House Judiciary Subcommittee Considers Controlled
Substances Amendments
At a mark-up session June 23, the House Judiciary
subcommittee on Crime, Terrorism, & Homeland Security reported two bills
to full committee that amend the Controlled Substances Act (CSA), H.R.184 and
869.
H.R.869 amends provisions of CSA allowing health
care practitioners, in the context of their own practices, to prescribe
opiates to treat
opiate addiction. Current law limits such prescribing to 30 patients
per practitioner or per group practice. Thus, regardless of how many
physicians are in a group practice, or how many patients may need treatment,
only 30 patients may be treated. This limitation has proven unworkable
for group practices and, according to practitioners and drug addiction
experts, has resulted in thousands of patients not receiving treatment.
H.R.869 removes the 30-patient limit for group practices, while retaining
it for individual practitioners.
Companion Senate legislation (S.45) is pending Senate Judiciary Committee
action.
H.R.184 modifies exportation of controlled substances requirements
which currently allow exportation only to the single country that will
use the product. The bill would allow a controlled substance be further
exported to another country, so long as certain reporting and record-keeping
requirements are met and the importing countries are signatories to
U.S. drug control treaties.
Both bills are expected to be considered by the full Judiciary Committee
shortly. They already have been reported by the Energy & Commerce
Committee.
Return to top
E&C Looks at Medicaid Drug
Payment
On June 22, the House Energy & Commerce subcommittee on Health
held a hearing on “Medicaid Prescription Drugs: Examining Options
for Payment Reform.” Testifying before the subcommittee were
representatives from the Congressional Budget Office (CBO), the Government
Accountability Office (GAO), the Arizona Health Care Cost Containment
System, the National Association of Chain Drug Stores, Health Management
Associates of Indianapolis and the American Enterprise Institute.
In his testimony, Dr. Douglas Holtz-Eakins of CBO
presented CBO’s
findings from the December 2004 report, “Medicaid’s Reimbursements
to Pharmacies for Prescription Drugs.” The report found
Medicaid prescription drug spending has increased substantially and
the amount paid for distributing and dispensing drugs to Medicaid beneficiaries
is a significant component of the programs drug spending. The report
also concludes much of the increase in mark up, from what pharmacies
or wholesalers pay for prescriptions to what Medicaid pays, is accounted
for by newer generic drugs. CBO attributes the size of the mark ups – and
thus a substantial cost to Medicaid – to the use of Average Wholesale
Price (AWP) as the basis for determining reimbursements. While CBO
does not make recommendations to Congress, it was clear from Holtz-Eakins’ responses
and the report that a recommendation would be to change from an AWP-based
system.
Testifying for GAO, Kathy King reported on the GAO
analysis of the Medicaid rebate program, “Inadequate Oversight
Raises Concerns About Rebates Paid to States.” The report, first
issued in February, notes GAO’s determination more oversight
is needed to ensure best price and rebates are calculated based on
reporting and that
CMS needs to issue clearer guidance on how prices should be calculated.
It is particularly important, GAO said, for CMS to be clear on how
manufacturers calculate what prices are included in the best price,
and which discounted prices are not included. Rep. Mike Bilirakis (R-FL)
asked whether Medicaid pays far more than anyone else for drugs; King
responded she was not able to answer based on the report.
Speaking on behalf of the chain drug stores, Craig
Fuller said if the AWP-based system is changed, an alternative payment
basis be
chosen that does not exacerbate existing problems. In particular, this
system should not achieve Medicaid savings principally through costs
to pharmacists. He recommended use of Wholesale Acquisition Cost (WAC)
rather than other methods such as Average Sales Price (ASP) or Average
Manufacturers Price (AMP). He also strongly recommended policies that
encourage and increase generic drug dispensing and utilization.
Members on both sides of the aisle agreed Medicaid’s drug payment
system is fundamentally flawed and needs changing. Among specific elements
of change highlighted by subcommittee Chair Rep. Nathan Deal (R-GA)
were price transparency, an accurate accounting of pharmacists’ actual
costs for prescriptions, and equitable payment to pharmacists for the
services they provide. Acknowledging the importance of generic drugs,
Deal also said generics are keeping Medicaid drug costs artificially
high because the mark-ups between what the pharmacy and Medicaid pays
are greater for newer generics than for branded drugs or older products.
The subcommittee is planning to hold additional hearings on Medicaid
reform, including discussions on drug payment changes.
Return
to top
Energy & Commerce Subcommittee Reports Rx Drug Abuse
Control Bill On June 22, the House Energy & Commerce subcommittee on Health
reported to the full Committee H.R.1132, the “National All Schedules
Prescription Electronic Reporting Act of 2005.” The bill, sponsored
by Rep. Ed Whitfield (R-KY) and 32 others, authorizes funding for states
to establish or improve systems to monitor the prescribing of controlled
substances, provide for information sharing among health care practitioners,
share information across state lines, and facilitate actions to prevent
inappropriate prescribing and ”doctor shopping.”
Specifically the bill would require HHS to award grants
to states, develop standards for information collection and sharing
to ensure
privacy is protected, recommend enforcement actions and penalties for
violating privacy, study state programs and report to Congress. State
systems would include an electronic database and requirements for those
who dispense controlled substances to report the dispensing to the
state within a week. The information in the database could be provided
to practitioners, law enforcement and drug control authorities, and
specified state and federal health agencies.
In speaking about the importance of the bill, Whitfield
noted the growing problem of prescription drug abuse. He said control
efforts
are hampered since some states have monitoring systems in place, but
others do not, allowing offenders to simply cross state lines. In opposing
the legislation, Rep. Henry Waxman (D-CA) raised concerns the
bill does not go far enough to ensure privacy protections. He acknowledged
the bill includes some protections and was assured the bill’s
sponsors will continue to work with him to address his concerns.
Sen. Jeff Sessions (R-AL) introduced a similar, S.518, which has been
reported by the Senate Health, Education, Labor, & Pensions Committee.
Return to top
PETA Alleged to Kill Animals
Last Wednesday, two employees of the People for the
Ethical Treatment of Animals (PETA) were charged with 31 felony counts
each of animal cruelty and eight misdemeanor counts each of illegal
disposal of dead animals. Adria Hinkle and Andrew Cook were arrested
for allegedly euthanizing dogs and cats taken from a North Carolina
animal shelter and tossing their bodies in a shopping center dumpster.
They made their first appearance June 17 in Hertford County District
Court, Virginia; the next court date has been set for July 19. The
maximum sentence for each of the 31 felony counts of animal cruelty
is 15 months in jail while the eight cases of misdemeanor counts of
illegal dumping of animal carries a maximum sentence of 60 days in
jail.
Return to top Mistrial Declared in Animal Terrorism Prosecution
A mistrial was declared this week in the criminal prosecution
of animal extremists, known as the "SHAC 6," on charges
they violated the Animal Enterprise Protection Act (AEPA). The prosecution
against defendants Kevin Kjonaas, Lauren Gazzola, Jacob Conroy, Joshua
Harper, Darius Fullmer, Andrew Stepanian, and Stop Huntingdon Animal
Cruelty (SHAC), was the first of its kind, since the AEPA was amended
in 2002 to include the crime of "animal enterprise terrorism."
U.S. District Judge Mary L. Cooper declared the mistrial following
a week-long delay that was granted after Kjonaas' attorney Isabel McGinty
became ill. McGinty fell faint during her opening argument and was
hospitalized for several days. Her doctor advised her she needed two
more weeks to recover.
Associated Press reports the six activists will be
retried some time in the future, "not likely before September," according
to a spokesman in the U.S. Attorney's office. Animal enterprise terrorism
carries a maximum penalty of three years in prison and $250,000 fine.
The activists also face charges of conspiracy and interstate stalking,
which are also punishable with a $250,000 fine.
Return to top
CAFTA Vote Possible Next Week; White House Trying to
Appease Sugar
The deal-makers are in overdrive trying to come up with a package
of concessions to the sugar industry that will “hold the industry
harmless” when CAFTA hits the floor, as early as next week. President
Bush sent the enabling legislation to the Hill late in the evening
June 23.
CAFTA proponents do not want the trade pact vote to linger until after
the July 4 congressional recess, giving opponents more time to line
up negative votes.
So far the deal to the sugar interests centers on enforcing the 1.5-million-ton
annual ceiling on sugar imports through the life of the Farm Bill,
which technically expires at the end of 2007. In addition, Secretary
of Agriculture Mike Johanns told members of the Senate this week that
he may use his Commodity Credit Corp. (CCC) authority to buy U.S. commodities
to donate to CAFTA countries in lieu of accepting increased sugar imports
under the trade pact. The move is part of efforts to assuage fears
that sugar imports would be high enough to collapse the federal sugar
program.
However, most sugar interests were saying they had not seen any offers
from the Administration and wouldn’t publicly comment. However,
the American Sugar Alliance called the Johanns offer “woefully
short and inadequate.” Members of the Senate were all over the
board, some saying the offers were “intriguing,” and others
saying they didn’t go far enough because the “relief” only
extends through 2007.
The Administration was not thrilled with a separate proposal that
would give sugar interests a $1.50 tax credit for ethanol production.
That offer also met with opposition from farm groups, particularly
the corn growers. Since a 51-cent per gallon ethanol subsidy for any
commodity from with ethanol can be made already exists, providing a
new and different tax incentive “would be divisive.”
Return to top
EPA Agrees to Delay Deadline for Signing Air Quality Agreements
EPA extended until July 29, 2005, the deadline for farmers to decide
whether to sign the agency’s air quality consent agreements,
providing additional time for producers to consider the ramifications
of signing on to the program.
The extension, in response to a request by the National Milk Producers
Federation (NMPF), also clarifies that farmers who do sign on to the
consent agreements and pay a penalty to gain “a safe harbor” from
past and current air quality violations, admit no legal liability or
any wrongdoing. Previously the agency had said a farmer’s signing “is
not an admission that any of his/her agricultural operations has been
operated negligently or improperly or that any such operation is or
was in violation of any federal, state or local law or regulation.”
EPA clarification is found at www.epa.gov/compliance/resources/agreements/caa/cafo-agr-response-com.html.
Return to top
Johanns Announces $141 Million for Ag Product Export Promotion
Agriculture Secretary Mike Johanns this week announced the department
will fund $141 million worth of promotion efforts by 70 trade organizations
for U.S. agriculture exports overseas. USDA said exports account for
about 25% of farm cash receipts. The programs funded include the Market
Access Program and the Quality Samples Program. Groups receiving the
cost-share funding and the amounts received are found at www.fas.usda.gov/mos/default.htm.
Return
to top Voluntary COOL Language Included in Senate Food Promotion Bill
Language to establish a voluntary country-of-origin labeling (COOL)
program for agriculture commodities, including meat, is included in
new legislation designed to help food producers promote their efforts
and the quality of their products
The key to the language introduced by Sen. Rick Santorum (R-PA), said
the National Cattlemen’s Beef Assn. (NCBA), is it returns control
of the program to the marketplace. Therefore, where demand is demonstrated,
COOL is available. Also, the program allows any group in food production,
retailing or food service to participate, meaning more products will
be promoted based on the success of existing regional, state and brand
name labeling programs.
Santorum said USDA can use existing labeling programs to serve the
same purpose of a national label, and consumers will receive the same
information regarding where their food comes from, but in a more cost-efficient
way.
Return to top
Senate Committee Approves $17.35-Billion FY2006 Ag Spending Bill
Maintaining the fast-track approach on appropriations, the Senate
subcommittee and full committee on FY2006 agricultural appropriations
completed action this week and approved a nearly $17.5-billion spending
package for the coming fiscal year.
Senate floor action is expected to occur after the Senate returns
from its July 4 recess. At that time several amendments, which full
committee chairman Sen. Thad Cochran (R-MS) asked not be brought to
the full committee, will be debated.
Overall spending for agriculture and FDA approved by the full Senate
committee totals $100.15 billion, slightly above the President’s
request of $99.561 billion, and about $15 billion more than spent in
FY2005.
Return to top Highway Conferees Might Have Conference Deal on Cost
It appears key House and Senate highway reauthorization
bill conferees cut a deal this week to approve $286.5 billion in federal
highway spending over six years. The price tag reportedly agreed to
means the Senate has given up nearly $30 billion, but the cost still
exceeds the White House limit of $283.9 billion, above which a veto
is threatened.
Optimists say the cost agreement sets the stage for completing work
on the highway bill early next week. However as of June 24, leadership
for the respective chambers said they had not signed off on an agreement
and that any such deal would need full conference approval. If the
deal holds, it will be a least Tuesday before a conference framework
is agreed to, meaning an eighth extension of existing highway programs
needs to be approved.
Return to top BSE UPDATE
Second U.S. BSE Case Confirmed
Agriculture Secretary Mike Johanns today confirmed the second U.S.
case of bovine spongiform encephalopathy (BSE). Johanns announced USDA
received positive final test results from the Weybridge, England testing
facility on an animal that was blocked from the food/feed supply in
November 2004.
“We are currently testing nearly 1,000 animals per day as part
of our BSE enhanced surveillance program, more than 388,000 total tests,
and this is the first confirmed case resulting from our surveillance,” Johanns
said in a statement. Johanns directed USDA scientists to work with
international experts to develop a new protocol that includes performing
dual confirmatory tests in the event of another "inconclusive" BSE
screening test.
USDA has not yet completed an epidemiological investigation to determine
the animal's herd of origin. However, it is known that the animal was
born before the U.S. instituted a ruminant-to-ruminant feed ban in
August 1997. The “downer” animal was selected for testing
because it was considered to be at higher risk for BSE.
Return to top
USDA’s Penn Says Japan Beef Talks Moving Slowly
USDA this week said it has warned the Japanese government again that
if the pace of negotiations to reopen beef trade doesn’t speed
up, Congress may intervene in the process. Undersecretary J.B. Penn
met with Japanese officials June 21, part of a team in the U.S. to
review feeding, processing and testing systems in this country. Penn
said conversations were “frank”, but the process is moving “terribly,
terribly slow.” Several members of Congress have introduced resolutions
calling for sanctions on Japanese trade if beef exports don’t
resume soon.
Return to top
Austria Reports Second Case of Mad Cow
The second case of BSE has been confirmed in Austria, the government
reported this week. The cow died unexpectedly in May after showing
possible neurological symptoms, officials said, adding their looking
at what the animal was fed as well as “spontaneous mutation in
the prions.” Feeding animal byproducts to cattle has been banned
in Austria since 1991.
Return to top
Consumers Union Calls on Johanns to Test All Cattle Over 20 Months
Old at Slaughter Using Western Blot
Consumers Union (CU) this week sent a formal request to Agriculture
Secretary Mike Johanns to immediately begin testing all beef animals
over 20 months of age at slaughter and to adopt the Western Blot test
as part of USDA’s testing protocol.
CU said it wants to see the supersensitive Western Blot test used
along with the IHC testing when confirming suspect cases, and to “make
clear to the public that a positive result on either test indicates
that the suspect cow is positive for BSE.”
Return to top
New Bills
A number of new bills have been introduced. Click
here to send a request for a copy of the text or more information about
the bill.
S.1281
Sens. Kay Bailey Hutchison (R-TX) and Bill Nelson (D-FL) introduced
the “NASA Authorization Act of 2005.”
S.1300
A bill offered by Sen. Rick Santorum (R-PA) would establish a voluntary
program for country of origin labeling of agricultural products.
Return to top
Inside
Track is produced as a service to clients of Policy Directions,
Inc., a Washington, DC-based government relations/strategic government
communications firm founded in 1995, specializing in customized
advocacy on health care; food; biomedical research; biotechnology,
human drug, and medical device regulation; federal nutrition policy
and programs; and environmental policies and programs. For more
information about PDI, please e-mail info@poldir.com.
All material © 2005 Policy Directions.
|
