february 6, 2012 monday memo health reform update · 2016-09-26 · deloitte center for health...

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Deloitte Center for Health Solutions February 6, 2012 Monday memo Health reform update My take From Paul Keckley, Executive Director, Deloitte Center for Health Solutions Last week was a numbers week: election returns in Florida and Nevada, the Super Bowl, speculation about Facebook’s initial public offering (IPO) valuation, the Dow at its peak since 2008, and others, but the numbers that caught my attention most came from the Congressional Budget Office (CBO) last Tuesday: For fiscal year (FY) 2012 ending September 30, the U.S. deficit will be $1.079 trillionthe fourth consecutive year of trillion-plus deficits. Just last August, the FY12 forecast had been a $953 billion deficit but the CBO update accounted a tepid economic recovery and less than optimal gross domestic product (GDP) growth. The Politico headline Wednesday summed it up well: “Deficit forecast gloomy for years”. In its 147-page report, the CBO says the GDP for FY12 will be 2.0% versus its August estimate at 2.7%, unemployment at 8.7% versus its earlier prediction of 8.5%, and $4.7 trillion additional deficit continuing through 2017 with interest expense at decade-end of $600 billionmore than the federal government spends on Medicaid. February 13, the President will present his budget for FY13. It will then begin its journey through the legislative processes of Congress and no doubt will be a target for political punditry. Regardless of party stripe or philosophical bent, the facts are clear: the U.S. economy has been struggling. And health costs are a contributing factor. Last month, the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary released its analysis of 2010 National Health Expenditures noting that spending increased 3.9%lowest annual increase in 30 years. It attributed the slowdown from double digits two decades earlier to a sluggish economy with lower utilization as consumers succumb to pocketbook pressures, plus lower insurance premiums and lower costs for technologies and therapies (medical inflation). But it warned costs would likely uptick again regardless of economic recovery. Seems to me the number one agenda item in discussing the U.S. health system is cost containment: the status quo is not sustainable, not just for those lacking insurance or small businesses, but for everyone. In May of 2009, the Deloitte Center for Health Solutions hosted a series of meetings in Washington with leading trade association representatives and the White House Office of Health Reform. The goal: to find $2 trillion in cost reductions that would simultaneously

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Page 1: February 6, 2012 Monday memo Health reform update · 2016-09-26 · Deloitte Center for Health Solutions February 6, 2012 Monday memo Health reform update My take From Paul Keckley,

Deloitte Center for Health Solutions

February 6, 2012

Monday memo

Health reform update

My take

From Paul Keckley, Executive Director, Deloitte Center for Health Solutions

Last week was a numbers week: election returns in Florida and Nevada, the Super Bowl,

speculation about Facebook’s initial public offering (IPO) valuation, the Dow at its peak

since 2008, and others, but the numbers that caught my attention most came from the

Congressional Budget Office (CBO) last Tuesday:

For fiscal year (FY) 2012 ending September 30, the U.S. deficit will be $1.079 trillion—the

fourth consecutive year of trillion-plus deficits. Just last August, the FY12 forecast had

been a $953 billion deficit but the CBO update accounted a tepid economic recovery and

less than optimal gross domestic product (GDP) growth.

The Politico headline Wednesday summed it up well: “Deficit forecast gloomy for years”.

In its 147-page report, the CBO says the GDP for FY12 will be 2.0% versus its August

estimate at 2.7%, unemployment at 8.7% versus its earlier prediction of 8.5%, and $4.7

trillion additional deficit continuing through 2017 with interest expense at decade-end of

$600 billion—more than the federal government spends on Medicaid.

February 13, the President will present his budget for FY13. It will then begin its journey

through the legislative processes of Congress and no doubt will be a target for political

punditry.

Regardless of party stripe or philosophical bent, the facts are clear: the U.S. economy has

been struggling. And health costs are a contributing factor.

Last month, the Centers for Medicare & Medicaid Services (CMS) Office of the Actuary

released its analysis of 2010 National Health Expenditures noting that spending increased

3.9%—lowest annual increase in 30 years. It attributed the slowdown from double digits

two decades earlier to a sluggish economy with lower utilization as consumers succumb

to pocketbook pressures, plus lower insurance premiums and lower costs for technologies

and therapies (medical inflation). But it warned costs would likely uptick again regardless

of economic recovery.

Seems to me the number one agenda item in discussing the U.S. health system is cost

containment: the status quo is not sustainable, not just for those lacking insurance or

small businesses, but for everyone.

In May of 2009, the Deloitte Center for Health Solutions hosted a series of meetings in

Washington with leading trade association representatives and the White House Office of

Health Reform. The goal: to find $2 trillion in cost reductions that would simultaneously

Page 2: February 6, 2012 Monday memo Health reform update · 2016-09-26 · Deloitte Center for Health Solutions February 6, 2012 Monday memo Health reform update My take From Paul Keckley,

improve population-based health and safety. I reviewed the file this weekend; it’s time to

reconsider some suggestions posed in that series of meetings:

Could health plans, Medicare and Medicaid leverage ICD-10 investments, and

accelerate administrative simplification to reduce paperwork and waste?

Could employers be given wider latitude to reward healthy behaviors and aggressively

address irresponsible behavior by employees/retirees/enrollees?

Could e-prescribing be significantly accelerated to reduce medication error and

avoidable admissions and re-admissions to hospitals?

Could the medical home methods be accelerated by states to manage dual eligibles?

Could incentives for physicians and hospitals be changed from volume to value-based

on demonstrated appropriateness for diagnostic testing and surgery?

Could frivolous lawsuits against physicians, hospitals, long term care providers, and

plans be eliminated through a streamlined medical court system?

Could funds from the Troubled Asset Relief Program (TARP) be used to reduce

unnecessary acute capacity in over-bedded markets?

Could fraud be more aggressively detected and prosecuted?

Could Medicare and Medicaid be structured as managed care programs to reward

coordination, efficiency, and quality?

Could “health” and “human services” services programs in local communities be

merged to provide a seamless, comprehensive preventive health program?

Could the education of health professionals in the U.S. be streamlined to produce

qualified individuals faster and reward competence from demonstrated lifelong

learning?

Could patent laws be re-structured to get promising therapies and companion

diagnostics to the market faster as generics while rewarding inventors?

Could primary care services be expanded and compensation increased to

aggressively arrest increased prevalence of chronic diseases and costs associated

with non-intervention?

Could elimination of the tax credit for employer sponsored coverage level force active

consumerism into the system?

And could the U.S. public education system at all levels increase education about

health and the health system in its core curriculum to combat widespread consumer

ignorance and irresponsible behavior?

These are bold ideas: they involve risk. Some found their way into the Affordable Care Act

(ACA), some did not.

Regardless of the outcome of the ACA’s constitutional challenges this year, the U.S.

health system must face its cost spiral as its number one aim. Solutions must be

developed based on facts and political brinksmanship set aside for the greater good.

This week marks the start of the 4th year I’ve written this Memo. On February 2, 2009 as

the American Recovery and Reconstruction Act (ARRA) was passing, I wrote: “The

stimulus program is only Chapter One of health reform. Chapter Two will be about the

more substantive health reforms likely to include tricky issues like individual mandates,

employer pay or play, comparative effectiveness implementation, insurance market

reform, and costs.”

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The book on U.S. health reform is not yet written. ACA is a chapter. The market will write

others. What’s clear is that the affordability of health care—costs—is a theme that will run

through each. It’s time to get serious about costs. To avoid the discussion is to guarantee

the demise of the system’s strengths and the certainty of a two tiered system long-term:

one for those that can afford it, and a second for those that can’t.

return to top

This week’s headlines: My take

Implementation update - HHS requests U.S. Supreme Court to extend argument on Anti-Injunction Act on ACA

challenge - Update: essential health benefits guidance - HHS: ACA saved $2.1 billion for Medicare prescription drug costs - Bill to exclude brokers’ commissions in the medical loss ratio calculation introduced - Representative introduces bill to repeal PCORI - House votes to repeal CLASS Act

Legislative update - CBO projects $1.079 trillion deficit for FY12 - FDA improvements sought to address drug shortages - CBO: war savings calculation, target for SGR fix proponents - GOP physicians ask AARP for Medicare reform details - Rubio seeks EHB exclusion for religious organizations - Representatives introduce bill to increase health care access in rural areas - Representatives introduce legislation to amend 510(k) drug review process

State update - State round-up

Industry news - Study: insurance fee cost Medicaid $38.4 billion - HHS: Medicare Advantage premiums down 7%, enrollment up 10% - GAO: prices for medical devices vary widely, not transparent - Moody’s: rough year ahead for not-for-profit hospitals - IRS releases proposed regulations for taxable medical devices - FDA and device industry recommend $595 million in drug user fees - Medical practices: ICD-10 Version 5010 conversion creating payment glitches - National Quality Forum endorses resource use and costs quality measures - Prior authorization of power mobility devices and recovery audit prepayment review

demonstrations to start June 1, 2012 - CBO: federal worker benefits better than private employers - FDA approves “first ever” drugs for cystic fibrosis, basal skin cell cancer - Study: state nursing workload mandates reduce RN overtime slightly - HHS OIG: data inconclusive about physicians opting out of Medicare

Quotable

Fact file

National Health Reform: what now?

Subscribe to the Health Care Reform Memo

Deloitte Center for Health Solutions research and news

Deloitte contacts

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Implementation update

HHS requests U.S. Supreme Court to extend argument on Anti-Injunction

Act on ACA challenge Friday, the U.S. Department of Health and Human Services (HHS) petitioned the U.S.

Supreme Court to add 30 minutes to the its scheduled one hour opening argument March

26 re: the applicability of the Anti-Injunction Act (AIA) to the ACA.

Note: AIA prevents individuals from suing over a tax until the tax has been paid. The

individual mandate is effective 2014, thus individuals would not start paying the penalty for

not obtaining health insurance until after 2015.

March 26-28, the Supreme Court has scheduled 5.5 hours of oral arguments on the four

ACA challenges: anti-injunction act applicability, individual mandate, severability, and

Medicaid expansion requirements.

return to top

Update: essential health benefits guidance

Tuesday was the last day for comments to HHS on its initial essential health benefits

(EHB) bulletin dated December 16, 2011, in which states are required to set a

“benchmark” for coverage in the EHB package based on standards that would vary in

each state. ACA Section 1302 requires EHB to include services in ten defined benefit

categories and requires coverage equivalent to a typical employer plan in a state.

Note: several health care trade organizations argue the need for uniformity across states;

others are pushing for state flexibility.

return to top

HHS: ACA saved $2.1 billion for Medicare prescription drug costs

Thursday, HHS released a report indicating 3.6 million Medicare enrollees saved $2.1

billion on their prescription drugs in 2011. The report forecasts that the average Medicare

enrollee who hits the “donut hole” will save $4,200 by 2021. Last year, 3.6 million seniors

hit the “donut hole” and saved an average of $604 on their medications.

return to top

Bill to exclude brokers’ commissions in the medical loss ratio calculation

introduced

Thursday, Senator Mary Landrieu (D-LA) introduced the “Access to Independent Health

Insurance Advisers Act of 2012” (S. 2068) that would exclude agents’ and brokers’

commissions from the medical loss ratio (MLR) calculation per Section 1001.

Note: Senate legislation re: medical loss ratio differ from the House version in three areas:

inclusion of broker commissions in MLR calculations, scope—whether applicable to other

than individual and small-group market commissions, and expansion allowances for MLR

waivers. Differences in the two will be resolved in forthcoming joint conference committee.

return to top

Representative introduces bill to repeal PCORI On January 25, Representative Brett Guthrie (R-KY) introduced a bill (H.R. 3827) that

would repeal the Patient-Centered Outcomes Research Institute (PCORI) and

comparative effectiveness research (CER).

Note: PCORI per Section 6301 of ACA is responsible for implementing the CER program

that will provide industry stakeholders and the public readily accessible information about

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the evidence supporting the full range of diagnostic and treatment options. Physicians are

concerned it will infringe on their clinical autonomy. Other critics argue it will lead to

government control of treatment decisions including end of life acre and rationing.

For more information on CER, see Deloitte Center for Health Solutions’ study,

“Comparative Effectiveness Research in the United States: Update and implications,”

June 27, 2011, www.deloitte.com/us/cerupdate2011.

return to top

House votes to repeal CLASS Act Wednesday, the U.S. House of Representatives voted (267-159) to repeal the Community

Living Assistance Services and Support (CLASS) program, per ACA Section 8002.

Republican members were joined by 28 Democrats in the majority vote.

Note: CMS announced last year that it would halt implementation of the CLASS program

because actuaries found that it is not actuarially sound. The CBO indicates it will reduce

revenues in ACA funding $75 billion over ten years.

The bill now goes to the Senate where it is expected to pass.

return to top

Legislative update

CBO projects $1.079 trillion deficit for FY12 Tuesday, the CBO released its budget projections for FY12 through FY22, projecting a

$1.079 trillion deficit for FY12 (year ending September 30, 2012). Measured as a share of

the nation’s GDP, a shortfall of 7% is projected, 2% below the FY11 deficit. Per the CBO

baseline projection, deficits will decline to $200 billion averaging 1.5% of GDP over the

2013–2022 period, assuming the 2001 and 2003 tax cuts and the payroll tax holiday

expire in 2013, spending cuts per the Budget Control Act of 2011 (averaging $109

billion/year including a 2% Medicare cut) are implemented, and physician pay is cut per

the sustainable growth rate (SGR) formula (27.4% scheduled March 1, 2012). If these

three assumptions are not included in the baseline budget, the CBO estimates deficits

would average 5.4% of GDP from 2013 to 2022 and public debt would increase to 94% of

GDP in 2022—the highest since 1946.

Key assumptions in CBO projections:

Focus CBO projections

Overall

economy

The economy will recover slowly, with real GDP growing 2% this year

and 1.1% next year.

Economic activity will quicken after 2013 but remain below the

economy’s potential until 2018.

The unemployment rate will remain above 8% in 2012 and next year,

due to weakness in demand for goods and services. As economic

growth picks up after 2013, the unemployment rate will gradually

decline to around 7% by the end of 2015, before dropping to near

5.5% by the end of 2017.

Affordable

Care Act

The ACA will cost $54 billion more than expected between 2012 and

2021, the result of repeal of the CLASS Act (reducing $76 billion in

premiums) and correction of the modified adjusted gross income

formula used to calculate Medicaid eligibility (the Medicaid glitch)

netting revenue increase of $22 billion).

Medicare If physician payment rates remain at current levels through 2022,

Medicare spending (net of premiums) will be $9 billion higher in 2012

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and $316 billion (or about 5%) higher from 2013 to 2022.

Medicare’s Hospital Insurance Trust Fund (hospitals and post-

treatment care service providers paid under Medicare Part A) will be

insolvent in 2022 vs. 2024 in its August projection.

Medicare spending (excluding receipts from premiums) increased 8%

in 2011 and are projected to be about 8% in 2012.

Federal

spending on

Medicaid

(does not

include state

matching

funds)

The Federal Medicaid spending match will be $605 billion in 2022—2.5

% of GDP, compared with 1.7% in FY12.

Federal Medicaid spending will increase by $24 billion from 2012 to

2021 due to medical inflation and higher enrollment.

The Federal spending match will decrease 5% in 2012 as states

become responsible for a higher share of total costs than in recent

years.

Total Medicaid spending will increase in 2013 and increase rapidly in

2014, 2015, and 2016 due to ACA.

Source: CBO, “The Budget and Economic Outlook: Fiscal Years 2012 to 2022,” January

2012.

return to top

FDA improvements sought to address drug shortages Tuesday, legislation was introduced in the House to expedite the U.S. Food and Drug

Administration (FDA) review of medications, improve communication within the agency

and with stakeholders about possible shortages, and increase Drug Enforcement

Administration quotas for medications in short supply.

return to top

CBO: war savings calculation, target for SGR fix proponents

Tuesday, the CBO released its budget outlook for 2012 noting savings of $838 billion over

ten years for planned reductions in defense spending. SGR fix advocates estimate a

permanent fix would cost $316 billion and are pushing administration officials to earmark

war savings to the SGR. Last week, several hospital trade groups sent a letter to

Congress suggesting a permanent fix to the SGR necessary and encouraging further cuts

to hospitals would hurt job growth and debilitate hospitals. In their letter Wednesday, the

groups said, “H.R. 3630 as passed by the House in December jeopardizes access to care

for all patients by cutting more than $20 billion in hospital payments. Cuts of this

magnitude will mean fewer nurses, longer waits for emergency care and decreased

access to new treatments… America's hospitals encourage you to look elsewhere to pay

for changes to the sustainable growth rate.”

return to top

GOP physicians ask AARP for Medicare reform details

In a letter Wednesday, GOP physicians Rep. Phil Gingrey (R-Ga.) and Sen. Tom Coburn

(R-Okla.), reached out to the AARP requesting “concrete details” for re-structuring

Medicare to achieve fiscal solvency.

return to top

Rubio seeks EHB exclusion for religious organizations

Sen. Marco Rubio (R-FL) introduced the “Religious Freedom Restoration Act of 2012” last

week to exclude provisions in the August 1, 2011 HHS directive that EHB must include

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free sterilization and all FDA-approved contraceptives, including drugs that many believe

induce abortions. His bill calls for an exemption for those religious organizations including

charities, hospitals, schools, or soup kitchens that hire or serve individuals who do not

share their religious tenets.

return to top

Representatives introduce bill to increase health care access in rural areas

Wednesday, Representatives Cathy McMorris Rodgers (R-WA) and Mike Thompson (D-

CA) introduced the “Rural Hospital and Provider Equity Act (R-HOPE) of 2012” to protect

and expand access to high quality health care in rural communities. The legislation would

increase Medicare and Medicaid disproportionate hospital payments to rural hospitals,

improve lab services payments in rural hospitals, continue geographic reclassification for

specific hospitals in less populated states, ensure adequate representation of rural

communities on the Medicare Payment Advisory Commission (MedPAC), increase rural

health clinic reimbursements, and extend several expiring Medicare incentive payments

for rural hospitals.

Note: 75 million (25%) Americans live in rural areas; 10% of physicians practice in rural

settings.

return to top

Representatives introduce legislation to amend 510(k) drug review process

Tuesday, Representative Edward Markey (D-MA) introduced the “Safety of Untested and

New Devices Act (SOUND Act)” to disallow the FDA rejection of new devices through the

510(k) device pathway to “ensure that a medical device is not marketed based on a

determination that the device is substantially equivalent to a predicate device that has

been recalled, corrected, or removed from the market because of an intrinsic flaw in

technology or design that adversely affects safety, and for other purposes.”

Note: the 510K process in the FDA is drawing increased scrutiny from legislators who

argue it has been lax in reviewing submissions resulting in safety issues with certain

medical devices that should not have been approved.

return to top

State update

State round-up Wednesday, a federal judge in California issued an injunction blocking a 10% reduction

in Medicaid reimbursements to doctors. California sought and received CMS permission

for the reimbursement cuts to help fill its budget deficit that stands at $9 billion. CMS

projected that the 10% Medicaid payment cuts would save California $623 million.

California’s governor is seeking approval to reduce Medicaid payments by almost an

additional $850 million.

Connecticut is projected to need 9,000 additional home care workers by 2016 to

provide long-term care at home or in the community: Connecticut’s population age 65 and

over will increase 64% while the population under age 65 will decrease.

Monday, a Florida state Senate committee voted against the Health Care Consumer

Protection bill that would require ambulatory care centers, diagnostic-imaging centers,

and physicians to publish out-of-pocket prices for commonly provided health care services

(already required for urgent care centers). This bill was previously passed by a Florida

state House committee.

Wednesday, Louisiana implemented the Bayou Health initiative that transitions 180,000

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residents in the southeast region of the state from the state Medicaid program to

managed care, including a shared savings and enhanced primary care case management

model. When implemented statewide, the program will cover 800,000 and cost $2.2 billion

annually.

Utah State Representative Paul Ray (R) proposed a bill to allow Medicaid to charge

higher copayments for Medicaid enrollees who use tobacco. Per Ray, Medicaid enrollees

who smoke increase health care costs in Utah by $104 million each year. Note: Medicaid

enrollees have a 60% on average higher smoking rate than the general population

(American Lung Association).

return to top

Industry news

Study: insurance fee cost Medicaid $38.4 billion Last week, Medicaid health insurance companies released a study by Milliman concluding

the fee levied against insurance companies starting in 2014 in the ACA (Section 9009) will

cost state Medicaid programs $38.4 billion ($13.6 billion for states and $28.4 billion for the

federal government) over ten years as a result of the state’s shared funding responsibility

with federal funds.

Note: per ACA, health insurance companies will pay an annual fee starting calendar year

2014 as follows: $8 billion (2014), $11.3 billion (2015), $11.3 billion (2016), $13.9 billion

(2017), $14.3 billion (2018) and thereafter indexed to the rate of premium growth for the

prior year.

return to top

HHS: Medicare Advantage premiums down 7%, enrollment up 10% HHS Secretary Sebelius announced Wednesday that Medicare Advantage average

premiums fell $33.97 in 2011, to $31.54 in 2012, and enrollment increased 11.7 million in

2011 to 12.8 million in 2012. Her report also noted that the average Medicare beneficiary

has 26 Medicare Advantage plan choices. Part C premiums fell by 16% and enrollment

increased 17% since passage of the ACA in March 2010.

return to top

GAO: prices for medical devices vary widely, not transparent Friday, the Government Accountability Office (GAO) released its analysis of device pricing

variation in 31 hospitals done at the request of Sen. Max Baucus (D-MT), Chairman of the

Senate Finance Committee. The key finding: prices for the same device vary widely and

are not transparent to physicians, employers, or consumers. The report noted that

contracts between hospitals and manufacturers and/or group purchasing organizations

often preclude disclosure of terms and limit transparency. It also noted that as hospitals

employ more physicians, they would be in a stronger position to engage employed

physicians in gainsharing arrangements to encourage use of cheaper but equally effective

devices.

return to top

Moody’s: rough year ahead for not-for-profit hospitals Last week, Moody’s released its outlook for non-profit hospitals, remaining negative for

four reasons:

1. Downward pressures on hospital revenue. Payments by Medicare, Medicaid and

commercial payers will cut margins.

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2. Uncertainty as a result of health reform. “Fiscal year 2013, which starts October 1,

2012, will be a telling year of the health care reform law, assuming it stands in the

Supreme Court. FY13 is when several new aspects of the healthcare reform law will

begin, including bundled payment programs and penalties for hospitals that have high

30-day readmission rates for acute myocardial infarction, heart failure, and

pneumonia. Additionally, hospitals have to gear up further for ICD-10 by October 1,

2013, and the potential of tens of millions of people that could be added to insurance

rolls by January 1, 2014, if the individual mandate passes.”

3. Sluggish economic recovery. “The sluggish economy means spending will not

increase dramatically and bad debt is likely to increase as employment stagnates,

consumers delay care and out-of-pocket responsibilities for consumers increase.”

4. Liquidity, balance sheet challenges. “Pressure on not-for-profit balance sheets is

high compared with historical levels due to investment volatility, growing pension

obligations, more exposure to non-cancellable operating leases, an increase of capital

spending funded with cash reserves.”

Note: not mentioned by Moody’s but relevant to hospital sustainability, three additional

factors: (1) as hospitals employ more physicians, capital & operating resources will be

deployed to support clinical integration and cut/delay other revenue producing

investments, (2) unrestricted gifts to NFP hospitals have slowed due to the economic

downturn, and (3) supply chain costs are increasing.

Later this month, the Deloitte Center for Health Solutions will release a summary of

interviews with 24 major health system CEOs, addressing their plans for the “new normal”.

Findings of these interviews are consistent with Moody’s forecast. Top concerns for health

system CEOs (number of mentions in 24 interviews):

Physician alignment and integration into leadership roles (23)

Reduction in operating costs to respond to cuts from payers (21)

Integration of non-acute services to become a system of care (20)

Management in uncertainty as a result of health reform, payer consolidation, fiscal

constraints (20)

Implementation of health information technologies and integration into evidence-

based care (13)

Building new/non-conventional relationships with commercial health plans to share

risk and savings (12)

More directly engagement with employers and consumers (8)

Re-design of current acute clinical programs to be responsive to innovation in

diagnostics and therapeutics (8)

Engagement with consumers in wellness, preventive health, and personal

accountability (8)

Protection or enhancement of the brand and reputation of the system (7)

The bottom line: health system CEOs believe market pressures inclusive of but not limited

to requirements of the ACA threaten their solvency and sustainability. While

acknowledging unknowns in the ACA, they are seemingly more vexed by increased

pressures on revenues and operating margins—the result of many factors.

return to top

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IRS releases proposed regulations for taxable medical devices February 3, 2012, the Internal Revenue Service (IRS) issued proposed regulations

addressing the Medical Device Excise Tax enacted in ACA Section 9009 as amended by

Section 1405. This provision adds a 2.3% excise tax on medical devices beginning

January 1, 2013, designed to raise up to $20 billion in revenues over ten years. The

proposed rules propose to define taxable devices as all devices listed under a single

product code listing in conjunction with the FDA device listing requirement. Exempt

products include exports, components for further manufacture, eyeglasses, contact

lenses, hearing aids, and other medical devices generally purchased by the general public

at retail for individual use (the “retail exemption”) as prescribed by the Secretary (of the

Treasury). Comments on the rule will be accepted until May 7, 2012. The IRS is also

accepting outlines of related topics to be potentially discussed at a public hearing on the

topic that will occur May 16, 2012.

Note: the Advanced Medical Technology Association (AdvaMed) has asked for this

medical device tax to be repealed and predicted a 43,000 job loss to occur if this provision

is implemented. For more information on the medical device tax, see the attached

document.

return to top

FDA and device industry recommend $595 million in drug user fees Wednesday, the FDA announced it reached an agreement with the medical device

industry to collect $595 million in prescription drug user fees over five years, plus

adjustments for inflation.

Note: Congress established the drug user fee program ten years ago to collect fees from

life science companies to fund the FDA’s drug and device approval process. The program

was reauthorized with the Medical Device User Fee Act of 2007 (MDUFA II) and will

expire on September 30, 2012. Some of the FDA’s funding is through the annual

appropriations process and is therefore subject to annual cuts. As a result, the FDA is

expected to increase industry user fees, thus forcing increased costs for device and drug

manufacturers that are passed through in supply chain costs to providers and consumers.

return to top

Medical practices: ICD-10 Version 5010 conversion creating payment

glitches Wednesday, the Medical Group Management Association (MGMA) and the American

College of Medical Practice Executives (ACMPE) sent a letter to HHS asking the

administration to correct payment disruptions that medical practices are experiencing due

to the transition to electronic claims processing system known as Version 5010. The

groups requested that the compliance deadline be extended from January 1, 2012 to June 30, 2012.

return to top

National Quality Forum endorses resource use and costs quality measures Tuesday, the National Quality Forum (NQF) endorsed four measures on health care

resource use and costs that are expected to be used broadly in the industry:

1. 1557: Relative Resource Use for People with Diabetes (National Committee for

Quality Assurance)

2. 1558: Relative Resource Use for People with Cardiovascular Conditions (National

Committee for Quality Assurance)

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3. 1598: Total Resource Use Population-based per member per month Index

(HealthPartners)

4. 1604: Total Cost of Population-based per member per month Index (HealthPartners)

Note: NQF is an important NGO (non-government organization) in that its determination

and validation of quality measures is usually incorporated into legislation. These

measures indicate cost and resource efficiency will be a focus of measures going forward

in addition to measures of safety, outcomes, and patient experiences.

return to top

Prior authorization of power mobility devices and recovery audit

prepayment review demonstrations to start June 1, 2012 Friday, CMS announced that the Prior Authorization of Power Mobility Devices (PMDs)

Demonstration and the Recovery Audit Prepayment Review Demonstration, which were

delayed from their initial January 1, 2012 start date, are expected to be implemented on

June 1, 2012.

return to top

CBO: federal worker benefits better than private employers A CBO report released Monday concluded that average benefits (e.g., health insurance,

retirement benefits, paid vacation) for federal workers with no more than a high school

diploma were 72% higher than their private-sector counterparts. Average benefits for

bachelor's degree were 46% higher, and workers with a professional degree/doctorate

received roughly the same level of average benefits in both sectors. On average, the

benefits earned by federal civilian employees cost 48% more than the benefits earned by

private sector employees with certain similar observable characteristics. (Source: CBO,

“How does the compensation of federal civilian employees compare with that of

employees in the private sector?” January 2012)

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FDA approves “first ever” drugs for cystic fibrosis, basal skin cell cancer Last week, the FDA announced approvals of two drugs first in their therapeutic

application: a new drug approved through the FDA’s expedited review process that treats

basal cell skin cancer that has spread to other parts of the body, and a new biologic that

treats cystic fibrosis by targeting the genetic mutation in a small minority of cystic fibrosis patients who have breathing disorders.

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Study: state nursing workload mandates reduce RN overtime slightly State-mandated caps on nurses' mandatory overtime hours have reduced overtime hours

for new registered nurses (RN), per the RN Work Project, a ten-year longitudinal study of

newly licensed RNs in 34 states funded by the Robert Wood Johnson Foundation. Key

finding: in 2010, in the 16 states that had rules restricting mandatory overtime hours for

nurses (Arkansas, California, Connecticut, Illinois, Maryland, Minnesota, Missouri, New

Jersey, New Hampshire, New York, Oregon, Pennsylvania, Rhode Island, Texas,

Washington, West Virginia), RNs were 59% less likely to work mandatory overtime than

their colleagues in unregulated states. Overall, 11.6% of nurses worked mandatory

overtime in a typical work week, averaging 6.1 hours. In the states regulating overtime,

RNs worked an average of 50 fewer minutes per week than their colleagues in states

without overtime regulations.

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Page 12: February 6, 2012 Monday memo Health reform update · 2016-09-26 · Deloitte Center for Health Solutions February 6, 2012 Monday memo Health reform update My take From Paul Keckley,

HHS OIG: data inconclusive about physicians opting out of Medicare The HHS Office of Inspector General (OIG) study of 7,900 physicians who opted out of

Medicare between 1998 and 2011 sought to analyze why physicians dropped Medicare in

their practices. It concluded the data was inconclusive to determine a cause: “Specifically,

we cannot determine the characteristics of physicians who opt out of Medicare, the trend

in the number of opted-out physicians, and why physicians choose to opt out of Medicare.

(Source: HHS OIG, “Lack of Data Regarding Physicians Opting Out of Medicare”, Report

OEI-07-11-00340, January 26, 2012)

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Quotable “During the coming decade and over the longer term, the aging of the population and

rising costs for health care will continue to exert significant pressure on the federal

budget. The number of people age 65 or older will increase by about one-third between

2012 and 2022—from 14 percent of the population to 17 percent—substantially raising the

cost of Social Security, Medicare, and Medicaid. In addition, the Affordable Care Act,

enacted in 2010, will significantly increase the number of nonelderly people receiving

assistance through federal health care programs. Of the total federal outlays for Medicare,

Medicaid, the subsidies offered through new health insurance exchanges, and related

programs that CBO projects for 2022, about half will go to benefits for people over age 65,

about a quarter will go to benefits for blind and disabled people, and about a quarter will

go to benefits for nonelderly people who are not blind or disabled. CBO projects that the

costs per enrollee for Social Security and the major health care programs also will

continue to rise, albeit at different rates because of differences in the laws that govern

them. Altogether, spending on those programs will increase at an average annual rate of

nearly 7 percent between 2013 and 2022, a pace that will outstrip growth in nominal GDP.

Combined outlays for all of those programs, which will account for 45 percent of

noninterest outlays in 2012, will constitute 60 percent of noninterest outlays in 2022, CBO

projects. Moreover, those trends will persist after 2022. Because of the aging of the

population and rising costs for health care, the set of budget policies that were in effect in

the past cannot be maintained in the future.” —CBO, “The Budget and Economic Outlook:

Fiscal Years 2012 to 2022,” January 31, 2012

“For the fourth year in a row, Washington faces a $1 trillion-plus deficit and just servicing

the debt will soon cost as much as paying for Medicaid, the federal-state program for the

poor and disabled. Those were two grim predictions in a 147-page report from the

Congressional Budget Office, which Tuesday stepped into the 2012 campaign like some

stern Aunt Cassandra—coming down from the attic to lecture the protagonists. ‘It’s not just the economy stupid, it’s the debt.’” —Politico, “Congressional Budget Office reports

another $1 trillion deficit”, originally published January 31, 2012, updated February 1,

2012

“The CBO’s latest alarm bell couldn’t be more ominous. For years, politicians from both

political parties have failed to be honest with the American people about the size and

scope of the debt threat. The CBO’s report today confirms that it is past time for serious leaders to put aside politics and start forging solutions.” —Congressman Paul Ryan (R-

WI) Tuesday, January 31, 2012

“Biopharmaceutical development, which has led to more than 300 new medicines in the

last decade, requires significant investment – an average new medicine can exceed $1

billion and take 12 to 15 years to develop. Advancements in regulatory science, greater

predictability, and communication, and a commitment to single-cycle review all represent

incentives that can help spur that investment. We urge Congress to pass PDUFA-V

legislation that reflects the performance goals letter in order to preserve those provisions

Page 13: February 6, 2012 Monday memo Health reform update · 2016-09-26 · Deloitte Center for Health Solutions February 6, 2012 Monday memo Health reform update My take From Paul Keckley,

that would boost innovation while promoting patient access and allowing FDA to continue

its essential mission.” —PhRMA, statement regarding the reauthorization of the

Prescription Drug User Fee Act (PDUFA), February 1, 2012

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Fact file

January 2012 unemployment: 8.3% from 8.5% in December 2011; health care

industry job growth—31,000; the industry will add additional 5.6 million jobs by 2020.

Manufacturing is predicted to lose 73,000 jobs by 2020. (Source: U.S. Department of

Labor)

Heart disease and strokes account for $1 out of every $6 spent in the U.S. health care system. (Source: HHS)

From 1993 to 2005, in communities where health department funding increased, for

every $10 increase in local health department spending there was a 7% decrease in

deaths from infectious disease. (Source: Robert Wood Johnson, Public Health

Services and Systems Research Service)

In 2010, inappropriate medical care contributed to the deaths of 15,000 Medicare enrollees. (Source: Bara Vaida, “Doctor, Did You Check Your Checklist?” Kaiser

Health News and Washingtonian, January 30, 2012)

Hospital errors affect 1 in 7 hospitalized. (Source: HHS, OIG)

Health data breaches in the U.S. increased 97% in 2011. (Source: Redspin, “Breach

Report 2011, Protected Health Information,” February 2012)

Not-for-profit hospitals spend 11.3% of total expenses on benefits to their community:

5.7% for direct benefits to patients in financial need through free care, financial assistance, and spending to fill in the gaps from Medicare underpayments. (Source:

Ernst & Young and The American Hospital Association)

Since 1948, every President with an approval rating above 50% was re-elected. President Obama’s current approval: 51%. (Gallup, New York Times/CBS Poll

January 30, 2012)

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National health reform: what now? National health reform is here. The health reform bills (HR3590 and

HR4872) are law and triggering sweeping changes and disruptions – some

rather quickly and some over many years. The industry is asking, “What

now?” At Deloitte, we continue to explore and debate the key questions

facing the industry, and we look forward to helping our clients find and

implement the right answers for their organizations. To learn more, visit

www.deloitte.com/us/healthreform/whatnow today. return to top

Subscribe to the Health Care Reform Memo

Health Care Reform Memo —The weekly Health Care Reform Memo is available for

subscription. Please visit www.deloitte.com/us/healthmemos/subscribe. First, confirm

your sector(s) of interest. Then, select the Health Care Reform Memo as one of your

Email Newsletters (under Health Sciences and Government). return to top

Page 14: February 6, 2012 Monday memo Health reform update · 2016-09-26 · Deloitte Center for Health Solutions February 6, 2012 Monday memo Health reform update My take From Paul Keckley,

Modern Healthcare’s 50 Most Influential Physician Executives Readers are encouraged to vote for Modern Healthcare’s 50 Most Influential Physician

Executives. Nominees include many of our clients and friends, including our own Senior

Advisor on Health Care Transformation and Technology, Dr. Harry Greenspun. Click here to vote: www.modernphysician.com/section/50mostinfluential-about.

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Deloitte Center for Health Solutions research

Coming soon: Issue Brief: The Voice of the Hospital C-Suite: Responding to the “New Normal”

Issue Brief: Supervisory care

Issue Brief: Physician perspectives about health information technology

Issue Brief: Engaging consumers through health information technology

Currently available: “Physician Perspectives about Health Care Reform and the Future of the Medical

Profession” —December 2011. Available online at

www.deloitte.com/us/physiciansurvey.

“2011 Global Survey of Health Care Consumers” – U.S. and country specific reports

and fact sheet library —2011. Available online at

www.deloitte.com/us/2011consumerism.

“Issue Brief: The fiscal impact to states of the Affordable Care Act (ACA):

Comprehensive analysis” —October 2011. Available online at

www.deloitte.com/us/acafiscalimpactstates.

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Deloitte contacts Paul H. Keckley, Ph.D., Executive Director, Deloitte Center for Health Solutions

([email protected])

Harry Greenspun, M.D., Senior Advisor, Health Care Transformation and Technology,

Deloitte Center for Health Solutions ([email protected])

Jessica Blume, U.S. Public Sector National Industry Leader, Deloitte LLP

([email protected])

Bill Copeland, U.S. Life Sciences and Health Care National Industry Leader, Deloitte LLP

([email protected])

Steve Kraus, Principal, Human Capital, Deloitte Consulting LLP ([email protected])

Mitch Morris, M.D., National Leader, Health Information Technology, Deloitte Consulting

LLP ([email protected])

Clint Stretch, Managing Principal, Tax Policy, Deloitte Tax LLP ([email protected])

Andrew Vaz, National Managing Director, Life Sciences & Health Care, Deloitte

Consulting LLP ([email protected])

To receive email alerts when new research is published by the Deloitte Center for Health

Solutions, please register at www.deloitte.com/centerforhealthsolutions/subscribe.

Page 15: February 6, 2012 Monday memo Health reform update · 2016-09-26 · Deloitte Center for Health Solutions February 6, 2012 Monday memo Health reform update My take From Paul Keckley,

To access Center research online, please visit

www.deloitte.com/centerforhealthsolutions.

To arrange a briefing for your team, contact Jennifer Bohn ([email protected]).

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