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CMS Releases FY 2012 Financial Report; Misses Target for Reductions in Improper Payments

CMS missed an important goal

set by President Obama to slash

improper government reimbursements

by 50 percent by 2012, according to

the Agency’s financial report released

on November 21. In June 2010,

President Obama launched a national

campaign to combat fraud and to

reduce wasteful government

spending. The campaign included a

government-wide program designed

to implement programs that would

target and reduce waste, fraud and

abuse in the Medicare program.

According to the Office of www.polsinelli.com

Management and Budget (OMB), the

improper payment rate for CMS at

that time (FY 2009) was 10.8 percent,

or $30.8 billion. The Obama

Administration set a target rate of 5.4

percent by 2012 for reducing

improper payments – half of what it

was in 2009. According to CMS’

financial report, the improper

payment rate for FY 2012 was 8.5

percent, down slightly from FY 2011

(8.6 percent). Durable medical

equipment claims held the highest

percentage of improper payment rates

at 66 percent. Physicians, labs and

ambulances combined carried a 9.9

percent improper payment rate,

inpatient hospitals had a 6.8 percent

Update for November 28, 2012

Top News ….. 1

State News ….. 7

Regulatory News ….. 8

Additional Reading …..11

Federal Register ….. 12

For More Information ….. 18

Top News

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rate, non-inpatient hospitals had a 4.8 percent rate, and

Medicare Part D had a 3.1 percent payment rate.

However, according to the OMB’s blog, the government

cut wasteful spending across all agencies and programs

by $47 billion over the past three years, “almost hitting

the President’s ambitious goal of avoiding $50 billion in

improper payments by the end of FY 2012.” The report,

“CMS Financial Report Fiscal Year 2012,” is available

here. The OMB’s blog post is available here.

CMS Releases Guidance on Medicaid/CHIP Issues

CMS’ Center for Medicaid and CHIP Services

released guidance in the form of a “frequently asked

questions” document on November 19 that addresses a

number of questions related to Medicaid/CHIP

Affordable Care Act-related implementation issues. The

document is intended to provide guidance to states as to

their obligations with respect to upgrading their eligibility

and enrollment systems for Medicaid and the Children's

Health Insurance Program. CMS said that states that are

not building their own exchanges or opting to expand

their Medicaid programs must still coordinate with the

federal government under the federally-facilitated

exchange, which will determine eligibility standards and

exchange subsidies. CMS also said that while enhanced

funding is available to all states and not just to those who

choose to expand their Medicaid programs, in order to

qualify for the enhanced federal match rate, their system

upgrades must meet all requirements, standards, and

conditions that were addressed in a final rule published

by CMS in April 2011. The FAQ document is available

here.

HHS Secretary Extends Deadline for Decision on

Exchanges

In response to a request from the Republican

Governors Association (RGA), HHS Secretary

Kathleen Sebelius has pushed back the deadline for

states to decide on the issue of the establishment of

their health insurance exchanges. She told the RGA on

November 16 that states will be granted a one month

extension to decide whether to set up their own

exchanges, and that they have until December 14 to

submit their letters of intent and detailed exchange

blueprint plans. February 15, 2013 remains the

deadline for states to decide if they will operate in

partnership with the federal government. She reassured

the RGA that guidance will be issued in the coming

days and weeks. Sebelius had previously extended the

deadline to December 14 for states to submit their

blueprints to build state-based exchanges. While a

number of governors have already declared their

intentions, several still remain undecided. Sebelius’

letter to the RGA is available here.

Three House Republicans Consider Creating New

Health Care Committee

Three House Republicans circulated a “Dear

Colleague” letter that

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deficit reductions that would prevent cuts to hospitals

by shifting them to other providers and increasing

beneficiary cost-sharing. The Affordable Care Act

mandated $155 billion in cuts, and hospitals are

concerned that deeper cuts will be made as part of the

deficit reduction talks. Hospitals particularly are

concerned about the potential for cuts to hospital

evaluation and management service payments. Instead,

the AHA pointed to other plans and proposals that have

been offered from a variety of sources, such as

President Obama’s budget proposals and the National

Commission on Fiscal Responsibility and Reform. The

list includes options such as creating a combined

Medicare Part A and Part B deductible, increasing the

Part B premium from 25 percent to 50 percent,

changing the Medicare eligibility age to 67, and

imposing a tax on certain employment-based health

plans in 2014 instead of 2018. Other provider groups

oppose such proposals, arguing they would hurt

beneficiaries.

Senate HELP Committee Holds Hearing on NECC

Compounding Issues

The Senate Committee on Health, Education, Labor

and Pensions (HELP Committee) held a hearing on

proposed shifting jurisdiction over health care from the

Energy & Commerce and Ways & Means committees to

a new Committee on Health Care. Reps. Doc Hastings

(R-WA), Rob Woodall (R-GA) and Reid Ribble (R-WI)

said that the jurisdictions of the current committees are a

“relic of decades of Democratic control” and that a new

health care committee would provide an opportunity to

reform or repeal the Affordable Care Act. The

Committee on Health Care would be a permanent

standing committee with complete jurisdiction on health

care matters and would “elevate and ensure relentless

oversight of Obamacare.” The three Republicans

reportedly are suggesting Rep. Paul Ryan (R-WI) to chair

the proposed committee.

Burgess Open to Shifting Part B Drug into Part D

Rep. Michael Burgess (R-TX) recently said he would

be open to moving the Part B outpatient drug benefit into

the Part D outpatient prescription drug benefit. He said

he would like to “eliminate all the silos – A, B, C and D –

and treat Medicare as an integrated program.” Part B

typically pays more for drugs, since prices are set at 106

percent of the average sales price except for vaccines and

DME-infused drugs, which are paid at 95 percent of the

average wholesale price as of October 1, 2003. Instead

of moving Part B drugs into Part D, some industry

sources said it would be better to consolidate all Part B

services, including the DME and laboratory fee schedule,

into a program that is modeled similarly to Part D.

Provider Groups Differ on Medicare Reform, Deficit

Reduction Targets

The American Hospital Association (AHA) is

circulating a list of previously discussed options for

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House Leaders Demand Documents from FDA

In related news, House leaders recently called on

FDA Commissioner Margaret Hamburg to submit

internal documents related to the deadly meningitis

outbreak no later than November 30, 2012. While

testifying before the House Energy & Commerce

Oversight and Investigations Subcommittee on

November 14, Commissioner Hamburg repeatedly

assured members that the Agency would provide the

documents, originally requested one month ago, in a

timely manner. In a letter to Commissioner Hamburg

dated November 16, Committee Chairman Fred Upton

(R-MI), Oversight and Investigations Subcommittee

Chairman Cliff Stearns (R-FL), Chairman Emeritus Joe

Barton (R-TX), Health Subcommittee Chairman Joe

Pitts (R-PA), and Rep. Michael C. Burgess, M.D. (R-

TX) wrote, “In order to effectively and responsibly

address the question of clarifying or enhancing FDA’s

authority over compounding pharmacies, the committee

must identify what happened at the New England

Compounding Center (NECC), and why FDA did not

use its authority to take enforcement action against

NECC until October 2012, after the meningitis

outbreak. Your agency has not provided any internal

communications or memoranda in response to the

committee’s bipartisan request letter of October 17,

November 15 over the recent meningitis outbreak that to

date has resulted in over 30 deaths and more than 500

serious illnesses. Lawmakers pressed pharmacy groups

testifying before the committee to provide assurances that

they would cooperate fully with lawmakers as they work

to develop preventative measures and to clarify the

FDA’s role in oversight of compounding pharmacies.

Committee Chairman Tom Harkin (D-IA) said the

Committee intends to pursue legislation to ensure the

safety of compounding pharmacies. Senator Lamar

Alexander (R-TN), slated to take over the ranking spot on

the committee, said not to expect the introduction of any

legislation until early next year, dismissing any concerns

that lobbying groups would move in with efforts against

any bill. “I don’t think lobbying forces are going to have

any luck on this one,” he said to reporters after the

hearing. The current Ranking Member, Senator Mike

Enzi (R-WY), said in his opening statement that the

Committee would continue to investigate the New

England Compounding Center conduct and the oversight

of state and federal regulators and would “leave no stone

unturned.” Top officials from the FDA, the CDC, the

Massachusetts and Tennessee Departments of Health,

Barry Cadden, the owner and director of the NECC, as

well as leaders of several pharmacy coalitions all testified

at the hearing. Testimony from the hearing is available

here. The Committee’s report, “The New England

Compounding Center and the Meningitis Outbreak of

2012: A Failure to Address Risk to the Public Health,” is

available here

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available here.

Medical Device Excise Tax Estimated to Increase

Industry’s Tax Liability by 29 Percent

The Affordable Care Act’s excise tax on medical

devices will add 29 percent a year to what the medical

device industry pays in federal income taxes, according

to AdvaMed. The device tax will increase taxes for the

industry by about $2.5 billion. This is in addition to the

$8.7 billion in overall federal income taxes the medical

device industry will pay in 2013. AdvaMed President

and CEO Stephen Ubl said, “A dramatic tax increase on

a job-creating industry like medical technology makes

no sense. A tax bill this big will only lead to fewer

jobs, reduced investment in tomorrow’s treatment and

cures, or higher health care costs for the consumer.”

AdvaMed, along with other industry trade groups, is

urging Congress to repeal the tax. A statement from

AdvaMed is available here.

GAO Finds CMS Delinquent in Reporting

Progress of FPS

A recent GAO study found that despite the

apparent success of CMS’ Fraud Prevention System

(FPS), CMS has

2012. We need these documents to identify any possible

weaknesses in FDA’s regulatory system that can be

immediately corrected administratively or legislatively.

Without gaining insight into whether FDA used its

existing authority effectively, providing clearer or

additional authority to FDA may not solve the actual,

underlying problem…” The letter to Commissioner

Hamburg is available here. Testimony from the hearing

“The Fungal Meningitis Outbreak: Could It Have Been

Prevented?” is available here.

Nursing Homes Criticize OIG Report on Billing

Errors

The American Health Care Association (AHCA)

sharply criticized a recent OIG report that found that

approximately 25 percent of skilled nursing home claims

billed in 2009 were in error. The OIG conducted a

medical record review of a random sample of SNF claims

from 2009 and concluded that Medicare inappropriately

paid $1.5 billion for these claims. The report said that

SNFs were improperly upcoding to achieve higher

reimbursement. The AHCA criticized the OIG for

questioning treatment decisions made three years ago

without the considering the patients’ and the clinicians’

perspectives. “Bureaucrats questioning these services

after three years and saying they know what’s in the best

interest of patients is not good medicine and doesn’t

make sense,” said AHCA President and CEO Mark

Parkinson. He added that the OIG report goes too far by

implying that “clinical decisions made in consultations

with doctors and therapists at the time of treatment

somehow constitutes wrongdoing.” The OIG report,

Inappropriate Payments to Skilled Nursing Facilities

Cost Medicare More Than a Billion Dollars in 2009, is

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Studies Find Alarming Rise in Diabetes Diagnoses

in the U.S.

The CDC published the results of a study that

shows an alarming rise in the number of diagnosed

cases of diabetes in the U.S. and Puerto Rico.

According to the report, the number of cases of diabetes

rose by 50 percent or more in 42 states over the period

between 1995 and 2010 and by 100 percent or more in

18 states during that same period. The states with the

largest increases were Oklahoma (226 percent),

Kentucky (158 percent), Georgia (145 percent),

Alabama (140 percent), Washington (135 percent), and

West Virginia (131 percent), according to the study.

The region with the greatest increase was the South and

the Northeast had the fewest number of newly

diagnosed cases. The investigators who conducted the

study predicted that barring significant lifestyle

changes, the number of cases of diabetes will climb to

as many as 552 million by the year 2030. The CDC

report, published in the CDC’s November 16, 2012

Morbidity and Mortality Weekly Report, is available

here.

In related news, researchers from the CDC have

generated yearly forecasts on the incidence of diabetes

diagnoses on youth under 20 years of age. The

researchers found that the numbers of individuals

failed to provide Congress with statutorily-required

updates on the usefulness of the system. The FPS,

initially launched in July 2011, uses computer-generated

predictive modeling and data analytics to ferret out

fraudulent Medicare fee-for-service claims. The

investigation was conducted at the request of a group of

senators who have made repeated requests to CMS for a

report outlining performance metrics associated with the

FPS. CMS reported initial performance measurements

and targets in September 2011 and said it would submit a

new report in June 2012, but has not yet done so. The

GAO recommended that CMS define quantifiable

benefits of the system, create performance targets and

milestones for use in measuring the success of the FPS,

develop a timeline for when the FPS system will be

integrated with the claims payments systems, and review

the system to assess its viability. The GAO report, “CMS

Has Implemented a Predictive Analytics System, but

Needs to Define Measures to Determine its

Effectiveness,” is available here.

“Doc Fix” to Cost More than Previously Estimated

According to the latest estimates from the

Congressional Budget Office (CBO), the “doc fix” is

going to cost taxpayers nearly $7 billion more for a one

year “fix” than was previously estimated in its last

projection. The CBO now says that delaying the cut and

freezing pay for doctors will cost $25 billion, a sharp

increase from its last projection of $18.5 billion.

According to its report, freezing doctors pay for 10 years

will cost as much as $244 billion, and a two-year “fix”

will cost $41.5 billion. Additional information about the

physician fee schedule is available here.

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about the exchange until our state receives clear,

binding rules from your department,” he wrote.

Tennessee Governor Bill Haslam announced that he

will wait until the new December deadline to decide,

anticipating that in the coming weeks HHS will issue

appropriate guidances.

Other governors have opted for federally-run

exchanges. Nebraska Governor Dave Heineman said

that although Nebraska was ready to run its own

exchange, his state is opting for a federally-run

exchange. He said in a statement that “the reality is

that the federal health care law is being totally dictated

and totally controlled by the federal government.”

Governor Robert Bentley of Alabama said that he

would not impose a “tax burden of up to $50 million on

the people of Alabama,” despite the fact that the state

has been actively planning for its exchange. Others

remain dubious. Indiana Governor-elect Mike Pence

said that running a state-based exchange would be too

expensive and thus, the state will have to opt for a

federally-run exchange. However, he said he would not

rule out a hybrid system. Wyoming will start with a

federal system, but lawmakers there are considering

measures to study progress and may opt for a state-

based exchange in the future. In Florida, Governor

Rick Scott, one of the most outspoken critics of the

ACA, said that he wants to negotiate with the federal

diagnosed with types 1 and 2 diabetes at ages younger

than 20 years is expected to rise significantly by 2050 –

by as much as 178 percent. The largest increases are

expected to occur in youth of minority racial and ethnic

groups. The study, “Projections of Type 1 and Type 2

Diabetes Burden in the U.S. Population Aged <20 Years

Through 2050,” is available here.

State News

Governors Speak Out on Exchanges

Following HHS Secretary Sebelius’ announcement

that states would be granted an additional 30 days to

decide about their health care exchanges, a number of

governors are again calling on HHS to produce rules and

guidance before they will make a formal decision. South

Carolina Governor Nikki Haley sent HHS a letter stating

that the state will not establish an exchange because HHS

has not issued formal rules defining how the exchanges

will operate. Utah Governor Gary Herbert sent HHS a

letter listing 10 questions regarding federal exchanges.

He said that he planned to continue to pursue Utah’s

state-based reforms, including “our vision for an

exchange based on defined contribution, consumer

choice, and free markets,” but Utah remains uncommitted

at this point. In Iowa, Governor Terry Branstad told

HHS that while Iowa will continue to create a state-based

exchange, it still is dependent on rules and guidance and

could end up switching over to a federally-run exchange

if it does not receive more details soon. “I cannot

provide you with a set of timelines or complete details

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that for fiscal years 2003 through 2007, five hospitals

were ineligible to receive those payments in one or

more of those years. In order to qualify as a DSH, at

least 1 percent of the hospital’s total inpatient

population must be Medicaid recipients. Over the five-

year period, New Jersey claimed $6.2 billion in DSH

payments to 109 hospitals. State officials contend that

while at least one of the hospitals involved may have

been ineligible, New Jersey submitted valid claims for

the other hospitals. The OIG report, “The New Jersey

Department of Human Services Claimed Medicaid

Disproportionate Share Hospital Payments to Five

Hospitals That Did Not Meet Federal Eligibility

Requirements (A-02-09-01017)” is available here.

Regulatory News

HHS Releases Proposed Rules to Implement

ACA’s Market Rules, Essential Health Benefits,

Wellness Provisions

HHS on November 20 released three proposed rules

to implement provisions of the Affordable Care Act

regarding essential health benefits, employer-based

wellness programs, requirements for insurance

government. He said that he is responsible for the

families of Florida and wants to “get to yes,” though he

would not clarify exactly how he intended to get there.

Massachusetts Implements New Healthcare Cost

Containment System

A newly-formed commission in Massachusetts has

taken on the task of overseeing reductions in state health

care expenditures as established under the state’s health

reform law. The panel, known as the Health Policy

Commission (HPC) will enforce cost containment

measures required by a state law that established a health

care cost growth benchmark equal to the potential

economic growth rate of the state for each of the next five

years. The HPC will focus on “gross abuses” and target

health care entities identified as excessively contributing

to cost growth. Those identified will be required to file a

performance improvement plan or seek a waiver, and

may be subject to a fine of up to $500,000. The HPC will

be assisted by a new state agency, the Center for Health

Information and Analysis, that will assume many of the

duties of the former Division of Health Care Finance and

Policy. Additional information about the Health Policy

Commission is available here.

OIG Says NJ Owes Feds $5 Million in Improper

Payments

A recent investigation conducted by HHS’ Office of

the Inspector General found that New Jersey owes the

federal government $50 million in improper payments

made to disproportionate share hospitals (DSH) that did

not meet the criteria for DSH status. The study found

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will prevent insurance companies from charging

individuals and small employers higher premiums due

to enrollee’s health status or gender. The proposed rule

is available here.

HHS also issued a proposed rule regarding

nondiscriminatory wellness programs in group health

coverage. The ACA allows employers to provide

discounts on health insurance to workers who achieve

certain medical or fitness goals, such as weight,

cholesterol level and blood pressure level. The

proposed rule raises the level of the permissible reward,

discount or penalty from 20 percent to 30 percent of the

cost of the health coverage. The rule also proposes to

increase the maximum reward to 50 percent for

programs to reduce tobacco use. The rule requires that

wellness programs must offer alternatives to programs

for people with doctor-certified health conditions that

make it “unreasonably difficult” to meet the specified

health-related standard. The proposed rule is available

here.

CMS Issues Guidance on Coverage Requirements

for Medicaid Expansion

CMS issued guidance on November 20 that defines

the minimum standards with which state Medicaid

programs must

premiums, risk pools and guaranteed availability of

coverage.

The essential health benefits proposed rule details the

items and benefits that health plans in the small and

individual group market will be required to cover. The

rule also proposes the specific actuarial values that health

plans will be required to meet. The rule proposes to

allow states to select a benchmark plan from four types of

health plans: the largest plan by enrollment in any of the

three largest small group insurance products in the state’s

small group market; any of the largest three state

employee health plans by enrollment; any of the largest

three national Federal Health Benefits Program plan

options; or the largest insured commercial non-Medicaid

Health Maintenance Organization operating in the state.

The essential health benefits proposed rule broadens

earlier HHS guidance on how plans must structure

prescription drug coverage. The proposed rule would

require that plans either cover one drug in every category

and class or the same number of drugs in each category

and class as the selected benchmark plan. This proposal

does not include “protected classes” of drugs that some

advocates requested. Advocates for patients with HIV/

AIDS are concerned that plans will only cover one drug

per class, which they considered inadequate protection.

The proposed rule is available here.

The “market” rule proposes a number of

requirements on health insurance premiums, guaranteed

availability, guaranteed renewability, risk pools, and

other insurance reforms. The rule would require health

insurers to accept individuals or employees who apply for

coverage in the individual or group market. Such

coverage also would include guaranteed renewability,

except for non-payment of premiums or fraud. The rule

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premiums as well as modest increases in the Part A

deductible. Medicare Part A pays for inpatient

hospitals, skilled nursing facilities, and some home

health care. Medicare Part A monthly premiums will

be $441 for 2013, a decrease of $10 from 2012. The

Part A deductible paid by beneficiaries when admitted

as a hospital inpatient will be $1,184 in 2013, an

increase of $28 from last year's deductible of $1,156.

The notice entitled “Medicare Program; Part A

Premiums for CY 2013 for the Uninsured Aged and for

Certain Disabled Individuals Who Have Exhausted

Other Entitlement [CMS-8047-N]” is available here.

The notice entitled “Medicare Program; Medicare Part

B Monthly Actuarial Rates, Premium Rate, and Annual

Deductible Beginning January 1, 2013 [CMS-8048-N]”

is available here. The notice entitled “Medicare

Program; Inpatient Hospital Deductible and Hospital

and Extended Care Services Coinsurance Amounts for

CY 2013 [CMS-8046-N]” is available here.

CMS Announces Data Sharing Performance

Measurement Project

CMS announced on November 21 a new project

designed to help consumers get more information

regarding the performance of their local doctors,

hospitals, and other health care providers. The

comply as they design coverage options under the

Medicaid expansion. In a letter to state Medicaid

directors, Cindy Mann, Director of the Center for

Medicaid and CHIP, said that there are a number of

options states may use in designing plans for their states’

Medicaid expansion, but at a minimum, benefits must be

actuarially equivalent to one of the four benchmark plans

as defined under the Deficit Reduction Act of 2005.

These include: 1) the Standard Blue Cross/Blue Shield

preferred provider option offered through the Federal

Employees Health Benefit program; 2) state employee

coverage that is generally made available to state

employees; 3) the commercial health maintenance

organization with the largest insured commercial, non-

Medicaid enrollment in the state; and 4) HHS Secretary-

approved coverage, which can include the Medicaid state

plan benefit package offered in that state. States seeking

to expand their Medicaid programs must also ensure that

the option they choose meets the essential health benefit

requirements as established under the ACA. The state

Medicaid director letter is available here.

HHS Publishes Medicare Parts A and B Rates for

CY 2013

HHS posted on November 16 the Medicare Part A

and Part B premiums, deductibles and coinsurance

amounts for 2013. The Medicare Part B standard

premium in 2013 will be $104.90, an increase over last

year’s premium of $99.90, and the Part B deductible will

be $147.00. Medicare Part B covers physicians’ services,

outpatient hospital services, certain home health services,

durable medical equipment, and other items. HHS also

announced a decrease in Medicare Part A monthly

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• Kaiser Commission on Medicaid and the

Uninsured: The Role of Medicaid for Adults with

Chronic Illnesses

• Kaiser Commission on Medicaid and the

Uninsured: The Cost and Coverage Implications of

the ACA Medicaid Expansion: National and State-

by-State Analysis

• Kaiser Health News: Doctors' and Nurses'

Licenses Snagged by New Immigration Law in

Georgia

• Kaiser Health News: Effort to Curb Medicare

Spending Begins With Crackdown on Hospital

Readmissions

• Los Angeles Times: U.S. Panel Advises HIV Tests

for Everyone Ages 15 to 64

• MedPage Today: Repeat Testing Common in

Older Patients

• Office of the Inspector General: Fall 2012

Semiannual Report to Congress

• Office of the Inspector General: OIG Reports $6.9

Billion in Expected Recoveries Among FY 2012

Accomplishments

• Office of the Inspector General Report: 2012 Top

Management and

Medicare Data Sharing for Performance Measurement

Program, also known as the Qualified Entity Program,

makes Medicare claims data available under strict

privacy requirements to groups that HHS certifies as

qualified to handle this data and protect patient privacy.

These groups will combine Medicare and private

insurance data to create comprehensive, useful reports on

provider performance. The three organizations selected

to participate in this project are the Health Improvement

Collaborative of Greater Cincinnati, the Kansas City

Quality Improvement Consortium (serving the Greater

Kansas City area in Missouri and Kansas), and the

Oregon Health Care Quality Corporation. All

participants have certified that they can manage and

process consumer-focused data and can prevent breaches

of protected health information. The organizations must

also show that they are working with private insurers to

access other payer data in order to produce

comprehensive reports on provider performance.

Additional details about this program are available here.

Additional Reading

• AHRQ: Long-Term Care for Older Adults: A

Review of Home and Community-Based Services

Versus Institutional Care

• Becker’s Hospital Review: U.S. Primary Care

Physician Adoption of EMRs Increases 50%, Still

Lags Other Countries

• Bloomberg: Hospital Medicare Cash Lures Doctors

as Costs Increase

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CDC published a notice announcing an upcoming

public meeting of the Advisory Committee on Breast

Cancer in Young Women. The meeting will be held

via telephone conference on December 13, 2012. The

notice is available here and appeared in the November

16 Federal Register.

CDC published a notice that a proposed collection

of information project entitled “Emergency Epidemic

Investigations” has been submitted to the OMB for

review and approval. Comments will be accepted for

30 days following publication. The notice is available

here and appeared in the November 19 Federal

Register.

CDC published a notice that a proposed collection

of information project entitled “Determining Causes of

Sudden, Unexpected Infant Death: A National Survey

of U.S. Medical Examiners and Coroners” has been

submitted to the OMB for review and approval.

Comments will be accepted for 60 days following

publication. The notice is available here and appeared

in the November 19 Federal Register.

Performance Challenges

• Urban Institute: Cross Cutting Issues: Will There Be

Enough Providers to Meet the Need? Provider

Capacity and the ACA

• Washington Post: Medicaid Personal-Care Programs

are Targets for Fraud, Investigators Say

• Washington Post: Millions Will Qualify for New

Options Under the Health Care Law. Most Have No

Idea.

• Washington Post: Report Says States Can Get More

Than $9 from Feds for Every $1 They Spend to

Expand Medicaid

Federal Register

CDC published a notice that a proposed collection

of information project entitled “Nationally Notifiable

Sexually Transmitted Disease (STD) Morbidity

Surveillance” has been submitted to the OMB for review

and approval. Comments will be accepted for 30 days

following publication. The notice is available here and

appeared in the November 16 Federal Register.

CDC published a notice that a proposed collection

of information project entitled “Spectrum of Flavoring

Chemical-Related Lung Disease” has been submitted to

the OMB for review and approval. Comments will be

accepted for 60 days following publication. The notice is

available here and appeared in the November 16 Federal

Register.

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Federal Register Continued

CDC published a notice announcing an upcoming public meeting of the Advisory Board on Radiation and Worker

Health. The meeting will be held December 11-12, 2012 in Knoxville, TN. The notice is available here and appeared in

the November 19 Federal Register.

CMS published a notice that a proposed collection of information project entitled “Children's Health Insurance

Program (CHIP) Report on Payables and Receivables” has been submitted to the OMB for review and approval.

Comments will be accepted for 31 days following publication. The notice is available here and appeared in the

November 16 Federal Register.

CMS published a notice that a proposed collection of information project entitled “Medicaid Report on Payables

and Receivables” has been submitted to the OMB for review and approval. Comments will be accepted for 31 days

following publication. The notice is available here and appeared in the November 16 Federal Register.

CMS published a notice that a proposed collection of information project entitled “State Health Insurance

Assistance Program (SHIP) Client Contact Form, Public and Media Activity Report Form, and Resource Report Form”

has been submitted to the OMB for review and approval. Comments will be accepted for 31 days following publication.

The notice is available here and appeared in the November 16 Federal Register.

CMS published a notice that a proposed collection of information project entitled “Valve Therapy Registry and

KCCQ-10” has been submitted to the OMB for review and approval. Comments will be accepted for 31 days following

publication. The notice is available here and appeared in the November 16 Federal Register.

CMS published a notice entitled “Recognition of Entities for the Accreditation of Qualified Health Plans.” This

notice announces the recognition of the National Committee for Quality Assurance (NCQA) and URAC as recognized

accrediting entities for the purposes of fulfilling the accreditation requirement as part of qualified health plan

certification. This notice is effective as of November 23, 2012. The notice is available here and appeared in the

November 23 Federal Register.

CMS, the Department of the Treasury, Internal Revenue Service, and the Department of Labor, Employee Benefits

Security Administration published a notice of proposed rulemaking entitled “Incentives

for Nondiscriminatory Wellness Programs in Group Health Plans [CMS-9979-P].”

This document proposes amendments to regulations, consistent with the Affordable

Care Act, regarding nondiscriminatory wellness programs in group health coverage.

These regulations also include other proposed clarifications regarding the reasonable

design of health-contingent wellness programs and the reasonable alternatives they

must offer in order to avoid prohibited discrimination. Comments will be accepted for

60 days following publication. The notice is available here and appeared in the

November 26 Federal Register.

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© 2012 Polsinelli Shughart Page 14 of 18

CMS published a notice that a proposed collection of information project entitled “Initial Plan Data Collection to

Support Qualified Health Plan (QHP) Certification and Other Financial Management and Exchange Operations” has

been submitted to the OMB for review and approval. Comments will be accepted for 30 days following publication.

The notice is available here and appeared in the November 21 Federal Register.

CMS published a notice that a proposed collection of information project entitled “Information Collection

Requirements for Compliance with Individual and Group Market Reforms under Title XXVII of the Public Health

Service Act” has been submitted to the OMB for review and approval. Comments will be accepted for 60 days

following publication. The notice is available here and appeared in the November 21 Federal Register.

CMS published a notice that a proposed collection of information project entitled “Medicare Uniform Institutional

Provider Bill and Supporting Regulations in 42 CFR 424.5” has been submitted to the OMB for review and approval.

Comments will be accepted for 60 days following publication. The notice is available here and appeared in the

November 21 Federal Register.

CMS published a notice that a proposed collection of information project entitled “Medicare Plan Finder

Experiment” has been submitted to the OMB for review and approval. Comments will be accepted until January 10,

2013. The notice is available here and appeared in the November 26 Federal Register.

CMS published a notice that a proposed collection of information project entitled “CMS Enterprise Identity

Management System” has been submitted to the OMB for review and approval. Comments will be accepted for 60 days

following publication. The notice is available here and appeared in the November 26 Federal Register.

CMS published a notice that a proposed collection of information project entitled “The Medicare Advantage and

Prescription Drug Program: Part C Explanation of Benefits CFR 422.111(b)(12)” has been submitted to the OMB for

review and approval. Comments will be accepted for 60 days following publication. The notice is available here and

appeared in the November 26 Federal Register.

CMS published a final notice announcing its decision to approve the American Association for Accreditation of

Ambulatory Surgery Facilities for continued recognition as a national accrediting organization for ambulatory surgery

centers that wish to participate in the Medicare or Medicaid programs, effective November 27, 2012 through November

27, 2018. The notice is available here and appeared in the November 26 Federal

Register.

CMS published a notice announcing an upcoming public meeting of the Advisory

Panel on Hospital Outpatient Payment. The meeting will be held March 11-12, 2013 at

the CMS Central Office in Woodlawn, MD. Individuals interested in attending this

meeting must preregister online and may do so January 9 through February 22, 2013.

Please see the notice available here for registration information. This notice appeared

in the November 26 Federal Register.

HEALTH REFORM + RELATED HEALTH POLICY NEWS | E-ALERT November 28, 2012

© 2012 Polsinelli Shughart Page 15 of 18

FDA published a notice that a proposed collection of information project entitled “Draft Guidance for Industry on

Safety Labeling Changes; Implementation of the Federal Food, Drug, and Cosmetic Act” has been submitted to the OMB

for review and approval. Comments will be accepted for 30 days following publication. The notice is available here and

appeared in the November 16 Federal Register.

FDA published a notice announcing an upcoming public meeting of the Neurological Devices Panel of the Medical

Devices Advisory Committee. The meeting will be held on December 10, 2012 in Gaithersburg, MD. The notice is

available here and appeared in the November 16 Federal Register.

FDA published a notice announcing an upcoming public hearing and request for comments entitled “Establishing a

List of Qualifying Pathogens that have the Potential to Pose a Serious Threat to Public Health.” The hearing will be held

on December 18, 2012 at the FDA’s White Oak Campus in Silver Spring, MD. Preregistration no later than December 3,

2012 is required for individuals who intend to make an oral presentation. Comments will be accepted until December 3,

2012. The notice is available here and appeared in the November 16 Federal Register.

FDA published a proposed rule entitled “Unique Device Identification System [Docket No. FDA-2011-N-0090].”

The FDA is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as

required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food

and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the

FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule’s requirements as

they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining. Comments will be accepted for

30 days following publication. The notice is available here and appeared in the November 19 Federal Register.

FDA published a notice entitled “Medical Devices; Custom Devices; Request for Comments.” The FDA is in the

process of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act

amended by FDASIA. FDA is seeking information on appropriate uses of the custom device exemption. Comments will

be accepted for 60 days following publication. The notice is available here and appeared in the November 19 Federal

Register.

FDA published a notice announcing the availability of draft guidance entitled “Draft Guidance for IRBs, Clinical

Investigators, and Sponsors: IRB Responsibilities for Review the Qualification of Investigators, Adequacy of Research

Sites, and the Determination of Whether an IND/IDE is Needed.’ To ensure

consideration, comments must be submitted no later than 60 days following

publication. The notice is available here and appeared in the November 20 Federal

Register.

FDA published a notice announcing the availability of draft guidance entitled

“Draft Guidance for Industry on Electronic Source Data in Clinical Investigations.” To

ensure consideration, comments must be submitted no later than 60 days following

publication. The notice is available here and appeared in the November 20 Federal

HEALTH REFORM + RELATED HEALTH POLICY NEWS | E-ALERT November 28, 2012

© 2012 Polsinelli Shughart Page 16 of 18

Register.

FDA published a notice announcing the availability of a guidance entitled “International Conference on

Harmonisation: Guidance on Q11 Development and Manufacture of Drug Substances.” The notice is available here and

appeared in the November 20 Federal Register.

FDA published two notices announcing an upcoming pubic meeting of the Pulmonary-Allergy Drugs Advisory

Committee. The meeting will be held January 29-30, 2013 at the FDA White Oak Campus in Silver Spring, MD. The

notices are available here and here and appeared in the November 20 Federal Register.

FDA published a notice and request for comments entitled “Development of Prioritized Therapeutic Area Data

Standards.” The FDA is announcing its intent to prioritize and develop therapeutic area data standards to facilitate the

conduct of clinical research and the regulatory review of medical products. Comments will be accepted for 60 days

following publication. The notice is available here and appeared in the November 20 Federal Register.

FDA published a notice announcing an upcoming public workshop entitled “Antiseptic Patient Preoperative Skin

Preparation Products; Public Hearing; Request for Comments.” The Agency is announcing a public hearing to obtain

input on how to address microbial contamination of patient preoperative skin preparation drug products. The public

hearing will be held December 12-13, 2012 in Silver Spring, MD. Preregistration no later than November 27 is required

of those wishing to make an oral presentation. Comments will be accepted until February 12, 2013. The notice is

available here and appeared in the November 21 Federal Register.

FDA published a notice entitled “Medical Device User Fee and Modernization Act; Notice to Public of Web Site

Location of Fiscal year 2013 Proposed Guidance Development. The FDA is announcing the website location where the

Agency will post two lists of guidance documents that the Center for Devices and Radiological Health is intending to

publish in FY 2013. In addition, FDA has established a docket where stakeholders may provide comments and/or

propose draft language for those topics, suggest new or different guidance documents, and comment on the priority of

topics for guidance. The notice is available here and appeared in the November 26 Federal Register.

FDA published a notice announcing an upcoming public meeting of the Risk Communication Advisory Committee.

The meeting will be held on February 12, 2013 at the FDA White Oak Campus in Silver Spring, MD. The notice is

available here and appeared in the November 26 Federal Register.

FDA published a notice announcing an upcoming public hearing and request for

comments entitled “FDA Actions Related to Nicotine Replacement Therapies and

Smoking-Cessation Products; Report to Congress on Innovative Products and

Treatments for Tobacco Dependence.” The hearing will be held on December 17,

2012 at the FDA White Oak Campus in Silver Spring, MD. Preregistration prior to

December 6 is required. Comments will be accepted until January 2, 2013. The notice

is available here and appeared in the November 28 Federal Register.

HEALTH REFORM + RELATED HEALTH POLICY NEWS | E-ALERT November 28, 2012

© 2012 Polsinelli Shughart Page 17 of 18

FDA published a notice withdrawing guidance for industry entitled “Enforcement Policy Concerning Rotational

Warning Plans for Smokeless Tobacco Products.” The withdrawal is effective November 28, 2012. The notice is

available here and appeared in the November 28 Federal Register.

FDA published a notice announcing an upcoming public meeting and request for comments entitled “Framework for

Pharmacy Compounding: State and Federal Roles.” The meeting will be held on December 19, 2012 at the FDA White

Oak Campus in Silver Spring, MD and via live webcast. Registration is required and will begin onsite at 2:00 p.m.

Comments will be accepted until January 18, 2013. The notice is available here and appeared in the November 28

Federal Register.

FDA put on display a notice that a proposed collection of information project entitled “Revision of the Requirements

for Constituent Materials” has been submitted to the OMB for review and approval. Comments will be accepted for 60

days following publication. The notice is available here and is scheduled to appear in the November 29 Federal Register.

FDA put on display a notice announcing the availability of draft guidance for industry entitled “Preclinical

Assessment of Investigational Cellular and Gene Therapy Products.” To ensure consideration, comments must be

received no later than 90 days following publication. The notice is available here and is scheduled to appear in the

November 29 Federal Register.

FDA put on display a notice announcing an upcoming public meeting of the Orthopaedic and Rehabilitation Devices

Panel of the Medical Devices Advisory Committee. The meeting will be held on April 5, 2013 in Gaithersburg, MD. The

notice is available here and is scheduled to appear in the November 29 Federal Register.

HHS published a notice announcing an upcoming public meeting of the President’s Advisory Council on Faith-

Based and Neighborhood Partnerships. The meeting will be held on November 29, 2012 at a location yet to be

determined in the White House complex. Space is extremely limited. Photo ID and RSVP are required to attend this

event. The notice is available here and appeared in the November 16 Federal Register.

HHS published a notice announcing an upcoming public meeting of the Advisory Committee on Minority Health.

The meeting will be held November 29-30, 2012 in Washington, DC. Preregistration is required. The notice is available

here and appeared in the November 19 Federal Register.

HHS published a notice that a proposed collection of information project entitled

“Medical Reserve Corps United Profile and Reports” has been submitted to the OMB

for review and approval. Comments will be accepted for 30 days following

publication. The notice is available here and appeared in the November 26 Federal

Register.

HHS published a notice entitled “Office of the National Coordinator for Health

Information Technology; Health Information Technology; HIT Policy Committee:

HEALTH REFORM + RELATED HEALTH POLICY NEWS | E-ALERT November 28, 2012

© 2012 Polsinelli Shughart Page 18 of 18

For questions regarding any of the issues covered in this Alert, please contact:

� Matthew J. Murer | Practice Area Chair | 312.873.3603 | mmurer@polsinelli.com

� Colleen M. Faddick | Practice Area Vice-Chair | 303.583.8201 | cfaddick@polsinelli.com

� Bruce A. Johnson | Practice Area Vice-Chair | 303.583.8203 | brucejohnson@polsinelli.com

� Alan K. Parver | Practice Area Vice-Chair | 202.626.8306 | aparver@polsinelli.com

� Darryl Drevna | Editor | 202.626.8303 | ddrevna@polsinelli.com

For More Information

Additional Health Care Public Policy Professionals

Julius W. Hobson, Jr. Washington, D.C. 202.626.8354 jhobson@polsinelli.com

Harry Sporidis Washington, D.C. 202.626.8349 hsporidis@polsinelli.com

Request for Comment Regarding the Stage 3 Definition of Meaningful Use of Electronic Health Records.” Comments

will be accepted until January 14, 2013. The notice is available here and appeared in the November 26 Federal Register.

HHS published a notice announcing an upcoming public meeting of the President’s Council on Fitness, Sports, and

Nutrition. The meeting will be held on December 13, 2012 via webinar. Preregistration is required. The notice is

available here and appeared in the November 28 Federal Register.

HHS published a notice announcing an upcoming public meeting of the World Health Organization’s Consultative

Expert Working Group on R&D Financing and Coordination. The meeting will be held on December 18, 2012 in

Washington, DC and via teleconference. Preregistration is required. The notice is available here and appeared in the

November 28 Federal Register.

NIH published a notice announcing an upcoming joint public meeting of the National Advisory Council on Alcohol

Abuse and Alcoholism, National Advisory Council on Drug Abuse, and the National Cancer Advisory Board. The

meeting will be held via telephone conference and webcast on December 13, 2012. The notice is available here and

appeared in the November 21 Federal Register.

HEALTH REFORM + RELATED HEALTH POLICY NEWS | ATTORNEYS November 28, 2012

© 2012 Polsinelli Shughart Page 19 of 18

Matthew J. Murer Practice Area Chair Chicago 312.873.3603 mmurer@polsinelli.com Colleen M. Faddick Practice Area Vice-Chair Denver 303.583.8201 cfaddick@polsinelli.com

Bruce A. Johnson Practice Area Vice-Chair Denver 303.583.8203 brucejohnson@polsinelli.com Alan K. Parver Practice Area Vice-Chair Washington, D.C. 202.626.8306 aparver@polsinelli.com Janice A. Anderson Chicago 312.873.3623 janderson@polsinelli.com Douglas K. Anning Kansas City 816.360.4188 danning@polsinelli.com

Jack M. Beal Kansas City 816.360.4216 jbeal@polsinelli.com

Cynthia E. Berry Washington, D.C. 202.626.8333 ceberry@polsinelli.com Mary Beth Blake Kansas City 816.360.4284 mblake@polsinelli.com Gerald W. Brenneman Kansas City 816.360.4221 gbrenneman@polsinelli.com

Teresa A. Brooks Washington, D.C. 202.626.8304 tbrooks@polsinelli.com Jared O. Brooner St. Joseph 816.364.2117 jbrooner@polsinelli.com Anika D. Clifton Denver

303.583.8275 aclifton@polsinelli.com Lawrence C. Conn Los Angeles 310.203.5336 lconn@polsinelli.com Anne M. Cooper Chicago 312.873.3606 acooper@polsinelli.com Lauren P. DeSantis-Then Washington, D.C. 202.626.8323 ldesantis@polsinelli.com S. Jay Dobbs St. Louis 314.552.6847 jdobbs@polsinelli.com Thomas M. Donohoe Denver

303.583.8257 tdonohoe@polsinelli.com Cavan K. Doyle Chicago 312.873.3685 cdoyle@polsinelli.com Meredith A. Duncan Chicago 312.873.3602 mduncan@polsinelli.com Erin Fleming Dunlap St. Louis 314.622.6661 edunlap@polsinelli.com

Fredric J. Entin Chicago 312.873.3601 fentin@polsinelli.com Jennifer L. Evans Denver 303.583.8211 jevans@polsinelli.com Colleen M. Fraddick Denver 303.583.8201 cfraddick@polsinelli.com T. Jeffrey Fitzgerald Denver 303.583.8205 jfitzgerald@polsinelli.com Kara M. Friedman Chicago 312.873.3639 kfriedman@polsinelli.com Rebecca L. Frigy St. Louis 314.889.7013 rfrigy@polsinelli.com Asher D. Funk Chicago 312.873.3635 afunk@polsinelli.com Randy S. Gerber St. Louis

314.889.7038 rgerber@polsinelli.com Mark H. Goran St. Louis 314.622.6686 mgroan@polsinelli.com Linas J. Grikis Chicago 312.873.2946 lgrikis@polsinelli.com Lauren Z. Groebe Kansas City 816.572.4588 lgroebe@polsinelli.com

Brett B. Heger Dallas 314.622.6664 bheger@polsinelli.com Jonathan K. Henderson Dallas 214.397.0016 jhenderson@polsinelli.com Margaret H. Hillman St. Louis 314.622.6663 mhillman@polsinelli.com Jay M. Howard Kansas City 816.360.4202 jhoward@polsinelli.com

Cullin B. Hughes Kansas City 816.360.4121 chughes@polsinelli.com Sara V. Iams Washington, D.C. 202.626.8361 siams@polsinelli.com George Jackson, III Chicago 312.873.3657 gjackson@polsinelli.com Bruce A. Johnson Denver 303.583.8203 brucejohnson@polsinelli.com

HEALTH REFORM + RELATED HEALTH POLICY NEWS | ATTORNEYS November 28, 2012

© 2012 Polsinelli Shughart Page 20 of 18

Joan B. Killgore St. Louis 314.889.7008 jkillgore@polsinelli.com Anne. L. Kleindienst Phoenix 602.650.2392 akleindienst@polsinelli.com Chad K. Knight Dallas

214.397.0017 cknight@polsinelli.com Dana M. Lach Chicago 312.873.2993 dlach@polsinelli.com Jason T. Lundy Chicago 312.873.3604 jlundy@polsinelli.com Ryan M. McAteer Los Angeles 310.203.5368 rmcateer@polsinelli.com Jane K. McCahill Chicago 312.873.3607 jmccahill@polsinelli.com Ann C. McCullough Denver

303.583.8202 amccullough@polsinelli.com

Aileen T. Murphy Denver 303.583.8210 amurphy@polsinelli.com Gerald A. Niederman Denver 303.583.8204 gniederman@polsinelli.com Edward F. Novak Phoenix

602.650.2020 enovak@polsinelli.com Thomas P. O’Donnell Kansas City 816.360.4173 todonnell@polsinelli.com Aaron E. Perry Chicago 312.873.3683 aperry@polsinelli.com Mitchell D. Raup Washington, D.C. 202.626.8352 mraup@polsinelli.com Daniel S. Reinberg Chicago 312.873.3636 dreinberg@polsinelli.com Donna J. Ruzicka St. Louis

314.622.6660 druzicka@polsinelli.com

Charles P. Sheets Chicago 312.873.3605 csheets@polsinelli.com Kathryn M. Stalmack Chicago 312.873.3608 kstalmack@polsinelli.com Leah Mendelsohn Stone Washington, D.C.

202.626.8329 lstone@polsinelli.com Chad C. Stout Kansas City 816.572.4479 cstout@polsinelli.com Steven K. Stranne Washington, D.C. 202.626.8313 sstranne@polsinelli.com William E. Swart Dallas 214.397.0015 bswart@polsinelli.com Tennille A. Syrstad Denver 312.873.3661 etremmel@polsinelli.com Emily C. Tremmel Chicago

303.583.8263 tysrstad@polsinelli.com

Andrew B. Turk Phoenix 602.650.2097 abturk@polsinelli.com Joseph T. Van Leer Chicago 312.873.3665 jvanleer@polsinelli.com Andrew J. Voss St. Louis

314.622.6673 avoss@polsinelli.com Joshua M. Weaver Dallas 214.661.5514 jweaver@polsinelli.com Emily Wey Denver 303.583.8255 ewey@polsinelli.com Mark R. Woodbury St. Joseph

816.364.2117 mwoodbury@polsinelli.com Janet E. Zeigler Chicago 312.873.3679 jzeigler@polsinelli.com

HEALTH REFORM + RELATED HEALTH POLICY NEWS | ABOUT November 28, 2012

© 2012 Polsinelli Shughart Page 21 of 18

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