NACHC Submits Comments on Navigator Proposed Rule

On March 21, 2014, the Centers for Medicare and Medicaid Services (“CMS”) released a proposed rule addressing a multitude of requirements applicable to health insurance issuers and the Affordable Insurance Exchanges under the Patient Protection and Affordable Care Act (“ACA”). NACHC submitted comments on April 21 that focused on the provisions of the proposed rule relating to Navigators, non-Navigator assistance personnel, and certified application counselors (which we refer to here collectively as “in-person assisters”).

New In-Person Assister Conduct Requirements
The proposed rule added a number of new standards restricting the conduct of in-person assisters, including:

• Prohibiting in-person assisters from charging consumers for application assistance or other assistance related to in-person assister activities;
• Prohibiting in-person assisters from going door-to-door or using other unsolicited means of direct contact, such as cold calls, to solicit consumers for application or enrollment assistance; and
• Prohibiting in-person assisters from using automated telephone or dialing systems.

The provisions limiting direct consumer marketing were of serious concern to many health centers and primary care associations. NACHC argued in its comments that health centers functioning as assisters should be exempted from those requirements, because they are in tension, if not open conflict, with long-standing health center outreach and enrollment practices. For example, health centers contact patients through mailings, emails, text messaging, phone calls, and referrals from medical staff. Often these “in-reach” contacts are unsolicited by patients, and may be made through automated communications. The prohibition in the proposed rule are in tension, NACHC argued, with requirements under the HRSA Health Center Outreach and Enrollment Assistance program and with the referral and linkage activities that health centers perform as a core service under Section 330 of the Public Health Service Act.

“Preemption” of State Regulation of In-Person Assisters
The proposed rule provides that in-person assisters will not be required by CMS to comply with certain types of non-Federal laws that in CMS’s judgment would undermine the application of Title I of the ACA. The proposed rule describes some of the non-Federal laws that may be preempted by Title I of the ACA. Examples include, but are not limited to, laws that require in-person assisters to refer consumers to agents or brokers or to any other sources not required to provide them with impartial advice; and laws that require Navigators to be agents or brokers or carry errors and omissions coverage.

In its comments, NACHC on the whole applauded these new provisions for providing more clarity for assisters struggling to comply with State and Federal legal requirements that may be in tension, if not in open conflict. However, NACHC recommended several changes. Specifically, NACHC suggested that CMS broaden the preemption of non-Federal laws requiring Navigators to be licensed agents or brokers or to carry errors and omissions coverage. This provision was based on CMS’s concern that these types of restrictions effectively exclude community and consumer-focused nonprofit groups from performing outreach and enrollment. NACHC agreed strongly with this logic but noted that other types of “financial responsibility” requirements (for example, a requirement that assisters post a bond) were equally stifling and should be included in the preemption.

NACHC also urged CMS to add a new category of laws to the proposed preemption rule: laws that bar in-person assisters from participating in voter registration activities. NACHC believes that such laws are inconsistent with Title I of the ACA and with the National Voter Registration Act of 1993 (NVRA). Under that law, states can designate health centers as voter registration sites.

Civil Money Penalties
The proposed rule imposes civil money penalties (“CMPs”) on in-person assisters for failing to comply with various Federal requirements. NACHC made several recommendations to CMS. First, NACHC suggested that solely CMS (and not the HHS Office of Inspector General) be solely authorized to impose CMPs on in-person assisters. NACHC also urged CMS to put in place a maximum allowable penalty under the CMPs to protect in-person assister entities. Finally, NACHC requested that CMS clarify what constitutes inappropriate use and disclosure of protected individual information under the CMPs.

Special Enrollment Periods
The proposed rule also sets forth provisions for special enrollment periods. NACHC and the Community HealthCorps program, in a separate set of comments [link here], suggested changes that would alleviate inadvertent penalization of AmeriCorps members exiting service. Specifically, NACHC supported designating an exit from an AmeriCorps program as a qualifying event triggering a special enrollment period.

Coverage Options in the Exchange for Lawfully Present Immigrants

By Heidi Emerson

As the March 31st  deadline for open enrollment in the Marketplace approaches,  it’s worth reviewing  the coverage options under the ACA for “lawfully present” immigrants who are in the income range for Medicaid coverage or exchange premium tax credits, and may be subject to the five-year waiting period for Medicaid or CHIP coverage. In July 2012, HHS defined “lawfully present” immigrants for the purposes of eligibility for the ACA’s high-risk insurance pools or the Pre-Existing Condition Insurance Plans (PCIP), and includes not only “qualified” immigrants, but other non-U.S. citizens who have permission to live and/or work in the U.S.[i]    The categories considered as “lawfully present” are described here. “Lawfully present” immigrants with incomes of less than 100 percent FPL, as well as those with incomes between 100-400% FPL , and who are not eligible for the Medicaid program, will be able to purchase coverage in the federal or state-run health insurance exchanges,[ii] and receive tax credits[iii].  The  Medicaid five-year waiting period for immigrant eligibility does not apply. A summary of coverage options are available here.

However, for Medicaid, “lawfully present” immigrants will continue to face the waiting period.  Medicaid and CHIP are available to eligible “qualified” immigrants who have resided in the US for five years or longer, and to others, such as refugees, who can obtain Medicaid or CHIP without a five-year waiting period. States have the option to eliminate the five-year wait for Medicaid or CHIP coverage for otherwise eligible children and pregnant women, but not for other adults. Coverage options for other categories of immigrants will continue to face eligibility restrictions for both Medicaid and the Exchanges leading to enrollment and access barriers as outlined in a Kaiser Commission report in March 2013 which can be accessed  here.  A new map by The National Immigration Law Center (NILC) highlighting current access to Medicaid and CHIP for immigrant children and pregnant women in all 50 States and the District Columbia is posted on their website. NILC also provides a list of  Medical Assistance Programs for Immigrants in Various States, including those funded solely by state dollars.

[i] 75 FR 45014 (July 30, 2010)

[ii] 26 C.F.R. § 1.36B-1(g); 77 FR 30377 (May 23, 2012),

[iii] 45 C.F.R. § 155.2; 77 FR 18310 (March 27, 2012)


HRSA Issues New Governance Policy & Revised Health Center Program Site Visit Guide Impacting Health Center Governance and Operations

As we mentioned earlier, the Health Resources and Services Administration  (HRSA) recently issued two new documents, the long-awaited final governance PIN and the revised site visit guide.  Both are incredibly important to health centers, and we have prepared a detailed analysis for your benefit below.  We also encourage you to take a closer look at these documents as well, to ensure you fully understand the new requirements.

New Governance PIN #2014-01

On January 27, 2014, HRSA issued the long-awaited final governance policy – Policy Information Notice (PIN) #2014-01: Health Center Program Governance – which applies to all health center grantees, look-alike entities, and sub-recipients.  As many of you may remember, HRSA issued a draft version of this policy in the latter half of 2009.  The final PIN is very similar to the draft version, with a few minor revisions.  The new PIN clarifies existing statutory and regulatory governance requirements, incorporating existing policy interpretations previously published in several different guidance documents.  It is important to note that other than the prior governance PIN #98-12, PIN #2014-01 does not supersede those other guidance documents unless provisions of those documents conflict with the requirements set forth in PIN #2014-01.  Thus, the new PIN serves as the primary but not sole HRSA policy source for information regarding health center governance requirements.

Specific clarifications of and modifications to existing policy include the following:

  • Clarification of the definition of “patient” for board representation purposes
    • A patient board member must be an individual who is a current registered patient of the health center who has accessed the health center in the past 24 months and has received at least one in-scope service that generated a health center visit
    • An individual who is a legal guardian of a patient who is a dependent child or adult or an individual who is a legal sponsor of an immigrant may serve as a “patient” board member on behalf of such dependent or immigrant.
  • Clarification that non-patient board members do not have to reflect specific expertise in all areas listed in the health center regulations and the PIN.
  • Clarification of the governance waivers available to health centers serving sparsely-populated areas and special population-only health centers (previously published in PIN #98-12).  The PIN eliminates the ability to waive the monthly meeting requirement.  While eligible centers can still request a waiver of the 51% patient majority requirement, HRSA will apply stricter scrutiny in obtaining and maintaining composition waivers.
  • Clarification of the public entity – co-applicant board relationship, and each entity’s roles and responsibilities (previously published in PIN #99-09), including clear statements that: (1) the public entity may not override or overrule the final approvals and required decision-making authorities of the co-applicant board; (2) the written co-applicant agreement and co-applicant board Bylaws must be two separate documents that are presented to HRSA for review and approval; and (3) no employee or immediate family member of an employee of the public agency may serve on the co-applicant board.
  • Incorporation of the existing proscriptions in the affiliation policies regarding the limited involvement of third parties in board composition and decision-making (previously published in PIN #97-27 and PIN #98-24).
  • Incorporation of required Bylaws provisions and board involvement in certain activities, both of which previously were suggestions only.

HRSA indicated that the new PIN was effective upon publication.  Health centers should review their governance structures, Bylaws, and affiliation and co-applicant agreements (as applicable) for compliance with PIN #2014-01 or risk the placement of grant conditions for identified non-compliance with governance requirements consistent with the Progressive Action Process outlined in PAL #2010-01.

 Revised Health Center Program Site Visit Guide

In addition to PIN #2014-01, HRSA issued a revised version of the Health Center Program Site Visit Guide (the Guide), which serves as the main review tool utilized by HRSA consultants when conducting Operational Site Visits (OSVs).  The new Guide applies to both grantees and look-alike organizations.  It reflects key structural changes to the OSV process and incorporates the requirements of the new governance PIN.  As such, it is critically important that all health centers review the revised Guide, in particular those centers for which OSVs will be conducted within the coming months.

In general, the updated Guide clarifies the nineteen Program Requirements that form the framework of compliant health center programs and reflects a shift in the OSV process to focus primarily on compliance with such requirements.  Other than a few revisions under Requirement #17: Board Authority and Requirement #18: Board Composition to reflect the policy clarifications and modifications in PIN #2014-01, the revised Guide does not reflect substantive changes to the program requirements.  Rather, key modifications focus on ensuring greater objectivity among reviewers, include the following:

  • Sections I – IV, which comprise the compliance assessment of the Nineteen Program Requirements, were modified to remove the performance improvement questions specific to each requirement.  Further, the compliance questions were stream-lined and clarified, and each requirement now includes a list of the documents that the consultants will review either on-site during or in advance of the OSV to assess compliance, which is separate from the list of HRSA resources provided as background for each requirement.
  • NEW Section V includes the clinical and financial performance measures that were previously included within the program requirements, and clarifies and stream-lines the instructions for assessing and documenting the health center’s progress.
  • NEW Section VI assesses the health center’s progress in completing activities funded under one-time capital grants awarded under the Affordable Care Act.
  • NEW Section VII documents innovative/best practices conducted by the health center that the reviewers observed during the OSV.

HRSA indicated that the new steam-lined process was established in response to feedback it received from health centers (as well as Primary Care Associations and NACHC) and should result in objective, in-depth assessments of compliance while minimizing subjectivity.

Please let us know if you have any questions about these new documents, or any other issues that might arise.

HHS Office of Inspector General Report on 340B Contract Pharmacy

On February 5, 2014, the HHS Office of Inspector General (OIG) released a report on the 340B drug discount program and the use of contract pharmacies in that program.  This report is the result of Congressional inquiry into the oversight of the 340B program, especially with the recent growth in the program.  The report looked at contract pharmacy arrangements for covered entities, specifically the policies on preventing duplicate discounts and diversion.  While the report did not make any formal recommendations, it found that there is a lack of clarity in current requirements for the program and noted that it will continue to review these arrangements and may issue additional reports on the subject.  HRSA released a memo in response to the report, reminding covered entities of their responsibilities with regards to contract pharmacy.  You can read a summary of the report here or the report itself here.

We would be interested to know if your health center was one of the 15 that the OIG spoke with in writing the report.   Please let Roger Schwartz and Susan Sumrell know if so.  

We will continue to keep you updated on the latest developments with regards to 340B.

Two New HRSA Funding Opportunities

We wanted to let you know about 2 new funding opportunities recently announced by HRSA.

The first opportunity, the Mental Health Expansion and Behavioral Health Integration Grant<>, requires applicants to submit proposals for up to $250,000 that will enhance access to behavioral health services and/or develop fully integrated behavioral health – primary care service delivery models by the end of an initial 2-year project period.   As a key element of the proposed project, applicants must demonstrate that at least one new on-site Full Time Equivalent behavioral health provider(s) (employed or contracted) will be in place within 120-days of the award.  HRSA expects approximately $50 million will be available for this opportunity and plans to award approximately 200 awards.  Applicants must submit project abstracts and budget information from the SF-424 by March 3, 2014, with full grant applications due April 3, 2014.  HRSA will hold a TA call on this opportunity on Feb 10, 2014 at 3pm eastern.

The second opportunity, the PCMH Facility Improvement Grant<>, is a one-time only grant of up to $250,000 to support new alteration and renovation activities and/or new construction costs that will facilitate the establishment of a Primary Care Medical Home (PCMH) model and lead to improvements in the delivery of care and patient access at an active delivery site included in the applicant’s existing federally-approved scope of project at the time of submission.  Applicants do not have to be PCMH-certified in order to apply for funds.  HRSA expects approximately $35 million in funding to fund approximately 150-175 awards.  Applicants must submit project abstracts and budget information by March 14, 2014, with full grant applications due April  17, 2014.  HRSA will hold a TA call on February 18, 2014 at 3pm eastern.

Neither grant opportunity is available to health centers that received initial Section 330 funding as a New Start organization in either FY 2013 or FY 2014.