Health Care Reform Blog : Health Care Law Reform : McDermott Will & Emery Law Firm

The Facts
The first draft of the House Democrats’ health care reform legislation published June 19, 2009, portends the government’s continued focus on Medicare program integrity, fraud and abuse reform, and transparency in industry-physician relationships. The bill includes several provisions that propose to enhance existing program penalties for fraud and abuse. Further, the bill explicitly provides that existing authority relating to program integrity and the authority to prevent and prosecute fraud, waste and abuse will apply equally to the public health insurance option. Other provisions of the bill propose to strengthen significantly compliance requirements for Medicare program participation.

Proposals for increasing existing penalties include enhanced penalties for:

• False statements on provider or supplier enrollment applications
• Submission of false Medicare, Medicaid or CHIP claims
• Delay of Inspector General investigations
• Exclusion of individuals from program participation
• Obstruction of program audits

Proposals aimed at enhancing program and provider protections include:

• Requiring providers and suppliers to adopt compliance programs that contain certain “core elements” established by the Secretary
• Requiring physicians to provide documentation on referrals to programs at high risk of waste and abuse, such as durable medical equipment or home health services
• Requiring repayments of known Medicare and Medicaid overpayments within a specified time period and making the failure to repay a false claim
• Increasing access to databases and information necessary to identify fraud, waste and abuse
• Proposing a more robust version of the Physician Payments Sunshine Act (S.301)

What’s at Stake
The provisions in the proposed bill underscore the federal government’s objective to fund some of the cost of health care reform through increased program penalties, reducing fraud, waste and abuse and enhancing payment protections. Physicians, providers and suppliers may see increased enforcement activities bolstered by greater scrutiny of program activities.

Steps to Consider

• Review and assess current compliance programs and procedures to ensure accuracy of claims data
• Consider whether existing policies and procedures for responding to government investigations should be modified or updated in light of the potential for increased government enforcement activity
• Evaluate the additional investment of time and resources to meet the proposed physician payment transparency requirements

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The Facts
Among the proposals set out in the draft health reform legislation introduced by Democrats from three key committees of the U.S. House of Representatives are provisions to significantly modify the Medicare Advantage (MA) Program, including:

• Benchmarks and Payment Rates: Beginning in 2011, the benchmark upon which MA Plan payment rates are calculated would be modified to reflect average per capita costs under traditional Medicare fee-for-service for the applicable service area. This would affect MA Plan payment rates as well as the potential scope of supplemental benefits MA Plans would offer.
  
  The legislation would provide up to 1% increases in the applicable benchmark for “high quality” MA Plans. Such “high quality” MA Plans would be identified based upon HEDIS data and consumer (CAHPS) surveys until the Secretary establishes a new metric to assess the quality of care available through MA Plans.
  
  The Secretary’s authority to implement coding intensity adjustments in the determination of MA Plan payment rates also would become permanent.
   
• Administrative Costs: The Centers for Medicare and Medicaid Services (CMS) would be required to publish annually MA Plans’ medical loss ratios (MLRs), risk-adjusted per enrollee payment and average risk score.
  
  CMS also would be required to audit MA Organizations’ (MAOs) administrative costs to assess MAOs’ compliance with the applicable requirements of the Federal Acquisition Regulations that apply to other government contractors.

The House bill also would mandate that CMS create an office or program designed to improve the coordination of benefits for dual-eligible beneficiaries, modify components of the Medicare Part D Program, and enhance the Secretary’s and CMS’s authority sanction MAOs and Part D Plan Sponsors that engage in (or contract with an individual or entity that engages in) prohibited marketing activities, among other activities.

What’s at Stake
As part of the reform process, the Democratic majority within the U.S. House of Representatives appears determined to make quality of care offered to MA enrollees a focus through increased performance reporting and corresponding payment adjustments. Additional obligations – including public reporting of MLRs and compliance with the FAR administrative cost requirements – will increase MAOs’ costs to participate in the Program.

Steps to Consider
In addition to monitoring the potential downward adjustments to the MA benchmarks, MAOs should consider the potential implications associated with the proposed requirements, such as:

• Competitive position in light of enhanced public reporting
• Costs of complying with new reporting requirements
• Potential risks of non-compliance with marketing and administrative cost provisions

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The Facts
On June 19, 2009, Democrats from three key House committees released a draft health reform bill that sheds light on plans to use the Internal Revenue Code to incentivize individuals to obtain, and employers to provide, adequate health care. The bill, however, leaves out details on the major sources of revenue needed to finance the health care expansion. Key tax provisions in the bill to date include:

• Imposing 2 percent tax on the income of individuals without “acceptable coverage,” with tax limited to national average premium
• Providing limited exceptions to 2 percent tax on individuals (e.g., nonresident aliens, religious conscience)
• Requiring providers of acceptable coverage to provide annual information reports to the IRS describing the names and types of coverage of each covered individual and other information that the IRS requires
• Imposing excise tax on employers that elect to help satisfy the health coverage participation requirement but that later fail to meet the requirement
• Imposing excise tax equal to 8 percent of wages paid on employers that elect not to help satisfy the health coverage participation requirement
• Providing 50 percent tax credit for employee health coverage expenses of small businesses providing employee coverage, with phaseouts for average employee compensation (greater than $20,000) and employee headcount (more than 10)
• Authorizing IRS disclosure of taxpayer information to determine whether individuals are eligible for affordability credits

What’s at Stake
With a promise by President Obama and key members of Congress to fully fund health care reform, which is anticipated to cost $1 to 2 trillion or more over 10 years, progress will require filling in the details on the revenue-raising provisions. Approximately half of the money needed to pay for health care reform is expected to come from changes in the tax law.

Steps to Consider

• Stay tuned for revenue-raising tax proposals, which may include significant amendments to the international tax rules
• Continue to monitor any additional guidance on required information reporting by employers to show they meet the health coverage participation requirements

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The Facts
On June 19, 2009, House Democrats unveiled their first draft of health care reform legislation. Despite exceeding 850 pages, the draft bill is still a work-in-progress. Many of the anticipated Medicare program payment reductions and revisions are absent from this draft, but providers should not draw too much comfort from that. President Obama has called for more than $600 billion in savings from Medicare, and those savings will be required to pay for the massive overhaul. Providers should still expect significant savings provisions to be added later.

In the meantime, the bill still includes considerable change, including:

• Annual Medicare payment updates for virtually every facility type, including all hospitals and post-acute care providers, would be reduced by a productivity adjustment factor. Given that hospital market baskets are expected to be between 2.0 and 2.5 percent in FY 2010, the actual update for providers, if this change were to be enacted, could be only slightly above zero.
• Medicare payment for post-acute services would be revamped and coordinated across settings.
• Medicare payments for imaging services would be reduced.
• Hospitals would be penalized for excess readmissions.
• Ambulatory Surgery Centers would for the first time submit cost reports and quality data.

What’s at Stake
The proposed bill foreshadows a new reimbursement paradigm that focuses on accountability for quality, cost savings, coordinated care, and increased scrutiny to preclude conflicts of interest and other skewed incentives. Health care service providers will face new systems, obligations and incentives that will dramatically alter how providers furnish services and interact with Medicare and its beneficiaries.

Steps to Consider

• Examine current approaches to patient care and consider internal and external steps necessary to manage the impending shift from traditional fee-for-service payments to payments based on quality measurements and care coordination.
• Explore relationships with management companies or other partners who can improve overall quality and reduce cost.
• Consider new relationships with physicians to invest doctors in quality outcomes.

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The Facts
The American Recovery and Reinvestment Act authorizes the Centers for Medicare & Medicaid Services (CMS) to provide incentives to certain physicians and hospitals who achieve “meaningful use” of a certified electronic health record (EHR) system.

The act established the Health Information Technology (HIT) Policy Committee, which issued a draft definition of “meaningful use” at its June 16, 2009, meeting.  The committee recommended a progressive definition, where “meaningful use” is ultimately linked to achieving measurable outcomes in patient engagement, care coordination and population health.  The 2011 objectives are intended to establish a foundation for affecting a more comprehensive set of health outcomes in the future.  By 2015, the objectives are to achieve and improve performance and support care processes.  A matrix including the full proposed definition of “meaningful use” is available at http://healthit.hhs.gov/.

The committee has asked a workgroup of the committee to submit a new set of recommendations for “meaningful use” at the committee’s July meeting.  The committee is currently accepting comments regarding the proposed draft, but it is not clear whether it will offer a comment period after the revised draft.  The committee’s recommendations are non-binding, but will provide guidance to CMS, which will ultimately establish the definition for “meaningful use.”

What’s at Stake
Beginning in 2011, those physicians and hospitals who can demonstrate “meaningful use” of a certified EHR system will receive incentive payments through additional Medicare reimbursement.  Beginning in 2015, those who have not achieved “meaningful use” will be subject to certain downward adjustments in their Medicare reimbursement rates.

Steps to Consider

• Consider submitting comments to the Department of Health and Human Services (HHS) on the draft definition of “meaningful use.”  Comments are due by 5 pm Eastern time, June 26, 2009.
• If your organization does not have an EHR system, consider options for EHR technology that fit within your organization’s structure and that will assist you in capturing data to meet evolving “meaningful use” requirements.
• If your organization already has an EHR, examine the systems and consider internal and external steps necessary to implement flexibility in capturing data required for an evolving definition of “meaningful use.”
• Obtain contractual commitments from EHR system vendors to assist you in achieving “meaningful use.”

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The Facts
The Family Smoking Prevention and Tobacco Control Act was approved by Congress on June 12, 2009, and is on its way to President Obama. The bill for the first time gives the U.S. Food and Drug Administration (FDA) the power to regulate tobacco, but not ban tobacco products outright. The agency may also limit nicotine, but may not require it to be removed completely. Particular tobacco products, just like other FDA-regulated products, may be found to be “misbranded” or “adulterated” by FDA and subject to an array of enforcement actions, including seizure of the products. The new tobacco center will be partially funded by user fees, similarly to other centers. 

What’s at Stake
The act marks a significant shift in focus at FDA. The relative weight within FDA of the tobacco center compared to existing centers, such as those for drugs, devices or foods, has yet to be determined, but it will certainly absorb time, funds and senior talent. Tobacco is estimated to be responsible for 400,000 deaths per year, according to the Centers for Disease Control and Prevention, far more than any other single product FDA regulates, and as such is a critical public health issue. A lengthy conversation internally at FDA over balance among the centers will undoubtedly occur over the next months and years. The bill’s implementation will likely receive a great deal of attention from the No. 2 at the U.S. Department of Health and Human Services, Deputy Secretary Bill Corr, former executive director of the Campaign for Tobacco-Free Kids.

Steps to Consider
Because the new tobacco center at FDA may divert resources and focus from other centers, and may slow down initiatives (or possibly even approvals) at the drug, biologics or devices centers, interested parties should watch this space closely and stay alert to the potential impact on approvals and needed initiatives being carried out by FDA and its other centers.

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The Facts
President Obama is driving an extremely ambitious effort to achieve comprehensive health reform by October 2009.  House and Senate leaders are responding with an aggressive timeline for developing legislation to be on the president’s desk this fall.

Heeding lessons learned from the failed Clinton health reform efforts, the president has until now resisted imposing his views directly on Congress.  Now visibly engaged, the president enunciated his policy preferences in a June 2, 2009, letter to Congress:

• A public health insurance option
• A health insurance exchange
• Allowing individuals to keep their current coverage
• Promoting best practices to improve health quality
• Paying for the full cost of health reform (estimated at $1.2 – $1.5 trillion) through a combination of reducing Medicare and Medicaid spending and raising revenue

The president also indicated a willingness to consider individual and employer mandates as well as an enhanced role for the Medicare Payment Advisory Commission.  Click here for a copy of the president’s letter.

Senate Finance Committee senior Republican Charles Grassley (R-IA) and eight of his nine Republican colleagues on the Finance Committee (all but Senator Olympia Snowe of Maine) responded with a joint letter to the president on June 5, 2009, that notes concern with the president’s expression of support for a public plan because a public plan is “one of the more divisive issues in the health care reform debate.”  Click here for a copy of the senators’ letter.  Clearly, as legislators move from options to concrete legislative proposals, it will be increasingly difficult to keep Republicans at the table in the Senate. 

Click here for the tentative timeline for achievement of health reform. 

What’s at Stake
Congress and the president are determined to overhaul the nation’s health care delivery system. Every aspect of the health sector will be affected. 

Steps to Consider
Providers, insurers, employers, drug and device makers, and every other entity in the health sector should closely examine the legislative proposals, assess their impact, and develop a course of action to maximize the positive impact of health system reform and minimize the negative impact.

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The Facts
This week Senator Edward Kennedy (D-MA), chairman of one of two Senate Committees with responsibility for advancing a health care reform proposal, released the first comprehensive draft of health care reform legislation, the Affordable Health Choices Act.  Note that final decisions on such critical issues as a public plan and an employer coverage mandate are described in the bill merely as “policy under discussion.”  Below are selected highlights of the draft: 

• Creates state-based insurance exchanges called “American Health Benefit Gateways”
• Requires insurers to report expenditures to the government, which could trigger mandatory rebates to plan members
• Stipulates that insurance premiums may only vary based on family structure, community rating, the actuarial value of the benefit and age 
• Prohibits pre-existing conditions exclusions
• Requires guaranteed availability and renewability of coverage
• Prohibits lifetime or annual limits on coverage
• Mandates individual coverage, with certain exceptions
• Significantly expands Medicaid

What’s at Stake
Senator Kennedy’s decision to table inclusion of a public plan and employer mandate reflects his effort to leave ground for forging a compromise with Republicans.  However, Senate Republicans continue to vociferously object to the public plan, and many other elements of the Kennedy proposal.  President Obama, sensing the rocky debut of the first health reform bill, summoned Senate leaders June 10, 2009, to the White House, where he reiterated his insistence that a bipartisan bill be achieved this year and made clear his flexibility on all aspects of the legislation.

Steps to Consider
Evaluate how reform proposals may require changes in the operations of your organization, and consider working with policy makers and key stakeholders to shape the ultimate outcome of health reform.

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The Facts
House Democrats released the broad parameters of their comprehensive health reform bill June 8, 2009.  The three House committees with jurisdiction over health reform plan to work from this common framework to develop a systemic reform proposal.  Click here for a health reform timeline.  Below are highlights of the plan: 

• Protects current coverage and preserves choice of doctors, hospitals and plans
• Creates a new national health insurance plan
• Creates a national health insurance exchange and allows for regional or state exchanges
• Initiates delivery system reforms, such as accountable care organizations, to incentivize quality and restrain health spending growth
• Imposes individual coverage requirement and employer “pay or play”
• Prohibits insurers from excluding pre-existing conditions and forbids rating based on gender, health status or occupation, and limits premium variation based on age 
• Reforms Medicare’s sustainable growth rate formula for physician payment
• Eliminates perceived overpayments to Medicare Advantage Plans

What’s at Stake
Reporting out a House bill by the August recess is at stake. While the House Democrats have united the three key House committees in producing this common framework, considerable dissension within the Democratic party remains.  A core area of disagreement is whether to include a public plan.  Pressure to achieve reform this year is considerable, as the Democrats do not want to risk spilling into next year’s congressional cycle.

Steps to Consider
Providers should assess the impact of a public plan option and expanded coverage, among other proposals.  Insurers should examine the impact of a Medicare-like public plan option on provider payments and the ultimate competitiveness of private plans, review the concept of the insurance exchange and assess the business impact of the proposed new insurance market reforms.  Insurers that act as Medicare Advantage Plans should monitor proposals to reduce payments.  Both providers and insurers should assess the potential impact of accountable care organizations.  Finally, employers should carefully monitor “pay or play” proposals and prepare to adapt to potential requirements.

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