NRHA Regulatory Comment Letters
In addition to legislation, federal regulations can have a tremendous impact on the rural health care system. NRHA frequently comments on proposed regulations so that rural Americans have a voice in the regulatory process. Here you will find the latest comments submitted to federal agencies by NRHA, as well as important information from various federal agencies. For more information please contact David Lee in the NRHA Government Affairs office at 202-639-0550.
In July 2011, the National Rural Health Association (NRHA) commented on a proposed regulation related to the 340B Pharmaceutical Program released by the Health Resources and Services Administration (HRSA). Following efforts by NRHA and others, as part of the Affordable Care Act the 340B program was expanded to include many rural hospitals. This program allows covered entities to access special pricing for outpatient drugs from pharmaceutical companies. This special pricing is limited, however, in regard to certain drugs that were developed to treat rare diseases. These drugs are generally known as “orphan drugs.” In many instances, however, these orphan drugs also can have great benefits for the treatment of common diseases and illnesses. HRSA has proposed to allow the rural facilities that participate in this program to buy orphan drugs at 340B pricing if they use pharmaceuticals bought at this special pricing only for common illnesses. Each facility buying orphan drugs would have to maintain “auditable” records that prove they are not using these drugs for their “orphan purpose.” NRHA applauds HRSA for the development of a reasonable interpretation of statute and for helping these vital safety net facilities access the pharmaceuticals they need.
Medicaid Assuring Access
In July 2011, NRHA submitted comments to the Centers for Medicare and Medicaid Services related to a “clarification regulation” associated with access to care barriers. NRHA’s comments included suggestions about reimbursement rates for doctors and facilities, concerns with the trend toward Medicaid managed care, and general economic concerns for rural communities.
Inpatient Prospective Payment System
In July 2011, NRHA submitted comments to the Centers for Medicare and Medicaid Services related to the update for the inpatient prospective payment system for fiscal year 2012. Included in the comments were concerns related to changes in the quality reports required of hospitals, changes in reimbursement rates intended to mitigate coding and reporting improvements, and reimbursements for certified registered nurse anesthetists in some critical access hospitals.
Accountable Care Organizations
In June 2011 NRHA submitted comments to the Centers for Medicare and Medicaid Services related to the proposed rule for the establishment of the statutorily mandated Medicare Shared Savings Program and Accountable Care Organizations (ACO). Mandated by the Affordable Care Act, ACOs are intended to produce significant savings for the Medicare program. An ACO is an integrated organization that endeavors to produce higher quality care through coordination and communication while reducing costs through the elimination of redundant procedures. Private ACOs have been around for 50 to 60 years and include big names such as Kaiser Permanente and Cleveland Clinic. While the ACO concept has garnered significant support, many organizations, associations and hospitals have been wary of the structure proposed in the current regulation. NRHA’s comment expressed concern with the beneficiary assignment calculation, “ACO professional” determination, anti-trust barriers, cost concerns, and a number of other issues.
CDC Community Transformation Grants
In May 2011 the Centers for Disease Control released its plan for distributing Community Transformation Grants. The money for these grants was mandated through the Affordable Care Act and included a provision that required a certain percent of the money be given to rural communities. NRHA’s comment expressed concern with the calculation of what is rural as well as the onerous application process.
Office of the National Coordinator 5-year Plan
In April 2011 the Office of the National Coordinator for Health IT (ONC) released a general plan for the developments and implementations it would like to see in the health IT field. NRHA is thankful to ONC for its leadership in this important arena and appreciates ONCs continued work on the development and implementation of health IT standards. The comment outlines suggestions that NRHA believes will strengthen the strategic plan in regards to rural implementation. NRHA supports the plan’s goals and looks forward to its continuing development. NRHA hopes that it continues to recognize the significant separation of large and small, rural and urban facilities in their ability to meet meaningful use standards.
In March 2011 the National Rural Health Association submitted comments to the Centers for Medicare and Medicaid Services related to the Value Based Purchasing program. In general, NRHA strongly supports the concept of aligning payment with the delivery of quality of care and supports the intent of the Affordable Care Act and the Hospital VBP proposed rule. Improved clinical quality for services delivered regardless of the size or location of hospitals should be the goal of all. To attain that laudable goal, equity for all facilities regardless of size or location is paramount. Comments include ideas and modifications that would make the program more rural friendly.
