New HRSA Guidelines May Hamper Health Center Innovation

by Admin | April 2, 2009 5:17 pm

By Stuart Gordon[1]

The Obama Administration’s efforts to expand community health center services could be complicated by new guidelines that set conditions for centers that seek the agency’s approval to add specialty services. This, in turn, could limit health center use or 340B drugs for specialty care where potential savings is often most attractive.

The problem: A Health Resources and Services Administration (HRSA) Policy Information Notice issued in December 2008. HRSA noted that technological advances have allowed providers to perform more complicated outpatient procedures, and that this has prompted more and more health centers to ask for permission to add specialty services such as chemotherapy or diagnostic tests.

Addressing community health centers, migrant health centers, public housing primary care centers, and homeless health care centers, HRSA reminded the centers that adding significant new healthcare services to the scope of services covered under a Section 330 funding grant requires prior approval by the agency.

This could stymie, or at least delay, the expansion of health center services that the $2 billion in stimulus money intended to bring. The HRSA approval process could also block or delay health center innovation with the 340B program and the delivery of pharmacy services to patients requiring specialty care. For example, if a county health department, jail or school wants to contract with a community health center to provide discounted drugs under the 340B program, it may not be able to until HRSA reviews and approves such a partnership arrangement.

to bring. The HRSA approval process could also block or delay health center innovation with the 340B program and the delivery of pharmacy services to patients requiring specialty care. For example, if a county health department, jail or school wants to contract with a community health center to provide discounted drugs under the 340B program, it may not be able to until HRSA reviews and approves the contract.

Such partnership arrangements are a growing trend within the 340B program. Pressure to establish them may build if Congress passes healthcare reform legislation and efforts to control costs intensify.

Summary of HRSA’s New Guidelines

In setting out the new conditions for prior approval, HRSA requires, among other things, that:

• any new service be offered on a sliding fee scale for patients with incomes between 100 percent and 200 percent of the federal poverty level and be equally available to all patients, regardless of their ability to pay.
• a center demonstrates that all required primary health care services covered under the grant will remain available to all patients after the specialty services have been added.
• a center demonstrates that the new specialty service will support the required primary care services offered and describes how the services will address unmet health needs of the population served by the center.
• the new services are a logical extension of the primary care services provided.
• the center documents how referrals will be made if specialty service is provided at a location qualified as an approved site, and the process for facilitating appropriate follow-up care at the center.

Finally, HRSA reminds the centers that all providers must be properly licensed, credentialed, and privileged to perform the activities and procedures expected of them. Centers must provide a clear and comprehensive description of staffing arrangements and describe how any altered staffing might impact the overall organization. They also must qualify for coverage under the Federal Tort Claims Act or have sufficient alternative malpractice insurance of their own.

And if all this proves to be too much?

A center could provide specialty services as a separate line of business. But then they would also have to opt out of federal funding for those services, HRSA said.

Source URL: https://340binformed.org/2009/04/new-hrsa-guidelines-may-hamper-health-center-innovation/

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