Edited Composite 2009 reg scorecard HHS Outpatient Prospective Payment 0938-AP41 by lanyuehua


									                                             Regulatory Scoring
Health and Human Services
Rule title:
Outpatient Prospective Payment
0938-AP41                                                                     RIA                  No
Stage                                                                         Publication Date
Proposed                                                                      7/20/2009
Rule summary:
This proposed rule would revise the Medicare hospital outpatient prospective payment system (OPPS) to
implement applicable statutory requirements and changes arising from our continuing experience with this
system. In this proposed rule, we describe the proposed changes to the amounts and factors used to
determine the payment rates for Medicare hospital outpatient services paid under the prospective payment
system. These changes would be applicable to services furnished on or after January 1, 2010. In addition,
this proposed rule would update the revised Medicare ambulatory surgical center (ASC) payment system to
Topic 1: Transparency                                                         Score    Comments
A. How easily were the RIA, the proposed rule, and any supplementary
materials found online?                                                       4       1A
B. How verifiable are the data used in the analysis?                          4       1B
C. How verifiable are the models and assumptions used in the analysis?        3       1C
D. Was the Regulatory Impact Analysis comprehensible to an informed
layperson?                                                                    2       1D

Total 1 (Sum of A, B, C, and D)                                               13

Topic 2: Accountability                                                       Score   Comments
A. How well does the analysis identify the desired outcomes and
demonstrate that the regulation will achieve them?                            1       2A

B. How well does the analysis identify and demonstrate the existence of a
market failure or other systemic problem the regulation is supposed to solve? 1       2B
C. How well does the analysis assess the effectiveness of alternative
approaches?                                                                   2       2C
D. How well does the analysis assess costs and benefits?                      2       2D

Total 2                                                                       6

Topic 3: Leadership                                                           Score   Comments
A. Does the proposed rule or the RIA present evidence that the agency used
the Regulatory Impact Analysis?                                               3       3A
B. Did the agency maximize net benefits or explain why it chose another
alternative?                                                                  0       3B
C. Does the proposed rule establish measures and goals that can be used to
track the regulation’s results in the future?                                 1       3C

D. Did the agency indicate what data it will use to assess the regulation’s
performance in the future and establish provisions for doing so?              1       3D

Total 3                                                                       5

Total Score                                                                   24
Rule Title RIN                                                   Transparency Accountability
                        Agency Pub Date RIA separate? Total (F+G+J)
       Health0938-AP41 Services 7/20/2009 No
              and Human
Outpatient Prospective Payment                                24            13              6
Quality (F+G) Leadership 1A       1B       1C       1D       2A       2A1       2A2
             19         5     4        4        3        2        1         1         2
2A3       2A4       2A5       2B       2B1       2B2       2B3       2B4       2C
      0         0         1        1         1         1         0         0        2
2C1       2C2       2C3       2C4       2D       2D-1       2D-2       2D-3       2D-4
      2         2         2         3        2          3          4          2          1
2D-6       2D-7       2D-8       2D-9       2D-10       3A       3B       3C       3D
       1          0          0          4           2        3        0        1        1
Transparency (Accessible, Verifiable, Peer-reviewed, and Comprehensible)
Category                        Score Com. No. Comment
                                               0938-AP41 can be found on
                                               regulations.gov using the RIN and a
                                               keyword search, as well as on the
                                               Department of Health and Human
                                               Service's website. A link can be found
                                               five clicks from the home page by
                                               clicking on regulations, regulations
                                               and guidance under medicare, then
                                               on Quarterly provider updates-
                                               regulations. Here, search under QPU
                                               July-August 2009. The Department
 A. How easily were the RIA ,                  offers a list of proposed rules. The
                                               reader has to know what the
 the proposed rule, and any                    "quarterly provider update" is in order
 supplementary materials                       to find the regulation and RIA on the
 found online?                  4     1A       website.

                                                  The data used to calculate payments
                                                  to hospitals are available for purchase
                                                  from HHS: "In addition, below in this
                                                  section we discuss the file of claims
                                                  that comprise the data set that is
                                                  available for purchase under a CMS
                                                  data use agreement" (p. 24). Links to
                                                  the HHS website provide additional
                                                  information about the data. Many
                                                  other data are reproduced in
 B. How verifiable are the                        appendices and available on the HHS
 data used in the analysis?     4     1B          website free of charge.
                                                  Calculations are explained in detail,
                                                  and links are provided to some
                                                  supporting info on the HHS website.
                                                  Many decisions changing the way
                                                  services will be coded are justified
                                                  based on some logic, references to
                                                  an advisory panel, or HHS's
                                                  judgment. Some studies by outside
 C. How verifiable are the                        contractors that supported these
 models and assumptions                           decisions are cited and sometimes
 used in the analysis?          3     1C          linked.
                                 The text includes a huge number of
                                 acronyms, abbreviations, and jargon.
                                 Exposition of the calculations is very
                                 turgid, though all the relevant
                                 explanations are there. Full
D. Was the regulatory
                                 understanding requires patience,
impact analysis                  persistence, and some specialized
comprehensible to an             knowledge of the program, not just
informed layperson?     2   1D   graduate training in economics.
       Accountability (Outcomes, Costs, Systemic Problem, and Alternatives)
Category                           Score   Com. No. Comment

A. Identify the desired
outcomes:                          1

                                                   A perfunctory sentence says the goal of the
                                                   prospective payment system is to ensure that the
                                                   government pays appropriately and to encourage
                                                   efficiency in treatment. "In this proposed rule, we
Does the analysis clearly
                                                   set forth proposed changes to the Medicare
identify ultimate outcomes                         hospital OPPS for CY 2010 to implement statutory
that affect citizens’ quality of                   requirements and changes arising from our
life?                              1       2A-1    continuing experience with the system."
Does the analysis identify                         The analysis does not measure these outcomes. It
how these outcomes are to                          just calculates payment rates. Payments are
be measured?                       2       2A-2    measured in dollars.
Does the analysis provide a
coherent and testable
theory showing how the
regulation will produce the
desired outcomes?                  0       2A-3    No theory is presented.
Does the analysis present                          The is no emprical support that would justify the
credible empirical support                         claim that these payment rates are appropriate
for the theory?                    0       2A-4    and lead to efficient care.
                                                   The closest the analysis comes to dealing with
                                                   uncertainty is an acknowledgement that it does not
                                                   try to project behavioral responses or adjust for
                                                   other factors that might change in the future. For
                                                   example, ""While we recognize the concerns the
                                                   APC Panel expressed with regards to cost
Does the analysis
                                                   variability in the system, we already engage in a
adequately assess                                  standard review process for all APCs that
uncertainty about the                              experience significant changes in median costs."
outcomes?                          1       2A-5    (p. 36)
B. Assess evidence of
market failure or other
systemic problem:                  1
                                                   The analysis offers no explicit discussion of why
                                                   HHS needs to do this beyond saying it must
                                                   comply with the law: "We are required under
                                                   section 1833(t)(3)(C)(ii) of the Act to update
                                                   annually…" The general problem is ensuring
                                                   adequate but not excessive payment for quality
                                                   care when the government is a large purchaser,
                                                   but HHS does not explicitly analyze this. The
Does the analysis identify a                       "systemic problem" this regulation deals with is
market failure or other                            that Medicare has to figure out how much to pay
systemic problem?                  1       2B-1    for various procedures.
Does the analysis outline a
coherent and testable
theory that explains why the
problem (associated with
                                          Problem not clearly explained in the first place.
the outcome above) is                     However, given the size of the payments, then one
systemic rather than                      can infer that they should be updated to reflect
anecdotal?                     1   2B-2   changing costs.
Does the analysis present
credible empirical support
for the theory?                0   2B-3   No relevant discussion.
Does the analysis
adequately assess
uncertainty about the
existence or size of the
problem?                       0   2B-4   No relevant discussion.
C. Assess effectiveness of
alternative approaches:        2
                                          Alternative ways of setting payments are
Does the analysis
                                          considered for several types of procedures.
enumerate other                           Alternatives also considered for dealing with
alternatives to address the               supervision fo certain provisions by non-physician
problem?                       2   2C-1   medical professionals.
Is the range of alternatives
considered narrow (e.g.,
some exemptions to a
regulation) or broad (e.g.,
regulation vs. command and
control, market
mechanisms, nonbinding
guidance, information                     The alternatives are small tweaks on a large
                                          system for which no alternatives were considered.
disclosure, addressing any
                                          Given the statutory guidelines, they honestly didn't
government failures that                  have much flexibility to consider significant
caused the original                       alternatives. (This is an explanation for the low
problem)?                      2   2C-2   score, not a reason for a higher score.)

                                          The analysis does not directly evaluate how the
Does the analysis evaluate
                                          alternatives would affect the amount of outcome.
how alternative approaches                Alternatives are rejected after some summary
would affect the amount of                argument of pros and cons that does not always
the outcome achieved?          2   2C-3   implicate outcomes.
Does the analysis
adequately address the
baseline? That is, what the                The baseline is based on a past year's data; the
                                           analysis does not try to project changes in case
state of the world is likely to
                                           mix or other factors: "To illustrate the impact of the
be in the absence of federal               proposed CY 2010 changes, our analysis begins
intervention not just now but              with a baseline simulation model that uses the final
in the future?                  3   2C-4   CY 2009 weights" (p. 184).
D. Costs and benefits:          2
Does the analysis identify
and quantify incremental                   The cost of the only alternative considered is
costs of all alternatives                  calculated in great detail. A table shows the
considered?                     3   2D-1   incremental effects of each adjustment.

Does the analysis identify all
expenditures likely to arise
as a result of the regulation? 4    2D-2   Only federal expenditures are identified.
                                           The analysis notes that these changes in
Does the analysis identify
                                           payments will also lead to changes in patients'
how the regulation would                   copayments; some will rise and some will fall.
likely affect the prices of                These are not presented in depth and are not in
goods and services?            2    2D-3   the accounting statement.

                                           The analysis acknowledges the possibility of
Does the analysis examine                  behavioral changes but explicitly declines to
costs that stem from                       estimate them: "We use the best data available,
                                           but do not attempt to predict behavioral responses
changes in human behavior
                                           to our proposed policy changes. In addition, we do
as consumers and                           not make adjustments for future changes in
producers respond to the                   variables such as service volume, service-mix, or
regulation?                    1    2D-4   number of encounters" (p. 183).

                                           There are one or two brief acknowledgements of
                                           uncertainty, but no attempts to deal with it: "We
                                           note that there are a number of factors that cause
                                           APC median costs to change from one year to the
If costs are uncertain, does
                                           next. Some of these are a reflection of hospital
the analysis present a range               behavior, and some of them are a reflection of
of estimates and/or perform                fundamental characteristics of the OPPS as
a sensitivity analysis?      1      2D-6   defined in the statute" (p 36).
Does the analysis identify
the alternative that                       Since benefits are not calculated, this is not
maximizes net benefits?      0      2D-7   possible.

Does the analysis identify
the cost-effectiveness of                  Since benefits are not calculated, this is not
each alternative considered? 0      2D-8   possible.
                                           Estimates of hospital-specific payments are
Does the analysis identify all
                                           available online. A table shows effects on hospitals
parties who would bear                     of various sizes, locations, ownership, and other
costs and assess the                       characteristics. The analysis considered effects on
incidence of costs?            4   2D-9    small rural hospitals.

Does the analysis identify all
                                           Some impacts on beneficiaries via copayments
parties who would receive                  are discussed briefly with a couple examples (p.
benefits and assess the                    188), but no calculation of how these changes
incidence of benefits?         2   2D-10   would affect ultimate beneficiaries.
Category                      Score Com. No. Comment
A. Does the rule or the RIA
present evidence that the                   The analysis was used only in the sense that the
agency used the regulatory                  calculations determine how much the
impact analysis?              3    3A       government will pay for various procedures.

B. Did the agency maximize                  Benefits are not estimated, so net benefits could
net benefits or explain why                 not be calculated. It is not clear whether net
it chose another alternative? 0    3B       benefits were even considered.
C. Does the proposed rule                   Providers must report process-oriented (not
                                            outcome-oriented) quality measures, which
establish measures and
                                            could be used to analyze effects of payments on
goals that can be used to                   outcomes. However, HHS articulates no plan to
track the regulation's results              use them specifically to evaluate the effects of
in the future?                 1   3C       this regulation.
D. Did the agency indicate
what data it will use to
assess the regulation's
performance in the future
and establish provisions for                Outcome data could perhaps be used to
doing so?                      1   3D       measure effects of this regulation.

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