Jan 23, 2017
Washington Healthcare Update
This Week: In this week of transition, the Senate held its first hearing on the HHS secretary nominee and the Obama administration released its last set of regulations.
Health Reform Takeaway
- CBO releases a report on the blueprint of the Republicans’ repeal plan
and Republicans call it incomplete. The HELP Committee holds a hearing on
Rep. Tom Price nomination for HHS secretary. The Republican plan to repeal
and replace starts to slow down.
3. State Activities
4. Regulations Open for Comment
House Ways & Means Committee to Hold Hearing on Replacing Individual Mandate
On Jan. 24, the House Ways & Means Committee will hold a hearing on
ways to replace the ACA’s mandate to purchase health insurance. Repealing
the Affordable Care Act’s individual mandate is viewed as a key component
of congressional Republicans’ emerging plan to repeal and replace the
Affordable Care Act, and replacing the mandate with alternative ways of
ensuring continuous coverage is viewed as crucial to a stable insurance
For more information,
Ohio Gov. Kasich Tells Republicans to Let States Keep Medicaid Expansion
Ohio Gov. John Kasich told congressional Republicans that states should
have the option of keeping Obamacare’s Medicaid expansion, and if Congress
decides to pare back the program, it should retain expansion funding for
low-income adults earning up to the federal poverty line.
In letters Kasich sent to the
Senate, he said he is still supportive of Medicaid block grants.
An outspoken supporter of Medicaid expansion in Ohio, Kasich has said it
has benefited 700,000 residents, brought the state’s uninsured rate to
record lows and provided necessary treatment for those with substance abuse
and mental health issues. Ohio is one of 16 states with Republican
governors who have adopted that core piece of Obamacare.
Kasich also warned against repealing Obamacare without a replacement at the
same time, writing that approach would create uncertainty for millions
currently covered and could destabilize insurance markets.
Finance Committee Schedules Price HHS Hearing
The Senate Finance Committee will hold a Jan. 24
on Rep. Tom Price’s (R-GA) nomination to lead HHS, the committee
“Installing Dr. Price to lead HHS is a paramount step in repealing and
replacing Obamacare with patient-centered reforms that address costs and
increase choice,” Chairman Orrin Hatch said in a statement.
The announcement comes as Democrats have urged Republicans to slow down the
nomination process to allow more time to scrutinize Price’s health care
investments. Ron Wyden (OR), the top Democrat on the Finance Committee,
criticized the decision to move forward with the hearing.
“Instead of confronting the serious issues raised about Congressman Price,
Republicans are rushing to sneak his nomination through before all
outstanding questions have been answered,” Wyden said.
Price went before the Senate HELP Committee on Jan. 18. At that
hearing, Republicans praised him while Democrats grilled him on everything from
his stock picks and ethics to asking him to pledge not to cut Medicare and
Medicaid. He will likely face the same kind of questioning at finance.
GOP Governors Meet With Senate Finance Committee Regarding Medicaid
Republican governors and lieutenant governors from 10 states — including
four that expanded Medicaid under Obamacare — discussed the future of
Medicaid with Senate Finance Committee Republicans in Washington on Jan.
19, according to a Senate aide.
Committee Republicans held the closed-door meeting to get input on
potential changes to the program, including what policies should be
considered as part of an Obamacare replacement plan, how to keep Medicaid
sustainable and whether states need more flexibility to enact reforms.
While the Republican governors oppose Obamacare and agree Medicaid needs
changes, officials in states that expanded Medicaid are looking to protect
health coverage for residents.
The following state officials will attend Thursday’s gathering: Arkansas
Gov. Asa Hutchinson; Florida Gov. Rick Scott; Idaho Gov. Butch Otter; Iowa
Gov. Terry Branstad and Lt. Gov. Kim Reynolds; Kansas Lt. Gov. Jeff Colyer;
Michigan Gov. Rick Snyder; Ohio Gov. John Kasich; South Dakota Gov. Dennis
Daugaard; Texas Gov. Greg Abbott; and Utah Gov. Gary Herbert.
President Trump Issues Executive Order on the ACA
On Jan. 20, as one of his first acts, President Donald Trump issued an
executive order that asks HHS and other agencies to exercise all authority
under the law to ease the costs of the Affordable Care Act on individuals
and industry, provide states flexibility and promote interstate commerce as
Congress and the administration work to repeal the law. It is unclear what
the new administration can do under the new executive order, but GOP
lawmakers have long said the HHS secretary has wide-ranging flexibility
when it comes to implementing the ACA.
“It is the policy of my Administration to seek the prompt repeal of the
Patient Protection and Affordable Care Act,” Trump’s executive order
states. “In the meantime, pending such repeal, it is imperative for the
executive branch to ensure that the law is being efficiently implemented,
take all actions consistent with law to minimize the unwarranted economic
and regulatory burdens of the Act, and prepare to afford the States more
flexibility and control to create a more free and open healthcare market.”
The executive order continues: “To the maximum extent permitted by law, the
Secretary of Health and Human Services (Secretary) and the heads of all
other executive departments and agencies (agencies) with authorities and
responsibilities under the Act shall exercise all authority and discretion
available to them to waive, defer, grant exemptions from, or delay the
implementation of any provision or requirement of the Act that would impose
a fiscal burden on any State or a cost, fee, tax, penalty, or regulatory
burden on individuals, families, healthcare providers, health insurers,
patients, recipients of healthcare services, purchasers of health
insurance, or makers of medical devices, products, or medications.”
HHS Releases Final Revision of Common Rule
On Jan. 18, HHS issued a long-awaited
revision of a rule
establishing how to properly inform people enrolling in medical experiments
about the risks and benefits of the research. The revision of the 1991
Common Rule dropped an earlier proposal that scientists said would have
made much of their work impossible.
HHS and 15 other agencies issued a September 2015 proposed rewrite of the
Common Rule that drew 2,100 comments, many of them opposing a provision
requiring researchers to get consent for using nonidentified biospecimens
like DNA samples. That part of the proposal was dropped in the new rule.
The final rule, most of which takes effect in 2018, calls for consent forms
to include concise explanations of the purpose of a medical experiment, as
well as the risks and benefits and alternative treatments a subject might
want to consider.
CMS Releases Corrected Year 2 Results for Independence at Home Demo
On Jan. 19, CMS released the corrected Year 2 results for the Independence
at Home Demonstration. The demonstration provides chronically ill patients
with a complete range of primary care services in the home setting. Medical
practices led by physicians or nurse practitioners provide primary care
home visits tailored to the needs of beneficiaries with multiple chronic
conditions and functional limitations. The demonstration also tests whether
home-based care can reduce the need for hospitalization, improve patient
and caregiver satisfaction, and lead to better health for beneficiaries and
lower costs to Medicare.
In the second performance year of the demonstration, 10,484 beneficiaries
were enrolled in the 15 participating practices. All 15 of the Independence
at Home practices improved performance from the first performance year in
at least two of the six quality measures for the demonstration. Four
practices met the performance thresholds for all six quality measures.
In the original release of Performance Year 2 results in August 2016, CMS
stated that the 15 participating practices saved $10,612,506 in aggregate,
and that seven participating practices earned incentive payments of
$5,719,526. After a corrected analysis, CMS stated that the practices saved
$7,821,374 in aggregate, an average of $746 per beneficiary. Seven
participating practices earned incentive payments in the amount of
For a fact sheet,
CMS Releases Second Year of Skilled Nursing Facility Utilization and Payment Data
On Jan. 18, CMS posted the second annual release of the
Skilled Nursing Facility Public Use File
(Skilled Nursing Facility PUF) with data for 2014. The Skilled Nursing
Facility PUF presents summarized information on services provided to
Medicare beneficiaries by skilled nursing facilities. It contains
information on utilization, payment (Medicare payment and Medicare
standardized payment), submitted charges, and beneficiary demographic and
chronic condition indicators organized by CMS Certification Number (6-digit
provider identification number), Resource Utilization Group (RUG) and state
The new 2014 PUF has information for 15,026 skilled nursing facilities,
almost 2.5 million stays and more than $27 billion in Medicare payments for
2014. New in the 2014 data is the demographic and chronic condition
information. CMS protects beneficiaries’ personal information in all public
CMS Updates Open Payments Data
On Jan. 17, CMS updated the Open Payments dataset to reflect changes to the
data that took place since the last publication on June 30, 2016. The
updated dataset is now available for viewing here.
Every year, CMS updates the Open Payments data at least once to include
updates from disputes and other data corrections made since the initial
publication of the data. The updates affect all types of payments or
transfers of value to physicians and teaching hospitals and physician
ownership or investment interests.
The updated Open Payments dataset reflects:
Changes made to records
Changes to delays in publication flags
Changes to disputed records
Records that were deleted
The financial data was submitted by applicable manufacturers and group
purchasing organizations (GPOs).
CMS Extends Meaningful Use Reporting Deadline
CMS has extended the deadline to March 13 for hospitals to submit data on
meaningful use and the Hospital Inpatient Quality Reporting program, an
agency official wrote in a
blog post. The previous deadline was Feb. 28.
Hospitals stand to receive a 4 percent penalty in their Medicare payments
if they fail to achieve meaningful use standards in data they report for
Kate Goodrich, CMS’s director of clinical standards and quality, said the
agency also plans to address hospital concerns about switching EHR vendors
or upgrading current systems in the agency’s annual inpatient hospital
payment rule later this spring. CMS also is considering changing the number
of required quality measures and shortening the reporting period.
CMS Releases Drug Utilization Review Annual State Reports and State
On Jan. 17, CMS posted the FFY 2015
Drug Utilization Review (DUR) Annual State Reports
along with the
State Comparison/Summary Report
for FFY 2015.
FDA Issues Guidance on Pharma-Payer Communications
On Jan. 18, FDA
outlining how drug companies can communicate with payers about
cost-effectiveness and other economic information regarding their products
without violating marketing regulations. The guidance also outlines how
companies can discuss their products with insurers before agency approval.
The 1997 FDA Modernization Act gave companies some safe harbor protections
to communicate economic information with payers, and the 21st Century Cures
Act expanded these protections. But companies say they still fear talking
about these issues because of a lack of clear FDA guardrails.
The new guidance describes what type of data qualify as health care
economic information, how they can be presented and the appropriate
audience for this communication. The guidance does not apply to
communications with physicians and other health care providers, the agency
put out a memo
expressing its views on the first amendment, public health and
communicating about unapproved uses of drugs and medical devices. Companies
have pressed FDA for clarity on marketing policies after a 2012 U.S. Court
of Appeals decision ruled that under the First Amendment the government
could not prohibit or criminalize the truthful off-label promotion of
put out by FDA on Jan. 17 describes how drug companies can communicate some
off-label information about their products and avoid charges of
misbranding. Per this guidance companies can communicate only off-label
information about FDA-approved uses of their products.
3. State Activities
California: California Withdraws Request for Obamacare Undocumented Coverage
On Jan. 18, California asked to withdraw its request for undocumented
immigrants to be allowed to purchase Obamacare plans entirely with their
own funds, according to the state lawmaker who spearheaded the plan.
Supporters of the proposal had hoped it would be approved by HHS before the
end of the Obama administration. But CMS took only an incremental step in
the waiver process on Jan. 17, leaving the final decision to the incoming
Trump administration, which is expected to be much more resistant to the
California sought the Obamacare waiver under a part of the law that allows
states to pursue their own health reform ideas beginning in 2017. But the
gesture would have been mostly symbolic. State officials estimated that
only 17,000 people would have enrolled in Obamacare plans if the proposal
was approved because undocumented individuals wouldn’t be eligible to
receive federal subsidies that lower premiums or out-of-pocket medical
Democrats in California’s congressional delegation urged that the request
be approved, but several Republican lawmakers said it should be rejected.
California: Exchange Mistake Causes Higher Premiums for Thousands
Almost 25,000 Covered California consumers will face higher-than-expected
health insurance bills because the exchange sent the wrong subsidy
information to their health plans. Insurers are reportedly sending out new
bills based on accurate tax credits for those consumers, and in most cases
that means higher premiums than consumers had anticipated. Covered
California officials couldn’t explain the glitch, but it followed a mistake
discovered last month that could have prevented as many as 24,000 consumers
from receiving their 2017 subsidies, at least temporarily. About 1.4
million residents are enrolled in the California exchange.
Florida: Hospitals Unable to Access Low Income Pool Funds
Florida hospitals have not been able to access $608 million in supplemental
Medicaid funds known as the Low Income Pool because the state hasn’t
secured the local contributions necessary to fund the program. The state
has been unable to send supplemental payments to any Florida hospital
because the required local match has not been collected.
Jackson Memorial, Broward Health, Shands Healthcare and Tampa General,
among others, notified the state that they would hold more than $200
million in local dollars normally sent to Tallahassee to fund the
supplemental Medicaid programs until Florida persuades more hospitals to
contribute. Florida uses the local contributions to pull down federal
matching Medicaid dollars.
Minnesota: Minnesotans in Immigration Program Can Now Seek Health Coverage
Minnesota is now granting eligibility for subsidized health coverage to
immigrants granted deferred action under former President Barack Obama’s
controversial DACA program, which Trump has vowed to repeal. Deferred
Action for Childhood Arrivals was created through an executive order by
Obama and it allows deportation stays to people brought into the United
States illegally as children. Minnesota estimates it can enroll some 6,000
recipients of DACA if they are income-eligible. Critics of the state’s move
to extend health benefits to DACA recipients say it encourages illegal
immigration. The idea was recommended by Gov. Mark Dayton’s health task
force last year as a way to close health equity gaps.
New Jersey: State Attorney General Limits Opioid Prescriptions in Emergency Rule
Acting on a directive from Gov. Chris Christie, the state attorney general
will use emergency rule-making powers to limit initial opioid prescriptions
for acute pain to a five-day supply. Failure by providers to adhere to the
new rules may result in a disciplinary hearing and the suspension or
limitation of medical licenses, Attorney General Christopher Porrino wrote
in a letter to the state’s board of medical examiners last week. He asked
for the board to agree to the new regulations by Feb. 16.
Oregon: RAND Assesses Options for Financing Health Care Delivery in
A new RAND analysis of three proposals to cover Oregon’s remaining
uninsured residents would be more expensive and difficult to implement if
part or all of the ACA is rolled back. The study, requested by the Oregon
Health Authority, found the two proposals that would provide universal
coverage — a single-payer plan, and one that would rely on private coverage
to achieve the same goal — would face obstacles in getting the federal
waivers needed. A third proposal, a state-administered public option that
would compete with private plans in Oregon’s ACA marketplace, would be the
easiest to do, but it wouldn’t cover everyone. About 5 percent of the
state’s residents remain uninsured. To see the study,
In other news, Oregon lawmakers are trying to get ahead of expected federal
rollbacks in care for reproductive health by pre-filing legislation — ahead
of the Feb. 1 session start — that would require coverage for abortion,
birth control, vasectomies and other health services. With
H.B. 2232, the Reproductive Health Equity Act, Oregon joins several other states
that are trying to preserve such benefits as coverage for contraception
without a copayment. The abortion protection may be controversial, but the
bill allows employers to make religious exemptions.
Tennessee: Lawmakers Introduce Bill to Switch to Medicaid Block Grant
Republican state lawmakers have
introduced a bill
that prepares Tennessee to switch to a Medicaid block grant, in case Trump
and congressional Republicans make good on a plan to revamp the program
financing. But the legislation would also pave the way for Tennessee to
expand eligibility up to 138 percent of the federal poverty level as the
ACA envisions. The block grant amount would take inflation into account as
well as population growth.
4. Regulations Open for Comment
CMS Releases Proposed Notice With Changes to Medicaid National Drug Rebate Agreement
On Nov. 7, CMS issued a proposed notice announcing changes that would be made to the Medicaid National Drug Rebate Agreement (NDRA) for use by the
Secretary of the Department of Health and Human Services and manufacturers under the Medicaid Drug Rebate Program. The NDRA is being updated to incorporate
legislative and regulatory changes that have occurred since the agreement was published in February 1991, as well as to make editorial and structural
revisions, such as references to the updated Office of Management and Budget (OMB)-approved data collection forms and electronic data reporting. There is a
90-day comment period for this proposed notice that will end on Feb. 7, 2017.
For more information, click here.
CMS Issues Proposed Rule for Medicaid Managed Care Plans
CMS has issued a new proposed rule detailing regulations for pass-through
payments to providers from Medicaid managed care plans. The guidance builds
on the Medicaid managed care rule finalized by the Obama administration in
Read the proposed rule
CMS Announces PACE Innovation Act Request for Information
On Jan. 4, CMS released a
Request for Information (RFI)
seeking public input on potential adaptations of the model of care employed
by the Program of All-Inclusive Care for the Elderly (PACE) for new
populations, including individuals with physical disabilities, under the
authority provided by the PACE Innovation Act. The PACE Innovation Act of
2015 (PIA) provides authority to test application of PACE-like models for
additional populations, including populations under the age of 55 and those
who do not qualify for a nursing home level of care, under Section 1115A of
the Social Security Act.
The RFI includes two parts:
- In the first part, CMS seeks comment on potential elements of a
five-year PACE-like model test for individuals dually eligible for
Medicare and Medicaid, age 21 and older, with disabilities that impair
their mobility and who are assessed as requiring a nursing home level
of care, among other eligibility criteria. We have provisionally named
this model “Person Centered Community Care” or P3C. This potential
model is designed to meet the requirements of a model test under
Section 1115A of the Social Security Act and to adapt the PACE model of
care for one population of focus. In addition to feedback on the
potential elements of the P3C model described in the RFI, CMS seeks
comment on the types of technical assistance that potential P3C
organizations and states would require to participate in the model
- In the second part of the RFI, CMS seeks information on additional
specific populations whose health outcomes could benefit from
enrollment in PACE-like models, and how the PACE model of care could be
adapted to better serve the needs of these populations and the
currently eligible population.
CMS is accepting feedback on this RFI until 5 p.m. EST on Feb. 10, 2017.
Comments should be submitted electronically in PDF form to
with the organization or individual submitting comments on the title of the
CMS Proposes Rule for Prosthetics and Orthotics Suppliers
On Jan. 11, CMS issued a proposed rule that would implement statutory
requirements and specify: the qualifications needed for practitioners to
furnish and fabricate prosthetics and custom-fabricated orthotics, and for
qualified suppliers to fabricate prosthetics and custom-fabricated
orthotics; accreditation requirements that qualified suppliers must meet in
order to bill for prosthetics and custom‑fabricated orthotics; requirements
that an organization must meet in order to accredit qualified suppliers to
bill for prosthetics and custom-fabricated orthotics; and a timeframe by
which qualified practitioners and qualified suppliers must meet the
applicable licensure, certification and accreditation requirements. This
rule would also remove the exemption from quality standards and
accreditation that is currently in place in accordance with Section
1834(a)(20) of the Act for certain practitioners and suppliers who furnish
or fabricate prosthetics and custom‑fabricated orthotics. In addition, this
rule also includes authority for the Centers for Medicare & Medicaid
Services (CMS) to revoke the Medicare enrollment of Durable Medical
Equipment, Prosthetics, Orthotics and Supplies (DMEPOS) suppliers that submit claims for items that do
not meet the requirements of the statute and this proposed rule.
Only qualified practitioners who furnish or fabricate prosthetics and
custom‑fabricated orthotics and qualified suppliers that fabricate or bill
for prosthetics and custom‑fabricated orthotics would be subject to these
CMS will accept comments on the proposed rule until March 13, 2017, and
will respond to comments in a final rule.
To see the proposed rule,
FDA Releases Draft Guidance for Interchangeable Biosimilars
On Jan. 17, FDA outlined the criteria companies must meet to get a copycat
biologic deemed interchangeable with its branded counterpart, a
certification that paves the way for the cheaper products to be
automatically substituted at the pharmacy level under state laws.
To get this designation, a biosimilar sponsor must show that its product
can be expected to produce the same clinical result as the branded biologic
in any given patient, for all of the drug’s approved uses, and that there
are no risks if a patient is switched back and forth between the
interchangeable biosimilar and the branded biologic,
per draft guidance
released by FDA.
Interchangeable biosimilars are expected to offer greater savings to the
health system than biosimilars that lack this designation. Without the
interchangeability designation a doctor must proactively write a
prescription for the biosimilar.
The guidance outlines the types of studies and scientific data that
companies will need to submit to FDA to get an interchangeable designation.
When companies seek that designation, FDA recommends they seek approval for
all of the branded biologic approved uses.
FDA is requesting comments on the draft guidance as well as a number of
questions outlined in a
Federal Register notice. FDA wants to know how it should regulate manufacturing changes of
interchangeable products that occur after approval. The agency also wants
to know how it should handle interchangeable designations if a branded
biologic gets another use approved for the drug, after the interchangeable
biosimilar is cleared by FDA.
FDA Releases Draft Guidance on Off-Label Drug Communication
On Jan. 17, FDA
issued draft guidance
that gives drug and device companies more flexibility to communicate
off-label information about their products and avoid charges of
misbranding. The new policy allows companies to promote a drug or device
with information not on the agency-approved label as long as that
information is truthful and non-misleading and is consistent with
Companies have asked FDA for clarity on marketing policies after a 2012
U.S. Court of Appeals decision ruled that under the First Amendment the
government could not prohibit and criminalize the truthful off-label
promotion of FDA-approved drugs.
The guidance outlines how FDA will determine whether a company’s
communication is consistent with FDA’s required labeling. For example,
companies will not be permitted to communicate information about the drug
or device related to a use that has not yet been approved by FDA. They also
can’t promote a patient population for the drug or device that has not been
cleared by the agency.
The agency offers some examples of information companies could communicate
that could be consistent with its FDA-required labels. For example, FDA
said companies can promote testimony of patients who used the drug for its
FDA-approved uses, such as the product’s effect on patients’ daily
activities. Companies could also communicate long-term safety and efficacy
information about products that were approved for chronic use based on a
six-month trial, if the company now has data on the drug lasting a couple
of years, FDA added.
The guidance also outlines the type of scientific data companies need to
support their off-label claims. Comments on the draft are due in 60 days.
CBO Reports on Effects of Repealing Portions of the ACA
On Jan. 17, the Congressional Budget Office (CBO) released a report on the
estimated changes in health insurance coverage and premiums that would
result from leaving the Affordable Care Act’s insurance market reforms in
place while repealing the law’s mandate penalties and subsidies. In brief,
CBO and the staff of the Joint Committee on Taxation (JCT) estimate that
enacting that legislation would affect insurance coverage and premiums in
The number of people who are uninsured would increase by 18 million in
the first new plan year following enactment of the bill. Later, after
the elimination of the ACA’s expansion of Medicaid eligibility and of
subsidies for insurance purchased through the ACA marketplaces, that
number would increase to 27 million, and then to 32 million in 2026.
Premiums in the nongroup market (for individual policies purchased
through the marketplaces or directly from insurers) would increase by
20 percent to 25 percent—relative to projections under current law—in
the first new plan year following enactment. The increase would reach
about 50 percent in the year following the elimination of the Medicaid
expansion and the marketplace subsidies, and premiums would about
double by 2026.
Republicans are using their 2015 Obamacare repeal bill as a framework for
their latest effort, although they have yet to release final details on how
much of Obamacare they plan to repeal and what they intend to enact as a
replacement. This report is based on the 2015 repeal legislation, and does
not take into account any GOP plan that would replace Obamacare.
The new CBO report was prepared at the request of Senate Minority Leader
Chuck Schumer and other Democratic leaders. It does a more in-depth
analysis than what the office provided when the 2015 bill was debated. That
bill was passed but President Barack Obama vetoed it.
To see the full report,
GAO Releases Report on Medicare Advantage Payments
On Jan. 17, GAO released a report on payments to Medicare Advantage
organizations. Medicare Advantage organizations—which offer a private
health plan alternative to traditional Medicare—were paid about $170
billion by the federal government and served nearly one-third of all
Medicare beneficiaries in 2015. To help ensure appropriate payments, CMS
collects data on the care and health status of Medicare Advantage
GAO previously reported that CMS had not fully validated these data for
completeness and accuracy. In this report, the agency found that CMS has
conducted some, but not all, remaining validation steps.
For the full report,
GAO Reports on Kidney Disease Research Funding and Priorities
On Jan. 18, GAO
released a report
on kidney disease research funding and priority setting. Given the high
costs of the disease, GAO looked at how the federal government funds and
prioritizes its research. The report found that the National Institutes of
Health (NIH) spent $564 million on kidney disease research in 2015—an
increase of 2.7 percent from 2014. Those funds supported a broad range of
projects, including research on kidney donation. GAO describes how NIH sets
priorities for kidney disease research.
About 17 percent of adults in the U.S. have chronic kidney disease. If the
disease progresses to kidney failure, patients need dialysis or a kidney
transplant to stay alive.
GAO Reports on FDA Foreign Drug Inspection Program
On Jan. 17, GAO released a report on FDA’s foreign drug inspection program.
FDA uses a risk-based approach to select which manufacturing establishments
to inspect. To help its inspection efforts, FDA opened offices in China,
India, Europe and Latin America. GAO found that although FDA has improved
the program, the agency has not assessed these offices’ contributions to
drug safety, and nearly half of their authorized positions are unfilled.
GAO made recommendations on how FDA can improve in these areas.
To see the full report,
GAO Issues First Annual Report on the Federal Government’s Fiscal
On Jan. 17, GAO issued its first annual outlook on the nation’s fiscal future. The report
warns of mounting debt and other challenges, urges prompt action to address
those challenges, and is designed to help inform Congress and the incoming
administration. In the report, GAO urges the development of a long-term
plan that will address levels of federal spending and investments and the
options to obtain needed resources.
Federal spending continues to outpace revenue—by $587 billion in 2016—and
absent policy changes, the structural gap between revenues and spending
puts the federal government on an unsustainable long-term fiscal path,
according to GAO.
The report discusses significant changes to the nation’s fiscal condition
in fiscal year 2016, long-term simulations of the federal debt and fiscal
risks placing additional pressure on the federal budget. GAO also
identifies steps that federal agencies can take to improve things, such as
reducing improper payments; closing the tax gap; eliminating duplication,
overlap and fragmentation in federal programs; and producing better
information on program and fiscal operations to strengthen decision-making.
To see the full report,
If you have any questions, contact the following individuals at
Kennan, Senior Vice President
Charlie Iovino, Vice
Caroline Perrin, Research Assistant
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