Experts Discuss Health IT, mHealth and Medical Device Regulation

During an event in Washington this week, federal officials and industry experts discussed the intersection of healthcare and the future of technology policy.  At issue was whether or not the federal government was in a position to regulate the future of mobile apps, evolving medical devices and the emergence of EHR technology in a way that allows for innovation.  By and large, industry experts agreed with the tact taken by officials at the FDA and ONC in trying to incorporate stakeholder opinions from all corners, while acknowledging that much more work is needed.  One participant who acts as general counsel for the mHealth Regulatory Coalition said he had “actually never seen the FDA be more hospitable to technology than they are right now,” but continuing that the agency should do a better job going after companies that are “blatantly over the line.”  ONC head Farzad Mostashari, M.D., said officials across HHS were working to make sure that current regulations were not duplicative and that entrepreneurs in the space between mobile, clinical decision support and traditional medical devices were educated on just how much current leeway existed in regulations.

CHIME is currently engaged in several conversations in this emerging policy area.  Of prime concern is how patient safety and clinical IT systems, such as EHRs, are viewed in future regulatory frameworks.

Texas Rep Wants HHS to Nix ICD-10 Plans

A bill was introduced this week in the House of Representatives that would “prohibit the Secretary of Health and Human Services replacing ICD-9 with ICD-10 in implementing the HIPAA code set standards.”  Rep. Ted Poe (R-Texas) has previously lambasted the cost, bureaucracy and redundancy of ICD-10, but this is the first legislative bill introduced since an August 2012 final rule set an Oct. 1, 2014 compliance date.  The Cutting Costly Codes Act of 2013 (H.R. 1701) would also require the Government Accountability Office (GAO) to conduct a study to identify steps “to mitigate the disruption on health care providers resulting from a replacement of ICD-9.”

The Cutting Costly Codes Act of 2013 would negate current rules requiring ICD-10 compliance by October 1, 2014, but the bill – as a standalone piece of legislation – does not have much momentum (there are no cosponsors) and previous efforts to push a permanent or multi-year delay have fallen short.  HHS is committed to the 2014 date, so it behooves CIOs to forget about further delay, let alone a complete abandonment of ICD-10, by agency officials. 

Meaningful Use Data Updated

CMS updated running totals for the EHR Incentive Payments program this week, indicating that eligible professionals are nearing the 50 percent mark and just over 30 percent of EPs have met Stage 1 Meaningful Use criteria.  According to March data, nearly 265,000 EPs have received payments through Medicare, Medicaid or Medicare Advantage.  The CMS data also show that 3,858 out of an estimated 5,011 eligible hospitals, about 77 percent, have received a combined total of nearly $8.5 billion in meaningful use incentive payments.  Total payouts for the program were $13.7 billion since its launch in 2011.

Big-Picture Delivery Reform Still En Vogue in Washington

According to Washington observers, Congress may be reaching an “inflection point” in healthcare.  There appears to be growing consensus around a series of granular policy recommendations meant to transition healthcare payment away from fee-for-service.  Two reports in particular, one from the Bipartisan Policy Center and the other from Brookings Institution, clue-in on the next iteration of Accountable Care Organizations.  The BPC calls them Medicare Networks and Brookings refers to them as Medicare Comprehensive Care (MCC) organization, but the idea is the same: encourage seniors to enroll in the care delivery organizations (similar looking to ACOs) by allowing the beneficiaries to share in the savings derived through coordinated care.  Other similarities between the plans include: rewarding beneficiaries for using MCCs; making Medicare Advantage plans bid against one another; replacing the Medicare physician pay formula; eliminating Medigap first dollar coverage along with capping catastrophic liability; ending the tax exemption for employer-provided health insurance; and sharing more Medicare savings with states. Both plans are estimated to save Medicare $300 billion over 10 years, which includes the cost of replacing the Sustainable Growth Rate (SGR) formula that determines physician pay rates.

Edited by Gabriel Perna