Senate Finance Votes Against Public Option

Breaking News. In an important advance for a more moderate, bipartisan health reforms the Senate Finance Committee Tuesday voted against including a "public option" provision in the bill. While the media is reporting this as some form of "set-back" related to health reform, in reality this may prove to be a critical victory towards advancing the more moderate health reform being proposed by Senator Max Baucus (D-MT). The panel rejected a proposal by Sen. John Rockefeller (D-WV) 15-8, and a second public option proposal by Sen. Charles Schumer (D-NY) was defeated 13-10. The votes clearly support the more moderate approach taken by the committee chairman, Senator Max Baucus thus creating new hope for bipartisan health reform legislation. The Senate Finance Committee continues it work today.

The Donut Hole -- Can we affort to fill it as part of health reform?

One of the most hotly debated issues being considered by the Senate Finance Committee relates to efforts to close the Part D "Donut Hole" coverage gap as part of health reform. The senior lobby is urging lawmakers to go further than the narrowing of the donut hole that has been proposed based on savings from PhRMA. This week Senator Bill Nelson's (D-FL) amendment to fill the donut hole failed 10-13 with three Democrats, including Senate Finance Chair Max Baucus (MT), joining the GOP members in opposing the measure. Nelson's amendment would have required an additional health reform contribution from drug companies beyond the $80 billion deal that Baucus and the White House reached over the summer.

Despite it's failure, we expect to see this as a key issue when legislation comes to the full Senate floor. We may see seniors weigh in heavily on this issue but the concern is of course the cost of this change and even whether we need to expand a program that has high marks overall from beneficiaries.

While many want to close the donut hole eventually, including President Obama, the question is how to balance cost considerations to fund such a change. Before asking for a final vote Baucus also said he supports closing the gap, but said staff needed time to find a “more appropriate way” to do so in terms of offsets. There is concern that dramatic changes could lead to premium increases that would negatively impact all seniors which is difficult to project or estimate.

The "Donut Hole Debate" has likely only just begun as efforts to bring senior on board with health reform overall. For many seniors, particularly those with chronic disease, the donut hole creates significant patient access issues each year so this is a sensitive topic for many interested parties.

Senate Finance Considers Key Amendments to Health Reform

With over 500 amendments for consideration by the Senate Finance Committee on Health Reform, progress was made to go through proposed changes and support was reached for some significant modifications or additions to the Chairman's Mark released last week by Max Baucus (D-MT). While the progress has been slow, it does feel like we are moving toward a Senate health reform bill that will have enough support to move forward. Key amendments passed by the Committee so far, include:

• Biosimilars Reimbursement. Offered by Senator Schumer (D-NY), an amendment that would reimburse biosimilars at the average sales price (ASP) plus the innovator/brand product's 6 percent add on, which is assumed to be greater than the biosimilar's own 6 percent. Senator Schumer had originally filed language that would have assigned the same billing codes to branded and biosimilar products but that language was removed in the modified proposal. PhRMA and BIO, reportedly, supported this amendment as modified. The amendment, as currently understood, contradicts some earlier press reports suggesting reimbursement for the innovator and biosimilar would be determined based on a volume-weighted average of the products. This one will be an important one to watch final bill language.
• PBM Transparency. Offered by Senator Cantwell (D-WA), an amendment that would require PBMs operating in the insurance exchanges to disclose to HHS information regarding: (1) the percent of all prescriptions provided through retail pharmacies compared to mail order pharmacies, and the generic dispensing and substitution rates in each location; (2) the aggregate amount and types of rebates, discounts, and price concessions that the PBM negotiates on behalf of the plan and the aggregate amount of these that are passed through to the plan sponsor; and (3) the average aggregate difference between the amount the plan pays the PBM and the amount that the PBM pays the retail and mail order pharmacy.
• Medicare Commission. Offered by Senator Rockefeller (D-WV), an amendment that would make binding the recommendations of a Medicare commission to lower spending growth unless the Senate voted by a two-thirds majority to reject them. The new commission's recommendations would have to be accepted by the president before being voted on by Congress.
• Patient-Centered Outcomes Research Institute. Offered by Senator Grassley (R-IA), an amendment which would remove cabinet secretaries and other high-ranking government officials from serving on the board of the Patient-Centered Outcomes Research Institute
  

Was anything key rejected? Yes and as is being widely reported, Baucus, voting along with Republicans, rejected an amendment that would have nullified the PhRMA accord reached earlier this year with Baucus and the White House. The amendment, offered by Senator Nelson (D-FL), would have scrapped the PhRMA agreement and would have made Medicaid-instead of Medicare- responsible for paying for low-income seniors' drugs; it would also eliminate the Part D coverage gap (or donut hole). The cost of the amendment would have been offset by requiring drug manufacturers to provide rebates to dual-eligible enrollees of Part D plans. It was estimated to produce $106 billion of revenue (after filling the doughnut hole, $50 billion would be left over).

Remember this is only what is included in the Senate side and we have not seen any legislative language yet and the Senate Finance Committee will resume its work on considering other amendments on Tuesday.

Senate Debates Proposed Health Bill -- Baucus adds new changes

Senator Max Baucus (D-MT), chairman of the Senate Finance Committee, opened the debate on healthcare reform with additional changes designed to expand support for working-class families and impose new obligations on the insurance industry. Sen. Baucus announced he was adding $50 billion to draft legislation to help those who would be required to purchase insurance. The changes would expand subsidies for individuals and families with incomes up to four times the government's poverty level ($43,320 for individuals and $88,200 for a family of four) that do not have access to health insurance. The debate and discussion feels like it will be slow with more than three hours of opening statements by both Republicans and Democrats. Committee members offered 564 amendments.

Other key proposed changes include:

• Proposals to increase tax credits for middle-income families that buy health insurance
• Limits to how many people would be subject to a new excise tax on "high-end" health plans so that high risk works like fire fighters are excluded.
• New proposals to expand discounts from the pharmaceutical industry beyond the PhRMA proposed savings.
• Proposals to expand Medicaid vs Medicare Part D for low-income seniors to further reduce costs
• Additional changes that would require PBMs to disclose rebates from drugmakers to clients

Amendments could be voted on as early as this week.

Baucus Plan Includes Doctor Payment Disclosure Regulations (Known as Sunshine Act)

Tucked into the details of the Senator Baucus' draft health reform bill is a measure that would require drug and medical device companies to publicly report payments or “transfers of any value, with limited exceptions” to physicians or teaching hospitals. While the actual bill is not yet available, it appears that this provision will impact both physicians and manufacturers. The scope of the Senate provision is unclear but the House reform bill would require reporting of payments to a broader category of recipients, including all hospitals, physicians, pharmacies, health insurers, continuing medical education sponsors, researchers and patient and professional organizations.

The proposal is based on a bill introduced by Sen. Charles Grassley (R-IA), the committee’s ranking Republican, which would require drug makers to publicly report gifts to physicians once the aggregate amount over a year totals $100. Currently, the House bill sets the threshold at $5. This language will be another aspect of health reform to watch as it could create new administrative burdens of physicians as well as manufacturers.

Will the Senate be able to drive toward bipartisan health reform?

Challenges continue to grow for some form of bipartisan health reform but the debate over health care appears far from over and may last until December.

Today, reports from Capitol Hill indicate virtually no Republican support for Senate Finance Chair Baucus (D-MT) and the health reform mark he released yesterday. Olympia Snowe (R-ME) is the only potential Republican name that may consider supporting the proposed Finance bill. Republicans may not even offer any of the other amendments to the proposed Senate Finance mark based on reports today. What does that mean? Basically, the best chance for bipartisan health reform legislation might start with a fresh, blank piece of paper.

The key areas of consensus remain focused on insurance reforms but virtually all other issues are being debated due to the cost issues with such reforms.

Senator Baucus Releases Draft Health Reform Legislation

Senator Baucus Released today the Chairman’s “Mark” (or draft legislation): America’s Healthy Future Act of 2009. While today in Washington the effort feels partisan, it is possible that this legislation can be adapted for bipartisan support.

Key highlights include the following:

• Individual Insurance Coverage Mandate: Starting in 2013, all U.S. citizens and legal residents would be required to purchase coverage through the individual market, a public health program (e.g.,Medicare, TRICARE), an employer, or a larger market exchange.
• Employer Obligations: While employers would not be required to offer health insurance coverage to employees, those employers with more 50 employees that do not offer health insurance would be required to pay a fee (often referred to as “pay-or-play”). The fee assessment would be capped for and the details of this will be critical. The effective date of this provision would be January 1, 2013.
• Creation of the Consumer Operated and Oriented Plan (CO-OP): The Chairman’s Mark does not offer a "true" public plan option, but does authorize $6 billion in funding for the creation of the Consumer Operated and Oriented Plan (COOP). The CO-OP would be comprised of non-profit, member-run health insurance companies that serve individuals in one or more states. These plans would establish state-based health insurance exchanges to help facilitate access to coverage for individual and non-group markets.
• Part D Drug Discount Program. Beginning in 2010, in order to have their drugs covered under Medicare, manufacturers would be required to provide a 50% discount off the negotiated price for brand-name drugs covered on plan formularies when beneficiaries enter the coverage gap. Beneficiaries are eligible provided they do not qualify for low-income subsidies, do not have employer sponsored coverage, or do not pay higher Medicare premiums under Part B or Part D.
• Medicaid Coverage for the Lowest Income Populations. Starting in January 2011, states would be given the option to cover non-elderly, non-pregnant adults (often referred to as childless adults) through a state plan amendment (SPA) at their current match rate. Effective January 1, 2014, the proposal would establish 133% of the federal poverty limit (FPL) as the new mandatory minimum Medicaid income eligibility level nationally.
• Medicaid Prescription Drug Coverage. According to the Mark, prescription drugs would become a mandatory Medicaid benefit for the categorically and medically needy effective January 1, 2014.
• Physician Reporting (Sunshine Provision). Under the Chairman’s Mark, a reporting requirement for payments to physicians would be required. Beginning on March 31, 2012, and each year thereafter, each manufacturer of a covered drug, device, biological, or medical supply would be required to electronically report information on payments or other transfers of value made during the prior year to physicians, physician medical practices (including group practices), and hospitals with residency training programs.
• New Fees. Under the Chairman’s Mark, an annual fee of $2.3 billion annually would be imposed on the pharmaceutical manufacturing sector beginning in 2010. The fee would be allocated by relative market share of covered domestic sales for the prior year. The fee would not be deductible for U.S. income tax purposes. Similar fees of $4 billion, $6 billion, and$750 million are proposed for medical device makers, health insurance sector, and clinical laboratory sectors, respectively. All proposed industry fees would be allocated by market share and start in 2010.
• National Pilot Program on Payment Bundling. This provision would direct the Secretary to develop a voluntary pilot program encouraging hospitals, doctors, and post-acute care providers to achieve savings for the Medicare program through increased collaboration and improved coordination of patient care by allowing the providers to share in such savings.
• Physician Fee Schedule Medicare Sustainable Growth Rate. The scheduled 21.5% reduction in Medicare physician payment rates in 2010 would be replaced with a 0.5% increase for 2010.

What happened to Bipartisan Support on the Senate Side? The original hope was that this bill would have bipartisan support among the G6, agreement was never reached. In addition, reports have indicated that three Democrats, Senator Jay Rockefeller (D-WV) and two other unnamed Democrats, have stated that they would not vote in favor of the bill as written. However, the next step of the process will be the mark-up by the Senate Finance Committee which is slated to begin on September 22, 2009. During the mark-up process, it is possible that the bill’s provisions could change to garner more bipartisan support.

Is Bipartisan Reform still possible?

Today, Senate Finance Chairman Max Baucus (D-MT) said there is “high probability” that he will release his health care reform bill Tuesday and that he hopes to simultaneously announce that it will be a bipartisan product. Clearly Baucus is working to bring the "gang of six" together and their has been focus this week to compromise together on the most controversial issues such as having more of a private co-op or exchange than a true "public option". After the Chairman's mark is released there will still be opportunities to modify the bill through the amendment process which does leave open the door for more bipartisan support. Other key issues being discussed include language intended to make sure that illegal immigrants can not participate in such coverage and also new funding to reduce medical malpractice lawsuits.
Stay tuned -- it will be a busy week for health care!

Baucus Healthcare Refom: New Details Released Today

Below is the framework of Baucus' healthcare reform approach, apparently released to the Senate Finance Committee "gang of 6" for consideration today. The official documents have not been released but new details (summarized below) have been widely shared across Washington experts today. It does includes some key imminent issues such as addressing the 2010 Medicare physician reimbursement cut (referred to as sustainable growth rate). It also includes some new "surprise" fees on health insurers, device industry and others.

The reported price tag comes in a $900 billion over 10 years and there is no "true" public plan option although the bill includes a number of insurance market reforms, including creation of state health insurance exchanges to help facilitate access to coverage for individual and non-group markets. The bill includes an individual mandate for coverage, beginning 2013, but would not require employers to provide coverage for employees (although employers with more than 50 employees must "pay" if they don't "play" per framework below).

The framework also creates/makes improvements to value-based purchasing programs for hospitals, physicians, home health agencies and SNFs, among other providers, and would facilitate payment bundling approaches through pilot programs. It also includes payment changes for some DMEPOS (e.g., oxygen, power wheelchairs, etc.). The framework also includes increased emphasis on industry transparency (e.g., Rx drug sampling reporting requirements) and fraud and abuse, including imposition of new fees on manufacturers.

Key highlights being reported today include the following proposals (please note the actual bill language has not been released):

• Part D Drug Discount Program. Beginning in 2010, in order to have their drugs covered under Medicare, manufacturers must provide a 50%discount off the negotiated price for brand-name drugs covered on plan formularies when beneficiaries enter the coverage gap. Beneficiaries are eligible provided they do not qualify for low-income subsidies, do not have employer sponsored coverage, or do not pay higher Medicare premiums under Part B or Part D.
• Medicaid Coverage for the Lowest Income Populations. In January 2011, prior to the expansion, states would be given the option to cover non-elderly non-pregnant adults through a state plan amendment (SPA) at their current match rate. Effective January 1,2014, the proposal would expand Medicaid income eligibility levels nationwide.
• Prescription Drug Coverage, Medicaid Rebates and AMP. Prescription drugs would become a mandatory Medicaid benefit. The status of drugs used to promote smoking cessation, barbiturates, and benzodiazepines would be changed from "excludable" to "non-excludable." Medicaid prescription drug rebates would be applied to Medicaid managed care organizations. Similarly, the rebates would be applied to new formulations of existing drugs, with an exception for orphan drugs. The rebate amounts would be increased, with the minimum rebate percentage for single-source and innovator multiple source drugs going from 15.1%to 23.1%and from 1 1%to 13% for generic drugs. For clotting factors and drugs approved by the FDA for pediatric use only, the rebate would be increased from 15.1%to 17.1%.The federal upper limit (FUL) would be changed to no less than 175% of the weighted average (determined on the basis of utilization) of the most recently reported monthly average manufacturer price (AMP).
• Hospital Value-Based Purchasing.The proposal would establish a value-based purchasing program for hospitals starting in 201 1. Under this program, a percentage of hospital payment would be tied to hospital performance on quality measures related to common and high-cost conditions, such as cardiac, surgical and pneumonia care. Quality measures included in the program (and in all other quality programs in this section) will be developed and chosen in cooperation with external stakeholders.
• Physician Value-Based Purchasing.This provision would make improvements to the Physician Quality Reporting Initiative (PQRI) program, including requiring all eligible health professionals to participate by 201 1, establishing payment incentives for physicians to appropriately order high-cost imaging services, expanding the Medicare physician feedback program, and penalizing physicians who utilize significantly more resources than their peers.
• CMS Innovation Center. This provision would establish an Innovation Center at CMS that would have the authority to test new provider payment models. Payment reforms that are shown to improve quality and reduce costs could be expanded throughout the Medicare program. The Innovation Center's funding would be set at $10 billion.
• National Pilot Program on Payment Bundling. This provision would direct the Secretary to develop a voluntary pilot program encouraging hospitals, doctors, and post-acute care providers to achieve savings for the Medicare program through increased collaboration and improved coordination of patient care by allowing the providers to share in such savings.
• Medicare Sustainable Growth Rate (SGR).The scheduled 21% reduction in Medicare physician payment rates in 2010 would be replaced with a 0.5% increase.
• Ensuring More Appropriate Physician Payment Rates.This provision would establish a panel comprised of health care providers, experts, and stakeholders to identify physicians' services that are overvalued in the Medicare physician fee schedule. In consultation with the expert panel, the Secretary would be required to adjust payments for those services that have increased at an unusually high annual rate without evidence supporting the clinical appropriateness of such growth.
• Prescription Drug Sample Transparency. Drug manufacturers and authorized drug distributors would be required to report to the Secretary information already collected pursuant to the Federal Food, Drug and Cosmetic Act. Specifically, manufacturers and distributors would be required to report the type and amount of drug samples requested by and distributed to practitioners, along with the practitioners' names, addresses, professional designations and signatures. The reported information would not be made publicly available.
• Pharmaceutical Manufacturing Companies Fee.Under this proposal, an annual fee of $2.3 billion would be imposed on the pharmaceutical manufacturing sector beginning in 2010. The fee would be allocated by market share.
• Medical Device Manufacturers Fee.Under this proposal, an annual fee of $4billion would be imposed on the medical devices manufacturing sector beginning in 201 0. The fee would be allocated by market share.
• Health Insurance Provider Fee.The proposal would impose an annual fee of$6billion on the health insurance sector beginning in 201 0. The fee would be allocated by market share.
  Clinical Laboratories Fee.Under this proposal, an annual fee of $750 million would be imposed on clinical laboratories beginning in 2010. The fee would be allocated by market share, except for small businesses.

Physicians and PQRI -- New updates from CMS

There have been lots of questions from physician offices regarding the 2009 Physician Quality Reporting Initiative (PQRI) and updates including questions regarding payments for prior years. To address this, CMS has just announced that they will host a national conference call (Q&A session) on Thursday, Sept 17, 2009 at 2:30 - 4:30 EDT. The topics covered on this national provider call will include:

• Status of the 2007 re-run and 2008 PQRI Incentive payments and feedback reports;
• How to access the 2007 re-run and 2008 PQRI feedback reports;
• Resources to assist eligible professionals; and
• PQRI and E-Prescribing Alternative Report Request Process

Following this presentation, the lines will be opened to allow participants to ask questions of CMS PQRI subject matter experts.

Educational resources are available on the PQRI dedicated web page located at, http://www.cms.hhs.gov/PQRI and specific to the e-prescribing incentive at http://www.cms.hhs.gov/ERxIncentive.

In order to receive the call-in information, you must register for the call in advance at http://www2.eventsvc.com/palmettogba/091709 additionally a transcript of the call will be available at least one week after the call at http://www.cms.hhs.gov/pqri on the CMS website.

Senator Baucus pushes for bipartisan support of Senate Finance Health Reform Proposal

In today's Washington Post, Senate Finance Chairman Max Baucus is said to be urging his Republican colleagues to support the $900 billion health-care reform package they have helped to negotiate over the past two months -- creating a bipartisan proposal before President Obama's speech Wednesday night.

The Baucus plan, circulating among the Finance Committee's "Gang of Six" this weekend, sets forth provisions that have already gained the group's unofficial support but now there is pressure from other Republican colleagues to let the Democrats fight for a health reform bill on their own.

The Baucus plan creates bipartisan options for some of the most controversial aspects of health reform. Instead of a government insurance option, the Baucus proposal would create a network of non-profit cooperatives which is an alternative that Grassley, the lead Republican negotiator, has backed. The Baucus plan also creates new fees on "high cost plans" which may be controversial since many union households could be impacted.

At a cost of under $900 billion for 10 years, the finance bill would appears to be at least $100 billion less than other legislation on the table. Analysts indicate the plan is designed to "bend the cost curve" downward over time to make health-care more affordable for businesses, individuals and government, while reducing the federal deficit within 10 years.

In addition to the fee on high-cost plans, the proposal also would extract about $400 billion in cost-savings from Medicare, cuts that are stirring unease among both parties.

Under Baucus's plan, Medicaid would be expanded to cover all individuals -- except illegal immigrants -- who make up to 33 percent above the current federal poverty level. The plan would provide tax credits to help low and middle-income families purchase private insurance coverage, and would set up health insurance exchanges so small business workers and other individuals whose employers don't provide health coverage, could select from a menu of plans.


We expect to see more detail tomorrow from the Senate Finance team tomorrow in advance of the President's speech on Wednesday. The Senate Finance health plan proposal has been projected to be the best opportunity for bipartisan health reform legislation this year.

President Obama: How will his address impact progress on health reform?

President Obama announced this week that he will greet the return of Congress next week with an address to a joint session of Congress on Wednesday night (September 9th). It is expected that the President will provide more specifics on some focused reforms he would like to see related to health reform legislation.

What do we expect to hear from the President? The White House has been very focused that the goal of health reform must be to:

1. lower costs
2. create a secure and stable health care system
3. provide access to affordable health care for all Americans

It is unclear how the President will address the most divisive issue of a public plan option but one scenario gaining support is to propose a public plan option that is used only as a fallback approach should savings from a market-based system not reach certain levels over time. Besides the controversial public plan issue, are there other specific ideas or policies the President will mention or will he keep to the big picture?

Is there a middle ground on health reform?

Despite the rhetoric and media coverage, there are appears to be some aspects of health reform with bipartisan support. In fact both parties are now saying indeed something must be done related to the cost and access issues regarding health care.

Bipartisan consensus proposals include some of the major health insurance industry reforms such as preventing insurance companies from:

• denying coverage to people with preexisting injuries and illnesses
• cutting insurance coverage off when a policyholder gets sick
• imposing a lifetime cap on benefits

Another key issue with new support from both the Senate and the House would be to require insurance companies to offer dependent coverage to young people through their parents' insurance plan until they turn the age of 26.

This feels modest but as Congress prepares to return from recess next week lets hope they focus on finding some middle ground that we can all agree on.