EPA Sets Ozone Standard

In March, EPA Administrator Stephen Johnson issued final rules for the national standard for ozone pollution. The new standard of 0.075 ppm/8-hours replaced the previous standard of 0.084 ppm/8-hours. The ATS had strongly recommended EPA adopt a stricter standard of 0.060 ppm/8-hours.

While this is a small, but welcome, step forward in protecting the nation from the adverse effects of ozone pollution it appears to come with a price. In announcing the new standard, EPA Administrator Johnson is calling for an overall of the Clean Air Act - asking Congress to change the legislation from its health-based principles. The Administrator is proposing change the Clean Air Act to meet the following 4 principles:

1) Must protect the public health and improve the overall well-being of our citizens;
2) Should allow decision-makers to consider benefits, costs, risk tradeoffs, and feasibility in making decisions about how to clean the air;
3) Should provide greater accountability and effective enforcement to ensure not only paper requirements but also air quality requirements are met, especially in areas with the furthest to go in meeting our standards;
4) Should allow the schedule for addressing NAAQS standards to be driven by the available science and the prioritization of health and environmental concerns, taking into account the multi-pollutant nature of air pollution.

The principles expressed by Administrator Johnson are of concern to the ATS.
By considering costs, as suggested in point 2, industry would be allowed to make the case it is too expensive to reduce air pollution. The Clean Air Act currently require EPA to set air pollution standards on health and cannot consider costs in developing their standard. Point 3 essentially states and cities that don't meet current standard be given leeway in meeting news standards, essentially rewarding areas with themost pollution. Point 4 is a bit ironic, an administration that failed to meet the Clean Air Act requirement of updating NAAQS standards every 5 years and had to be sued by the environment community to promulgate the ozone standard, wants additional flexibility - read delay - to set standards going forward. The ATS has strong concerns with legislative principle suggested by Administrator Johnson.

On April 2, in a victory for ATS advocacy efforts and global tuberculosis (TB) control, the U.S. House of Representatives passed broad global health legislation that includes the global tuberculosis bill, the Stop TB Now Act, sponsored by Reps. Engel
(D-NY) and Wilson (R-NM). The broader legislation, the Tom Lantos and Henry Hyde U.S. Global Leadership Against HIV/AIDS, Tuberculosis and Malaria Act, H.R. 5501, also known as PEPFAR, reauthorizes the President's Emergency Plan for AIDS Relief (PEPFAR), which provides resources for fighting HIV/AIDS, HIV-related TB and malaria in fifteen focus countries. The PEPFAR bill passed the House on a bipartisan vote of 308 - 116.

The Stop TB Now Act provides authority and resources for the U.S. Agency for International Development (USAID) to play a leading role in eradicating tuberculosis worldwide by committing the U.S. to the Stop TB Partnership's Global Plan to reduce the TB deaths and disease burden by half. Specifically, the bill will:
- enhance US technical assistance in responding to the global drug resistant TB crisis
- support global TB control activities at the USAID, including expansion of directly observed treatment short-course (DOTS) coverage, strengthening of health systems, and promotion of the International Standards of TB Care
- Provide $4 billion over 5 years for global TB control programs

The Senate version of the PEPFAR bill is awaiting a floor vote, expected within the next few weeks. House passage of the Stop TB Now Act is a significant success for the ATS, which drafted the bill and has led efforts on its advancement for several years.

In March, the Centers for Medicare and Medicaid Services (CMS) issued the final Notice of Coverage Determination for continuous positive airway pressure (CPAP) devices for the treatment of obstructive sleep apnea (OSA).

The final CMS policy closely followed the proposed notice of coverage determination issued earlier this year that proposed two major changes in CMS coverage for CPAP. The first major component of the decision was to cover CPAP for an initial 12 week period. Coverage beyond 12 weeks is "covered for those beneficiaries diagnosed with OSA whose OSA improved as a result of CPAP during this 12 week period."

The second major component of the CMS policy is to broaden diagnosis of OSA to include unattended monitoring devices. Previously, CMS policy had limited OSA diagnosis to facility based polysomnography tests.

While it will take some time for local Medicare durable medical equipment regional carriers (DMERCs) to implement, the final policy will likely have significant impacts on patient access to CPAP therapy for OSA. What constitutes "improved" is not explained in the decision memo and will likely be further fleshed out in local coverage policies developed by DMERCs. The ATS will work with CMS, DMERCs to help establish reasonable standards for DMERCs to evaluate improvements in OSA.