AMDIS: Will the political climate change meaningful use funding?

A confluence of events on the national government stage in the U.S. could drastically alter the current path of meaningful use funding and processes, according to a July 13 presentation by David W. Roberts, MPA, vice president of government relations, HIMSS, at AMDIS’ 20th Annual Physician-Computer Connection Symposium.

Roberts pointed out that payment reform in U.S. healthcare is occurring even without the formal implementation of healthcare reform, with widespread initiatives such as increased transparency, public reporting on quality and cost, increased emphasis on chronic disease management and care coordination, and increased risk being assumed by providers. He cited pay-for-performance (P4P) programs, bundled payments, episodes of care and accountable care organizations as examples of payment reform that increase the risk incurred by providers.

Roberts pointed to a number of “unknowns” as well, including the form and extent of exchanges and insurance regulations, as well as the capacity of the U.S. system to absorb large numbers of new patients. He said that many challenging issues will be pushed to state and local governments.

As a subtext to the uncertainty about the direction of post-reform healthcare, he noted that the congressional budget battles following the 2010 elections, including the current debt ceiling debate, spur more questions about the current status of meaningful use funding.
 
In fact, he noted several bills already introduced in the House of Representatives that seek to reduce federal spending, all of which could impact healthcare funding. These include: Repealing the Job-Killing Healthcare Law Act (HR 2); Health Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011 (HR 5); Spending Reduction Act of 2011 (HR 408); Repeal the Patient Protection and Affordable Care Act and Replace with FEHBP (HR 429); and Preserving Patients’ Choices Act (HR 556).

As an example, he parsed the Spending Reduction Act, drafted by the Republican Study Committee and submitted Jan. 24. The Act is intended to save $2.5 billion over the next 10 years by cutting or significantly reducing more than 200 programs. According to Roberts, HR 408 would rescind all unobligated funds that were appropriated under the American Recovery and Reinvestment Act, including the Office of the National Coordinator for Health IT operating and grant funds (HITECH Act). It also seeks to repeal the EHR incentives program and restore Medicare and Medicaid law as before enacted. This bill has been sent to multiple House committees for consideration.

At the state level, Rep. Renee Ellmers (R-N.C.) introduced Stripping The E-prescribe Arbitrary Mandates (STEAM) Act (SB 2128) to the North Carolina Senate. The Act seeks to prevent Medicare fees and penalties to hospitals and doctors that cannot yet e-prescribe, and removes e-prescribing as a requirement for fulfilling the meaningful use definition of the EHR incentive program.

The STEAM Act also would prevent “doctors and hospitals that are already receiving Medicare payments from further payment reductions due to the cumbersome regulations in the EHR program,” according to the bill. “Many doctors and hospitals may be penalized because they either cannot afford the e-prescribe system, don't have the technology to implement the e-prescribe system or they simply have no need for it and refuse to implement it.”

In addition, the FDA has begun regulating EHRs as medical devices because, according to the agency, health IT has advanced so far that the professional intermediary is no longer required or used. Thus, under the Federal Food, Drug and Cosmetic Act, health IT is characterized as a medical device. Per voluntary reports from patients, clinicians and user facilities, the FDA has cited data indicating 260 reports of health IT-related adverse events, including 44 reported injuries and six reported deaths, resulting in the agency issuing its final rule in February classifying “Medical Device Data Systems” as low Class 1 medical devices, requiring post-market surveillance.

According to Roberts, the FDA has three possible options for regulations:

• Focus on post-market safety;
• Focus on quality manufacturing and post-market safety; or
• Require pre-market approval.

 
Finally, Roberts suggested that tying health IT and evidenced-based medicine to liability safe harbors might encourage adoption, despite the “partisan gridlock preventing advances on medical liability reform in Congress.”