ONC Health IT Meetings - July 14 - 21, 2009

The HHS Office of the National Coordinator for Health Information Technology (ONC) has announced several upcoming meetings as part of its efforts to implement the Federal Health IT Strategic Plan. First, the HIT Policy Committee's Certification/Adoption Workgroup is meeting on July 14 and 15, 2009 to hear testimony from stakeholder groups, such as purchasers, vendors, and users, on the electronic health information certification process. In addition, the HIT Policy Committee is meeting on July 16, 2009 to discuss the preliminary draft definition of “Meaningful Use.” Finally, on July 21, 2009, the HIT Standards Committee is meeting to discuss the certification process.

FDA Seeks Comments on New Tobacco Law

The FDA is opening a public docket to obtain public input on implementation of the Family Smoking Prevention and Tobacco Control Act. The agency is particularly interested in comments on the approaches and actions the agency should consider initially to increase the likelihood of reducing the incidence and prevalence of tobacco product use and protecting the public health. In the future, the agency intends to solicit public input on specific issues. Comments will be accepted until September 29, 2009. 

CBO Scores Finance Committee Health Reform Bill at Under $1 Trillion

On June 24, 2009, Senate Finance Committee Chairman Baucus announced that the CBO has scored the Finance Committee health reform plan under development as costing under $1 trillion.  The CBO also has determined that the plan makes offsetting cuts and/or raises revenues to fully pay for those new costs.  Note that the text of the Committee's legislation is not yet available; it is expected to be released after the 4th of July Congressional recess.

 

New Postings on the Reed Smith Health Industry Washington Watch Blog

The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

  • Legislative Developments: Major health reform legislation has been proposed in the House and Senate, including provisions to expand access to insurance coverage while controlling Medicare and Medicaid costs. The White House also has endorsed additional Medicare and Medicaid cuts. President Obama has signed into law legislation to give the FDA authority to regulate tobacco products. Congressional committees have held a number of hearings on health policy issues, including a hearing on a new FTC report on follow-on biologic drug competition.
  • Regulatory Developments. CMS is seeking comments on plans to amend its rules regarding Medicaid home and community-based services waivers, and the FDA is seeking comments on a study on how to present quantitative effectiveness information in direct-to-consumer advertising. 
  • Other HHS Developments. HHS is soliciting comments on what constitutes "meaningful use" of electronic health records under the American Recovery and Reinvestment Act (ARRA). CMS has issued guidance on nursing home surveys and state use of civil money penalty funds, ARRA Medicaid and CHIP provisions, and unannounced surveys. CMS also has released the July 2009 Medicare Part B drug average sales price files and announced the availability of funds for states to survey ambulatory surgical centers regarding infection control practices. The agency also is warning of a new scam targeting physician offices. 
  • Odds & Ends.  The OIG has posted its Semiannual Report to Congress for October 1, 2008–March 31, 2009. MedPAC has issued a report to Congress on “Improving Incentives in the Medicare Program." AHRQ is seeking comments on a draft technology assessment on the use of Bayesian techniques in randomized clinical trials.
  • Looking Ahead. Upcoming health industry events include an HHS meeting on healthcare-associated infections, a CMS meeting on HCPCS codes for negative pressure wound therapy devices, and a CMS meeting on Medicare clinical laboratory test payments.

Medicaid Home and Community-Based Services Waivers

On June 22, 2009, the Centers for Medicare & Medicaid Services (CMS) published an advance notice of proposed rulemaking announcing its intention to amend its regulations implementing Medicaid home and community-based services waivers under section 1915(c) of the Social Security Act. The notice solicits advance public comments on the merits of providing states the option to combine or eliminate the existing three permitted waiver targeting groups (i.e., aged or disabled, or both; mentally retarded or developmentally disabled, or both; and mentally ill). Comments also are solicited on the most effective means to define home and community. Comments will be accepted until August 21, 2009.  

FDA Comment Solicitation on Drug Advertising

On June 22, 2009, the FDA announced a public comment opportunity on its “Experimental Study of Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer (DTC) Television and Print Advertisements for Prescription Drugs.” The study will examine: (1) various ways of communicating quantitative efficacy in DTC print ads and (2) whether the findings translate to DTC television ads. Comments will be accepted until August 21, 2009. 

CMS Guidance on Nursing Home Surveys, Use of Nursing Home CMP Funds

CMS has announced revisions to its guidance for nursing home surveyors, effective June 12, 2009. The new guidelines emphasize resident rights in areas such as: ensuring residents live with dignity; offering choices in care and services; accommodating the environment to each resident’s needs and preferences; and creating a more homelike environment for residents, including access for visitors.  Separately, CMS has issued a memo on the use of nursing facility civil money penalty (CMP) funds by states.  Specifically, the memo: clarifies that states may direct collected CMP funds to entities other than nursing homes as long as funds are used in accordance with statutory intent; shares innovative practices for states to consider when deciding how to use CMP funds to improve the quality of care and life for nursing home residents; and announces that CMS will consider reporting CMP amounts that have been returned to each state. 

CMS Warns of Scam Targeting Physician Offices

CMS is alerting providers that certain individuals are sending faxes to physician offices posing as the Medicare carrier or Medicare Administrative Contractor.  The fax instructs physician staff to respond to a questionnaire to provide account information within 48 hours in order to prevent a gap in Medicare payments.  CMS recommends that providers check with their contractor before submitting any information in response to such a solicitation, and to only send information to actual contractor addresses posted on the CMS web site. 

CMS Issues Guidance to States on ARRA Medicaid/CHIP Provisions

On June 17, 2009, CMS issued guidance to state Medicaid directors on implementation of the American Recovery and Reinvestment Act of 2009 (ARRA) Medicaid and Children’s Health Insurance Program provisions, including details on payments that should not be counted for purposes of eligibility for federal programs. 

Unannounced State Surveys

CMS has issued a memo to state survey agencies reiterating current policy that all surveys must be unannounced for all providers and suppliers, except for standard Clinical Laboratory Improvement Amendments surveys of laboratories and other limited exceptions. 

New Funds to Survey ASCs for Healthcare-Associated Infections

CMS is working with states to implement a new survey process to promote better infection control practices in ambulatory surgical centers (ASCs). Specifically, $10 million of ARRA funding is being made available to states in FYs 2009 and 2010 to implement a new survey process and increase the frequency of inspections for ASCs. In addition to remedying current infection control lapses and preventing future healthcare-associated infections, the funds will help states avoid otherwise planned layoffs or furloughs and/or recruit additional surveyors to inspect more ASCs.  

CMS Information on ARRA Health IT Provisions

CMS has announced a website dedicated to information on the health information technology provisions in the American Recovery and Reinvestment Act of 2009, including information on Medicare and Medicaid incentives for electronic health records adoption. 

OIG Semiannual Report

The HHS Office of Inspector General (OIG) has posted its Semiannual Report to Congress for October 1, 2008–March 31, 2009. The OIG’s expected recoveries for this period include $274.8 million in audit-related receivables and $2.2 billion in investigative-related receivables (which includes nearly $552 million in non-HHS receivables resulting from OIG work, such as states’ share of Medicaid restitution). Also during this period, the OIG reported exclusions of 1,415 individuals and organizations for fraud or abuse involving federal health care programs and/or their beneficiaries; 293 criminal actions involving crimes against HHS programs; and 243 civil actions, including False Claims Act and unjust enrichment suits, CMP Law settlements, and administrative recoveries related to provider self-disclosure matters.

New Law Allows FDA to Regulate Tobacco Products

On June 22, 2009, President Obama signed into law H.R. 1256, the “Family Smoking Prevention and Tobacco Control Act,” as amended. The law gives the Food and Drug Administration (FDA) authority to regulate the advertising, marketing, and manufacturing of tobacco products under the Federal Food, Drug, and Cosmetic Act, funded through user fees on tobacco product manufacturers.

Congressional Hearings

A number of Congressional panels have held hearings recently on health policy issues, including the following:

In addition, on June 24, 2009, the House Small Business Regulations and Healthcare Subcommittee is holding a hearing on "Health Information Technology and the New Challenges Faced by Solo and Small Group Healthcare Practices." Also on June 24, the Senate Homeland Security and Governmental Affairs Committee is holding a hearing on "Type 1 Diabetes Research: Real Progress and Real Hope for a Cure."

Clinical Trial Technology Assessment

On June 25, 2009, the Agency for Healthcare Research and Quality's (AHRQ) Technology Assessment Program will be releasing a draft technology assessment on “Use of Bayesian Techniques in Randomized Clinical Trials: A CMS Case Study.” Comments on the draft will be accepted until July 10, 2009.

CMS Meeting on NPWT Coding

On July 9, 2009, CMS is holding meetings to discuss preliminary determinations on public requests for HCPCS codes for negative pressure wound therapy (NPWT) devices.  CMS has tentatively decided not to establish new coding for NPWT systems/components, citing a technology assessment  that found that the available evidence does not support significant therapeutic distinction of a NPWT system or component of a system.

House Leaders Unveil Draft Health Reform Bill

Today the Chairmen of the three House committees that share jurisdiction over health policy released their 852-page draft health reform bill. As expected, the legislation would create a public health insurance plan to compete with private insurers, with provider payments based initially on Medicare payment amounts. Other mechanisms to expand access to insurance include low-income subsidies, creation of a health insurance exchange, Medicaid expansion, and private insurance market reforms, coupled with mandates for individuals to purchase insurance and employers to contribute to health care costs (with certain exceptions). The bill also includes extensive Medicare and Medicaid policy changes affecting virtually every type of health care entity. Among many other things, the bill would:

  • Reform the physician fee schedule formula, including erasing cumulative shortfalls triggered by the current payment formula, establishing separate updates for evaluation and management and other types of services, and requiring review of potentially misvalued codes;
  • Reduce payments to hospitals for a preventable readmissions;
  • Bundle payments to hospitals and certain post-acute care providers (SNFs, IRFs, LTCHs, and HHAs) for services provided within 30 days of hospital discharge (the HHS Secretary would be required to study how the readmission policy also could be applied to physicians), and require the HHS Secretary to develop a detailed plan to reform Medicare payment for post-acute care services;
  • Reduce Medicare reimbursement for imaging services by increasing equipment utilization factor for advanced imaging from 50% to 75% and increasing the multiple imaging procedure technical component discount from 25% to 50% for second and subsequent imaging studies on the same patient/same day;
  • Reduce inflation updates for a variety of providers, revise the skilled nursing facility payment methodology, and incorporate productivity improvements into market basket updates for several types of providers;
  • Limit the "whole hospital" exception to the Stark law's self-referral prohibition to those hospitals with physician ownership or investment on January 1, 2009, and add significant new conditions to that exception for existing hospitals with physician ownership;
  • Reform graduate medical education payments;
  • Reduce Medicare Advantage payments;
  • Expand drug rebates in a number of ways (increase the Medicaid drug rebate amount for brand-name drugs from 15.1% to 22.1% of the average manufacturer price, apply the additional rebate to new drug formulations, allow rebates on drugs provided through Medicaid managed care organizations, and require drug manufacturers to provide rebates for certain full premium subsidy eligible individuals under the Part D drug program);
  • Expand penalties for various types of health care fraud and abuse, including penalties for hospices that demonstrate substandard quality of care;
  • Gradually phase out the Part D coverage gap ("donut hole");
  • Establish an accountable care organization pilot program;
  • Expand comparative effectiveness research;
  • Require reporting of financial relationships between drug and device manufacturers and physicians (with a limitation on the deductions for advertising for failure to file required transparency reports); and
  • Require the disclosure of nursing home ownership information and address other nursing home quality issues.

The three House committees -- Ways and Means, Energy and Commerce, and Education and Labor -- have scheduled hearings on the legislation next week, with committee voting expected in July.

CBO Warns of Health Reform's Impact on Federal Budget

On June 16, 2009, the Congressional Budget Office (CBO) outlined the potential impact of health reform on the federal budget.  In a letter to the Senate Budget Committee, the CBO warns that "without meaningful reforms, the substantial costs of many current proposals to expand federal subsidies for health insurance would be much more likely to worsen the long-run budget outlook than to improve it."   Moreover, despite consensus about the need to make changes to make the health sector more efficient, such as paying providers for value, providing incentives for both providers and patients to control costs, and promoting comparative effectiveness information, "little reliable evidence exists about exactly how to implement those types of changes—especially at the level of specificity required for legislation."

Health Reform Documents Begin to Emerge

The Reed Smith Health Industry Washington Watch blog includes news on Congressional health reform developments, including the following:

The blog also reports that the federal Health Information Technology (HIT) Policy Committee is soliciting comments on what constitutes "meaningful use" of electronic health records (EHRs) under the American Recovery and Reinvestment Act. Other recent postings address White House Medicare cut proposals, follow-on biologicals, Part B drug pricing, and MedPAC recommendations for Medicare policy changes.

"Meaningful Use" of Electronic Health Records -- Comments Due June 26, 2009

On June 16, 2009, the federal Health Information Technology (HIT) Policy Committee met to begin defining what constitutes "meaningful use" of electronic health records (EHRs) under the American Recovery and Reinvestment Act, which authorizes Medicare and Medicaid incentive payments to eligible health care providers who demonstrate "meaningful use" of a certified EHR.  At the June 16, 2009 meeting, the Committee received recommendations from its Meaningful Use Workgroup on the definition of meaningful use, and the Committee is accepting comments on the Workgroup’s update until June 26, 2009. The Centers for Medicare & Medicaid Services (CMS) expects to issue a proposed rule later this year on the incentive program and the definition of meaningful use, and the public will have another opportunity to comment at that time.

MedPAC Report on Medicare Payment Policy

MedPAC has issued its June 2009 "Report to the Congress: Improving Incentives in the Medicare Program."   Among other things, the report addresses follow-on biologicals, chronic care management, physician self-referrals involving imaging services, physician resource use measurement, graduate medical education, accountable care organizations, Medicare benefit design, and Medicare Advantage payment policy.

CBO Estimates $1 Trillion Price Tag for Senate HELP Health Reform Bill Without Key Features

On June 15, 2009, the Congressional Budget Office posted its preliminary analysis of the major provisions related to health insurance coverage in the "Affordable Health Choices Act," which was released by the Senate Committee on Health, Education, Labor, and Pensions (HELP) on June 9, 2009.  Among other things, that draft legislation would establish insurance exchanges through which individuals and families could purchase coverage and would provide federal subsidies to substantially reduce the cost of that coverage for some enrollees.  The CBO estimates that the HELP health reform proposal would increase the federal budget deficit by about $1.0 trillion over the 2010–2019 period. Once fully implemented, about 39 million individuals would obtain coverage through the new insurance exchanges; however, because employer-provided insurance and coverage through other sources would decline, the net decrease in the number of people uninsured would be about 16 million. The $1 trillion figure also does not include the costs of a potential expansion of Medicaid eligibility or a public health insurance options, both of which might be added at a later date.  The HELP Committee is scheduled to begin markup of the legislation on June 17.

House Chairmen Outline Draft Physician Fee Schedule/SGR Reforms

 

On June 15, 2009, the House Ways and Means Committee posted a press release outlining Medicare physician fee schedule reforms being developed by key House lawmakers.  Under current law, known as the sustainable growth rate (SGR) formula, Medicare physician payments are expected to be reduced by 21% in 2010 and by additional amounts in future years.  Under the plan being developed in the House, the SGR formula would replaced with a new formula that:

  • Removes items such as drugs and laboratory services not paid directly to practitioners from spending targets;
  • Allows the volume of most services to grow at the rate of GDP plus 1 percentage point per year;
  • Allows the volume of primary and preventive care services to grow at GDP plus 2% per year; and
  • Encourages new Accountable Care Organizations "to be responsible for their own growth paths, irrespective of reductions or increases that apply elsewhere in the system."

The press release touts the reforms as costing "less than $300 billion over ten years."

White House proposes $313 billion in additional Medicare/Medicaid cuts

The White House has proposed $313 billion in new Medicare and Medicaid cuts over 10 years, in addition to the provisions included in the Administration's proposed FY 2010 budget. Among other things, the Administration is endorsing: incorporating productivity adjustments into Medicare payment updates; reducing hospital subsidies for treating the uninsured as coverage increases; paying "better" prices for Medicare Part D drugs (including reducing reimbursement for beneficiaries dually eligible for Medicare and Medicaid); increasing the equipment utilization factor for advanced imaging from 50 percent to 95 percent; adopting MedPAC’s recommendations for 2010 payments to skilled nursing facilities, inpatient rehabilitation facilities, and long-term care hospitals; and cutting waste, fraud, and abuse (including prepayment review for physicians in high-risk areas or those that order a high volume of high-risk services such as durable medical equipment, home health, and home infusion services).

The following chart summarizes the Obama Administration's health reform financing proposals released to date:

 
 
Source
Health Care Reserve Fund
($ in billions)
10 years
FY 2010 Budget
-  Medicare and Medicaid Savings
-  Revenues
$635
$309
$326
Additional Medicare and Medicaid Savings
-  Incorporate productivity adjustments into Medicare payment 
    updates
-  Reduce hospital subsidies for treating the uninsured as  
    coverage increases
-  Pay better prices for Medicare Part D drugs

-  Other

$313
$110

 
$106

 
$75
$22
Total
$948

July 2009 Medicare Part B Drug ASP Files Posted

CMS has posted the July 2009 Medicare Part B drug average sales price (ASP) files.  CMS notes that prices generally have been stable, with prices for the top part B drugs increasing by less than one percent over the previous quarter, and most of the higher-volume drugs (30 out of the top 50), changing 2 percent or less.
 

2009 PQRI Call (June 17, 2009)

On June 17, 2009, CMS is hosting a national provider conference call on the 2009 Physician Quality Reporting Initiative (PQRI). Under the PQRI, eligible professionals who meet the criteria for satisfactory submission of quality measures data for services furnished during the reporting period, January 1, 2009 - December 31, 2009, will earn an incentive payment of 2.0 percent of their total allowed charges for Physician Fee Schedule covered professional services furnished during the period. Topics on the call will include: how to access the PQRI help desk; review of the incentive payments and feedback reports timeline; and an update on the upcoming decisions registries for 2009. Registration for the call is required.

HIT Standards Committee Meeting (June 23, 2009)

The second meeting of the HIT Standards Committee will take place on June 23, 2009. The meeting, which will include presentations from the HIT Standards Committee Workgroups, is a web-based meeting with teleconference dial-in.

FTC Issues Report on Follow-On Biological Drug Competition

A lengthy new FTC report on “Follow-on Biologic Drug Competition" issued June 10, 2009 concludes that:

  • Competition between a biologic drug and a follow-on biological (FOB) is much more likely to resemble brand-to-brand competition than the dynamics of brand-generic competition under Hatch-Waxman.
  • Existing incentives that support brand-to-brand competition among biologic drugs – patent protection and market-based pricing – are likely to be sufficient to support FOB competition and biologic innovation.
  • A 12-14-year exclusivity period is unnecessary to promote innovation by pioneer biologic drug manufacturers.
  • Special procedures to resolve patent issues between pioneer and FOB drug manufacturers prior to FDA approval are unnecessary and they could undermine patent incentives and harm consumers.
  • FOB drug manufacturers are unlikely to need additional incentives to develop interchangeable FOB products.

The FTC paper will be the subject of a June 11 Energy and Commerce Health Subcommittee hearing.