The HHS retrospective regulatory review update from January 2012 highlights significant progress in revising regulations, with several proposed and final rules aimed at reducing costs in the healthcare sector, including an estimated savings of $5 billion from Medicare reforms. Notably, the rules also aim to enhance efficiency for providers and ease access to care for patients. The update emphasizes ongoing efforts to incorporate public feedback and streamline regulatory processes within the department.

1. HHS Retrospective Regulatory Review
Update January 2012
, HHS
has made significant progress in its retrospective review activities. To date, we published
eight proposed rules and nine final rules on the list of regulations identified for retrospective
regulatory review. An additional four proposed rules and three final rules are targeted for
publication during the first quarter of 2012.
Two of the proposed rules we published are expected to result in significant savings to the
health industry. The first, a major revision to the Medicare Conditions of Participation for
Hospitals, is likely to result in an estimated savings of close to $5 billion over five years.
The second, Regulatory Provisions to Promote Program Efficiency, Transparency and Burden
Reduction, may result in cost savings that approach $200 million during the first year. HHS
is working to finalize these rules.
Some of the key cost savers of these proposed rules include:
Permit laboratory services to operate on-­site at critical access hospitals, saving
roughly $15.8 million per year.
Allow hospitals to determine the total number of directors needed for the various
outpatient services that a hospital offers, saving $300 million per year.
Allow hospitals to set their own policies regarding the duties and privileges of
Advanced Practice Registered Nurses, Physician Assistants, and other licensed
nonphysician practitioners in accordance with their state laws and scope-­of-­practice
acts. This reform should save hospitals roughly $330 million per year.
Permit hospital nursing service care plans to be integrated into
interdisciplinary care plan, thereby eliminating the requirement that nursing staff
develop two care plans. Estimated savings are roughly $110 million per year.
Allow hospitals to use standing medical orders approved by the
leadership to advance the practice of evidence-­based medicine and ensure more
consistent care for all patients. This reform should save $90 million per year.
Remove certain Medicare reenrollment bars and revocations for incidental failures to
comply with Medicare requirements such as a failure of a provider or supplier to
respond timely to a re-­validation request or failure to submit a Medicare claim for a
consecutive 12-­month period. Expected savings are $10 million per year.
Other rules recently published as final will make provider practice more efficient and less
burdensome. One rule, the Home Health Prospective Payment System Rate Update for
Calendar Year 2012 (0938-­AQ30), removes the previous regulatory requirement that the
physician who conducts the face-­to-­face visit with a Medicare home health patient prior to
recertification must be the same physician who completes the recertification. Yet another
final rule, Changes Affecting Hospital and Critical Access Hospital (CAH) Conditions of
Participation (CoPs): Credentialing and Privileging of Telemedicine Physicians and

2. HHS Retrospective Regulatory Review
Update January 2012
Practitioners (0938-­AQ05), allows hospitals to more easily credential and provide privileges
for physicians and other practitioners who provide telemedicine services.
Still other rules give patients easier access to information about their health care. One such
final rule, Changes to the Ambulatory Surgical Centers Patient Rights Conditions for
Coverage (0938-­AP93), removes the requirement that an ambulatory surgery center
provide
prior to the date of the procedure. Now those centers can give patients that
information on the day of the procedure, thereby saving time and travel costs for the
patient. Another proposed rule, AQ38),
permits patients to more easily access their clinical lab test results. This rule, coupled with
the Fiscal Year 2012 Physician Fee Schedule final rule (0938-­AR06) that removes the
requirement for the physician to sign every order for a clinical lab test, will save costs and
increase efficiency in the system.
Additional rules propose to provide much needed relief to states. For example, the
Disallowance of Claims for Federal Financial Participation (FFP) and Technical Corrections
(0938-­AQ32) rule proposed to revise the repayment schedule for states that received more
Medicaid funds than they were entitled to receive. The proposal provides three options for
states to elect a repayment schedule that recognizes the unique fiscal pressures states are
experiencing and allows for a longer repayment period. A second rule, the Medicaid Home
& Community Based Services Waiver final rule (0938-­AP61) will permit states greater
flexibility to design and operate fewer Medicaid waiver programs for home and community
based services by designing packages based on need rather than diagnosis.
In a rule providing greater flexibility, efficiency, and modernization in the child support
enforcement programs (970-­AC50), states will be able to submit and accept information
electronically, maintain electronic records, and accept electronic signatures in these
programs. States will also have the flexibility to use cost-­saving and efficient technologies,
such as email or electronic document storage, wherever possible. Finally, states will have
greater flexibility to close unenforceable cases and redirect resources to more productive
efforts and, in some cases, close and transfer appropriate cases to a tribal child support
program.
In another major undertaking, retrospective review will result in major modifications to the
Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule requirements for
distribution of Notices of Privacy Practices (0991-­AB80).
F Bar Code Rule for Drugs.
Under the current rule, drug manufacturers must use a certain type of bar code to identify
the drug, but recent changes in technology have resulted in the availability of multiple types
of bar codes and bar code readers on the market. FDA will conduct an extensive economic
review to determine if the rule should be modified to permit a wider range of bar code uses
in light of these changes in technology that have occurred since the rule went into effect.
To that end, FDA published a notice in the Federal Register requesting comment on this
matter by February 23, 2012. Those comments will help FDA determine whether and how
to proceed with a major revision to this rule.
2

3. HHS Retrospective Regulatory Review
Update January 2012
In addition to these regulatory changes, the Department established an Analytics Team
based in the Office of the Assistant Secretary for Planning and Evaluation to share
information, make the quality of analysis more consistent across the Department, and
ensure the integration of such analysis into regulatory decision-­making to improve the
quality of regulation. The Analytics Team has already had a significant impact on several of
the regulations developed as a result of the retrospective review activity.
The Department also established a webpage on its HHS.gov/Open website devoted to
retrospective review activities: http://www.hhs.gov/open/execorders/13563/index.html.
This is the first step in the long-­term development of a single portal access point for all
regulatory information across the Department.
Finally, the Department is moving forward with a Public Participation Task Force to develop
innovative ideas for involving the public in the regulatory process. In two major efforts to
involve the public thus far, the Department published an Advance Notice of Proposed
Rulemaking to solicit public comment on revising the Common Rule, the signature rule on
protection of human subjects that has not been revised for more than 20 years, and a
second Notice inviting comment on whether and how the pharmaceutical bar code rule
should be revised.
A full list of the regulations for which a review is complete or which are currently under
environment where agencies incorporate and integrate the ongoing retrospective review of
regulations into Department operations to achieve a more streamlined and effective
regulatory framework. The Department conducted its initial inventory of significant
regulations that have been in effect for at least five years without revision when it
developed the initial list of candidate rules targeted for review. HHS is continuing to take
inventory of its existing, significant regulations to identify potentially outdated regulations,
which can be integrated into the retrospective regulatory review plan on an ongoing basis.
3

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