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Regulations

When Congress and the President enact a new bill, the federal agencies are charged with creating the detail and implementing the law. These regulations, also called rules, are the guiding requirements for our hospitals, health facilities and providers.  By submitting comment letters to federal regulatory agencies, CHI helps shape proposed rules into fair, reasonable, and workable final rules.

ACO Final Regulation Summary
On October 20, 2011, the Centers for Medicare and Medicaid Services (CMS) released a final rule creating the Medicare Shared Savings Program and Accountable Care Organizations (ACO). This new rule, in conjunction with related guidance from other agencies, makes significant changes to the proposed rules.

CMS accepted many of the recommendations of the hospital industry, including CHI, when drafting the final regulation. The PDF linked above provides an overview of the revised ACO program and a chart of key changes to the regulations that may be useful to CHI organizations as they evaluate the merits of ACO formation and participation.

Federal Mandates for Contraceptive Coverage: Religious Employer conscience Protections in Group Health Insurance Plans
The Centers for Medicare and Medicaid Services (CMS) has proposed an inadequate "religious employer" exemption from the federal mandate for group health insurers to cover women's contraceptive services.  In its current form, the definition of "religious employer" will not exclude Catholic hospitals and health care providers from the federal mandate.  This letter urges CMS to broaden the exemption and protect our conscience rights. 

Establishment of Exchanges and Qualified Health Plans
This is the first significant regulation to create health insurance exchanges, as mandated in the health reform law. CHI provided comment to support CMS’ vision of maintaining state flexibility, while also advocating for certain consumer protections particularly in rural areas. CHI also focused on clinician representation in governing board and stakeholder meetings. Submitted September 19, 2011.

Community Health Needs Assessment
As part of the health reform law, nonprofit hospitals will need to conduct an assessment of the health needs in their community and a plan to implement positive change to affect those needs. This tri-annual assessment will determine a hospital’s nonprofit status. CHI worked in close collaboration with the Catholic Health Association to develop comments that will help our hospitals meet the law. Submitted September 19, 2011.

2012 Outpatient Prospective Payment System
The proposed outpatient prospective payment system (OPPS) regulation is an annual update. The 2012 proposed rule addressed typical payment adjustments as well as policy language related to value-based purchasing, physician supervision, hospital quality reporting, and other non-payment issues. Submitted August  30, 2011.

IRS Form 990
The IRS proposed a significant number of changes to the IRS Form 990 that all nonprofit hospitals have to submit annually. We worked with our tax department to develop comments that reflected the complexity of some of the changes IRS was proposing. Submitted August 1, 2011.

Orphan Drug Status in the 340B Program
This regulation affected the way hospitals could purchase so-called “orphan drugs” through the discounted 340B program. Luckily, the changes HRSA proposed were largely beneficial to CHI. We commented to thank them for their consideration of our concerns and to request clarification on a few important issues. Submitted July 19, 2011.

Tax-Exempt Hospitals
CMS proposed requirements for tax-exempt hospitals and community benefit. CHI submitted comments crucial to CHI’s future not-for-profit status. Final ruling on some issues related to nonprofit status, including the IRS 990 Form, are still outstanding. Submitted July 22, 2011.

Accountable Care Organizations and the Medicare Shared Savings Program
The proposed ACO and MSSP rule would implement a new program to improve quality while decreasing costs in the Medicare system by allowing groups of providers to implement new efficiencies and share in any savings. CHI commented on numerous provisions, including many problems with the implementation of this program. Submitted June 6, 2011.

Inpatient Value-Based Purchasing
The proposed VBP rule intended to provide a financial bonus to hospitals that rank highest in quality measures. CHI comments focused on excluding provisions of the regulation that were unnecessarily burdensome and detrimental to CHI facilities. Submitted March 2, 2011.

Request for Information Related to Accountable Care Organizations
CMS sought comment before drafting the ACO proposed rule. CHI provided comments that would make an ACO more attractive to CHI facilities and more operationally viable in the current market. Submitted December 3, 2010

Fraud and Abuse
CMS proposed new regulations governing aspects of fraud and abuse rules, such as fingerprint background checks and compliance plans. CHI commented on the incongruity in some of the proposals as well as the need for additional guidance and clarification. Submitted November 15, 2010.

Barriers to Clinical Integration
CMS sought comment for ways existing regulation created barriers to clinical integration for provider groups. Together with other Catholic-sponsored health systems, CHI provided comment on a set of specific recommendations for regulatory policy changes that we believe will help clear the path for more rapid adoption of ACOs, as well as bundled payment and other new payment models. Submitted September 27, 2010.

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