Feb 13, 2017
Washington Healthcare Update
This Week: Rep. Price confirmed as secretary of HHS…Energy and Commerce works on two
Medicaid bills…Drug bill held up in Energy and Commerce for vetting…CMS
nominee hearing on the 16th.
4. State Activities
5. Regulations Open for Comment
House Energy and Commerce Approves Minor Changes to Medicaid
On Feb. 7, the House Energy and Commerce health subcommittee approved two
bills making minor changes to Medicaid.
would require states to consider lottery winnings and other lump-sum
payments above $80,000 when determining whether someone is eligible for
Medicaid or CHIP. The second bill,
H.R. 181, would revise the rules for counting income for married couples when
determining whether one spouse qualifies for Medicaid long-term care
benefits—that legislation would count half of the income that a spouse
receives from an annuity as income.
Republicans said the two bills were the starting point for a discussion on
making broader reforms to Medicaid, a program they argue needs
belt-tightening. But committee Democrats argued that the bills were
essentially a smoke screen to distract from the GOP’s broader goals to gut
Obamacare and sharply curtail spending on the country’s social safety net.
The bills were both approved largely along party lines. Republicans
criticized Democrats for making the tweaks a partisan issue.
Senate Confirms Rep. Price as Secretary of HHS
Early Friday morning, the Senate confirmed Rep. Tom Price (R-GA) as
secretary of HHS, putting him in charge of Republicans’ effort to repeal
and replace the Affordable Care Act.
Price’s confirmation went through by a small 52-47 vote along party lines.
The seven-term congressman maintained full Republican support throughout
the process. No Democrats voted for him.
The opposition to Price’s confirmation—which was delayed nearly 30 hours by
Democrats—served as a preview of the partisan fights to come over the
future of American health care.
The Georgia Republican, who has served as House Budget chairman, favors a
far more conservative approach to health care. He authored a 2015
replacement bill that would have eliminated many of Obamacare’s broad
health benefits, and he supports drastically rolling back funding for both
Medicare and Medicaid.
At HHS, Price is expected to start immediately reforming the health care
system, using administrative powers to ease Obamacare’s regulations and
create a path for congressional Republicans to repeal and ultimately
replace the law.
Senate Finance Committee Announces Confirmation Hearing on Seema Varma
Seema Varma, the Trump administration’s nominee to head the Centers for
Medicare and Medicaid Services (CMS), will be appearing before the Senate
Finance Committee on Feb. 16.
Sen. Carper Raises Concerns Over Hiring Freeze and Medicare, Medicaid Fraud
Sen. Tom Carper (D-DE) is raising concerns that President Donald Trump’s
federal hiring freeze could leave Medicare and Medicaid more vulnerable to
fraud if HHS can’t hire staff focused on program integrity. However, newly
confirmed HHS Secretary Tom Price (R-GA) says he will take into account the
role of fraud fighters as he works with the White House to implement the
A Trump administration memo dated Jan. 22 froze the hiring of employees
across the executive branch except in limited circumstances. The memo says
the head of an agency may exempt positions necessary to meet national
security or public safety, and the Office of Management and Budget director
can grant exemptions from the freeze where necessary. Guidance on the memo
released Jan. 31 clarifies that for the director of the Office of Personnel
Management to sign off on an exemption, an agency would need to explain why
it has a critical need for the position with relation to mission
requirements, why reallocation isn’t possible and the consequences of not
filling the position within a three-to-six-month timeline.
Sen. Carper asked whether Rep. Price will recommend the hiring freeze be
lifted for federal workers fighting criminal activity, waste and fraud in
Medicare and Medicaid. Price has told lawmakers he would take these
concerns into account.
Senators Probe Price Hike of Kaléo’s Naloxone, Company Says WAC Not A Fair Price Gauge
Thirty-one senators led by Judiciary Committee ranking Democrat Patrick
Leahy (VT) are asking Kaléo Pharmaceuticals to
justify the price hike of its opioid reversal product, a naloxone auto
injector called Evzio. The price went from $690 in 2014 to a current
wholesale acquisition cost (WAC) of over $4,000. This is not the first time
that Kaléo has come under scrutiny by Congress for the price of its
naloxone product. Previously, members of the Senate Aging Committee wrote
to five companies, including Kaléo, in June 2016 requesting an explanation
of price changes for various naloxone products.
Kaléo argues that the WAC is not an accurate representation of the amount
consumers pay, because many users receive discounts, thus lowering the cost
or eliminating it entirely. However, the senators still worry about the
impact the price would have on those who do not qualify for discounts, and
bulk buyers of the product, such as health departments.
While the senators acknowledge the company’s claims that their product is
cheaper for many consumers, they argue the WAC still impacts those
ineligible for discount programs, and bulk buyers of the product.
The senators are also scrutinizing Kaléo’s Evzio donation program. FDA
reported Kaléo donated 120,466 Evzio products between April 1, 2015, and
April 3, 2016. The Feb. 8 letter asks Williamson to detail the proportion
of Evzio devices that have been donated, and the outreach being used to
publicize the program.
The senators also want to know what portion of Evzio profits are coming
from government payers. They ask Williamson to provide the total amount
Evzio received in reimbursements from the federal government in the past 12
months, and the percentage of customers that rely on federally funded
dollars to purchase the product.
Retail sales of naloxone are increasing, with Evzio leading brand sales,
according to FDA. “Retail sales of naloxone products intended for use by
the general public (Evzio, Narcan Nasal) are rapidly increasing,” FDA wrote
in an October 2016 presentation.
Evzio represented 17.9 percent of retail sales from July 2015 to June 2016,
which was nearly double the market share for the other branded naloxone
product on the market, Adapt Pharma’s Narcan nasal spray, which represented
9.1 percent of the market. However, both branded products were dwarfed by
generic product utilization.
Price increases for naloxone products have come under fire previously from
both lawmakers and stakeholders, and FDA has tried to nudge companies
toward making their products available over the counter. The FDA took steps
in August 2016 to encourage an Rx-to-OTC switch by drafting a sample Drug
Facts Label, sample pictogram and arranging label comprehension testing.
FDA also told lawmakers in November it was willing to meet with sponsors to
discuss an Rx-to-OTC switch for the product.
FDA Approves Old Drug to Treat Rare Disease, Raises Concerns About Pricing
On Feb. 9, the FDA approved an old drug to treat a rare disease, a move
that generated fears that the manufacturer will dramatically increase the
drug’s price. The approval is also raising red flags among health policy
experts who say this looks like another case of a drug company abusing
incentives designed to encourage new innovations for patients.
The FDA approved Marathon Pharmaceutical’s Emflaza (deflazacort) to treat
patients age five and older with Duchenne muscular dystrophy, a rare
genetic disorder that typically kills patients in early adulthood.
This is the first time the drug has been approved for any use in the U.S.,
however FDA notes that steroids like Emflaza are commonly used around the
world to treat the disease. Patients in the U.S. are regularly able to gain
access to the drug by ordering it from E
urope. Online pharmacies sell it for prices that range from less than a
dollar per pill to a few dollars, depending on the dosage.
According to a
from the Chicago Tribune, Emflaza could now come with a list price
of $89,000 for a year’s supply, thousands of dollars more than the cost of
purchasing the drug overseas. Marathon has come under
in the past for raising the prices of old medicines by nearly 400 percent.
In addition, drugs used to treat rare diseases are typically able to
command large prices with less pushback from payers. For example, Sarepta’s
recently approved drug to treat Duchenne comes with a list price of
$300,000 per year.
Marathon could also benefit because it pursued a rare disease indication.
This allowed the company to get an orphan drug designation, which comes
with seven years of marketing exclusivity, compared to the traditional
three to five years granted to most new drugs. It also received a rare
pediatric disease priority review voucher, meant to encourage companies to
develop treatments that might not otherwise be economically attractive.
Drug manufacturers that have acquired this fast-track voucher have reaped
millions by selling them to other pharmaceutical companies.
Drugmakers Ask FDA to Halt Final Rule on Off-Label Use
citizen petition posted online Feb. 9, PhRMA,
BIO and the Medical Information Working Group, which represents a number of
large drug companies, asked the FDA to halt a final rule they argue
improperly expands the agency’s power to sanction companies when their
medicines are used for unapproved or off-label purposes.
The industry argues that the final rule—issued in early
January—significantly changed the definition of “intended use.” That
designation determines when a drug or device is subject to FDA regulation
and also whether a drug is marketed for off-label uses.
The petition states the rule would considerably expand the government’s
ability to seek criminal penalties for misbranding drugs. Drugmakers say
they could be penalized for having knowledge that their products are being
used for off-label purposes, even though such uses are common and legal.
CMS also reimburses for some off-label use.
Drug companies also say the final rule included extensive changes that were
not included in a proposed rule, offering no opportunity for public
feedback. They claim it was a last-ditch attempt by the Obama
administration to settle a long-running debate over one of the FDA’s most
important issues without any notice or comment.
Early last week, FDA delayed implementation of the final
rule until March 21 due to the White House’s regulatory freeze. It was
previously set to take effect Feb. 8.
HHS Memo Points Out Positions That Are Exempt From Hiring Freeze
internal HHS memo dated Feb. 6
reveals that a number of positions at the Office of Medicare Hearings and
Appeals (OMHA) and Departmental Appeals Board (DAB) are exempted from
President Donald Trump’s federal hiring freeze. Those exemptions are
intended to cut down on the backlog of Medicare appeals and to meet court
On Jan. 22, President Donald Trump froze hiring across the executive
branch, but the White House told agencies that they may exempt positions
necessary to national security or public safety, and that the Office of
Management and Budget director separately may grant exemptions. White House
guidance released Jan. 31 lays out criteria for exempting personnel from
In the memo, HHS Acting Deputy Secretary Colleen Barros used that criteria
to apply an exemption to those positions, which handle appeals at the third
and fourth levels of appeals where there is an appeals backlog.
As of Sept. 30, OMHA had a backlog of 650,000 appeals, and the agency can
handle only about 92,000 appeals annually. Administrative law judges are
supposed to decide appeals within 90 days, but in fiscal 2016, the average
processing time for an appeal was more than 877 days.
The criteria laid out in the memo states that “positions under programs
where limiting the hiring of personnel would conflict with applicable law”
are exempt from the hiring freeze, and at HHS that includes positions
within the OMHA and DAB.
Judge Blocks Anthem-Cigna Merger
A District of Columbia federal judge on Feb. 8 prohibited health insurers
Anthem and Cigna from proceeding with a proposed $54 billion merger,
agreeing with the government that the industry’s largest-ever merger would
create an unlawful concentration of market power.
U.S. District Judge Amy Berman Jackson
that Anthem and Cigna’s deal, which would create the country’s largest
insurance company, would stifle competition for large employers in a market
dominated by just four insurers. Jackson also did not accept Anthem’s
argument that more insurer market power would indirectly benefit consumers
because a combined Anthem-Cigna could depress the rates they paid to
hospitals and doctors.
The judge was not persuaded by Anthem’s argument that any anticompetitive
effects would be offset by some $2 billion in savings for customers
generated by the merger. The companies’ claimed efficiencies were not
necessarily dependent on the merger and were unverifiable, she said.
A representative of Anthem said the company was reviewing the decision but
declined to comment further. A representative of Cigna did not immediately
respond to a request for comment. Anthem can appeal the ruling, but it
faces a tight timeline. At the end of April, either of the merging
companies can pull the plug on the deal, and Cigna is expected to do so
immediately. That would trigger a $1.85 billion breakup fee that Anthem
would owe to Cigna.
Groups File Suit to Block Trump Executive Order
On Feb. 8, three organizations sued the Trump
administration over the president’s Jan. 30 executive order directing
agencies to identify two regulations for repeal for every rule written.
The Natural Resources Defense Council, the Communications Workers of
America and Public Citizen are seeking to have the order, as well as an
interim guidance document issued on Feb. 2, declared unconstitutional and
Trump’s order “will block or force the repeal of regulations needed to
protect health, safety, and the environment, across a broad range of
topics—from automobile safety, to occupational health, to air pollution, to
endangered species,” the groups write in their joint lawsuit.
“To repeal two regulations for the purpose of adopting one new one, based
solely on a directive to impose zero net costs and without any
consideration of benefits, is arbitrary, capricious, an abuse of
discretion, and not in accordance with law,” the suit continues.
The suit describes potential problems with implementing the order when it
comes to regulations on vehicle safety, labor laws, chemical reviews, mine
safety, energy efficiency, endangered species and air quality.
The case was assigned to Judge Gladys Kessler of the U.S. District Court
for D.C. Kessler was named to the bench by Bill Clinton.
4. State Activities
California: Exchange Enrollment Numbers for 2017 Fall Short
California exchange officials say they met their 2017 projections for new
enrollment, even though the numbers slipped compared to 2016. More than
412,000 new enrollees signed up through Feb. 4, including those people who
later backed out, according to figures released Feb. 6. That exceeded the
agency’s projection of 400,000 new enrollees, but is still 6 percent less
than the 439,000 Californians who enrolled for the first time for 2016
coverage. Once the number of new consumers who signed up but then changed
their minds is factored in, 2017 new enrollment stands at 368,000—a 16
percent drop. Exchange officials say that, adding in all the renewals,
total Covered California enrollment will reach 1.5 million, which is
slightly more than the current 1.4 million.
Colorado: Republicans Aim to Repeal Colorado’s Obamacare Exchange
Republicans in the Colorado Legislature are trying to repeal the state’s
Obamacare exchange, with the state Senate Finance Committee approving
legislation early last week. The legislation’s sponsor argues that the
exchange has not brought down insurance costs or provided more choice to
consumers, but those against repeal say those problems would not be solved
by scrapping the marketplace. The bill faces an uphill battle in the
Democratic-controlled state House. Colorado’s exchange recently
roughly 176,000 individuals chose plans during the most recent open
enrollment period, a boost of 12 percent compared to last year.
Florida: Health Groups in Florida Debate Over HMOs
The Florida Senate is considering the possibility of modifying the state’s
mandate that all Medicaid beneficiaries be placed in a managed care plan to
exclude long-term nursing home residents. The Florida Health Care
Association told members of a Senate health care spending panel this week
that HMOs are not value-added for long-term nursing home residents and that
the mandate shouldn’t apply to individuals who have been in a facility for
60 days or more. By eliminating the HMO requirement and returning to a
fee-for-service system, the state could save $68 million in administrative
and case management fees, the nursing home group said.
However, the Florida Association of Health Plans argued that HMOs have
transitioned back to the community residents who have lived in nursing
homes for as many as two years. The debate occurs as the state prepares for
its second round of bids with Medicaid managed care plans this summer. As
of January, there were more than more than 94,000 elderly and disabled
people enrolled in one of six HMOs that contract with Florida to provide
Hawaii: State Legislature Considers Bills Combating Chronic Homelessness
Two bills aimed at combating chronic homelessness are gaining traction in
the Hawaii legislature as lawmakers look to reduce the state’s high rate of
homelessness—the highest in the country. One bill, which requires certain
plans to cover treatment for people who are homeless, advanced through a
Senate committee this week. The other measure would classify homelessness
as a medical condition for Medicaid reimbursement purposes. It’s still in
committee but has attracted attention from both Democratic and Republican
lawmakers who believe it could effectively treat people who are chronically
homeless and often use emergency rooms while reducing uncompensated care
Kansas: Health Committee to Vote on Medicaid Expansion
The Kansas House Health and Human Services Committee is preparing to vote
next week on a Medicaid expansion—an idea that previously fell flat with
the state’s conservative lawmakers. Expansion proponents estimate it would
provide coverage to nearly 150,000 Kansans who earn too much to qualify for
the state’s traditional Medicaid program but not enough to qualify for
subsidies on the exchange. Gov. Sam Brownback, a staunch opponent of the
ACA, is against expansion.
Minnesota: Gov. Dayton Pushing Plan to Create Public Option in Minnesota
Minnesota Gov. Mark Dayton is
advocating a plan
that essentially creates a public option in Minnesota—letting anyone who
has a plan on the individual market buy into the state’s ACA Basic Health
Program, known as MinnesotaCare. Under the proposal, individuals who opt to
buy MinnesotaCare coverage would have to pay the full premium for a plan
rather than receiving any subsidies. On average, that monthly premium is
$469 per person this year, according to state officials. MinnesotaCare
existed before Obamacare, but the program was refurbished to comply with
federal parameters for the Basic Health Program, which takes individuals
between 138 and 200 percent of the federal poverty level and enrolls them
in a state-sponsored plan rather than in Obamacare exchange coverage.
5. Regulations Open for Comment
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.
CMS Proposes Average 0.25 Percent Hike for Medicare Advantage Plans
On Feb. 1, the Trump administration issued guidance that proposes updates
to the methodologies used to pay Medicare Advantage plans and Part D
sponsors. The guidance calls for raising Medicare Advantage payments an
average of 0.25 percent.
Health plans take in roughly $200 billion a year from the government to
provide care for seniors enrolled in private Medicare plans. There are
currently more than 18 million people enrolled in Medicare Advantage,
accounting for roughly a third of all of the program's beneficiaries. More
than 1 million seniors have been added to private Medicare plans in the
past year, continuing a trend of robust growth that goes back a decade.
"These proposals will continue to keep Medicare Advantage strong and stable
and provide high quality, affordable care to seniors and people living with
disabilities," said Patrick Conway, acting administrator of the Centers for
Medicare and Medicaid Services.
Obamacare included major cuts to Medicare Advantage—America's Health
Insurance Plans puts the total figure at $200 billion—that were designed to
bring payments more in line with traditional government-run Medicare. Last
year, the federal government paid private plans an average of 102 percent
of traditional fee-for-service costs per member.
UnitedHealth Group and Humana are the biggest national players, accounting
for roughly 40 percent of the Medicare Advantage market in 2015.
CMS will accept comments until March 3 and the final notice will be posted
on April 3.
To read a fact sheet on the rate proposal,
Brookings Center for Health Policy Releases Report on ACA Marketplace Competition
In a new
Brookings report, researchers with the ACA Implementation Research Network present analyses
of competition in five states: California, Florida, Michigan, North
Carolina and Texas.
According to the findings, pent-up demand for care and higher-than-expected
coverage costs shook the five state marketplaces for the ACA. Though
Obamacare compensated health plans for covering people with pre-existing
conditions, some major insurers still withdrew from the exchanges.
Researchers question if the unforeseen high demand was due to enrollees’
receiving coverage for the first time or if the problem would be an ongoing
They found that the easiest way to keep costs down is competition—although
that is particularly difficult in rural areas where plans have a limited
number of doctors and hospitals to negotiate with.
Findings for the report are based on telephone or face-to-face interviews
with people involved with health law exchanges in the five states. Some
results and findings from those interactions were then applied nationwide.
GAO Recommends Ways to Ensure Quality of New Medicaid Data
On Feb. 6, GAO
on ways to assess and ensure the quality of new Medicaid data. Federal
Medicaid administrators rely on state-reported data to inform oversight
activities, but GAO found continuing concerns regarding such data’s
completeness, accuracy and timeliness. Those administrators have not
developed plans to ensure the quality of this new data, or how to use it
for better oversight.
GAO recommended that the administrator of CMS take immediate steps to
assess and improve the data available for Medicaid program oversight,
including the Transformed Medicaid Statistical Information System (T-MSIS).
Such steps could include refining the overall data priority areas in T-MSIS
to reduce improper payments and expediting efforts to ensure the quality of
the T-MSIS data.
Medicaid made an estimated $36 billion in payment errors in 2016.
GAO Recommends Better Federal Oversight of Data Used to Set Managed Care Payment Rates
In a new report, GAO recommended better federal oversight of the data used
to set payment rates, as well as the rates’ effects on care and other
outcomes. Medicaid provides long-term care to states’ most vulnerable
populations, such as the elderly or disabled. States are increasingly
paying for long-term care through managed care programs, paying based on
set, monthly rates. How states structure these rates—aligning incentives to
minimize cost and maximize service—is critical to enhancing community-based
To see the full report,
GAO Reviews Actions Taken by FDA in Response to Cancer Risk From Medical Devices
In a new report, GAO reviewed actions taken by FDA in response to adverse
event reports about the spread of unsuspected cancer following the use of a
laparoscopic power morcellator to treat uterine fibroids.
In 1991, FDA allowed the first laparoscopic power morcellator—a device that
cuts tissue into small pieces, which can be removed during minimally
invasive surgeries—on the U.S. market. In late 2013, the agency began
receiving reports that these devices might spread a type of cancer when
used to treat uterine fibroids. FDA began to warn against the use of these
power morcellators to treat fibroids, and recommended new labeling.
To see the actions FDA has taken on this matter since 2013,
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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