting and performance results, registries
must calculate and submit eligible professionals' quality measure
reporting and performance results to us. In implementing registry-based
reporting for the 2008 PQRI, we determined that a February deadline for
submission of data on PQRI quality measures would be insufficient for
registries to collect the data from their participants, calculate PQRI
quality measure results, and submit the quality measure results and
numerator and denominator data to CMS. Thus, registries are given
additional time beyond February 28, 2011, to submit their data on
behalf of participating eligible professionals. Eligible professionals
participating in the 2010 PQRI via registry reporting should check with
their selected registry regarding the registry's deadline for
submission of data on PQRI quality measures from eligible
professionals.
For the reasons discussed above and based on the comments received,
as well as our experience with the EHR testing process to date, we are
finalizing the option for an eligible professional to be able to choose
to report data on 2010 PQRI quality measures through claims, through a
qualified registry, or through a qualified EHR product (contingent on
there being a qualified 2010 EHR product). Depending on which PQRI
individual quality measures or measures groups an eligible professional
selects, however, one or more of the 2010 reporting mechanisms may not
be available for reporting a particular 2010 PQRI individual quality
measure or measures group. The 2010 reporting mechanism(s) through
which each 2010 PQRI individual quality measure and measures group can
be reported is identified in Tables 11 through 27 of this final rule
with comment period.
Regardless of the reporting mechanism chosen by an eligible
professional, there is no requirement for the eligible professional to
sign up or register to participate in the PQRI. However, there may be
some requirements for participation through a specific reporting
mechanism that are unique to that particular reporting mechanism. In
addition to the criteria for satisfactory reporting of individual
measures and measures groups described in sections II.G.2.e. and
II.G.2.f. of this final rule with comment period, eligible
professionals must ensure that they meet all requirements for their
chosen reporting mechanism as described in sections II.G.2.d.1. through
II.G.2.d.3. of this final rule.
(1) Final Requirements for Individual Eligible Professionals Who Choose
the Claims-Based Reporting Mechanism
For eligible professionals who choose to participate in the 2010
PQRI by submitting data on individual quality measures or measures
groups through the claims-based reporting mechanism, we proposed that
the eligible professional would be required to submit the appropriate
PQRI quality data codes on the professionals' Medicare Part B claims.
As in previous years, an eligible professional would be permitted to
start submitting the quality data codes for the eligible professional's
selected individual PQRI quality measures or measures group at any time
during 2010. Please note, however, that as required by section
1848(m)(1)(A) of the Act, all claims for services furnished between
January 1, 2010 and December 31, 2010, would need to be processed by no
later than February 28, 2011, to be included in the 2010 PQRI analysis.
We did not receive any comments specific to the requirements for
individual eligible professionals who choose claims-based reporting.
Therefore, we are finalizing the requirements as proposed. Eligible
professionals should refer to the ``2010 PQRI Implementation Guide'' to
facilitate satisfactory reporting of quality data codes for 2010 PQRI
individual measures on claims and to the ``Getting Started with 2010
PQRI Reporting of Measures Groups'' to facilitate satisfactory
reporting of quality data codes for 2010 PQRI measures groups on
claims. By no later than December 31, 2009, both of these documents
will be posted on the PQRI section of the CMS Web site at http://
www.cms.hhs.gov/pqri.
(2) Final Requirements for Individual Eligible Professionals Who Choose
the Registry-Based Reporting Mechanism
In order to report quality measures results and numerator and
denominator data on the 2010 PQRI individual quality measures or
measures group through a qualified clinical registry, we
[[Page 61796]]
proposed that eligible professionals would need to enter into and
maintain an appropriate legal arrangement with a qualified 2010 PQRI
registry. Such arrangements would provide for the registry's receipt of
patient-specific data from the eligible professional and the registry's
disclosure of quality measures results and numerator and denominator
data on PQRI quality measures or measures groups on behalf of the
eligible professional to CMS. Thus, the registry would act as a Health
Insurance Portability and Accountability Act of 1996 (Pub. L. 104-191)
(HIPAA) Business Associate and agent of the eligible professional. Such
agents are referred to as ``data submission vendors.'' The ``data
submission vendors'' would have the requisite legal authority to
provide clinical quality measures results and numerator and denominator
data on individual quality measures or measures groups on behalf of the
eligible professional for the PQRI. The registry, acting as a data
submission vendor, would submit CMS-defined registry-derived measures
information to the CMS designated database for the PQRI, using a CMS-
specified record layout. The record layout will be provided to the
registry by CMS.
To maintain compliance with applicable statutes and regulations,
our program and its data system must maintain compliance with the HIPAA
requirements for requesting, processing, storing, and transmitting
data. Eligible professionals that conduct HIPAA covered transactions
also would need to maintain compliance with the HIPAA requirements.
We proposed that eligible professionals choosing to participate in
PQRI by submitting quality measures results and numerator and
denominator data on PQRI individual quality measures or measures groups
through the registry-based reporting mechanism for 2010 would be
required to select a qualified PQRI registry and submit information on
PQRI individual quality measures or measures groups to the selected
registry in the form and manner and by the deadline specified by the
registry (74 FR 33562).
In addition to meeting the above proposed requirements specific to
registry-based reporting, we proposed that eligible professionals who
choose to participate in PQRI through the registry-based reporting
mechanism would need to meet the relevant criteria proposed for
satisfactory reporting of individual measures or measures groups that
all eligible professionals must meet in order to qualify to earn a 2010
PQRI incentive payment (74 FR 33563).
The following is a summary of the comments we received regarding
the proposed requirements for individual eligible professionals who
choose the registry-based reporting mechanism for the 2010 PQRI.
Comment: We received multiple comments requesting that we not wait
until the qualified 2009 registries successfully submit their 2009 PQRI
data to publish the list of qualified registries for 2010 PQRI.
Commenters suggested that approved registries and the vetting of the
self-nominated registries must occur earlier in the reporting year to
allow eligible providers time to review and select an appropriate
registry for their needs. A few commenters suggested that the list of
eligible registries be made available prior to the start of the
reporting period and one commenter recommended these registries be
announced at least one month prior to the reporting period. Another
commenter suggested the delay in listing qualified registries for 2010
PQRI would penalize 2009 qualified registries and could lead to an
unintended consequence of decreasing the number of participating
eligible professionals in 2010.
Response: We understand the concern posed by the commenters. We
make every effort to increase the likelihood of successful data
submission to PQRI on behalf of eligible professionals from qualified
registries. While we cannot guarantee that a qualified registry will be
able to send the quality measure data on behalf of their eligible
professionals, a thorough vetting process has been established in order
to qualify new registries. Part of this process includes determining
the success of the 2009 PQRI registries with respect to their data
submission. As in 2009, we are again requiring a self-nomination
process for registries wishing to submit quality measures results and
numerator and denominator data on 2010 PQRI quality measures or measure
groups on behalf of eligible professionals for services furnished
during the applicable reporting periods in 2010. Similar to previous
years, the 2010 PQRI registry self-nomination process is based on a
registry meeting specific technical and other requirements. While we
strive to announce the qualified 2010 registries in advance of our
target date, the selection process to determine qualified registries
for 2010 PQRI is time-consuming. We anticipate posting the complete
list of qualified 2010 registries as soon as we have completed vetting
the registries interested in participating in the 2010 PQRI and
identified the qualified registries for the 2010 PQRI. We expect to
post the qualified registries no later than Summer 2010. In an attempt
to address the commenters' requests, however, we do intend to post the
names of the successful 2008 registries who intend to continue their
participation in the 2010 PQRI. As stated in the CY 2010 PFS proposed
rule (74 FR 33562 through 33563), this initial list of 2010 qualified
registries will be available on the Web site by no later than December
31, 2009.
Comment: One commenter suggested we consider implementing a
registry submission process that allows registries to demonstrate the
recording and feedback of quality information, rather than go through a
cumbersome method to transform the data for submission to CMS. The
commenter noted that the current registry requirements appear to be
designed in a way that would allow registry data to be transformed to
claims data.
Response: We believe the commenter is reacting to the fact that the
PQRI originated as a claims-based quality reporting program and he or
she believes that registry requirements are still being designed to
allow registry data to be transformed to claims data. We do not require
registries to transform the quality data that they collect into a
claims data format, as such a requirement would be overly prescriptive.
In accordance with the registry qualifications set forth in section
II.G.2.d.4. of this final rule with comment period, registries may
collect and analyze data on PQRI measures and measures groups on behalf
of eligible professionals pursuing incentive payment for the 2010 PQRI
in any manner they deem appropriate for successful business operations.
Therefore, an eligible professional who chooses registry-based
reporting must submit data on PQRI quality measures or measures groups
in whatever manner that is required by his or her selected qualified
registry.
Comment: A commenter suggested that individual eligible
professionals and small practices be offered a mechanism by which
registry data could be cross-referenced with claims data to see if any
other provider has supplied the appropriate care. The commenter
remarked that this would allow eligible professionals to participate in
registry-based reporting even if they do not have access to the quality
information needed to report.
Response: The PQRI does not allow for one eligible professional's
data to be ``cross-referenced'' with other eligible professional's data
at the individual eligible professional level. This is however,
consistent with one of the benefits of the physician group option
[[Page 61797]]
method of PQRI reporting, which will start in 2010 and is discussed in
further detail in section II.G.2.g. of this final rule with comment
period. Satisfactory participation in PQRI for individuals looks at
reporting rates at the individual TIN/NPI level.
As a result of the comments, we are finalizing the requirements for
individual eligible professionals who choose the registry-based
reporting mechanism as proposed (74 FR 33562 through 33563) and
discussed above.
We will post on the PQRI section of the CMS Web site at http://www.cms.hhs.gov a list of qualified registries for the 2010 PQRI,
including the registry name, contact information, and the 2010
measure(s) and/or measures group(s) for which the registry is qualified
and intends to report. As proposed in the CY 2010 PFS proposed rule (74
FR 33562 through 33563), we will post the names of 2010 PQRI qualified
registries in 2 phases. In either event, even though a registry is
listed as ``qualified,'' we cannot guarantee or assume responsibility
for the registry's successful submission of PQRI quality measures
results and numerator and denominator data on PQRI quality measures or
measures groups on behalf of eligible professionals.
In the first phase, we will post, by December 31, 2009, a list of
those registries qualified for the 2010 PQRI based on: (1) Being a
qualified registry for the 2008 and 2009 PQRI that successfully
submitted 2008 PQRI quality measures results and numerator and
denominator data on the quality measures; (2) having received a letter
indicating their continued interest in being a PQRI registry for 2010;
and (3) the registry's compliance with the 2010 PQRI registry
requirements. By posting this first list of qualified registries for
the 2010 PQRI, we seek to make available the names of registries that
can be qualified at the start of the 2010 reporting period.
In the second phase, we will complete posting of the list of
qualified 2010 registries as soon as we have completed vetting the
additional registries interested in participating in the 2010 PQRI and
identified the qualified registries for the 2010 PQRI, which we
anticipate will be completed by no later than Summer 2010. An eligible
professional's ability to report PQRI quality measures results and
numerator and denominator data on PQRI quality measures or measures
groups using the registry-based reporting mechanism should not be
impacted by the complete list of qualified registries for the 2010 PQRI
being made available after the start of the reporting period. First,
registries will not begin submitting eligible professionals' PQRI
quality measures results and numerator and denominator data on the
quality measures or measures groups to CMS until 2011. Second, if an
eligible professional decides that he or she is no longer interested in
submitting quality measures results and numerator and denominator data
on PQRI individual quality measures or measures group through the
registry-based reporting mechanism after the complete list of qualified
registries becomes available, this does not preclude the eligible
professional from attempting to meet the criteria for satisfactory
reporting through another 2010 PQRI reporting mechanism.
The process and requirements that will be used to determine whether
a registry is qualified to submit quality measures results and
numerator data on PQRI quality measures or measures groups on an
eligible professional's behalf in 2010 are described in section
II.G.2.d.4. of this final rule with comment period.
(3) Requirements for Individual Eligible Professionals Who Choose the
EHR-Based Reporting Mechanism
For eligible professionals who choose to participate in the 2010
PQRI by submitting data on individual quality measures through the EHR-
based reporting mechanism, the requirements we proposed associated with
EHR-based reporting other than meeting the criteria for satisfactory
reporting of individual measures were to: (1) select a qualified EHR
product and (2) submit clinical quality data extracted from the EHR to
a CMS clinical data warehouse (74 FR 33563). Provided that our 2009 EHR
data submission testing process is successful, we proposed to begin
accepting submission of clinical quality data extracted from
``qualified'' EHRs on January 1, 2010, or as soon thereafter as is
technically feasible. We proposed that eligible professionals will have
until March 31, 2011, to complete data submission through qualified
EHRs for services furnished during the 2010 PQRI reporting period.
We did not propose any option to report measures groups through
EHR-based reporting on services furnished during 2010. Because EHR-
based reporting to CMS of data on quality measures would be new to PQRI
for 2010, we proposed, for EHR-based reporting, to make available only
the criteria applicable to reporting of individual PQRI measures. The
criteria applicable to reporting of measures groups were not proposed
to be available for EHR-based reporting for 2010.
The following is a summary of the comments we received regarding
the proposed requirements for individual eligible professionals who
choose the EHR-based reporting mechanism.
Comment: Some commenters urged CMS to conduct extensive education
and outreach prior to implementation of EHR reporting for PQRI.
Response: We agree that it is necessary to educate eligible
professionals regarding this new reporting mechanism prior to
implementation. We anticipate doing so through PQRI National Provider
Calls, or other CMS-sponsored calls, and through educational materials
to be posted on the PQRI section of CMS Web site once qualified EHR
vendors have been identified for the 2010 PQRI.
Comment: One commenter noted his or her expectation that the 2009
EHR Testing Program would be a success. Another commenter suggested we
include a discussion of the 2009 EHR submission testing experience in
this final rule.
Response: We appreciate the positive comment and anticipate the
ongoing 2009 EHR data submission testing process will be a success.
However, we have not completed the final beta test as of the writing of
this final rule with comment period and therefore, we are unable to
discuss the results of the testing process in this final rule with
comment period.
Comment: Many commenters supported further expanding reporting
mechanisms and moving forward with accepting quality measures data
through EHRs for the PQRI program. Several commenters were pleased with
our proposal to accept PQRI quality measure data extracted from
qualified EHRs in 2010 and one commenter urged us to quickly finalize
testing for the EHR-based reporting mechanism and allow participation
in 2010 PQRI through the use of qualified EHRs. One commenter indicated
the use of EHR data submission will result in the reporting of more
robust quality measures.
Response: We encourage the adoption and use of EHRs and are
appreciative of the commenters' support. We believe EHR-based reporting
will enhance the quality of PQRI data reported by eligible
professionals participating in the PQRI program and, compared to
claims-based reporting, will relieve some of the reporting burden on
eligible professionals.
Comment: One commenter remarked that all eligible professionals
should have the option to report measures through an EHR. Similarly,
another
[[Page 61798]]
commenter indicated opposition to the decision to limit EHR based
reporting initially to a narrow subset of the universe of approved
quality measures.
Response: We have selected 10 measures which can be reported from
an EHR in this initial phase of quality data reporting from EHRs for
PQRI. As we gain experience accepting quality measures data
electronically, we will evaluate the feasibility of expanding the list
of measures for which we have this capability.
Comment: A commenter suggested we allow hospital EHR systems to
qualify as a reporting method for PQRI, as some eligible professionals
are employed in a hospital facility which may be using an EHR (for
example, Registered Dietitians).
Response: To the extent that a hospital utilizes an EHR system that
is ``qualified'' for the 2010 PQRI, eligible professionals employed by
the hospital can participate in the 2010 PQRI by submitting PQRI
quality measures data extracted from the hospital's EHR system. We do
not place restrictions on who can self-nominate to have one or more of
their EHR products become qualified PQRI EHR products as long as the
vendor successfully completes the self-nomination process described in
section II.G.2.d.5. of this final rule with comment period.
Comment: One commenter concurred that we cannot assume
responsibility for the successful submission of data from an eligible
professional's EHRs.
Response: As discussed in the proposed rule (74 FR 33563), we
cannot assume responsibility for the successful submission of data from
any eligible professional's EHR. It is each EHR vendor's responsibility
to ensure that it has updated its EHR product(s) to facilitate PQRI
quality measures data submission.
Comment: One commenter recommended a more streamlined approach to
simplify the reporting criteria and time-periods for EHR users, by
allowing EHR users to report on all their patients throughout the year.
Response: For satisfactory PQRI reporting via a qualified EHR, we
are requiring all PQRI quality data to be submitted at one time. This
will allow us to finish the infrastructure development and will also
allow CMS and eligible professionals to avoid redundant reporting by
inadvertently submitting data previously reported. Also, we believe
one-time reporting is more convenient for eligible professionals.
Comment: One commenter commended CMS for acknowledging the Health
Information Technology for Economic and Clinical Health (HITECH) Act
and its focus on EHR implementation for incentive payments, meaningful
use, and quality reporting. Some commenters suggested that we align
initiatives in response to the health information technology (HIT)
incentives and with applicable provisions in the HITECH Act regarding
EHR certification requirements (that is, HITECH requires eligible
professionals to use certified technology) so that eligible
professionals can follow similar qualification and/or certification
requirements as they prepare for quality reporting for both PQRI and
the HITECH Act incentive programs. Another commenter remarked that EHR
systems may require reinstallation or significant maintenance/upgrades
to meet ``meaningful use'' criteria, which could potentially take
months to achieve. Coordinating reporting standards may help minimize
preparation and reporting requirements for program participants.
Another commenter suggested we advocate to the Certification Commission
of Health Information Technology for the inclusion of PQRI reporting
capabilities in the certification criteria.
Response: Any EHR quality data submission will be required to
comply with all current regulations regarding security and privacy.
``Meaningful use'' criteria will be reviewed as they are finalized and
we will endeavor to align our work in the future, as appropriate.
However, since meaningful use criteria have not yet been finalized,
this comment is currently beyond the scope of this final rule with
comment period.
Comment: One commenter remarked that an EHR is a tool that allows
physicians to improve work flow and efficiency by electronically
documenting data, however it does not, in all cases, have a quality
feedback loop for providers. One commenter recommended that we provide
back to the submitter, feedback on the extracted data that is received
and then that feedback should be provided back to the eligible
professional. The commenter also suggested we require that this process
include return receipt for the data content prior to scoring for PQRI
participation and calculation of incentive payment.
Response: With regard to a ``feedback loop,'' we note that the EHR
data submission process is such that the eligible professional will
know if the file he or she sent to us has been successfully submitted
and accepted. A file which is not accepted will be returned with an
error code. We note, however, that successful submission of a data file
does not indicate that the eligible professional met the criteria for
satisfactory reporting; it just indicates that we received the data
file that was sent to us.
As is the case for other eligible professionals participating in
PQRI, eligible professionals submitting their quality data through an
EHR will receive a feedback report from us that will be accessible in
the same manner as other feedback reports we provide for other
reporting mechanisms.
As a result of the comments and our experience thus far with the
ongoing 2009 EHR Testing Program, eligible professionals who choose the
EHR-based reporting mechanism for the 2010 PQRI will be required to (in
addition to meeting the criteria for satisfactory reporting of
individual measures):
Have a qualified EHR product;
Have an active IACS user account that will be used to
submit clinical quality data extracted from the EHR to a CMS clinical
data warehouse;
Submit a test file containing real or dummy clinical
quality data extracted from the EHR to a CMS clinical data warehouse
via IACS between July 1, 2010 and September 30, 2010 (if technically
feasible); and
Submit a file containing the eligible professional's 2010
PQRI clinical quality data extracted from the EHR for the entire
reporting period (that is January 1, 2010 through December 31, 2010)
via IACS between January 1, 2011 through February 28, 2011.
As stated above, however, the 2009 EHR Testing Program is still
ongoing. Since only EHR vendors that self-nominated to participate in
the 2009 EHR Testing Program and successfully complete the 2009 EHR
Testing Program will be considered qualified EHR vendors for the 2010
PQRI, there is no guarantee that there will be any qualified EHR
vendors available for the 2010 PQRI. In addition, as we complete the
2009 EHR Testing Program and are better able to determine what is
technically feasible, the actual dates on which eligible professionals
are required to submit their test files and/or to begin submitting the
actual 2010 PQRI data are subject to change.
As stated above, we also cannot assume responsibility for the
successful submission of data from eligible professionals' EHRs. Any
eligible professional who chooses to submit PQRI data extracted from an
EHR should contact the EHR product's vendor to determine if the product
is qualified and has been updated to facilitate PQRI quality measures
data submission. Such professionals also should begin attempting
submission soon after the opening of the clinical
[[Page 61799]]
data warehouse in order to assure the professional has a reasonable
period of time to work with his or her EHR and/or its vendor to correct
any problems that may complicate or preclude successful quality
measures data submission through that EHR. As we indicated above, data
submission for the 2010 PQRI will need to be completed by February 28,
2011.
The specifications for the electronic transmission of the 2010 PQRI
measures identified in Table 14 of this final rule as being available
for EHR-based reporting in 2010 are posted on Alternative Reporting
Mechanisms page of the PQRI section of the CMS Web site.
(4) Qualification Requirements for Registries
For the 2010 PQRI, we proposed to require a self-nomination process
for registries wishing to submit 2010 PQRI quality measures or measures
groups on behalf of eligible professionals for services furnished
during the applicable reporting periods in 2010 (74 FR 33563). The
proposed registry self-nomination process for the 2010 PQRI would be
based on a registry meeting specific technical and other requirements.
To be considered a qualified registry for purposes of submitting
individual quality measures and measures groups on behalf of eligible
professionals who choose to report using this reporting mechanism under
the 2010 PQRI, we proposed that a registry would need to:
Be in existence as of January 1, 2009;
Be able to collect all needed data elements and calculate
results for at least 3 measures in the 2010 PQRI program (according to
the posted 2010 PQRI Measure Specifications);
Be able to calculate and submit measure-level reporting
rates by TIN/NPI;
Be able to calculate and submit, by TIN/NPI, a performance
rate (that is, the percentage of a defined population who receive a
particular process of care or achieve a particular outcome) for each
measure on which the TIN/NPI reports;
Be able to separate out and report on Medicare Part B FFS
patients;
Provide the name of the registry;
Provide the reporting period start date the registry will
cover;
Provide the reporting period end date the registry will
cover;
Provide the measure numbers for the PQRI quality measures
on which the registry is reporting;
Provide the measure title for the PQRI quality measures on
which the registry is reporting;
Report the number of eligible instances (reporting
denominator);
Report the number of instances of quality service
performed (numerator);
Report the number of performance exclusions;
Report the number of reported instances, performance not
met (eligible professional receives credit for reporting, not for
performance);
Be able to transmit this data in a CMS-approved XML
format. We expect that this CMS-specified record layout will be
substantially the same as for the 2008 and 2009 PQRI. This layout will
be provided to registries in 2010;
Comply with a CMS-specified secure method for data
submission, such as submitting its data in an XML file through an IACS
user account;
Submit an acceptable ``validation strategy'' to CMS by
March 31, 2010. A validation strategy ascertains whether eligible
professionals have submitted accurately and on at least the minimum
number (80 percent) of their eligible patients, visits, procedures, or
episodes for a given measure. Acceptable validation strategies often
include such provisions as the registry being able to conduct random
sampling of their participants' data, but may also be based on other
credible means of verifying the accuracy of data content and
completeness of reporting or adherence to a required sampling method;
Enter into and maintain with its participating
professionals an appropriate Business Associate agreement that provides
for the registry's receipt of patient-specific data from the eligible
professionals, as well as the registry's disclosure of quality measure
results and numerator and denominator data on behalf of eligible
professionals who wish to participate in the PQRI program;
Obtain and keep on file signed documentation that each
holder of an NPI whose data are submitted to the registry has
authorized the registry to submit quality measures results and
numerator and denominator data to CMS for the purpose of PQRI
participation. This documentation must be obtained at the time the
eligible professional signs up with the registry to submit PQRI quality
measures data to the registry and must meet any applicable laws,
regulations, and contractual business associate agreements;
Provide CMS access (if requested) to review the Medicare
beneficiary data on which 2010 PQRI registry-based submissions are
founded;
Provide the reporting option (reporting period and
reporting criteria) that the eligible professional has satisfied or
chosen; and
Provide CMS a signed, written attestation statement via
mail or e-mail which states that the quality measure results and
numerator and denominator data provided to CMS are accurate and
complete (74 FR 33563 through 33564).
With respect to the submission of 2010 measure results and
numerator and denominator data on measures groups, we proposed to
retain in 2010 the following registry requirements from the 2009 PQRI:
Indicate the reporting period chosen for each eligible
professional who chooses to submit data on measures groups;
Base reported information on measures groups only on
patients to whom services were furnished during the 12-month reporting
period of January through December 2010 or the 6-month reporting period
of July 2010 through December 2010;
Agree that the registry's data may be inspected by CMS
under our oversight authority if non-Medicare patients are included in
the patient sample;
Be able to report data on all of the measures in a given
measures group and on either 30 patients from January 1 through
December 31, 2010 (note this patient sample must include some Medicare
Part B FFS beneficiaries) or on 80 percent of applicable Medicare Part
B FFS patients for each eligible professional (with a minimum of 15
patients during the January 1, 2010 through December 31, 2010 reporting
period or a minimum of 8 patients during the July 1, 2010 through
December 31, 2010 reporting period); and
Be able to report the number of Medicare FFS patients and
the number of Medicare Advantage patients that are included in the
patient sample for a given measures group (74 FR 33564).
In addition to the above requirements, we proposed the following
new requirements for registries for the 2010 PQRI:
Registries must have at least 25 participants;
Registries must provide at least 1 feedback report per
year to participating eligible professionals;
Registries must not be owned and managed by an individual
locally-owned single-specialty group (in other words, single-specialty
practices with only 1 practice location or solo practitioner practices
would be prohibited from self-nominating to become a qualified PQRI
registry);
Registries must participate in ongoing 2010 PQRI mandatory
support conference calls hosted by CMS
[[Page 61800]]
(approximately 1 call per month), including an in-person registry kick-
off meeting to be held at CMS headquarters in Baltimore, MD;
Registries must provide a flow and XML of a measure's
calculation process for each measure type that the registry intends to
calculate; and
Registries must use PQRI measure specifications to
calculate reporting or performance unless otherwise stated (74 FR
33654).
The following is summary of the comments we received regarding the
proposed qualification requirements and self-nomination process for
registries for the 2010 PQRI.
Comment: We received several comments supporting many of the
proposed qualification requirements for registries. A number of
commenters agreed with the proposed requirement that registries must
have a minimum of 25 participants. Similarly, one commenter remarked
that the rationale for restricting a single practice site or solo
practitioners from becoming a qualified registry is unclear and
suggested that such entities should not be prohibited from becoming a
qualified registry if they otherwise meet the requirements.
Response: We appreciate the supportive comments and believe that
the additional requirements will improve registry based reporting. We
limited registry participation to registries with at least 25
participants to conserve both CMS and eligible professionals'
resources. Every registry goes through a vetting process which includes
providing a sample measure flow illustrating how that registry will
calculate an example of each type of measure it plans to submit to CMS.
Additionally, registries must send in a sample XML file per the CMS
specifications. This process occurs over a 2-3 month period and
requires resources on the part of CMS, as well as the potential
registry. Finally, a mandatory in-person registry kick-off meeting is
held each year at CMS headquarters in Baltimore, MD. We believe the
time and expense for a solo practitioner or single practice site to go
through these steps would be prohibitive for most practitioners or
practice sites. We do not believe that a majority of solo practitioners
or single practice sites do not have the information technology (IT)
staffing and resources needed to successfully complete the vetting
process. Furthermore, we do not have the resources to provide IT
support to such entities.
Comment: Numerous commenters strongly supported the requirement for
registries to provide at least one feedback report per year to
participating eligible professionals. Several commenters suggested the
feedback reports from registries be issued to eligible professionals at
some point during the reporting year so as to allow practices to assess
their performance both on reporting and on performance, which may
inform and promote internal quality improvement. One commenter stated
providing eligible professionals with access to feedback reports during
the reporting year would allow more accurate assessment of their
performance before the close of the reporting period.
Response: We agree that the requirement for registries to provide
at least one feedback report per year is an essential tool for quality
improvement and must be provided to participating eligible
professionals. The information contained within feedback reports will
allow the eligible professional to assess the quality of care they
provided to their patients during the specific reporting timeframe of
the report. Furthermore the report may provide information for the
promotion of internal quality improvement. While we will not require
registries to provide more than the minimum number of feedback reports
per year (one) to participating eligible professionals, we would be
supportive of such a decision by a registry.
Comment: One commenter recommended we develop an audit program for
registry vendors, as the PQRI program moves away from claims-based
reporting. The commenter suggested eligible professionals participating
in the PQRI look to CMS for assurance that registry vendors are
regularly inspected for quality.
Response: As we gain more experience with registry submission, we
would expect to further specify through rulemaking qualification
requirements for registries that may include more comprehensive
validation requirements. As we evaluate our policies, we plan to
continue a dialogue with stakeholders to discuss opportunities for
program efficiency and flexibility.
As a result of the comments, we are finalizing the 2010
qualification requirements for registries as proposed (74 FR 33563
through 33565).
We will post the 2010 PQRI registry requirements, including the
exact date by which registries that wish to qualify for 2010 must
submit a self-nomination letter and instructions for submitting the
self-nomination letter, on the PQRI section of the CMS Web site at
http://www.cms.hhs.gov/PQRI by November 15, 2009. We anticipate that
new registries that wish to self-nominate for 2010 will be required to
do so by January 31, 2010.
We are finalizing our proposal (74 FR 33563 through 33565) that
registries that were ``qualified'' for 2009 and wish to continue to
participate in 2010 will not need to be ``re-qualified'' for 2010
unless they are unsuccessful at submitting 2009 PQRI data (that is,
fail to submit 2009 PQRI data per the 2009 PQRI registry requirements).
Registries that are ``qualified'' for 2009 and wish to continue to
participate in 2010 were required to indicate their desire to continue
participation for 2010 by submitting a letter to CMS indicating their
continued interest in being a PQRI registry for 2010 and their
compliance with the 2010 PQRI registry requirements by no later than
October 31, 2009. Instructions regarding the procedures for submitting
this letter were provided to qualified 2009 PQRI registries on the 2009
PQRI registry support conference calls.
If a qualified 2009 PQRI registry fails to submit 2009 PQRI data
per the 2009 PQRI registry requirements, the registry will be
considered unsuccessful at submitting 2009 PQRI data and will need to
go through the full self-nomination process again to participate in the
2010 PQRI. By March 31, 2010, registries that are unsuccessful
submitting quality measures results and numerator and denominator data
for 2009 will need to be able to meet the 2010 PQRI registry
requirements and go through the full vetting process again.
As stated in the proposed rule, the above registry requirements
will apply not only for the purpose of a registry qualifying to report
2010 PQRI quality measure results and numerator and denominator data on
PQRI individual quality measures or measures groups, but also for the
purpose of a registry qualifying to submit the proposed electronic
prescribing measure for the 2010 E-Prescribing Incentive Program (see
section II.G.5. of this final rule with comment period.
(5) Qualification Requirements for EHR Vendors and Their Products
As stated in the proposed rule (74 FR 33565), we proposed that EHR
products listed on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI as a ``qualified'' EHR product (that is, the name
of the vendor software product and the version that is qualified),
would be available for the product's users to submit quality data to
CMS directly from their system for the 2010 PQRI. We also proposed that
we would post this list of qualified EHR vendors and products upon
completion of the 2009 EHR Testing Program. We
[[Page 61801]]
anticipate the 2009 EHR Testing Program will be complete in early 2010.
Vendors' EHR products that are listed as ``qualified'' products
were selected because the vendor self-nominated to participate in the
2009 EHR Testing Program and demonstrated that their products met the
``Requirements for Electronic Health Record (EHR) Vendors to
Participate in the 2009 PQRI EHR Testing Program'' that were posted on
the Alternative Reporting Mechanisms page of the PQRI section of the
CMS Web site at http://www.cms.hhs.gov/PQRI/20_Reporting.asp#TopOfPage
on December 31, 2008. Additionally, a vendor's EHR system must be
updated according to the Draft 2010 EHR specifications posted on the
Alternative Reporting Mechanisms page of the PQRI section of the CMS
Web site in order for an EHR vendor and its product to be qualified to
submit information on 2010 PQRI measures.
As stated in the proposed rule (74 FR 33565), we proposed that the
EHR vendor requirements described above would apply not only for the
purpose of a vendor's EHR product being qualified for the purpose of
the product's users being able to submit data extracted from the EHR
for the 2010 PQRI, but also for the purpose of a vendor's EHR product
being qualified for the purpose of the product's users being able to
electronically submit data extracted from the EHR for the electronic
prescribing measure for the 2010 E-Prescribing Incentive Program.
The following is a summary of the comments received regarding the
proposed 2010 EHR vendor qualification requirements and/or process.
Comment: One commenter recommended we implement an ongoing
qualification process for new vendors and systems to enable inclusion
of vendors that did not self-nominate or did not exist prior to the
reporting year.
Response: Currently there is an ongoing qualification process for
new EHR vendors and their products. EHR vendors interested in enabling
their customers to submit data on PQRI that is extracted from their
customers' EHRs must complete the EHR vendor quality data submission
qualification process to be considered. For the 2010 PQRI, we will
consider those EHR vendors who successfully completed the 2009 EHR
Testing Program to be qualified for purposes of the 2010 PQRI. We will
list the vendors qualified for the 2010 PQRI on the PQRI section of the
CMS Web site upon completion of the 2009 PQRI EHR Testing Process. We
anticipate completing the 2009 PQRI EHR Testing Process in early 2010.
During 2010, we expect to use a similar self-nomination process
described in the ``Requirements for Electronic Heath Record (EHR)
Vendors to Participate in the 2009 PQRI EHR Testing Program'' posted on
the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/20_Reporting.asp#TopOfPage to qualify additional vendors for the 2011
PQRI. This document is subject to modification for the 2011 EHR self-
nomination process. In any case, a vendor must self-nominate no later
than January 31, 2010 to be eligible to participate in the 2011 PQRI
Testing Process in 2010. Sometime in 2010, those EHR products that meet
all of the EHR vendor requirements will be listed on the PQRI section
page of the CMS Web site at http://www.cms.hhs.gov/PQRI as a
``qualified'' EHR product, which indicates that the vendor's product's
users may submit quality data to CMS for the 2011 PQRI or subsequent
years.
Comment: Some commenters commended the establishment of electronic
standards for EHR-based reporting.
Response: We appreciate the supportive comments regarding the
establishment of standard qualification requirements for EHR reporting.
Comment: A few of commenters expressed concern regarding the
criteria set forth to rigidly define ``qualified'' EHRs. These concerns
stem from the fact that some EHR products are developed for health care
professionals specific to their needs (such as physical therapists,
oncologists, etc.). Another commenter remarked that vendors for
specialty-specific EHR products, such as oncology-specific EHR
products, should not have to adjust their software to comply with
certification procedures designed for a general ambulatory system. This
commenter stated that the goal of EHRs should be to contain
comprehensive information relevant to each patient's condition, their
treatment plan and outcomes, but in some cases, specific terminology
and data collection to support the eligible professional.
Response: We recognize that some EHR products have been designed to
accommodate specific specialties, however, we are unclear how this
would prevent the EHR product from meeting the EHR qualification
requirements other than that there are no measures available for
reporting via EHR. As we analyze the EHR reporting mechanism for 2010,
we will consider expanding the measures available for electronic
submission in the future.
Comment: One commenter recommended that we develop an audit program
for EHR vendors, as the PQRI moves away from claims-based reporting.
The commenter suggested eligible professionals participating in the
PQRI look to CMS for assurance that vendors are regularly inspected for
quality.
Response: Ensuring that vendors meet and perform properly would
fall under the purview of their certifying body, which is currently
CCHIT (if the product is CCHIT certified). During the qualification
process (in which we conduct testing to ensure that the EHR can extract
and transmit the necessary quality data elements), we evaluate the
vendor and their program to see if the system is capable of performing
the necessary tasks required for quality reporting to us for PQRI.
Comment: One commenter noted that some practitioners do not have
authority under state law to prescribe medications, and thus products
developed to meet the needs of these eligible professionals need not
incorporate electronic prescribing functionality at this time.
Response: We recognize the concerns cited by the commenter and note
that PQRI does not require qualified EHRs to have an electronic
prescribing module in order for eligible professionals to participate
in the PQRI via a qualified EHR. We believe the commenter is referring
to the idea of ``meaningful use'' with respect to requiring an
electronic prescribing module in the EHR system for purposes of the
HITECH Act incentive programs. The issue of ``meaningful use'' is
beyond the scope of this rule.
As previously stated above, only EHR vendors that self-nominated to
participate in the 2009 EHR Testing Program and successfully complete
the 2009 EHR Testing Program will be considered qualified EHR vendors
for the 2010 PQRI. There is no guarantee that there will be any
qualified EHR vendors available for the 2010 PQRI since the 2009 EHR
Testing Program is still ongoing.
During 2010, we expect to use the self-nomination process described
in the ``Requirements for Electronic Health Record (EHR) Vendors to
Participate in the 2009 PQRI EHR Testing Program'' posted on the PQRI
section of the CMS Web site at http://www.cms.hhs.gov/PQRI/20_AlternativeReportingMechanisms.asp#TopOfPage, to qualify additional EHR
vendors and their EHR products to submit quality data extracted from
their EHR products to the CMS clinical quality data warehouse for
program years after 2010. We anticipate that the requirements will be
similar to those used to qualify EHR products for
[[Page 61802]]
the 2009 PQRI EHR Testing Program, but they may be modified based on
the results of our 2009 EHR testing. Any updates to the EHR vendor
requirements, which would be based on our experience with the 2009 EHR
Testing Program and would be non-substantive in nature, will be made
December 15, 2009, and will be posted on the PQRI section of CMS Web
site at http://www.cms.hhs.gov/PQRI. As stated previously, any EHR
vendor interested in having one or more of their EHR products
``qualified'' to submit quality data extracted from their EHR products
to the CMS clinical quality data warehouse for 2011 and subsequent
years must submit their self-nomination letter by January 31, 2010.
Instructions for submitting the self-nomination letter will be provided
in the 2011 EHR vendor requirements. At the conclusion of this process,
those EHR products that meet all of the EHR vendor requirements will be
listed on the PQRI section of the CMS Web site as a ``qualified'' EHR
product, which indicates that the product's users may submit quality
data to CMS for the 2011 PQRI or subsequent years.
e. Criteria for Satisfactory Reporting of Individual Quality Measures
for Individual Eligible Professionals
As discussed in the proposed rule (74 33565 through 33568), for
years after 2009, section 1848(m)(3)(D) of the Act authorizes the
Secretary, in consultation with stakeholders and experts, to revise the
criteria for satisfactorily reporting data on quality measures. Based
on this authority and the input we have received from stakeholders via
the invitation to submit suggestions for the 2010 PQRI reporting
options posted on the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI in April 2009, we proposed 3 criteria for
satisfactory reporting of individual PQRI quality measures for 2010. In
an effort to continue to be consistent with the criteria of
satisfactory reporting used in prior PQRI program years, we proposed to
retain the following 2 criteria with respect to satisfactorily
reporting data on individual quality measures in circumstances where 3
or more individual quality measures apply to the services furnished by
an eligible professional:
Report on at least 3 2010 PQRI measures; and
Report each measure for at least 80 percent of the
eligible professional's Medicare Part B FFS patients for whom services
were furnished during the reporting period to which the measure
applies.
These criteria would apply to all 2010 PQRI reporting mechanisms
available for reporting individual PQRI quality measures.
If an eligible professional has fewer than 3 PQRI measures that
apply to the professional's services, then the professional would be
able to meet the criteria for satisfactorily reporting data on
individual quality measures by meeting the following 2 criteria:
Reporting on all measures that apply to the services
furnished by the professional (that is 1 to 2 measures); and
Reporting each measure for at least 80 percent of the
eligible professional's Medicare Part B FFS patients for whom services
were furnished during the reporting period to which the measure
applies.
We proposed that, as in previous years, these criteria for
satisfactorily reporting data on fewer than 3 individual quality
measures would be available for the claims-based reporting mechanism
only. An eligible professional who has fewer than 3 PQRI measures that
apply to the professional's services would not be able to meet the
criteria for satisfactory reporting by reporting on all applicable
measures (that is, 1 or 2 measures) through the registry-based or EHR-
based reporting mechanisms.
We also proposed that an eligible professional who reports on fewer
than 3 measures through the claims-based reporting mechanism in 2010
may be subject to the Measure Applicability Validation (MAV) process,
which allows us to determine whether an eligible professional should
have reported quality data codes for additional measures. When an
eligible professional reports on fewer than 3 measures, we proposed to
review whether there are other closely related measures (such as those
that share a common diagnosis or those that are representative of
services typically provided by a particular type of professional). If
an eligible professional who reports on fewer than 3 measures in 2010
reports on a measure that is part of an identified cluster of closely
related measures and did not report on any other measure that is part
of that identified cluster of closely related measures, then the
professional would not qualify to receive a 2010 PQRI incentive
payment. Additional information on the MAV process can be found on the
Analysis and Payment page of the PQRI section of the CMS Web site at
http://www.cms.hhs.gov/PQRI.
In addition to the above criteria related to the number of measures
on which an eligible professional would be required to report and the
frequency of reporting, we proposed a third criterion for satisfactory
reporting of individual measures. Based on our authority to revise the
criteria for satisfactory reporting under section 1848(m)(3)(D) of the
Act, we proposed (74 FR 33566) that an eligible professional also be
required to report data on at least one individual measure on a minimum
number of Medicare Part B FFS patients seen during the reporting
period, as detailed below.
Regardless of the reporting mechanism chosen by the eligible
professional, we proposed (74 FR 33567) that the minimum patient sample
size for reporting individual quality measures be 15 Medicare Part B
FFS patients for the 12-month reporting period. An eligible
professional would need to meet this minimum patient sample size
requirement for at least one measure on which the eligible professional
chooses to report. Similarly, for the 6-month reporting period (which
was proposed to be available for registry-based reporting only), we
proposed that the minimum patient sample size for reporting on
individual quality measures be 8 Medicare Part B FFS patients seen
during the 6-month reporting period. An eligible professional would
need to meet this minimum patient sample size requirement for at least
one measure on which the eligible professional chooses to report.
We solicited comments on the proposal to add a minimum patient
sample size criterion to the criteria for satisfactory reporting of
data on individual quality measures. In addition, we solicited comments
on the specific thresholds proposed for the 12-month reporting period
(which was proposed to be available for claims-based, registry-based,
and EHR-based reporting) and for the 6-month reporting period (which
was proposed to be available for registry-based reporting only) for
reporting individual quality measures.
The following is summary of the comments we received regarding the
criteria for satisfactory reporting of individual quality measures for
individual eligible professionals.
Comment: We received several comments supporting the proposed
minimum patient sample size requirement for PQRI reporting of
individual measures (that is, at least 15 patients for at least 1
measure for the 12-month reporting period and at least 8 patients for
at least 1 measure for the 6-month reporting period). A few commenters
supported the proposed minimum patient sample requirement
[[Page 61803]]
only if eligible professionals are required to meet the proposed
threshold(s) for only 1 measure on which they report. Many commenters
remarked that the minimum patient sample size requirement would
encourage eligible professionals to select more applicable measures
while discouraging eligible professionals from selectively reporting
measures that are not representative of the types of services they
normally provide in their practice. The commenters also remarked that
the minimum sample size requirements will enhance the scientific
validity of eligible professionals' performance results.
Response: We agree with the reasons cited by commenters for why the
minimum patient sample size requirement is important. However, analysis
of preliminary data from the 2008 PQRI indicates that a significant
number of eligible professionals who would otherwise meet the criteria
for satisfactory reporting would be adversely impacted by the addition
of a minimum patient sample size requirement to the criteria for
satisfactory reporting of individual measures by individual eligible
professionals. Therefore, we are not finalizing the proposed minimum
patient sample requirement. We will reconsider adding a minimum patient
sample requirement to the criteria for satisfactory reporting of
individual measures for future years upon further analysis of the PQRI
data.
Comment: We also received comments requesting that we withdraw the
proposed minimum patient sample requirement. The commenters were
concerned that this requirement would create a participation barrier
for certain eligible professionals, such as those who treat patients
with rare conditions, those with small practices, and/or those with
relatively few Medicare patients.
Response: For the reasons stated above and based on the commenters'
concerns that such a requirement would create participation barriers
for certain eligible professionals, we are not finalizing the proposed
minimum patient sample size requirement for the PQRI reporting options
for individual measures reporting. However, upon further analysis of
the PQRI data, we will reconsider adding a minimum patient sample
requirement to the criteria for satisfactory reporting of individual
measures and explore other means of enhancing the PQRI criteria for
satisfactory reporting for future years.
Comment: A majority of commenters believed that the proposed
minimum patient sample size thresholds were appropriate. Some
commenters, however, believed that the thresholds should be lowered to
10 or 15 for the 12-month reporting period and 6 for the 6-month
reporting period. Other commenters believed that the thresholds should
be higher, such as 25 or 30 for the 12-month reporting period.
Response: As stated previously, we are not finalizing the proposed
minimum patient sample size requirement for reporting of 2010 PQRI
individual measures. As we reassess this requirement for future years,
we anticipate that we will continue to monitor the PQRI data on an
ongoing basis and reassess the thresholds as needed for future years.
Comment: One commenter suggested that we reconsider allowing
registry-based reporting for fewer than 3 measures, primarily to
encourage eligible professionals to transition to registry-based
reporting, as the claims-based option becomes phased out. This option
may also allow greater flexibility for the program.
Response: We appreciate the intent of this comment, however, as in
previous years, satisfactorily reporting data on fewer than 3
individual quality measures will only be available for the claims-based
reporting mechanism. While we have received similar comments in the
past, we continue to believe that permitting an eligible professional
to report fewer than 3 measures through the registry-based reporting
mechanism, (if fewer than 3 measures apply to him or her) would be
inefficient at this time. Analytically it would be difficult to
implement in that if an eligible professional submits fewer than 3
measures via registries, we would not know whether the eligible
professional did so because only 2 measures applied to him or her or
because the registry only accepts data for 2 of the provider's measures
and he or she is reporting their third measure via claims. We also look
for the most favorable method of reporting (that is, did the eligible
professional report via a different method for a longer reporting
period as well as whether an eligible professional satisfactorily
reported under a different reporting option if he or she did not
satisfactorily report for a particular reporting option). Accepting
fewer than 3 measures from registries would increase the amount of
cross-checking already required and makes it impractical to implement
the commenter's suggestions at this time. Should the claims-based
reporting mechanism be removed entirely from the PQRI program at some
point in the future, we may revisit the issue of allowing registries to
submit data for eligible professionals on fewer than 3 measures.
Comment: One commenter remarked that limiting EHR-based reporting
to reporting on individual measures would limit the ability of some
eligible professionals to report on the measures most relevant to them
by eliminating one reporting mechanism (such as electronic reporting of
the back pain measures for spine care).
Response: The EHR reporting mechanism for PQRI is still in an early
development phase. This mechanism will be closely examined in the
future, and may be expanded as appropriate. We believe that the first
set of measures specified electronically have broad appeal in that they
deal with common conditions such as diabetes and prevention.
Comment: Some commenters recommended significant changes to the
criteria for satisfactory reporting that would not be consistent with
the criteria for satisfactory reporting for prior years. For example,
one commenter recommended that as the PQRI moves forward, the
definition of satisfactory reporting should not be determined by what
the commenter believed were somewhat arbitrary formulas but rather by
accurate data that is able to reflect the ways in which a provider
attempted to relay the quality of their patient care. Another commenter
recommended that CMS phase out the existing process by which
participating professionals select the measures on which they will be
report. Instead CMS should assign each participating individual
eligible professional with sets of measures for high volume conditions,
based on services provided to their patient population. Similarly,
another commenter recommended more criteria to guide measure selection
by eligible professionals and that we require eligible professionals to
report on 6 measures.
Response: We agree with commenters that as the PQRI matures, we
will need to reassess the criteria for satisfactory reporting so that
the information that we collect becomes more representative of the
quality of care provided by eligible professionals. We also generally
agree with the goals cited by the commenters, but have concerns that
the specific suggestions offered by the commenters are not
operationally practical and feasible when we take into account the vast
numbers of eligible professionals and the diversity of their practices.
In addition, we believe that such significant changes should occur
gradually. The criteria for satisfactory reporting are specifically
defined under section 1848(m)(3)(A) of the Act. With
[[Page 61804]]
the authority under section 1848(m)(3)(D) of the Act to revise the
criteria for satisfactory reporting for years after 2009, we have
started to move towards the direction recommended by commenters with
the introduction of the minimum patient sample size requirement for
individual measures reporting for the 2010 PQRI. In addition, the new
PQRI group practice reporting option also moves the PQRI towards the
direction recommended by commenters in that we assign participating
group practices both the measures and patients on which they are
required to report. We will consider additional changes to the criteria
for satisfactory reporting for 2011 and beyond and look forward to
receiving stakeholder input on how we can revise the criteria for
satisfactory reporting in an operationally practical and feasible
manner to achieve the goals cited by commenters.
Comment: One comment was received with respect to the MAV, which
allows us to determine whether an eligible professional should have
reported quality data codes for additional measures when an eligible
professional submits fewer than 3 individual PQRI measures. The
commenter requested that CMS provide updates on newly identified
clusters of closely related measures that will be employed in the MAV
for 2010.
Response: No changes are planned for the MAV process for 2010.
Additional information on the MAV process are listed on the Analysis
and Payment page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI. However, we are contemplating some changes to the
clusters of closely related measures based on the addition or removal
of measures in the 2010 PQRI or the fact that certain measures included
in these clusters will become registry-only measures for 2010. For
example, if measures in an existing cluster are retired for the 2010
PQRI or are made registry-only then the cluster will be revised or
deleted as appropriate.
Based on the new 2010 PQRI measures, the only new clusters being
contemplated are a second preventive cluster, 2 new anesthesia care
clusters, an ear care cluster, and an Ischemic Vascular (IVD) cluster.
The second preventive cluster would consist of the following 2
measures: (1) Measure 114 Preventive Care and Screening:
Inquiry Regarding Tobacco Use and (2) Measure 115 Preventive
Care and Screening: Advising Smokers and Tobacco Users to Quit. The
first anesthesia care cluster would consist of 2 measures: (1) Measure
30 Perioperative Care: Timely Administration of Prophylactic
Parenteral Antibiotics and (2) Measure 76 Prevention of
Catheter-Related Bloodstream Infections (CRBI): Central Venous Catheter
(CVC) Insertion Protocol. The second anesthesia care cluster would
consist of Measure 76 and the new Perioperative Temperature
Management measure. For both of the anesthesia care clusters, however,
the MAV would not apply if an eligible professional reports only
Measure 76. Measure 76 is a broadly applicable
measure that encompasses services often provided by eligible
professionals for whom Measure 30 and the Perioperative
Temperature Management measure do not apply such as intensivists,
hospitalists, internists, and emergency physicians. The ear care
cluster would consist of the 3 new referral for otologic evaluation
measures listed in Table 13 of this final rule. The IVD cluster would
consist of the following 4 new PQRI measures:
Ischemic Vascular Disease (IVD): Blood Pressure Management
Control;
Ischemic Vascular Disease (IVD): Complete Lipid Profile;
Ischemic Vascular Disease (IVD): Low Density Lipoprotein
(LDL-C) Control; and
Ischemic Vascular Disease (IVD): Use of Aspirin or Another
Anti-Thrombotic.
By no later than December 31, 2009, we will post the final MAV
process for 2010 and the final 2010 MAV clusters on the Analysis and
Payment page of the PQRI section of the CMS Web site at http://www.cms.hhs.gov/PQRI/25_AnalysisAndPayment.asp#TopOfPage.
After considering the comments and the new 6-month reporting period
for claims-based reporting of individual PQRI quality measures that we
are adding to the 2010 PQRI at the request of commenters, the final
2010 criteria for satisfactory reporting of data on individual PQRI
quality measures are summarized in Table 7 and are arranged by
reporting mechanism and reporting period. The criteria for satisfactory
reporting for claims-based reporting of individual PQRI quality
measures for the 6-month reporting period are consistent with the
criteria for satisfactory reporting of individual PQRI quality
measures.
For the 2010 PQRI, there are a total of 5 reporting options, or
ways, in which an eligible professional may meet the criteria for
satisfactory reporting on individual quality measures. Each reporting
option consists of the criteria for satisfactory reporting such data
and results on individual quality measures relevant to a given
reporting mechanism and reporting period. While eligible professionals
may potentially qualify as satisfactorily reporting individual quality
measures under more than one of the reporting criteria, reporting
mechanisms, and/or for more than one reporting period, only one
incentive payment will be made to an eligible professional based on the
longest reporting period for which the eligible professional
satisfactorily reports.
Table 7--2010 Criteria for Satisfactory Reporting of Data on Individual
PQRI Quality Measures, by Reporting Mechanism and Reporting Period
------------------------------------------------------------------------
Reporting mechanism Reporting criteria Reporting period
------------------------------------------------------------------------
Claims-based reporting........ Report at January 1, 2010-
least 3 PQRI December 31,
measures, or 1-2 2010.
measures if less
than 3 measures
apply to the
eligible
professional; and
Report each
measure for at least
80% of the eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measure
applies.
Claims-based reporting........ Report at July 1, 2010-
least 3 PQRI December 31,
measures, or 1-2 2010.
measures if less
than 3 measures
apply to the
eligible
professional; and
Report each
measure for at least
80% of the eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measure
applies.
Registry-based reporting...... Report at January 1, 2010-
least 3 PQRI December 31,
measures; and 2010.
[[Page 61805]]
Report each
measure for at least
80% of the eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measure
applies.
Registry-based reporting...... Report at July 1, 2010-
least 3 PQRI December 31,
measures; and 2010.
Report each
measure for at least
80% of the eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measure
applies.
EHR-based reporting........... Report at January 1, 2010-
least 3 PQRI December 31,
measures; and 2010.
Report each
measure for at least
80% of the eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measure
applies.
------------------------------------------------------------------------
f. Proposed Criteria for Satisfactory Reporting Measures Groups for
Individual Eligible Professionals
For the 2010 PQRI, we proposed 2 basic sets of criteria for
satisfactory reporting on a measures group (74 FR 33568). Both sets of
criteria would apply to the claims-based and registry-based reporting
mechanism. We did not propose to make the EHR-based reporting mechanism
available for reporting on measures groups in 2010.
The first set of proposed criteria, which we proposed to make
available for either the 12-month or 6-month reporting period in 2010,
would be consistent with the 2009 criteria for satisfactory reporting
of measures groups through registry-based reporting, which require the
reporting of at least 1 measures group for at least 80 percent of
patients to whom the measures group applies during the applicable
reporting period (with reporting required on a minimum number of
Medicare Part B FFS patients commensurate with the reporting period
duration). In the 2009 PQRI, there was a requirement under these
criteria to report each measures group on at least 30 Medicare Part B
FFS patients for the 12-month reporting period and at least 15 Medicare
Part B FFS patients for the 6-month reporting period for registry-based
reporting of measures groups. For the 2010 PQRI, we proposed to revise
the requirement by making these criteria applicable to both registry-
based and claims-based reporting and to change the number of Medicare
Part B FFS patients on which an eligible professional would be required
to report a measures group. We proposed to require an eligible
professional who chooses to report on measures groups based on
reporting on 80 percent of applicable patients to report on a minimum
of 15 Medicare Part B FFS patients for the 12-month reporting period
and a minimum of 8 Medicare Part B FFS patients for the 6-month
reporting period, regardless of whether the eligible professional
chooses to report the measures group through claims-based reporting or
registry-based reporting.
The second set of proposed criteria, which we proposed to make
available for the 12-month reporting period only, would be based on
reporting on a measures group on a specified minimum number of patients
(74 FR 33568). The second set of criteria would require reporting on at
least 1 measures group for at least 30 patients seen between January 1,
2010 and December 31, 2010 to whom the measures group applies. Unlike
the 2009 PQRI, which required that eligible professionals report on
consecutive patients (that is, patients seen in order, by date of
service), the 30 patients on which an eligible professional would need
to report a measures group for 2010 would not need to be consecutive
patients. The eligible professional would be able to report on any 30
unique patients seen during the reporting period to which the measures
group applies. As in previous years, we proposed that for 2010, the
patients, for claims-based reporting, would be limited to Medicare Part
B FFS patients. For registry-based reporting, however, we proposed that
the patients could include some, but not be exclusively, non-Medicare
Part B FFS patients.
We solicited comments on our proposal to make the criteria for
satisfactory reporting of measures groups more consistent with those
proposed for reporting individual measures, including our proposal to
revise the minimum sample size requirement related to satisfactory
reporting on measures group through the registry-based reporting
mechanism so that the criteria for satisfactory reporting of measures
groups, regardless of reporting mechanism, would be identical to those
proposed for reporting individual measures. We also solicited comments
on our proposal to allow eligible professionals to report on measures
groups on any 30 patients rather than a consecutive patient sample.
The following is summary of the comments we received regarding the
criteria for satisfactory reporting measures groups for individual
eligible professionals.
Comment: A few commenters agreed with the proposal to make the
criteria for satisfactory reporting of measures groups more consistent
with those proposed for reporting individual measures. One commenter
cited that doing so makes the program more accessible and improves the
commenter's ability to educate their members.
Response: We agree that making the criteria for satisfactory
reporting of measures groups more consistent with those proposed for
reporting individual measures should facilitate participation and
enhance education efforts. For the reasons cited in section II.G.2.e.
of this final rule with comment period, we are not finalizing our
proposal to add a minimum patient sample requirement to the criteria
for satisfactory reporting of individual measures. For the 2010 PQRI
criteria for satisfactory reporting of measures groups, however, we
will retain the minimum patient sample size requirement for those
eligible professionals who choose to report on measures groups based on
reporting on 80 percent of applicable patients and will finalize the
lower thresholds for the minimum patient sample size requirement
proposed for 2010.
Comment: We received numerous comments in support of our proposal
to allow eligible professionals to report on measures groups on any 30
patients rather than a consecutive patient sample.
Response: We appreciate the commenters' positive feedback and hope
that this change will make measures group reporting a more
[[Page 61806]]
attractive option for eligible professionals.
Comment: A few commenters were opposed to removing the requirement
that the 30 patients be consecutive. A few commenters expressed that
reporting of measures groups on consecutive patients reduces
opportunities for selectively reporting patients or cases with more
favorable results or would result in reporting on non-representative
patient samples. Another commenter suggested the CMS eliminate the
option of reporting on 30 patients through claims altogether or allow
eligible professionals to report on non-consecutive patients but
require a reporting period within which the 30 patients must be
selected.
Response: We believe that retaining the option to report on 30
patients provides an incentive to eligible professionals to consider
reporting measures groups instead of individual PQRI measures. As we
have stated previously, we believe that measures groups enable a more
comprehensive assessment of patient care for a given clinical condition
or focus by addressing several aspects of care for that particular
clinical condition or focus. Because we believe that measures groups
may often provide more meaningful information about the care being
furnished to Medicare beneficiaries than individual measures reported
in isolation, we would like to encourage measures group reporting where
possible.
With respect to commenters' concerns that removing the requirement
that eligible professionals report on 30 patients, we reiterate that we
believe that it would be difficult for eligible professionals to
selectively choose which patients to report on since they must report
on multiple measures for a given clinical condition or focus. We will,
however, continue to monitor the PQRI data to determine whether this
needs to be reassessed in future years.
Comment: We received some comments supporting the proposed
revisions to the minimum patient sample size requirement for PQRI
reporting of measures group (that is, reducing the thresholds from
reporting at least 30 patients for at least 1 measures group for the
12-month reporting period and at least 15 patients for at least 1
measures group for the 6-month reporting period to 15 and 8 patients,
respectively). Some commenters also remarked that the proposed
thresholds were reasonable and appropriate. One commenter, however,
remarked that the proposed thresholds were not adequate.
Response: We are finalizing the thresholds as proposed to provide
eligible professionals with fewer than 30 patients an opportunity to
report on PQRI measures groups for 2010. As identified in Table 8, the
new minimum patient sample size thresholds for measures groups
reporting for the 2010 PQRI will be 15 patients for at least 1 measures
group for the 12-month reporting period and 8 patients for at least 1
measures group for the 6-month reporting period.
As suggested by another commenter, however, we will continue to
monitor the PQRI data on an ongoing basis to determine whether the
criteria for satisfactory reporting of measures groups, including the
minimum patient sample size requirements, need to be re-evaluated for
future years.
After considering the comments and for the reasons discussed
previously, the final 2010 criteria for satisfactory reporting of data
on measures groups are summarized in Table 8 and are arranged by
reporting mechanism and reporting period. Accordingly, there are a
total of 6 reporting options, or ways in which an eligible professional
may meet the criteria for satisfactory reporting of measures groups for
the 2010 PQRI. Each reporting option consists of the criteria for
satisfactory reporting relevant to a given reporting mechanism and
reporting period. As stated previously, while eligible professionals
may potentially qualify as satisfactorily reporting on measures groups
under more than one of the reporting criteria, reporting mechanisms,
and/or for more than one reporting period, only one incentive payment
will be made to an eligible professional based on the longest reporting
period for which the eligible professional satisfactorily reports.
Similarly, an eligible professional could also potentially qualify for
the PQRI incentive payment by satisfactorily reporting both individual
measures and measures groups. However, only one incentive payment will
be made to the eligible professional based on the longest reporting
period for which the professional satisfactorily reports.
Table 8--2010 Criteria for Satisfactory Reporting on Measures Groups, by
Reporting Mechanism and Reporting Period
------------------------------------------------------------------------
Reporting mechanism Reporting criteria Reporting period
------------------------------------------------------------------------
Claims-based reporting........ Report at January 1, 2010--
least 1 PQRI December 31,
measures group; 2010.
Report each
measures group for
at least 30 Medicare
Part B FFS patients.
Claims-based reporting........ Report at January 1, 2010--
least 1 PQRI December 31,
measures group; 2010.
Report each
measures group for
at least 80% of the
eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measures
group applies; and
Report each
measures group on at
least 15 Medicare
Part B FFS patients
seen during the
reporting period to
which the measures
group applies.
Claims-based reporting........ Report at July 1, 2010-
least 1 PQRI December 31,
measures group; 2010.
Report each
measures group for
at least 80% of the
eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measures
group applies; and
Report each
measures group on at
least 8 Medicare
Part B FFS patients
seen during the
reporting period to
which the measures
group applies.
Registry-based reporting...... Report at January 1, 2010-
least 1 PQRI December 31,
measures group; 2010.
Report each
measures group for
at least 30
patients. Patients
may include, but may
not be exclusively,
non-Medicare Part B
FFS patients.
[[Page 61807]]
Registry-based reporting...... Report at January 1, 2010-
least 1 PQRI December 31,
measures group; 2010.
Report each
measures group for
at least 80% of the
eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measures
group applies; and
Report each
measures group on at
least 15 Medicare
Part B FFS patients
seen during the
reporting period to
which the measures
group applies.
Registry-based reporting...... Report at July 1, 2010-
least 1 PQRI December 31,
measures group; 2010.
Report each
measures group for
at least 80% of the
eligible
professional's
Medicare Part B FFS
patients seen during
the reporting period
to whom the measures
group applies; and
Report each
measures group on at
least 8 Medicare
Part B FFS patients
seen during the
reporting period to
which the measures
group applies.
------------------------------------------------------------------------
g. Reporting Option for Satisfactory Reporting on Quality Measures by
Group Practices
As discussed above, for 2010, incentive payments will be available
to group practices based on the determination that the group practice,
as a whole (that is, for the TIN), satisfactorily reports on PQRI
quality measures for 2010. If, however, an individual eligible
professional is affiliated with a group practice participating in the
group practice reporting option and the group practice satisfactorily
reports under the group practice reporting option, the eligible
professional will not be eligible to earn a separate PQRI incentive
payment for 2010 on the basis of his or her satisfactorily reporting
PQRI quality measures data at the individual level under that same TIN
(that is, for the same TIN/NPI combination).
(1) Definition of ``Group Practice''
As stated in the proposed rule (74 FR 33570), section
1848(m)(3)(C)(i) of the Act authorizes the Secretary to define ``group
practice.'' For purposes of determining whether a group practice
satisfactorily submits PQRI quality measures data, we proposed that a
``group practice'' would consist of a physician group practice, as
defined by a single TIN, with at least 200 or more individual eligible
professionals (as identified by Individual NPIs) who have reassigned
their billing rights to the TIN. We solicited comments on the proposed
definition of ``group practice'' and our proposal to limit initial
implementation of the PQRI group practice reporting option in 2010 to
practices with 200 or more individual eligible professionals.
We also proposed to require group practices to complete a self-
nomination process and to meet certain technical and other requirements
in order to participate in the 2010 PQRI through the group practice
reporting option (74 FR 33570). Group practices interested in
participating in the 2010 PQRI through the group practice reporting
option would be required to submit a self-nomination letter to CMS
requesting to participate in the 2010 PQRI group practice reporting
option. The following is a summary of the comments received regarding
the proposed definition of ``group practice'' and the proposed self-
nomination requirements.
Comment: Several commenters requested that we consider allowing
smaller group practices to participate in this reporting option.
Commenters were concerned that defining a group practice as 200 or more
eligible professionals will lead to inaccurate data and further bias.
Commenters encouraged us to look for ways to make the option more
accessible for most group practices, including those that are not large
group practices. Commenters requested that we consider whether in the
future smaller group practice sizes should be allowed to participate in
this option. Commenters also requested an alternative reporting option
that uses statistical sampling for primary care oriented group
practices that report measures only applicable to primary care
physicians.
Response: We are appreciative of the commenters' thoughtful and
constructive feedback and will take these concerns into consideration
as we further develop the group practice reporting option. However, the
group practice reporting option draws from the experiences of the
Physician Group Practice (PGP) demonstration and the Medicare Care
Management Performance (MCMP) demonstration. Each of these
demonstrations included physician groups, but of different sizes. The
PGP demonstration, which the group practice reporting option
statistical sampling method is primarily modeled after, has been
successful. We recognize that the group practice size of 200 or more
individual eligible professionals limits participation. The inclusion
of smaller group practices that is those with less than 200 individual
eligible professionals, in the group practice reporting option was not
proposed at this time because we believe it is unlikely that the
smaller groups would be able to achieve 411 assigned Medicare
beneficiaries per disease module or preventive care measure that we use
under the demonstration. We will use this initial implementation year
to further develop and refine aspects of the group practice reporting
option and anticipate adapting and expanding this option to group
practices less than 200 individual eligible professionals in future
program years.
Comment: Several commenters were supportive of the group practice
reporting option and thought that the group level data would be more
meaningful. Commenters expressed that they are pleased to see the group
practice reporting option which has many benefits and that CMS has
taken a logical step of initially basing the group reporting process on
the PGP and MCMP demonstrations. A commenter stated that group practice
reporting option encourages voluntary reporting and promotes better
care coordination and a team-based approach to care. One commenter
suggested that the group practice reporting option reduces the
significant resources which practices currently need to report
measures. Another commenter stated the group
[[Page 61808]]
practice reporting option allows for increased provider participation
and greater transparency in the healthcare provided to Medicare
beneficiaries and suggested that the group practice reporting option
will bring greater attention to a range of important therapeutic areas.
Response: The group practice reporting option is based on certain
aspects of the PGP and the MCMP demonstrations. As defined, the group
practice reporting option is intended for large physician groups to
report on the high-cost chronic care quality measures for the specific
disease modules and preventive care.
Comment: A few commenters supported the proposal for public
reporting of group practices' performance results. One commenter,
however, did so with the caveat that CMS monitors the results to ensure
that there are no unintended consequences.
Response: We appreciate the commenters' positive feedback. As we
have stated previously, it is our desire to be able to move towards
public reporting of performance results for physicians and other
eligible professionals. We believe that public reporting of group
practice performance results provides an opportunity to move towards
achieving that goal with PQRI data.
Comment: Several commenters were opposed to public reporting of the
group practices' PQRI performance results because they believe:
The reporting process for group practices needs to be
further tested to ensure that there are no problems when we implement
this process into PQRI, that validity and accuracy of the measures as a
reflection of performance, and that there are no unintended
consequences;
CMS does not have specific authority from the Congress to
post performance results;
Doing so would be premature and discourage groups from
participating in this option;
Many issues identified in the CMS Issue Paper: Development
of a Plan to Transition to a Medicare Value-Based Purchasing Program
for Physician and Other Professional Services should be addressed prior
to public reporting of performance results. Once addressed, public
reporting of performance results should be conducted for all PQRI
participants, not just group practices;
For similar reasons, other commenters requested that we delay
public reporting of the group practices' performance results for at
least 1 year or wait until we are fully satisfied with the reliability
and validity of the performance data collected from group practices.
Response: Section 1848(m)(3)(C) of the Act requires us to establish
a process under which eligible professionals in a group practice shall
be treated as satisfactorily submitting data on PQRI quality measures
and provides the Secretary with the discretion to determine how to set
up this process. For group practices that choose to participate in the
PQRI, participation in the group practice reporting option is
voluntary. Group practices have a choice as to whether they wish to
participate in PQRI with each eligible professional in the group
participating individually using one of the reporting options available
to individual eligible professionals or to participate as a group
through the group practice reporting option.
Furthermore, we believe that public reporting of performance
information at the group level does not present some of the same issues
that public reporting of performance information at the individual
eligible professional would. For example, as we stated in the CY 2010
PFS proposed rule, no performance results would be calculated based on
small denominator sizes due to the reporting criteria for the group
practice reporting option, which require that group practices report
each disease module or preventive care measure under the group practice
reporting option for 411 patients. Nevertheless, we take note of the
importance of working through the concerns raised by commenters about
publicly posting groups' performance results, especially commenters'
concerns about doing so in the first year of implementation of the
group practice reporting option and the importance of giving
participating group practices an opportunity to review their results
from the first year of the group practice reporting option before any
information is publicly reported. Therefore, we are not finalizing our
proposal to require group practices that wish to utilize the group
practice reporting option in 2010 to agree to have their PQRI
performance results publicly reported. In addition, we will not report
any 2010 group practice performance results publicly except as
otherwise required by law and will limit public reporting of
information on the PQRI group practice reporting for 2010 to the
information required by section 1848(m)(5)(G)(i) of the Act (that is,
the names of group practices that satisfactorily submitted data on 2010
PQRI quality measures). Instead, we will consider implementing public
reporting of group practices' performance results in the 2011 PQRI
program year.
For the reasons discussed above and based on these comments, a
group practice, for purposes of finalizing the 2010 PQRI group practice
reporting option, a group practice will consist of a single TIN with at
least 200 or more individual eligible professionals (as identified by
Individual NPIs) who have reassigned their billing rights to the TIN.
Additionally, the TIN and all Individual NPIs must be established
Medicare providers.
To participate in the 2010 PQRI group practice reporting option, a
group practice will be required to submit a self-nomination letter
indicating the group practice's interest in participating in the 2010
PQRI group practice reporting option. Also, the letter must be
accompanied by an electronic file submitted in a format specified by
CMS (such as, a Microsoft Excel file) that includes the group
practice's TIN and the Individual NPI numbers, name of the group
practice, and names of all eligible professionals who will be
participating as part of the group practice (that is, all Individual
NPI numbers, which are established Medicare providers and associated
with the group practice's TIN), a single point of contact for handling
administrative issues as well as a single point of contact for
technical support purposes. In addition, the self-nomination letter
must also indicate the group practice's compliance with the following
requirements:
Have an active IACS user account;
Agree to attend and participate in all mandatory training
sessions; and
Have billed Medicare Part A and Part B on or after January
1, 2009 and prior to October 29, 2009.
The final participation requirements listed above for group
practices, including instructions for submitting the self-nomination
letter and other requested information, will be posted on the PQRI
section of the CMS Web site at http://www.cms.hhs.gov/PQRI by November
15, 2009. Group practices that wish to self-nominate for 2010 will be
required to do so by January 31, 2010. Upon receipt of the self-
nomination letters we will assess whether the participation
requirements were met by each self-nominated group practice using 2009
Medicare claims data.
As discussed further in section II.G.5. of this final rule,
participation in the E-Prescribing Incentive Program is voluntary for
group practices selected to participate in the PQRI group practice
reporting option. However, we are requiring group practices to
participate in the PQRI group practice reporting option in order to be
eligible to
[[Page 61809]]
participate in the electronic prescribing group practice reporting
option. Therefore, a group practice that wishes to participate in both
the PQRI group practice reporting option and the electronic prescribing
group practice reporting must notify CMS of its desire to do so at the
time that it self-nominates to participate in the PQRI group practice
reporting option.
(2) Process for Physician Group Practices to Participate as Group
Practices and Criteria for Satisfactory Reporting Data on Quality
Measures by Group Practices
For physician groups selected to participate in the PQRI group
practice reporting option for 2010, we proposed (74 FR 33570) the
reporting period would be the 12-month reporting period beginning
January 1, 2010. We proposed that group practices would be required to
submit information on these measures using a data collection tool based
on the data collection tool used in CMS' MCMP demonstration and the
quality measurement and reporting methods used in CMS' PGP
demonstration. We proposed that physician groups selected to
participate in the 2010 PQRI through the group practice reporting
option would be required to report on a common set of 26 NQF-endorsed
quality measures that are based on measures currently used in the MCMP
and/or PGP demonstration and that target high-cost chronic conditions
and preventive care.
As part of the data submission process, we proposed that, beginning
in 2011, each group practice would be required to report quality
measures with respect to services furnished during the 2010 reporting
period (that is, January 1, 2010 through December 31, 2010) on an
assigned sample of Medicare beneficiaries. We proposed to analyze the
January 1, 2010 through October 29, 2010 (that is, the last business
day of October 2010) National Claims History (NCH) file to assign
Medicare beneficiaries to each physician group practice using the same
patient assignment methodology used in the PGP demonstration.
We solicited comments on our proposal to adopt the PGP
demonstration's quality measurement and reporting methods for the PQRI
group practice reporting option. We specifically requested comments on
the proposed patient assignment methodology and our proposal to use a
data collection tool based on the one used in the MCMP demonstration as
the reporting mechanism for physician groups selected to participate in
the PQRI group practice reporting option.
We also proposed 2 criteria for satisfactory reporting of quality
measures by a physician group (74 FR 33571). First, the physician group
would be required to report completely on all of the proposed modules
and measures listed in Table 34 of the proposed rule (74 FR 33588).
Second, the physician group would be required to report completely on
the first 411 consecutively assigned and ranked Medicare beneficiaries
per disease module or preventive care measure.
The following is a summary of the comments we received regarding
the proposed reporting option for satisfactory reporting on quality
measures by group practices under PQRI.
Comment: One commenter was troubled by our proposal to model the
PQRI group practice reporting option on the PGP demonstration since
only half of PGP participants earned the incentive payment in the 3rd
year of the demonstration. Another commenter noted that transitioning
from individual eligible professional reporting to group practice
reporting and from pay-for-reporting to pay-for-performance are major
and challenging steps.
Response: Although we are planning to model the data collection and
sampling process for the PQRI group practice reporting option after the
PGP demonstration, we reiterate that the PQRI group practice reporting
option is distinct from the PGP demonstration. The requirements to
qualify for the incentive for PQRI are different from the requirements
to qualify for an incentive payment under the demonstration. Whereas
the PGP demonstration is a pay-for-performance demonstration, the PQRI
group practice reporting option, like the remainder of the PQRI
program, is solely a pay-for-reporting program. Group practices will
qualify for a PQRI incentive payment based on meeting the reporting
criteria. The PQRI incentive is not based on the group practice's
performance on the measures nor on cost savings.
Comment: Several Commenters were concerned with the proposed
patient assignment methodology. A few commenters asked CMS to
reconsider requirements in order to refine the attribution methodology.
One commenter opposed the retrospective attribution. One commenter
suggested that we limit the E/M visits to primary care physicians
selected other specialists, such as endocrinologists and cardiologists,
who frequently provide and coordinate care for Medicare beneficiaries.
Another commenter recommended the following refinements: (1) Use claims
that have the CPT code for ``established'' patients only; (2) use
claims that show the place of service code 11 (the code for office
visits); and (3) require that the patients have had at least two office
visits during the year in order to get into the sample.
Response: For the group practice reporting option, the patient
sample will be based on Medicare Part B claims submitted by the group
practices' TIN for services provided from January 1, 2010 through
October 29, 2010. Only claims appearing in CMS NCH by October 29, 2010,
will be considered in the patient sampling and assignment processes.
Patients will be assigned to the group practice if they receive the
plurality of their Office or Other Outpatient E/M services from the
practice. The assigned patients who are selected for quality reporting
must have received Office or Other Outpatient E/M services from the
practice at least two times in the 10-month period. Furthermore, part-
year and managed care patients will not be considered since we have
incomplete claims for these individuals and groups may not have had
sufficient time to impact the quality of their care. The retrospective
attribution will allow CMS to more accurately assign patients using
Medicare Part B claims that have been submitted by the group practices'
TIN and processed into the NCH.
Comment: One commenter stated that the eligible professionals'
affiliation with a group practice will dictate participation. A
commenter asked us to allow group practices the flexibility to decide
at any stage in the reporting process whether they want to continue
with the group reporting process.
Response: The group practice reporting option provides an
additional method of participating in PQRI. We do not dictate
participation in PQRI, nor do we dictate whether an eligible
professional participates in PQRI as an individual or as part of a
group. PQRI is a voluntary program. The decision to participate in PQRI
is at the discretion of the eligible professional. The eligible
professional may participate in PQRI under multiple unique TIN/NPI
combinations. An eligible professional may also report via more than
one reporting option. The eligible professional cannot, however,
receive a duplicate incentive payment for the same TIN/NPI combination.
The eligible professional can receive separate incentive payments
by participating and qualifying under one or more unique TIN/NPI
combinations. For example, if an eligible professional with TIN/NPI
003/001 participates in the group practice reporting option for one
practice and also participates as an
[[Page 61810]]
individual using TIN/NPI 005/001 the eligible professional can qualify
and earn a separate incentive payment for both TIN/NPI combinations
because this is under a different TIN/NPI combination. In the event
that a group practice is unsuccessful with the group practice reporting
option, we will not conduct analysis to determine if the TIN/NPI
qualified and is incentive eligible for other methods of PQRI
participation. There is no appeals process for PQRI.
Comment: One commenter asked that we provide a mechanism for
allowing group practices to deselect patients who have been assigned to
the group practice.
Response: We understand that due to circumstances out of the
groups' control (that is, death, unable to locate a medical record,
etc.) that the group practice may not be able to report completely on
100 percent of the first 411 consecutively ranked assigned patient
sample. The reporting tool allows for exclusions in certain instances
and the group will not be required to populate the tool when these
circumstances arise. In order to accommodate for such issues, each
group practice will be assigned an over sample of patients, which will
assure that the group practice reports completely on 411 consecutively
assigned patients per disease module and preventive care measure to
report on. The experience from the PGP demonstration has shown that
this sampling method provides a sufficient number of assigned patients
in the event that the deselection of assigned patients is warranted.
Comment: One commenter specifically supported using the Performance
Assessment Tool (PAT), which is the data collection tool used in the
PGP and MCMP demonstrations and proposed for use in PQRI group practice
reporting option. Another commenter supports using the PAT and applauds
quick turnaround time we anticipate for providing pre-populated results
to practices.
Response: We appreciate the commenters' support for the data
collection tool. We anticipate providing the selected group practices
with a pre-populated data collection tool. Data fields will be pre-
populated based on Medicare claims and demographic information for
dates of service between January 1, 2010 and October 29, 2010. This
tool will be modeled after the PAT currently in use for the MCMP
program, with some modifications. The tool will require, at a minimum,
standard PC image with Microsoft Office and Microsoft Access software
installed and minimum software configurations for the group practices
to successfully complete the data collection tool. The data collection
tool may potentially provide a high level feedback (submission) report
to the group practice, including such information as percentage of
patients that have been completed in the sample and percentage of
positive measure results. These features will allow the group practices
to verify data prior to submitting it to us. We reserve the right to
audit the data submitted by the group practices.
Comment: One commenter stated that only those group practices that
have participated in the PGP demonstration will be successful in
completing the tool and participating in the group practice reporting
option.
Response: Group practices participating in the PGP demonstration
will not be allowed to participate in the PQRI group practice reporting
option in 2010. We acknowledge that there will be a learning period
needed to become familiar with and to complete the tool. Group
practices that are selected to participate in the PQRI group practice
reporting option will be required to attend mandatory training
sessions. Prior to these mandatory training sessions, we anticipate
providing the group practices with a sample tool to become familiar
with its functionality and reporting process. Additionally, we may
establish periodic conference calls with the group practices, with most
calls being held during the tool data entry period, to provide
technical support to practices. The group practices will be required to
designate administrative and technical points of contact to streamline
and assist with communication.
Comment: One commenter stated that it would be challenging for
group practices to report on 26 measures.
Response: We disagree that it would be challenging for group
practices to report on 26 measures. We will be prepopulating the data
collection tool that will be used for the PQRI group practice reporting
option with claims and other demographic information on the group
practices' assigned Medicare beneficiaries prior to sending the data
collection tool to the groups to complete. Furthermore, we believe the
burden of reporting the 26 measures is outweighed by the potential
incentive payment. Completion of this data collection tool on all 26
measures for the required number of patients essentially qualifies the
group practice for an incentive payment equal to 2.0 percent of the
group practice's estimated total Medicare Part B PFS allowed charges
for services furnished during the reporting period.
For the reasons discussed above and after taking into consideration
the comments, we are finalizing the process group practices will be
required to use to report data on quality measures for the 2010 PQRI as
a group practice and the associated criteria for satisfactory reporting
of data on quality measures by group practices, which are summarized in
Table 9. Group practices participating in PQRI as a group practice will
be required to report on all of the measures listed in Table 28 of this
final rule with comment period. These quality measures are grouped into
preventive care measures and four disease modules: diabetes; heart
failure; coronary artery disease; and hypertension.
Although the process for physician groups to participate in PQRI as
a group practice incorporates some characteristics and methods from the
PGP demonstration and the MCMP demonstration, the PQRI group practice
reporting option is a separate program with its own specifications and
methodology from the PGP and MCMP demonstration programs. The reporting
process for the group practice reporting option, including the use of a
data collection tool as the reporting mechanism, will not be available
to individual eligible professionals participating in the 2010 PQRI.
As stated in the proposed rule (74 FR 33570 through 33571), we will
analyze the January 1, 2010 through October 29, 2010, NCH file to
assign Medicare beneficiaries to each physician group practice using
the same patient assignment methodology used in the PGP demonstration.
Assigned beneficiaries will be limited to those Medicare FFS
beneficiaries with Medicare Parts A and B for whom Medicare is the
primary payer. Assigned beneficiaries will not include Medicare
Advantage enrollees. A beneficiary will be assigned to the physician
group that provides the plurality of a beneficiary's office or other
outpatient E/M allowed charges (based on Medicare Part B claims
submitted for the beneficiary for dates of services between January 1,
2010 and October 29, 2010). Beneficiaries with only 1 visit to the
group practice between January 1, 2010 and October 29, 2010, will be
eliminated from the group practice's assigned patient sample. For
inclusion in the sample, beneficiaries will be required to have at
least 2 visits to the group practice between January 1, 2010 and
October 29, 2010.
Once the beneficiary assignment has been made for each physician
group
[[Page 61811]]
during the fourth quarter of 2010, we will provide each physician group
selected to participate in the group practice reporting option with
access to a database (that is, a data collection tool) that will
include the group's assigned beneficiary samples and the quality
measures listed in Table 28. We will prepopulate the data collection
tool with the assigned beneficiaries' demographic and utilization
information based on all of their Medicare claims data. We intend to
provide the selected physician groups with access to this prepopulated
database by no later than the first quarter of 2011. The physician
group will be required to populate the remaining data fields necessary
for capturing quality measure information on each of the assigned
beneficiaries. Numerators for each of the quality measures will include
all beneficiaries in the denominator population who also satisfy the
quality performance criteria for that measure. Denominators for each
quality measure will include a sample of the assigned beneficiaries who
meet the eligibility criteria for that disease module or each
preventive care quality measure. All of the assigned patients'
inpatient, outpatient, and physician claims will be used in determining
clinical eligibility for each module. Identical to the sampling method
used in the PGP demonstration, the random sample must consist of at
least 411 assigned beneficiaries. If the pool of eligible assigned
beneficiaries is less than 411, then the group practice must report on
100 percent, or all, of the assigned beneficiaries to satisfactorily
participate in the group practice reporting option. For each disease
module or preventive care measure, the physician group will be required
to report information on the assigned patients in the order in which
they appear in the group's sample (that is, consecutively).
Table 9--2010 Process for Physician Group Practices To Participate as
Group Practices and Criteria for Satisfactory Reporting of Data on
Quality Measures by Group Practices
------------------------------------------------------------------------
Reporting mechanism Reporting criteria Reporting period
------------------------------------------------------------------------
A pre-populated data Report on all January 1, 2010-
collection tool provided by measures included in December 31,
CMS. the data collection 2010.
tool (26 measures);
and
Complete the
tool for the first
411 consecutively
ranked and assigned
beneficiaries in the
order in which they
appear in the group's
sample for each
disease module or
preventive care
measure. If the pool
of eligible assigned
beneficiaries is less
than 411, then report
on 100% of assigned
beneficiaries.
------------------------------------------------------------------------
h. Statutory Requirements and Other Considerations for 2010 PQRI
Measures
(1) Statutory Requirements for 2010 PQRI Measures
As discussed in the proposed rule (74 FR 33571 through 33572), the
statutory requirements with respect to the use of quality measures for
the 2010 PQRI are different from the statutory requirements for
previous program years. For purposes of reporting data on quality
measures for covered professional services furnished during 2010 and
subsequent years for the PQRI, subject to the exception noted below,
section 1848(k)(2)(C)(i) of the Act, as added by MIPPA, requires that
the quality measures shall be such measures selected by the Secretary
from measures that have been endorsed by the entity with a contract
with the Secretary under subsection 1890(a) of the Act (that is, the
National Quality Forum, or NQF). In the case of a specified area or
medical topic determined appropriate by the Secretary for which a
feasible and practical measure has not been endorsed by the NQF,
however, section 1848(k)(2)(C)(ii) of the Act authorizes the Secretary
to specify a measure that is not so endorsed as long as due
consideration is given to measures that have been endorsed or adopted
by a consensus organization identified by the Secretary, such as the
AQA alliance.
Finally, section 1848(k)(2)(D) of the Act requires that for each
2010 PQRI quality measure, ``the Secretary shall ensure that eligible
professionals have the opportunity to provide input during the
development, endorsement, or selection of measures applicable to
services they furnish.''
(2) Other Considerations for Measures Selected for Inclusion in the
2010 PQRI
Based on the statutory requirements described above, we stated in
the CY 2010 PFS proposed rule (74 FR 33572 through 33573) that we
proposed to apply the following considerations with respect to the
selection of 2009 PQRI quality measures for inclusion in the 2010 PQRI
quality measure set:
Where some 2009 PQRI quality measures have been endorsed
by the NQF and others have not, those 2009 PQRI quality measures that
have been specifically considered by NQF for possible endorsement, but
NQF has declined to endorse it, will not be included in the 2010 PQRI
quality measure set (that is, we will retire the measure for 2010).
In circumstances where no NQF-endorsed measure is
available, we will exercise the exception under section 1848
(k)(2)(C)(ii) of the Act. Under these circumstances, a 2009 PQRI
quality measure that previously (that is, prior to January 31, 2009)
has been adopted by the AQA will meet the requirements under the Act
and it would be appropriate for eligible professionals to use the
measure to submit quality measures data and/or quality measures results
and numerator and denominator data on quality measures, as appropriate.
Although we are not including any 2009 PQRI measures that
have not been endorsed by the NQF or adopted by the AQA in the final
2010 PQRI quality measure set, we acknowledge that section
1848(k)(C)(ii) of the Act provides an exception to the requirement that
the Secretary select measures that have been endorsed by the entity
with a contract under section 1890(a) of the Act (that is, the NQF) as
long as an area or medical topic for which a feasible and practical
NQF-endorsed measure is not available has been identified and due
consideration has been given to measures that have been endorsed by the
NQF and/or, prior to January 31, 2009, adopted by the AQA.
The statutory requirements under section 1848(k)(2)(C) of
the Act, subject to the exception noted above, require only that the
measures be selected from measures that have been endorsed by the
entity with a contract with the Secretary under section 1890(a) (that
is, the NQF) and are silent with respect to how the measures that are
submitted to the NQF for endorsement were developed. The basic steps
for
[[Page 61812]]
developing measures applicable to physicians and other eligible
professionals prior to submission of the measures for endorsement may
be carried out by a variety of different organizations. We do not
believe there needs to be any special restrictions on the type or make
up of the organizations carrying out this basic development of
physician measures, such as restricting the initial development to
physician-controlled organizations. Any such restriction would unduly
limit the basic development of quality measures and the scope and
utility of measures that may be considered for endorsement as voluntary
consensus standards.
2009 PQRI measures that were part of the 2007 and/or 2008
PQRI in which the 2007 and 2008 PQRI analytics indicate a lack of
significant reporting and usage were not considered for inclusion in
the 2010 PQRI.
In addition to reviewing the 2009 PQRI measures and previously
retired measures, for purposes of developing the proposed 2010 PQRI
measures, we reviewed and considered measure suggestions including
comments received in response to the CY 2009 PFS proposed rule and
final rule with comment period. Additionally, suggestions and input
received through other venues, such as an invitation for measures
suggestions posted on the PQRI section of the CMS Web site in February
2009 were also reviewed and considered for purposes of our development
of the list of proposed 2010 PQRI quality measures. All measures and
measures groups reviewed for potential inclusion in the 2010 PQRI
measure set are listed in the ``Table of 2010 Measure Suggestions''
posted on the Statute/Regulations/Program Instructions page of the PQRI
section of the CMS Web site at http://www.cms.hhs.gov/PQRI/05_StatuteRegulationsProgramInstructions.asp#TopOfPage.
With respect to the selection of new measures (that is, measures
that have never been selected as part of a PQRI quality measure set for
2009 or any prior year), we stated in the CY 2010 PFS proposed rule (74
FR 33572 through 33573) that we would apply the following
considerations, which include many of the same considerations applied
to the selection of 2009 PQRI quality measures for inclusion in the
2010 PQRI quality measure set described above:
High Impact on Healthcare.
+ Measures that are high impact and support CMS and HHS priorities
for improved quality and efficiency of care for Medicare beneficiaries.
These current and long term priority topics include: prevention;
chronic conditions; high cost and high volume conditions; elimination
of health disparities; healthcare-associated infections and other
conditions; improved care coordination; improved efficiency; improved
patient and family experience of care; improved end-of-life/palliative
care; effective management of acute and chronic episodes of care;
reduced unwarranted geographic variation in quality and efficiency; and
adoption and use of interoperable HIT.
+ Measures that are included in, or facilitate alignment with,
other Medicare, Medicaid, and CHIP programs in furtherance of
overarching healthcare goals.
NQF Endorsement.
+ Measures must be NQF-endorsed by July 1, 2009, in order to be
considered for inclusion in the 2010 PQRI quality measure set.
+ Although we did not propose to include any new measures that were
not endorsed by the NQF by July 1, 2009 in the final 2010 PQRI quality
measure set, we acknowledge that section(k)(2)(C)(ii) of the Act
provides an exception to the requirement that the Secretary select
measures that have been endorsed by the entity with a contract under
section 1890(a) of the Act (that is, the NQF). As long as an area or
medical topic for which a feasible and practical NQF-endorsed measure
is not available has been identified and due consideration has been
given to measures that have been adopted by the AQA or other consensus
organization identified by the Secretary.
+ The statutory requirements under section 1848(k)(2)(C) of the
Act, subject to the exception noted above, require only that the
measures be selected from measures that have been endorsed by the
entity with a contract with the Secretary under section 1890(a) (that
is, the NQF) and are silent with respect to how the measures that are
submitted to the NQF for endorsement were developed. The basic steps
for developing measures applicable to physicians and other eligible
professionals prior to submission of the measures for endorsement may
be carried out by a variety of different organizations. We do not
believe there needs to be any special restrictions on the type or make
up of the organizations carrying out this basic development of
physician measures, such as restricting the initial development to
physician-controlled organizations. Any such restriction would unduly
limit the basic development of quality measures and the scope and
utility of measures that may be considered for endorsement as voluntary
consensus standards. The requirements under section 1848(k)(2)(C) of
the Act pertain only to the selection of measures and not to the
development of measures.
Address Gaps in PQRI Measure Set.
+ Measures that increase the scope of applicability of the PQRI
measures to services furnished to Medicare beneficiaries and expand
opportunities for eligible professionals to participate in PQRI. We
seek to achieve broad ability to assess the quality of care furnished
to Medicare beneficiaries, and ultimately to compare performance among
professionals. We seek to increase the circumstances where eligible
professionals have at least three measures applicable to their practice
and measures that help expand the number of measures groups with at
least four measures in a group.
+ Measures of various aspects of clinical quality including outcome
measures, where appropriate and feasible, process measures, structural
measures, efficiency measures, and measures of patient experience of
care.
Other considerations that we proposed to apply to the selection of
measures for 2010, regardless of whether the measure is a 2009 PQRI
measure or not, were:
Measures that are functional, which is to say measures
that can be technically implemented within the capacity of the CMS
infrastructure for data collection, analysis, and calculation of
reporting and performance rates. This leads to preference for measures
that reflect readiness for implementation, such as those that are
currently in the 2009 PQRI program or have been through testing. The
purpose of measure testing is to reveal the measure's strengths and
weaknesses so that the limitations can be addressed and the measure
refined and strengthened prior to implementation. For new measures,
preference is given to those that can be most efficiently implemented
for data collection and submission. Therefore, any measures that have
been found to be technically impractical to report because they are
analytically challenging due to any number of factors, including those
that are claims-based, have not been included in the 2010 PQRI. For
example, in some cases, we are replacing existing 2009 PQRI measures
with updated and improved measures that are less technically
challenging to report.
For some measures that are useful, but where data
submission is not feasible through all otherwise available PQRI
reporting mechanisms, a measure may be included for reporting solely
through specific reporting mechanism(s)
[[Page 61813]]
in which its submission is feasible. For example, we proposed to limit
reporting of some measures that previously were available for claims-
based reporting and registry-based reporting to registry-based
reporting only because they were technically challenging to report and/
or analyze through the claims-based reporting mechanism (74 FR 33579
through 33580).
We also reviewed 33 measures that have been retired from the PQRI
in previous years using the considerations for selecting measures for
the 2010 PQRI discussed above (74 FR 33573). None were found to be
eligible for inclusion in the 2010 PQRI quality measure set because
they did not meet the criteria described above.
We solicited comments on the implication of including or excluding
any given measure or measures in the final 2010 PQRI quality measure
set and to our approach in selecting measures. As we stated in the
proposed rule, we recognize that some commenters may also wish to
recommend additional measures for inclusion in the 2010 PQRI measures
that we did not propose (74 FR 33573). While we may consider such
recommended measures for inclusion in future measure sets for PQRI and/
or other programs to which such measures may be relevant, we will not
be able to consider such additional measures for inclusion in the 2010
measure set.
(3) Summary of Comments and Responses
The following is a summary of the comments we received regarding
the statutory requirements and other considerations for the selection
of 2010 PQRI measures.
Comment: Some commenters appreciated our continued efforts to
expand the PQRI quality measure set with measures that are
scientifically valid and minimize eligible professional burden. In
order to promote the provisions that reflect up-to-date care for
beneficiaries as the program matures, these commenters urged us to
revise its quality measures regularly to reflect current guidelines.
Response: We appreciate these supportive comments regarding our
continued efforts to expand the PQRI quality measure set. As the
program evolves, we will continue to consider more effective processes
to update and/or revise the PQRI quality measure set to reflect the
most current guidelines of care.
Comment: Several commenters supported our proposal to only use
quality measures that have been endorsed by the NQF, thereby ensuring a
rigorous evaluation of the measures by multiple stakeholders and
providing an opportunity for public comment from those various
stakeholders. These commenters suggested the utilization of NQF
endorsed measures reflect areas that are common to providers, allow for
appropriate measurement of services provided in Medicare, and provide a
thorough standardized review framework. One commenter, however, was
unclear whether NQF or consensus organization endorsement or adoption
is required for all suggested measures for 2010 or 2011 or whether the
Secretary can suggest measures of her own accord when measures do not
already exist with this endorsement.
Response: We appreciate the commenters' supportive feedback and
agree with the points raised by the commenters with respect to the
benefits of NQF endorsement. As we stated above, subject to the
exception under section 1848(k)(2)(C)(ii) of the Act, measures selected
for the 2010 PQRI are required by section 1848(k)(2)(C)(i) of the Act
to be endorsed by Secretary. Section 1848(k)(2)(C)(ii) of the Act
authorizes us to select measures for the 2010 PQRI and subsequent years
that have not been endorsed by the NQF in a specified area or medical
topic for which a feasible and practical measure has not been so
endorsed as long as we give due to consideration to measures that have
been endorsed or adopted by other consensus organizations identified by
the Secretary.
Comment: One commenter notes that the proposed rule makes allowance
for measures used in the 2009 PQRI that have not been endorsed by the
NQF but were previously approved by the AQA. The commenter believes
that for new measures, NQF endorsement should be a requirement not only
for the PQRI measures but also for measures for the hospital outpatient
quality data reporting program, or HOP QDRP. While the underlying
statutes for both reporting programs differ, the commenter believes CMS
has the discretion to adopt a consistent policy with respect to NQF
endorsement.
Response: As discussed previously, the requirements for measures
selected for the PQRI are defined in statute. The requirements for
other quality data reporting programs are beyond the scope of this
rule.
Comment: Some commenters recommended that we require NQF
endorsement not only of individual measures, but also NQF endorsement
of measures groups.
Response: When we create measures groups, we only utilize
individual measures that meet statutory requirements. All measures in
current measures groups meet the statutory requirements. We are unaware
of any efforts by NQF to review groups of measures for separate
endorsement. Section 1848(m)(5)(F) of the Act required us to establish
alternative criteria for satisfactorily reporting and alternative
reporting periods for reporting groups of measures for 2008 and
subsequent years but did not establish any additional limitations on
the discretion of the Secretary.
Comment: Some commenters urged us to recognize additional consensus
organizations to endorse quality measures for the PQRI. The commenters
suggested we recognize measure development organizations such as the
American Medical Association's Physician Consortium for Performance
Improvement (AMA-PCPI) or the National Committee for Quality Assurance
(NCQA) as consensus endorsement organizations.
Response: MIPPA modified the requirements for measure selection by
the Secretary for PQRI as previously described. Further, as we stated
in response to similar comments in previous years, we are unaware of
other consensus organizations that are comparable to the NQF in terms
of meeting the formal requirements of the NTTAA or of organizations
other than AQA that do not strictly meet the requirements of the
National Institute of Standards and Technology Act (NISTA), as amended
by the NTTAA but that feature the breadth of stakeholder involvement in
the consensus process necessary to meet the intent of the Act.
Comment: One commenter suggested that the measure development
process should not be restricted to physician-controlled organizations
but that the measure development process must include relevant
physician input due to their expertise in the subject areas.
Response: We are in agreement that while physician expertise is an
important ingredient in measure development and in the consensus
process, physicians should not be in complete control of the process of
measure development. Any such restriction would unduly limit the basic
development of physician quality measures.
Comment: A few commenters did not believe that endorsement or
adoption by the NQF or the AQA, respectively, was a necessary condition
for inclusion of a measure in the PQRI for 2010 or subsequent years.
One commenter urged us to use measures from other nationally recognized
sources in areas for which NQF-endorsed measures are not available on
the condition that the
[[Page 61814]]
measures are expedited through the NQF endorsement process.
Response: We agree that NQF endorsement or AQA adoption is not a
necessary condition for all measures included in the PQRI quality
measure set. As stated previously, section 1848(k)(2)(C)(ii) of the Act
does permit us to select measures for the 2010 PQRI and subsequent
years that have not been endorsed by the NQF in a specified area or
medical topic for which a feasible and practical measure has not been
so endorsed as long as we give due consideration to measures that have
been endorsed or adopted by other consensus organizations identified by
the Secretary.
We proposed to exercise this authority for 2010 in the CY 2010 PFS
proposed rule (74 FR 33576 through 33579) by proposing to include in
the 2010 PQRI several 2009 PQRI measures that had not yet achieved NQF
endorsement but that were AQA adopted. As we stated in the proposed
rule, we would include such measures in the 2010 PQRI as long as a
measure had not been reviewed by the NQF prior to July 1, 2009 and
specifically declined for endorsement.
We are also exercising this authority with respect to our decision
to finalize 3 proposed new measures (that is, Referral for Otologic
Evaluation for Patients with Congenital or Traumatic Deformity of the
Ear; Referral for Otologic Evaluation for Patients with History of
Active Drainage from the Ear within the Previous 90 days; and Referral
for Otologic Evaluation for Patients with History of Sudden or Rapidly
Progressive Hearing Loss) that were neither NQF endorsed prior to July
1, 2009 nor AQA adopted prior to January 31, 2009. We decided to
finalize these 3 measures despite the lack of consensus endorsement or
adoption due to the lack of measures available for audiologists to
report on. Audiologists are a new a category of eligible professionals
that were added to the list of professionals eligible to participate in
the PQRI beginning with the 2009 PQRI.
We stress, however, that inclusion of measures that are not NQF
endorsed or AQA adopted is an exception to the requirement under
section 1848(k)(2)(C)(i) of the Act that measures be endorsed by the
NQF. Therefore, we do believe that this exception authority should be
exercised in very limited circumstances, such as when few or no
measures are available for a particular specialty or category of
eligible professionals to report.
Comment: Several commenters suggested what the PQRI quality measure
set should focus on and how the PQRI quality measure set should evolve.
One commenter believes the PQRI quality measure set should evolve with
the development of better clinical evidence and a greater understanding
of the benefit-cost tradeoffs of particular services and treatments.
Another commenter urged us to adopt quality measures that would address
the existing gaps in quality and that focus on services with the
potential to deliver high value to Medicare beneficiaries and to avoid
services that may have little or no value to beneficiaries, such as
high-cost or high-volume services. One commenter suggested additional
criteria that should be utilized in the selection of measures, which
include selecting: (1) More outcome and resource use measures; (2) care
coordination measures; (3) measures addressing appropriateness of care
which deliver high value to Medicare patients; (4) measures that allow
for assessing and reporting on disparities of care. Some commenters
also believe the measures selected for PQRI should not reward eligible
professionals for providing marginally effective care or care that is
already routinely furnished.
Response: In the 2010 PFS proposed rule, we listed the
considerations that we applied for the selection of proposed 2010 PQRI
quality measures. As described above, many of these considerations
reflect the commenters' suggestions, particularly our focus on:
Measures with high impact on healthcare.
Measures that support CMS and HHS priorities for improved
quality and efficiency of care for Medicare beneficiaries (such as,
prevention; chronic conditions; high cost and high volume conditions;
elimination of health disparities; healthcare-associated infections and
other conditions; improved care coordination; improved efficiency;
improved patient and family experience of care; improved end-of-life/
palliative care; effective management of acute and chronic episodes of
care; reduced unwarranted geographic variation in quality and
efficiency; and adoption and use of interoperable HIT).
Measures that are included in, or facilitate alignment
with, other Medicare, Medicaid, and CHIP programs in furtherance of
overarching healthcare goals.
Measures that address gaps in the PQRI measure set in
order to increase the scope of applicability of the PQRI measures to
services furnished to Medicare beneficiaries and expand opportunities
for eligible professionals to participate in PQRI.
Comment: Some commenters encouraged us to identify and add more
quality measures and to develop interim opportunities for eligible
professionals that have a dearth of available measures to participate
in PQRI. One commenter specifically recommended that we expand the
number of measures to reflect all types of services provided to all
beneficiaries.
Response: Despite our efforts to expand the PQRI quality measure
set to increase the scope of applicability of the PQRI measures to
services furnished to Medicare beneficiaries and expand opportunities
for eligible professionals to participate in PQRI, we are aware that
there remains some gaps in the PQRI quality measure set. However, we
largely depend on the development of measures by professional
organizations and other measure developers. Although we had significant
involvement in the development of measures applicable to eligible
professionals at the start of the PQRI, ideally we would not need to be
closely involved in the development of clinician-level quality measures
but would select from measures that meet the statutory requirements.
Thus, we encourage professional organizations and other measure
developers to fund and develop measures that address some of the gaps
identified by the commenters.
Comment: Some commenters recommended we utilize data from previous
reporting periods to determine the appropriateness and effectiveness of
the measures. The commenters recommended that we continually evaluate
and revise the criteria for measure selection to ensure measures align
with clinical practice and can be reported with minimal administrative
burden.
Response: We will continue to evaluate data from previous reporting
periods to assess the appropriateness and effectiveness of the PQRI
measures. We will also continue to work with measure developers to urge
alignment of the PQRI measures with clinical practice as the program
evolves and matures.
i. The Final 2010 PQRI Quality Measures for Individual Eligible
Professionals
For 2010, we proposed that final PQRI quality measures would be
selected from 153 of the 2009 PQRI measures and the measures listed in
the ``Table of 2010 Measure Suggestions'' posted on the Statute/
Regulations/Program Instructions page of the PQRI section of the CMS
Web site at http://www.cms.hhs.gov/PQRI/05_
StatuteRegulationsProgramInstructions.asp#
[[Page 61815]]
TopOfPage. We proposed to include a total of 176 measures (this
includes both individual measures and measures that are part of a
proposed 2010 measures group) on which individual eligible
professionals can report for the 2010 PQRI (74 FR 33574 through 33587,
and 39032). In addition, we proposed to retire 7 measures because they
did not meet one or more of the considerations for selection of
proposed 2010 measures (74 FR 33574). In addition we proposed 13
measures groups for the 2010 PQRI (74 FR 33582 through 33587).
The following is a summary of the comments received on the 2010
PQRI measures in general and comments on the measures from the 2009
PQRI not proposed for inclusion in the 2010 PQRI, which are addressed
below. Comments specific to measures proposed for inclusion in the 2010
PQRI are addressed in sections II.G.2.i.1. through II.G.2.i.5. below.
Comment: Several commenters requested or recommended that we make
readily available on an ongoing basis more detailed information on the
measure development process and on measures in development.
Response: We agree that it is desirable for the public to have
information on the measures development process and measures in
development. To this end, we have developed a standardized process to
be used for CMS contracted measures development. This standardized
process is detailed in the ``Measures Management System Blueprint''
found on the CMS Web site at http://www.cms.hhs.gov/apps/QMIS/mmsBlueprint.asp.
As stated previously, however, we largely depend on the development
of measures by professional organizations and other measure developers
for the PQRI. Many major measures developers follow a similar process
for the measures that they develop, in that they publish measures and
specifications during development and seek public comment. Both the NQF
and AQA also publish measures and specifications during their consensus
processes and seek public comment.
Comment: Numerous commenters requested final measure specifications
for the 2010 PQRI be published as far in advance of the beginning of
the reporting period as possible, and that more detailed information
about measures proposed or finalized for use in PQRI be published at
the same time as or in advance of future rulemaking.
Response: We agree with the commenters that it is desirable to
provide final measure specifications sufficiently in advance of the
reporting period to allow reasonable time for professionals to analyze
new or revised measures and implement any needed changes in their
office workflows to accurately capture and successfully submit data on
a selection of measures applicable to their practice on which they can
act to improve the quality of the services they furnish.
Having detailed information on measures available in advance of the
reporting period also enhances the ability of vendors (such as practice
management software, billing services, and electronic health records
vendors) to support professionals' successful implementation of revised
data-capture processes for the measures. Our intent is to provide the
final list of 2010 PQRI measures and the detailed measures
specifications on the PQRI section of the CMS Web site by November 15,
2009, but no later than December 31, 2009. These detailed
specifications will include instructions for reporting and identifying
the circumstances in which each measure is applicable. The detailed
technical specifications for measures in the final listing for the 2010
PQRI remain potentially subject to corrections until the start of the
2010 reporting period, as we stated in the proposed rule.
Comment: One commenter supported removal from the PQRI quality
measure set for 2010 and 2009 PQRI measure that was part of the 2007
and/or 2008 PQRI for which the 2007 and 2008 PQRI analytics indicate a
lack of significant reporting and usage. The commenter remarked that
continued review and revision of the measures list will help to refine
the process and validity of the program and reduce undue burden on
participants, increasing meaningful participation.
Response: We appreciate the commenter's constructive feedback and
agree that it is necessary to review and revise the PQRI quality
measure set on an ongoing basis as we gain more experience with
particular measures and/or new measures become available to replace
existing measures.
We are unclear, however, with respect to the commenter's remark
that continued revision of the PQRI quality measure set will reduce
undue burden on participants. Although there are several measures
available in the PQRI quality measure set, participants are not
required, nor are they expected to, report on all measures included in
the PQRI quality measure set. As discussed further in sections
II.G.2.e. and II.G.2.f. above, an individual eligible professional
generally needs to report on only 3 individual 2010 PQRI quality
measures or 1 2010 PQRI measures group in order to meet the criteria
for satisfactory reporting for 2010.
Comment: Some commenters specifically suggested that Measure
143 Oncology: Medical and Radiation--Pain Intensity Quantified
and Measure 144 Oncology: Medical and Radiation Plan of Care
for Pain be retained for the 2010 PQRI because they believe the
measures address quality of life issue for patients with cancer. One
commenter requested that if the measures are analytically challenging
as claims-based measures, we retain the measures as registry-only
measures instead.
Response: We only proposed to retire these measures because they
were too complex to calculate via claims. Based on the commenter's
suggestion to retain these measures as registry-only measures for the
2010 PQRI, we are finalizing and including them in the measures listed
in ``Table 11: 2010 Measures Selected From the 2009 PQRI Quality
Measure Set Available for Registry-based Reporting Only.''
Comment: One commenter requested that Measure 94 Otitis
Media with Effusion (OME): Diagnostic Evaluation--Assessment of
Tympanic Membrane Mobility and Measure 95 Otitis Media with
Effusion (OME) Hearing Testing not be retired since audiologists were
just added to the list of eligible professionals with the 2009 PQRI and
there are few measures on which they can report. The commenter
requested that we retain both measures for at least an additional year
to reassess the level of use since PQRI reporting, for audiologists, is
a new process that requires extensive training.
Response: We agree that in order to provide audiologists with
opportunities to participate in the PQRI, it is necessary to retain at
least one of these measures for at least another year. Thus, we have
decided to retain Measure 94 Otitits Media with Effusion
(OME): Diagnostic Evaluation--Assessment of Tympanic Membrane Mobility
and retire only Measure 95 Otitis Media with Effusion (OME)
Hearing Testing for 2010. Measure 94, in conjunction with the
3 new measures developed by the Audiology Quality Consortium (AQC)
listed in Table 13, will provide audiologists with at least 4 measures
on which they can report for the 2010 PQRI.
Comment: One commenter was not clear on which measure was being
proposed to replace Measure 34 Stroke and Stroke
Rehabilitation: Tissue Plasminogen Activator (tPA) Considered and
requested that CMS not retire Measure 34 until clarification
is provided. Another commenter,
[[Page 61816]]
however, supported the retirement of Measure 34 and CMS'
decision to replace this measure with the proposed new Stroke and
Stroke Rehabilitation: Thrombolytic Therapy measure (see Table 19 of
the CY 2010 PFS proposed rule).
Response: As indicated by the commenter, we are replacing Measure
34 with the Stroke and Stroke Rehabilitation: Thrombolytic
Therapy measure listed in Table 13 of this final rule with comment
period.
Comment: One commenter expressed support for a proposed revision of
Measure 11 for 2010 PQRI that expands the eligible denominator
patient population.
Response: We wish to clarify that at the request of the measure
developer, we are retiring Measure 11 and replacing it with
the proposed new NQF-endorsed measure: Stenosis Management in Cardiac
Imaging Studies (see Table 13 of this final rule with comment period).
Based on the criteria discussed above and our review of these
comments, we are retiring the 4 measures listed in Table 10 and are
including the 175 individual measures listed in Tables 11 through 13 in
the final 2010 PQRI individual quality measure set. We are also
including 13 measures groups in the final 2010 PQRI quality measure
set, which are listed in Tables 15 through 27. The individual measures
selected for the 2010 PQRI can be categorized as follows:
(1) 2010 Individual Quality Measures Selected From the 2009 PQRI
Quality Measures Set Available for Claims-based Reporting and Registry-
Based Reporting;
(2) 2010 Individual Quality Measures Selected From the 2009 PQRI
Quality Measures Set Available for Registry-based Reporting Only;
(3) New Individual Quality Measures Selected for 2010; and
(4) 2010 Measures Available for EHR-based Reporting.
Table 10--2009 PQRI Quality Measures Not Included in the 2010 PQRI
------------------------------------------------------------------------
Measure No. Measure title
------------------------------------------------------------------------
11..................................... Stroke and Stroke
Rehabilitation: Carotid
Imaging Reporting.
34..................................... Stroke and Stroke
Rehabilitation: Tissue
Plasminogen Activator (tPA)
Considered.
95..................................... Otitis Media with Effusion
(OME): Hearing Testing.
152.................................... Coronary Artery Disease (CAD):
Lipid Profile in Patients with
CAD.
------------------------------------------------------------------------
(1) 2010 Individual Quality Measures Selected From the 2009 PQRI
Quality Measures Set Available for Claims-based Reporting and Registry-
based Reporting
We proposed to include in the 2010 PQRI quality measure set 116 of
the 2009 PQRI measures, which would be available for either claims-
based reporting or registry-based reporting as individual quality
measures (74 FR 33574 through 33579). We also noted that one of the
proposed measures, Measure 46 Medication Reconciliation:
Reconciliation After Discharge from an Inpatient Facility, is
reportable through the registry-based reporting mechanism only in the
2009 PQRI. However, for the 2010 PQRI, we proposed to make this measure
available for either claims-based reporting or registry-based
reporting.
These 116 proposed measures did not include any measures that were
proposed to be included as part of the 2010 Back Pain measures group.
Similar to the 2009 PQRI, we proposed that any 2010 PQRI measure that
is included in the Back Pain measures group would not be reportable as
individual measures through claims-based reporting or registry-based
reporting.
The following is a summary of the comments received on the 116
proposed measures selected from the 2009 PQRI quality measure set.
Comment: We received numerous comments in support of the 2009 PQRI
quality measures proposed for inclusion in the 2010 PQRI. Several
commenters supported the retention of all the 2009 PQRI measures
proposed for 2010. Other commenters supported inclusion of specific
2009 PQRI measures in the 2010 PQRI. Measures on which we received
specific support include:
Measure 1 Diabetes Mellitus: Hemoglobin A1c Poor
Control in Diabetes Mellitus;
Measure 2 Diabetes Mellitus: Low Density
Lipoprotein (LDL-C) Control in Diabetes Mellitus;
Measure 3 Diabetes Mellitus: High Blood Pressure
Control in Diabetes Mellitus;
Measure 9 Major Depressive Disorder (MDD):
Antidepressant Medication During Acute Phase for Patients with MDD;
Measure 18 Diabetic Retinopathy: Documentation of
Presence or Absence of Macular Edema and Level of Severity of
Retinopathy;
Measure 19 Diabetic Retinopathy: Communication
with the Physician Managing On-going Diabetes Care;
Measure 67 Myelodysplastic Syndrome (MDS) and
Acute Leukemias: Baseline Cytogenetic Testing Performed on Bone Marrow;
Measure 68 Myelodysplastic Syndrome (MDS):
Documentation of Iron Stores in Patients Receiving Erythopoietin
Therapy;
Measure 102 Prostate Cancer: Avoidance of Overuse
of Bone Scan for Staging Low-Risk Prostate Cancer Patients;
Measure 104 Prostate Cancer: Adjuvant Hormonal
Therapy for High-Risk Prostate Cancer Patients;
Measure 105 Prostate Cancer: Three-Dimensional
(3D) Radiotherapy;
Measure 106 Major Depressive Disorder (MDD):
Diagnostic Evaluation;
Measure 107 Major Depressive Disorder (MDD):
Suicide Risk Assessment;
Measure 110 Preventive Care and Screening:
Influenza Immunization for Patients >=50 Years Old;
Measure 111 Preventive Care and Screening:
Pneumonia Vaccination for Patients 65 Years and Older;
Measure 112 Preventive Care and Screening:
Screening Mammography;
Measure 113 Preventive Care and Screening:
Colorectal Cancer Screening;
Measure 114 Preventive Care and Screening:
Inquiry Regarding Tobacco Use;
Measure 115 Preventive Care and Screening:
Advising Smokers and Tobacco Users to Quit;
Measure 117 Diabetes Mellitus: Dilated Eye Exam
in Diabetic Patient;
Measure 119 Diabetes Mellitus: Urine Screening
for Microalbumin or Medical Attention for Nephropathy in Diabetic
Patients;
Measure 124 Health Information Technology (HIT):
Adoption/Use of Electronic Health Records (EHR);
Measure 126 Diabetes Mellitus: Diabetic Foot and
Ankle Care, Peripheral Neuropathy-Neurological Evaluation;
Measure 127 Diabetes Mellitus: Diabetic Foot and
Ankle Care, Ulcer Prevention--Evaluation of Footwear;
Measure 134 Screening for Clinical Depression and
Follow-Up Plan;
Measure 136 Melanoma: Follow-Up Aspects of Care;
Measure 137 Melanoma: Continuity of Care--Recall
System;
Measure 138 Melanoma: Coordination of Care;
Measure 156 Oncology: Radiation Dose Limits to
Normal Tissues; and
Measure 163 Diabetes Mellitus: Foot exam.
Response: All 116 of the proposed measures listed in Table 17 of
the proposed rule (74 FR 33575 through 33579), including all of the
measures specifically supported by commenters, have been finalized for
the 2010 PQRI, and are included in Table 11.
[[Page 61817]]
Comment: One commenter commended CMS on the format of Table 17 of
the proposed rule (74 FR 33575 through 33579) which clearly stated the
status of NQF endorsement, AQA adoption, and the measure developer for
each proposed measure. The commenter encouraged us to use this format
in future rules.
Response: We appreciate the positive feedback on the newly
formatted tables in the proposed rule.
Comment: One commenter urged us to finalize the proposed new
measures related to age-related macular degeneration, osteoporosis, and
cancer care and to work with the community to ensure these measures are
appropriately reported.
Response: We note that the measures referenced by the commenter are
existing 2009 PQRI measures that will be included for 2010 PQRI. As
noted previously, we have developed an education and outreach plan that
is continuously expanding in scope in our efforts to educate eligible
professionals on the nuances of the PQRI, including educating eligible
professionals and office staff on appropriate reporting of the PQRI
measures.
Comment: Several commenters recommended changes to specific quality
measures' titles, definitions, and detailed specifications or coding.
Many of these recommendations were based on alternative interpretations
of clinical evidence or concerns about the utility of the measures.
Some requests were specifically concerned that measures be expanded to
include specific professionals to whom the measure may be applicable
such as physical therapists, audiologists, and hospitalists.
Specifically, one commenter suggested that in order to maximize the
impact of Measure 1 Diabetes Mellitus: Hemoglobin A1c Poor
Control in Diabetes Mellitus, the PQRI specification should continue to
require a performance period of 12 months and reporting that identifies
whether A1c control is good (that is, A1c <= 7.0 percent), moderate
(that is, A1c <= 9.0 percent, but > 7.0 percent), or poor (that is, A1c
> 9.0 percent).
Another commenter suggested that audiologists should be included in
Measure 154 Falls: Risk Assessment. The commenter noted that
audiologists are consulted to provide vestibular rehabilitation that
results in improved quality of care for these patients and reduces
unnecessary and excessive cost.
Another commenter requested that Measure 52 Chronic
Obstructive Pulmonary Disease (COPD): Spirometry Evaluation needs to be
re-evaluated and CMS should consider modifying this measure or creating
a new one that addresses the appropriate use of LABA.
We received one comment regarding Measure 158 Carotid
Endarterectomy: Use of Patch During Conventional Carotid
Endarterectomy, expressing concern that there is no reliable data,
controlled or otherwise, that shows that use of patch graft results in
better outcomes.
Finally, one commenter suggested that the following proposed 2010
measures selected from the 2009 PQRI quality measure set available for
either claims-based reporting or registry-based reporting may not
promote quality care because they do not adequately address concerns of
patient groups that rely on plasma derived treatments such as those
with primary immune deficiency or alpha-1 antitrypsin deficiency:
Measure 51 Chronic Obstructive Pulmonary Disease
(COPD): Spirometry Evaluation;
Measure 64 Asthma: Asthma Assessment;
Measure 65 Treatment for Children with Upper
Respiratory Infection (URI): Avoidance of Inappropriate Use;
Measure 110 Preventive Care and Screening:
Influenza Immunization for Patients >= 50 Years Old; and
Measure 126 Diabetes Mellitus: Diabetic Foot and
Ankle Care, Peripheral Neuropathy--Neurological Evaluation.
The commenter suggested that we focus on aligning these measures
with accepted clinical practices for patients that rely on plasma-
derived treatments.
Response: Health care quality measures are currently developed by a
variety of organizations and used by a variety of governmental and
nongovernmental, and public-private initiatives which have various and
at times differing priorities and programmatic needs for quality
measures. As reflected by the considerations for identifying proposed
PQRI quality measures described above, we are committed to having a
broad and robust set of quality measures for the PQRI. However, we
largely depend on the development of measures by professional
organizations and other measure developers. Although we had significant
involvement in the development of measures applicable to eligible
professionals at the start of the PQRI, currently we are not directly
involved in the development of clinician-level quality measures for
PQRI, but do select from measures that meet the statutory requirements
and other considerations described above.
Quality measures that have completed the consensus processes of NQF
or AQA have a designated party (generally the measure developer/owner)
who has accepted responsibility for maintaining the measure. In
general, it is the role of the measure owner, developer, or maintainer
to make substantive changes to a measure, including any updates to the
measure to reflect the current clinical evidence such as the changes
suggested by the commenters above. The measure maintainer and/or the
developer/owner of a measure included in the final set of quality
measures selected for the 2010 PQRI is identified as the ``Measure
Developer'' in Tables 11 through 28. In addition, NQF has, for its
endorsed measures, an established maintenance process which may be
accessed. The Secretary is required to provide opportunities for public
comment on selected measures and do so through notice and comment
rulemaking. We do not, however, use notice and comment rulemaking as a
means to update or modify measure specifications. We retain the ability
to update or modify specifications to the measures until December 31,
2009.
After that date, there will be no changes to the measure for the
2010 reporting period(s).
Comment: One commenter was concerned about the potential retention
of claims-based reporting for Measure