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E-mail: iscd@ISCD.org
Web site: www.ISCD.org
OFFICERS
President
September 2, 2014
Diane C. Krueger, BS, CBDT
Madison, WI (USA)
Marilynn Tavenner
Administrator and Chief Operating Officer
William D. Leslie, MD, CCD
Centers for Medicare and Medicaid Services
Winnipeg, Manitoba (CANADA)
Department of Health and Human Services
Vice President Attn: CMS-1590-P
John A. Shepherd, PhD, CCD
P.O. Box 8013
San Francisco, CA (USA)
Baltimore, MD 21244-8013
President-Elect
Treasurer
Kate T. Queen, MD, CCD
Waynesville, NC (USA)
Submitted electronically via http://www.regulations.gov
Secretary
RE: CMS-1612-P Medicare Program; Revisions to Payment
Policies under the Physician Fee Schedule, Clinical Laboratory
Fee Schedule, Access to Identifiable Data for the Center for
Immediate Past President
Medicare and Medicaid Innovation Models & Other Revisions to
John T. Schousboe MD, PhD, CCD
Minneapolis, MN (USA) Part B for CY 2015.
Catherine Gordon, MD, CCD
Providence, RI (USA)
Executive Director/CEO
Peter D. Brown
Middletown, CT (USA)
Comments to be offered on:
Proposed Rule Section III. K.4.- Other Provisions of the
BOARD OF DIRECTORS Proposed Rule – Physician Payment, Efficiency and Quality
Ann M. Babbitt, MD, CCD Improvements- Physician Quality Reporting System
South Portland, ME (USA)
Robert D. Blank, MD, PhD, CCD
Milwaukee, WI (USA)
Bruno Muzzi Camargos, MD, CCD, CDT
Belo Horizonte, (Brazil)
John J. Carey, MB, BCh, MS, CCD
Galway, (Ireland)
Beatrice Edwards, MD, FACP, MPH, CCD
Houston, TX (USA)
Ronald C. Hamdy, MD, CCD
Johnson City, TN (USA)
Kyla K. Kent, CBDT
Redwood City, CA (USA)
Andrew J. Laster, MD, FACR, CCD
Charlotte, NC (USA)
Sarah L. Morgan, MD, RD, CCD
Birmingham, AL (USA)
J. Edward Puzas, PhD
Rochester, NY (USA)
Christopher R. Shuhart, MD, CCD
Seattle, WA (USA)
Wendy J. Tolman-Andrews, BS, RT(R),
CBDT
Vernon, CT (USA)
Sharon R. Wartenbee, RT(R)(BD),
FASRT, CBDT
Dear Ms Tavenner:
The International Society for Clinical Densitometry (ISCD) welcomes
the opportunity to comment on the CMS proposed rule, CMS-1612-P
Medicare Program; Revisions to Payment Policies under the
Physician Fee Schedule, Clinical Laboratory Fee Schedule, Access
to Identifiable Data for the Center for Medicare and Medicaid
Innovation Models & Other Revisions to Part B for CY 2015,
published in the July 11, 2014 Federal Register.
The ISCD will address the importance of establishing (a) sound
payment policies for osteoporosis testing and (b) a Measures Group
for Osteoporosis.
Proposed Rule Section III. K.4. Other Provisions of the
Proposed Rule – Physician Payment, Efficiency and Quality
Improvements- Physician Quality Reporting System
Background on ISCD
Sioux Falls, SD (USA)
Chih-Hsing Wu, MD, CCD, CDT
Tainan, (Taiwan
The ISCD is a multidisciplinary, nonprofit organization that was
founded in June of 1993 with approximately 3300 members.
ISCD provides a central resource for a number of scientific
disciplines with an interest in the assessment of skeletal health. The
Society is the only one of its kind worldwide with membership of
physicians, technologists, other allied health providers and scientists
representing 30 disciplines including family practice, internal
medicine, obstetrics, gynecology, endocrinology, gerontology,
nephrology, orthopedics, pediatrics, radiology and rheumatology.
The ISCD’s mission is to advance excellence in the assessment of
skeletal health. As such, the ISCD offers comprehensive educational
courses in bone densitometry and vertebral fracture assessment
(VFA) as well as certification in dual energy X-ray absorptiometry
(DXA) acquisition and interpretation for technologists and physicians.
The ISCD now also offers facility accreditation to demonstrate to
healthcare providers, payers and patients that a DXA testing facility
meets accepted standards of excellence.
Background on Osteoporosis
Osteoporosis remains a major public health risk that
disproportionately affects women who account for 71% of fractures
and 75% of costs. A women's risk of having an osteoporotic fracture
in one year is greater than her combined risk of having a heart
attack, stroke or developing breast cancer. About 25% of women
over the age of 50 who sustain a hip fracture die in the year following
the fracture. In fact, more women die each year from complications
following hip fractures than from breast cancer. Fully 50% of
patients who sustain a hip fracture never walk independently again
and 20% require permanent nursing home placement. The ability to
better prevent, detect and treat osteoporosis will decrease the
incidence of fractures and associated healthcare costs.
The cost to Medicare due to osteoporosis-related fractures has been
estimated to be $22 billion (2008).i When applied to the entire U.S.
population, the cost is estimated to increase to more than $25 billion
by 2025.ii In 2010, osteoporosis was the ninth ranked major illness
among the top 5 percent highest cost Medicare beneficiaries (12
percent of all beneficiaries and 18 percent of high costs
beneficiaries).iii
A study in The Journal of Bone and Mineral Research found that
10.2 million adults have osteoporosis and another 43.4 million have
low bone mass; more than one-half of the total U.S. adult population
is currently affected.iv Assuming osteoporosis and low bone mass
prevalence remain unchanged, the NOF study projects that by 2020,
the number of adults over age 50 with osteoporosis or low bone
mass will grow from approximately 54 million to 64.4 million and by
2030, the number will increase to 71.2 million (a 29% increase from
2010). It is anticipated that the number of fractures will grow
proportionally.v
Axial dual energy X-ray absorptiometry of the lumbar spine and hip
(CPT 77080) herein referred to as DXA, is a noninvasive test that
measures bone mineral density and is used to diagnose and monitor
the treatment response to osteoporosis. DXA is the best predictor of
future fracture risk and the only test covered by Medicare for
monitoring response to drug therapy.
Physician Payment, Efficiency and Quality Improvements—
Physician Quality Reporting System (PQRS) – ISCD Urges CMS
to Create an Osteoporosis Measures Group
During the past few years, there has been extensive debate between
regulators and stakeholders about the content and grouping of
osteoporosis quality measures.
In 2012, CMS proposed to establish an Osteoporosis Measures
Group. This proposed action was consistent with recommendations
from the National Quality Forum (NQF) May 2010 Measure
Prioritization Advisory Committee Report, which highlighted
osteoporosis as one of the 20 medical conditions identified by CMS
that impose “heavy health burdens on patients …(,) account for over
95 percent of Medicare’s costs”vi and are currently challenged with
important (quality) measurement gaps.
Last year, CMS proposed to delete the Osteoporosis Measures
Group that was introduced in 2012 and finalized during the CY 2013
MPFS rulemaking.
The six current, National Quality Forum (NQF)-endorsed PQRS
individual measures (measures 24, 39, 40, 41, 154 and 155) vii more
closely reflect the desired outcomes to improve osteoporosis disease
prevention. The six existing National Quality Forum (NQF)-endorsed
PQRS measures are:
1. Osteoporosis: Communication with the Physician Managing
Ongoing Care Post Fracture of Hip, Spine, or Distal Radius
for Men and Women Aged 50 Years and Older (NQF# /
PQRS# 0045/24).
2. Osteoporosis: Screening or Therapy for Women Aged 65
Years and Older (NQF# / PQRS# 0046/39).
3. Osteoporosis: Management Following Fracture of Hip, Spine
or Distal Radius for Men and Women Aged 50 Years and
Older (NQF# / PQRS# 0048/40).
4. Osteoporosis: Pharmacologic Therapy for Men and Women
Aged 50 Years and Older (NQF# / PQRS# 0049/41)
5. Falls: Risk Assessment (NQF# / PQRS# 0101/154)
6. Falls: Plan of Care (NQF# / PQRS# 0101/155)
ISCD urges CMS to use these six measures as the basis for an
Osteoporosis Measures Group
CMS should provide clinicians with an opportunity to enhance their
tracking and reporting of Medicare osteoporosis patient activity. A
formalized osteoporosis-focused measures group will strongly
augment and complement the current PQRS individual osteoporosis
measures.
We urge CMS to adopt an Osteoporosis Measures Group as a way
to acknowledge the prevalence of osteoporosis and the significant
and growing gap in patient care. Highlighting the significance of
osteoporosis is needed today, more than ever. As noted previously,
the number of adults over age 50 with osteoporosis or low bone
mass will grow from approximately 54 million to 64.4 million and by
2030 the prevalence of osteoporosis is increasing and the gap in
diagnosis and treatment is getting worse. viiiA recent retrospective
study of more than 97,000 patients over the age of 50 who had been
hospitalized with hip fractures, confirmed the widening gap in care:
Patients treated with medication for osteoporosis excluding
estrogens declined significantly from 40.2% in 2002, to 20.5% in
2011. ix
We hope that the establishment of an Osteoporosis Measures Group
will help improve the profound under-utilizaton of DXA testing in
older women (where 41% of older women did not have even one
DXA over a nine-year period (2002-2010) and 24% of older women
had only one DXA test during that nine-year period.)
Conclusion
We urge CMS to adopt the osteoporosis measures group to help
increase awareness of the disease among both clinicians and
patients.
Both the Affordable Care Act (ACA) and CMS have independently
acknowledged that osteoporosis is a serious medical condition. The
ACA recognizes the value of DXA testing, designating it as a
preventive service where a co-pay or deductible cannot be applied.
CMS includes bone density testing in the Welcome to Medicare
Exam as a way of underscoring the importance of prevention of the
disease.
Clinicians and healthcare practitioners should have the opportunity to
enhance the tracking and reporting of Medicare osteoporosis patient
activity. A formalized osteoporosis-focused measures group would
serve that purpose while complementing the current PQRS individual
osteoporosis measures by ensuring that clinicians report on all
measures within the group when they are caring for, patients with
osteoporosis.
While establishing a measures group would be a welcome policy
change, we implore CMS to review other CMS policies that are
working at cross-purposes with the agency’s acknowledgement of
the importance of screening, diagnosing and treating osteoporosis.
Specifically, the 65% Medicare reimbursement cuts to DXA in the
office setting that began in 2007, have already wiped out a decade of
prevention efforts and reversed the critical trend of increased
osteoporosis testing in older women. From 2008 to 2012, there was
a 12.9% decrease in DXA providers overall and an18.4% decline in
office providers. This decline in office providers was only partially
offset by 8.5% growth in hospital outpatient providers. During that
period, 41 states lost over 10% of office providers, including eight
states that lost over 30%. With the loss in providers came the
inevitable decline in patients tested. From 2010- 2012, 556,000
fewer claims were submitted to CMS for DXA testing (77080) as
compared to 2008, when DXA testing peaked. x
Establishing quality and reporting measures is a commendable step.
However, these measures are meaningless if CMS does not address
the current decline in DXA providers and patients being tested. If
patient access to DXA continues to follow this trend, the discussion
of quality measures and measures groups will be irrelevant.
If you have questions please feel free to contact ISCD Legislative
Counsel, Donna Fiorentino at dfiorentino@iscd.org or by phone
at (860) 402-2159.
Sincerely,
Diane C. Krueger, BS, CBDT
President, ISCD
Andrew Laster, M.D., FACR, CCD
Chair, Public Policy Committee, International Society for Clinical
Densitometry
i. Blume SW, Curtis JR, Medical Costs of Osteoporosis in the Eldery Population. Osteporosis International 2011 Jun; 22(6):
1835-44.
ii. Burge R, Dawson-Hughes B, Solomon DH, Wong JB, King A, Tosteson A. Incidence and economic burden of osteoporosisrelated fractures in the United States, 2005–2025. Journal of Bone and Mineral Research 2007, 22: 465–475.
iii. Gawande A. Slide referencing 2010 data from Centers for Medicare & Medicaid Services, presented at Care Innovations
Summit, January 26, 2012, Renaissance Hotel, Washington, DC.
iv. Wright NC, Looker AC, Saag, KG et al, The Recent Prevalence of Osteoporosis and Low Bone Mass in the United States
Based on Bone Mineral Density at the Femural Neck or Lumbar Spine, Jouranl of Bone and Mineral Research 2014
v. Ibid.
vi. www.qualityforum.org/WorkArea/linket.aspx?LinkIdentifier=id&ItemID=26140.;accessed August13, 2012
vii. www.cms.gov/PQRS/downloads/2011_PhysQualRptg_MeasuresList_033111.pdf; accessed August 13, 2012
viii. Wright NC, Looker AC, Saag, KG et al, The Recent Prevalence of Osteoporosis and Low Bone Mass in the United States
Based on Bone Mineral Density at the Femural Neck or Lumbar Spine, Jouranl of Bone and Mineral Research 2014
ix. Solomon, DH. Johnston, SS, Boytsov, NN et al, Osteoporosis Medication Use After Hip Fracture in U.S. Patients Between
2002 and 2011, Journal of Bone and Mineral Research 2014, DOI 10.1002/jbmr.2202