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07/11/2012

Inside Health Policy: OIG Claims ACA Prevention Fund Grantees May Be Violating Anti-Lobbying Statutes

insidehealthpolicy.com

 

OIG: ACA Prevention Fund Grantees May Be Violating Anti-Lobbying Statutes

By Amy Lotven

Updated Story

HHS’ Office of Inspector General is asking CDC to ensure that the grantees of a community prevention program funded with health reform law money are not violating anti-lobbying statutes, saying that grantees’ quarterly reports suggest some funding may have been used for “inappropriate lobbying activities.” OIG also raises concerns that the Centers for Disease Control and Prevention may have encouraged the behavior by posting confusing guidance on its website for the Communities Putting Prevention to Work (CPPW) grantees, echoing GOP congressional concerns that grant money may have been inappropriately used for lobbying on school beverage and public smoking issues.

CDC agrees with IG of the need to clarify this issue with its grantees and is moving aggressively to do so,” a CDC spokesperson tells Inside Health Policy in an email. “The agency has already refined and reinforced its guidance with grantees in light of recent legislation from Congress, conducted new project officer training, and has undertaken a broad education of CDC leadership and program staff on the issue.”

A GOP congressional aide tells Inside Health Policy that several staffers had raised concerns about the grant funding, and says that additional congressional oversight and other activities should be expected. The report calls into question not only the $120 million in CPPW grants, but larger amounts of funding that have been distributed, the aide says. The aide also says that the report highlights government management issues that should be of concern to both parties.
The OIG says in a June 29 letter to CDC Director Thomas Frieden that the review was initiated after OIG received allegations from congressional staff concerning potentially inappropriate use of funds by the certain grantees, and specifically that grantees may be violating anti-lobbying statutes. OIG subsequently reviewed the quarterly reports from the grantees and met with officials from CDC, the CPPW program and the Office of the General Counsel. “We are concerned that some statements in those reports may reflect inappropriate lobbying activities using CPPW grant funds,” OIG writes. “Our review also indicated that this may have originated from a lack of clear guidance — or even conflicting information — from CDC to CPPW grantees concerning the anti-lobbying restrictions.”

The OIG’s letter also comes in the wake of a May 2 letter from Sen. Susan Collins (R-ME) to HHS Secretary Kathleen Sebelius requesting information on the activities reported by various CPPW grantees that indicated funding was being used for policymaking even though the use of federal funding to lobby at the state or federal level has been prohibited since 2002.

For example, the letter notes that the California Department of Public Health, which received a $2.2 million grant, reported that funds would be used to advance policy making. She also raised concerns about funding that went toward analyzing state legislative proposals that would levy taxes and remove certain beverages from middle and elementary schools.

The letter also noted that King County, Washington reported as a description of its activities the fact that County Board of Health “adopted changes to code on smoking in public places and places of employment that closed loopholes in the existing code, and passed a resolution encouraging no-smoking policies in multi-family housing…”

Collins in her letter stressed that since she is a “ strong supporter of wellness and prevention effort…I am eager to ensure that these important programs are operating within the law and that any misuses of funds are quickly addressed.” “The actual or perceived misuse of wellness and prevention funding has the potential of eroding support for these programs,” she wrote.

Collins also found it especially troubling that CDC’s official guidance to grantees appears to include an expectation that the funds should be used for prevention and wellness strategies that result in changes state and local policies and law. “If true, without express authorization by Congress, CDC would be guiding its grantees to potentially violate federal law, exposing them to hefty civil penalties for each violation,” she writes.
The OIG also found that CDC’s information — as well as non-CDC resource material posted on the CDC website — “appear to authorize, or even encourage, grantees to use grant funds for impermissible lobbying.” Furthermore, OIG says, “grantee activity reports posted online make troubling assertion that, on their face, raise the possibility that these anti-lobbying provisions were violated.”

OIG notes, however, that it is possible that the grantees were describing activities accomplished before the grants were awarded, or that were achieved by other entities or with other, non-federal funds. However, OIG, adds, the fact that the grantees are reporting favorably about the lobbying is of concern, and may indicate a faulty understanding of the funding prohibitions.

OIG calls for CDC do the following: review its guidance and other materials posted on its Web site; clarify any misleading statements about lobbying activities; train CDC employers; and provide updated and more detailed guidance to grantees on how to avoid violating anti-lobbying provisions. OIG says guidance should also inform grantees about new lobbying restrictions included in the FY 2012 HHS Appropriations bill.

The group non-partisan group Cause of Action has also cited concerns about the potentially anti-lobbying violations by the CPPW grantees. On March 16, COA wrote a letter to Attorney General Eric Holder asking him to “launch a comprehensive investigation” into the use of taxpayer money to influence public officials in favor of “anti-soda” or “anti-tobacco” policies.

In an emailed response to Inside Health Policy, Cause of Action says: “While it is a positive step for the OIG to review and clarify CDC materials, the real issue here is that it has taken Congressional attention for the OIG to do their job. If the CDC had been properly overseeing its grant awards and the use of taxpayer dollars by their grantees, there would be no need for Congress to intervene.

“In terms of accountability, is it too little too late for the funds that have already been used for lobbying purposes? Moving forward, we expect the OIG to monitor the implementation of the proposals in its June 29 letter and bring proper oversight to HHS, as taxpayers deserve a government that ensures proper use of their money,” COA adds. — Amy Lotven (alotven@iwpnews.com)

Editor’s note: This updated version includes comment from the CDC.

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07/11/2012

KKSF Radio: Amber Abbasi Discussing Suit Against the FDA

Amber Abbasi joined Gil Gross to discuss Cause of Action’s suit against the Food and Drug Administration for their unfair regulation of sperm donation.

Amber Abbasi – Gill Gross – July 10, 2012

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07/9/2012

SFGate: Woman sues FDA for right to use donor’s free sperm

Read the full story here. SF Gate

“So “Jane Doe,” as she calls herself, is suing. Cause of Action, a government accountability group, has filed a lawsuit in U.S. District Court for the Northern District of California on her behalf against the FDA… Those rules, argues Cause of Action in the lawsuit filed last week, are “costly and burdensome” and “unconstitutional to the extent that they operate to regulate noncommercial, sexually intimate choices and activity.”

“If there are donors like this who are not charging as a service, and not serving as a business, the FDA should not be intervening,” said Amber Abbasi, the group’s chief counsel for regulatory affairs….”

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07/6/2012

Fox News: Woman sues FDA for right to select sperm donor, bypass sperm bank

Woman sues FDA for right to select sperm donor, bypass sperm bank

By Judson Berger     Published July 03, 2012

 

A California woman pursuing artificial insemination is suing the federal government for the right to choose how she’ll get the sperm.

The unusual case was filed Monday in U.S. District Court. On the heels of the Supreme Court decision upholding the federal health care overhaul, the plaintiff in this case is challenging another area of federal health care regulation.

At issue are Food and Drug Administration rules that set standards for sperm banks — like requiring tests for communicable diseases. But the woman in the California suit doesn’t want to go through a standard sperm bank or other clinic. The anonymous plaintiff instead, according to the suit, wants to use the sperm of someone she knows — at no cost — without going through all the federal regulatory rigmarole.

She and her lawyers call the FDA rules an unconstitutional violation of her rights — that is, her right to start a family with whomever she wants.

“When you are regulating private decisions between two individuals in a non-commercial context that have to do with something so intimate and personal as whether they want to have a child together, then the FDA regulations should not apply,” Amber Abbasi , attorney in the case, told FoxNews.com.

Abbasi’s group Cause of Action filed the suit on the California woman’s behalf.

The plaintiff did not release her identity, but according to Abbasi her situation is as follows:

She’s in a relationship with another woman and would like to conceive a child. She does not want to go to a regulated sperm bank because she wants to know the biological father and wants the child to know the father as well — and she’s concerned about the cost of going through a sperm bank.

The argument may have gotten a boost with the high court ruling last week, which upheld the health care overhaul but at the same time affirmed limits on the Constitution’s so-called Commerce Clause.

“The Commerce Clause is not a blank check,” Abbasi said. Their suit claims, among other things, that the federal regulations on sperm donation overstep the Commerce Clause.

The FDA rules stem from a 1944 law passed by Congress allowing for regulations to prevent the spread of communicable diseases. The FDA later applied those regulations to sperm banks and donors, as part of the effort to prevent infection from a range of diseases.

Abbasi, in explaining her client’s concern, pointed to the FDA’s 2010 decision to order one California sperm donor to cease and desist over concerns he wasn’t following FDA standards.

Their current lawsuit questions the extent to which the rules have been applied, suggesting there’s a double standard.

The plaintiff “does not want to be forced to engage in sexual intercourse with a male partner to conceive a child, even though such a male partner would not be subject to FDA-required screening and testing and other FDA-mandated donor-eligibility requirements,” the suit says.

The plaintiff in the case wants the court to declare as unconstitutional any rule that would regulate “private, uncompensated” sperm donations.

A representative with the FDA did not return a request for comment on the case.

 

 

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07/6/2012

Media Highlights CoA Lawsuit Against the FDA

Cause of Action filed a lawsuit last week in the U.S. District Court of Northern California on behalf of a Bay-Area woman whose plans to start a family have been blocked by overregulation by the Food and Drug Administration (FDA).  This is an important case related to government overreach and constitutional issues. Read the following stories to see how the media are covering the issue:

 

 

Woman sues FDA for right to select sperm donor, bypass sperm bank

Woman sues FDA over right to select her own sperm donor

 

 

Free the Sperm!

 

 

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07/3/2012

The Legal Eagle Eye: The Impact Of The SCOTUS Healthcare Decision

Why Chief Justice Roberts’s Opinion in NFIB v. Sebelius May Ultimately Advance Economic Freedom and Promote Limited-Government and Federalism Values

By Cause of Action Staff

Although at first blush it may appear that Chief Justice Roberts’s opinion in NFIB v. Sebelius upholding the Affordable Care Act’s individual mandate will lead to a dramatic expansion of federal regulatory authority, proponents of economic freedom, federalism, and limited government may be surprised to learn that Chief Justice Roberts’s opinion reaffirmed and strengthened important limits on the scope of federal power.

First, Chief Justice Roberts concluded that the Commerce Clause—even as augmented by the Necessary and Proper Clause—does not allow Congress to regulate inactivity:  “The Court today holds that our Constitution protects us from federal regulation under the Commerce Clause so long as we abstain from the regulated activity.”   (The four dissenting Justices—Scalia, Alito, Kennedy, and Thomas—agreed.)  Second, Chief Justice Roberts—joined by Justices Breyer and Kagan—concluded that the Medicaid expansion was unconstitutional, reasoning that the portion of the law requiring the States to “either accept a basic change in the nature of Medicaid, or risk losing all Medicaid funding,” exceeded limits on Congress’s Spending Clause authority.  (The four dissenting Justices reached the same conclusion.)  He not only reaffirmed the principle that “Congress has no authority to order the States to regulate according to its instructions” but placed a new limit on Congress’s exercise of its Spending Clause powers:  Congress can no longer use “coercive” financial incentives to compel States to adopt changes that it wants.  Chief Justice Roberts went so far as to describe the Medicaid expansion as “a gun to the head” of the States and “economic dragooning” that is contrary to our system of federalism and principles of dual sovereignty.

With that said, Chief Justice Roberts’s opinion in NFIB v. Sebelius leaves open important questions that the Court may be required to answer in subsequent cases:

(1)  Although Chief Justice Roberts noted that “Congress’s ability to use its taxing power to influence conduct is not without limits,” it is unclear what those limits are.

(2)  It is uncertain whether Chief Justice Roberts’s conclusion that the individual mandate was unconstitutional under the Commerce Clause is part of the Court’s holding (and thus binding precedent) or merely dicta that other courts may ignore.

(3)  It remains to be seen whether the fact that a majority of the Court believed that the individual mandate exceeded Congress’s Commerce Clause authority indicates a willingness to revisit—and scale back—prior case law interpreting Congress’s authority under that clause expansively.

(4) The extent to which Chief Justice Roberts’s new limiting principle for Congress’s use of its Spending Clause power will leave other federal statutes conditioning receipt of federal money on States adopting federal regulatory and policy mandates vulnerable to constitutional challenge is unclear.

Finally, it is worth briefly noting that Chief Justice Roberts’s opinion upholding the individual mandate should not be read as a ringing endorsement of the Affordable Care Act but rather as an invitation for “We the People”—the ultimate sovereign in our constitutional system of limited government—to resolve the issue through the democratic process:

The Framers created a Federal Government of limited powers, and assigned to this Court the duty of enforcing those limits. The Court does so today. But the Court does not express any opinion on the wisdom of the Affordable Care Act. Under the Constitution, that judgment is reserved to the people.

 

 

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07/2/2012

Cause of Action Sues FDA For Overreach Into Private Lives

 

CAUSE OF ACTION SUES FDA FOR OVERREACH INTO PRIVATE LIVES

FDA prohibits a form of artificial insemination, attempts to define relationships

WASHINGTON – Cause of Action, a nonpartisan nonprofit based in Washington, DC, filed a lawsuit today in the U.S. District Court of Northern California on behalf of a Bay-Area woman whose plans to start a family have been blocked by overregulation by the Food and Drug Administration (FDA).

Citing FDA regulations on sperm donation, Cause of Action states that the plaintiff’s ability to become pregnant through the means of her choice has been directly affected. Cause of Action argues that the right to procreate is fundamental and one that cannot be regulated by a government agency.

“We don’t think the FDA’s intentions are bad—they are trying to protect the public from communicable diseases—but this is literally stepping between two people who have agreed to have a child; the FDA should not regulate that,” said Cause of Action’s Chief Counsel for Regulatory Affairs Amber Abbasi.

Abbasi explains in Cause of Action’s complaint that the plaintiff wants to conceive a child by means of artificial insemination without a medical intermediary such as a donor bank, but is prohibited from doing so by FDA regulations.

Federal regulations set standards for manufacturing and distributing human cells, tissues, and tissue-based products, but they treat noncommercial, individual actors the same as commercial establishments, making any individual a potential human cells, tissue, and tissue-based product producer. Once an individual is labeled as a manufacturer, he is subject to the same regulatory standards as sperm banks. The FDA does exempt people engaged in sexually intimate relationships from the standard, but it is with the government’s attempt to define “relationship” that Abbasi and Cause of Action take the most issue.

“Essentially, the FDA is trying to define a personal relationship and regulate individuals’ intimate decisions,” said Abbasi. “These actions grossly exceed the reach of the FDA’s regulatory authority. If unchecked, it could set a dangerous precedent for the future.”

The lawsuit asks the federal district court to declare the FDA’s regulatory overreach unconstitutional, which will allow the plaintiff to start a family as she desires.

“This case really highlights how arbitrary regulations can take away freedom,” said Dan Epstein, executive director of Cause of Action. “Cause of Action is committed to exposing instances like these where the government is threatening freedom with rogue regulations.”

About Cause of Action:

Cause of Action is a non-partisan, non-profit organization that uses public advocacy and legal reform tools to ensure greater transparency in government, protect taxpayer interests and promote economic freedom. For more information, visit www.causeofaction.org.

To schedule an interview with Amber Abbasi, Cause of Action’s Chief Counsel for Regulatory Affairs, contact Mary Beth Hutchins or Briton Bennett at 202-507-5880.

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