May 15, 2017
Washington Healthcare Update
This Week: FDA administrator confirmed…HELP Committee reports out a User Fee bill…Chronic Care bill hearing coming…Senate Republicans create work group to develop repeal/replace legislation.
5. State Activities
6. Regulations Open for Comment
NGA Asks Congress to Extend Federal CHIP Funding
Virginia Gov. Terry McAuliffe and Massachusetts Gov. Charlie Baker,
co-chairs of the National Governors Association (NGA), wrote in a
bipartisan letter to leaders of the House Energy and
Commerce and Senate Finance committees urging Congress to extend federal
funding for the Children’s Health Insurance Program (CHIP) another five
years at current levels. Congress faces a Sept. 30 deadline to extend
funding for the program, which covered roughly 5.6 million children as of
February, according to the
latest CMS data. Without an extension, states will start running out of federal funds in
October, with the majority of states exhausting their money between January
and March, according to the Medicaid and CHIP Payment and Access
Commission. McAuliffe and Baker said states quickly need funding certainty
for their budgets.
Energy and Commerce Leaders Want Response to Alleged Pill Dumping in West Virginia
On May 9, both Republican and Democratic leaders of the House Energy and
Commerce Committee sent letters to the Drug Enforcement Administration
(DEA) and distributers regarding reports of unusually large quantities of
opioids being distributed in West Virginia—one of the states hit hardest by
the opioid epidemic.
To see the letters,
Senate GOP Looks at Medicaid Expansion States in Health Reform
Sen. Rob Portman (R-OH), among those working on the Senate version of
health reform, said the group discussed a softer landing for Medicaid
expansion states than that provided by the House bill during a meeting May
9 on Medicaid policy.
Senate Majority Leader Mitch McConnell’s (R-KY) select group of lawmakers
working on health reform legislation met to discuss Medicaid policy prior
to a meeting that included all the Senate Republicans as well as Vice
President Mike Pence. Majority Whip John Cornyn (R-TX) said Medicaid is an
area where Senate Republicans can negotiate a compromise in order to pass
their own version of the American Health Care Act (AHCA).
Under the House-passed version of the AHCA, increased federal funding for
the Medicaid expansion population would stop by 2020. Should states choose
to continue covering childless adults with annual incomes up to 138 percent
of poverty, they would receive only the state’s traditional matching rate.
On top of that, the federal contribution would be further limited to the
designated per-person amount laid out under AHCA’s per-capita caps system.
Medicaid advocates have said that states are unlikely to extend coverage
for that population beyond 2020 because they won’t be able to afford it.
Several states have triggers in place to end expansion if federal financing
Senate Finance Committee to Hold Hearing on Bipartisan Chronic Care Bill
The Senate Finance Committee
plans to hold a hearing on Medicare chronic care legislation on May 16.
Committee Chair Orrin Hatch (R-UT) has touted the legislation as the first
major bipartisan health care bill of this Congress. The committee postponed
a hearing on the Children’s Health Insurance Program (CHIP).
The legislation would expand testing of the CMS Innovation Center’s
Value-Based Insurance Design model, ease telehealth restrictions and change
beneficiary assignment to accountable care organizations. It would extend
the Independence at Home demonstration for two years and increase the cap
on the total number of beneficiaries from 10,000 to 15,000. The bill also
would permanently authorize dual-eligible special needs plans, chronic
condition SNPs and institutional SNPs, if certain requirements are met.
Democrats may use the platform provided by the hearing to talk about AHCA.
Senate Democrats Demand HHS Enforce Obamacare Anti-Discrimination Rules
On May 10, twenty-one Democratic senators wrote to HHS Secretary Tom Price
demanding that HHS’s Office of Civil Rights continue enforcing Obamacare
requirements that prevent discrimination in health programs, after what
they describe as troubling signals that HHS will undermine them.
The issue centers on a
brought last year by several GOP states and provider organizations that
challenged Section 1557 of the Affordable Care Act, which prohibits
discrimination on the basis of race, color, national origin, sex, age or
disability in health care programs.
Under the Obama administration, HHS issued final regulations that prevented
insurers from having blanket bans on coverage for gender reassignment
services and that forbade providers from refusing care to transgender
patients, among other protections. But several red states and provider
groups argued that the regulation required doctors to perform gender
transition procedures even when doing so is against the physician’s medical
judgment. A federal judge in late December blocked enforcement nationwide
of certain pieces of the Obama-era regulation, and in recent
court filings, the Trump administration has suggested it may rework it.
Senate Democrats previously wrote HHS protesting Trump’s decision to
appoint Roger Severino as the head of the HHS civil rights office.
Senate HELP Committee Advances FDA User Fee Bill
On May 11, the Senate HELP Committee voted 21-2 to advance the FDA user fee
reauthorization bill out of committee with minimal changes. The markup was
originally scheduled for May 10 but was postponed.
The committee agreed by voice vote to add two amendments, including a
provision from Sens. Susan Collins and Al Franken requiring the FDA to
review generic drug applications in about eight months if at least three
versions of the treatment are not already on the market.
The panel also agreed by voice vote to a bipartisan amendment led by Sen.
Orrin Hatch that would expand clinical trial criteria to allow sicker
patients to participate. It would also make it easier for patients to use
an FDA program to receive unapproved drugs when they don’t qualify for
The committee voted 13-10 to table an amendment by Sen. Bernie Sanders that
would have allowed drug importation from Canada. Committee Chairman Lamar
Alexander described the amendment as controversial and asked to delay a
vote on it until the bill reaches the floor, to keep the committee process
Sanders and Rand Paul were the only members who voted against the bill.
Sen. Michael Bennet offered but then withdrew an amendment that would
require companies to conduct more clinical trials of cancer medicines in
Seventeen amendments were filed in advance of the hearing, but most were
not offered, including Democratic amendments that would have tried to
preserve key parts of Obamacare. Many Democrats used the hearing to protest
the Senate process for developing a counterpart to the House-passed
Obamacare repeal bill, calling on committee Republicans to hold hearings.
The committee also advanced by voice vote S. 1028, the RAISE Family
Caregivers Act, out of committee. It would direct the HHS secretary to
develop a national strategy to support family caregivers.
To see the 17 proposed amendments, click
Scott Gottlieb Confirmed as FDA Chief
On May 9, the Senate confirmed Scott Gottlieb as FDA commissioner,
thrusting the conservative drug industry insider into the heated debate
over rising drug costs that President Donald Trump has pledged to
Gottlieb, a former FDA and CMS official in the George W. Bush
administration, sailed through confirmation on a 57-42 vote. He will lead a
15,000-person, $5 billion agency that approves drugs, vaccines and medical
devices and regulates tobacco, cosmetics and food.
The position will make Gottlieb an important player in the Trump
administration’s plans to speed up the drug approval process and cut back
on regulations and red tape, which the president has argued will bring down
Democrats Agree to Work With GOP on Health Care, But Not Repeal
Senate Democrats are demanding that Republicans have a “bipartisan, open
and transparent” debate on health care.
All 48 Senate Democrats—including two independents who caucus with them—in
a new letter say they will work on health care legislation as long as
Republicans drop their pledge to repeal Obamacare.
The pitch is unlikely to sway the GOP from their seven-year-long promise to
do away with the Affordable Care Act. Now that the House has passed its
repeal bill, Senate Republicans are starting to figure out how they would
repeal and replace the health law.
Republicans are operating under the assumption that no Democrat will cross
party lines to support Obamacare repeal.
“Democrats stand ready—as we always have—to develop legislation with
Republicans that will improve quality, lower costs, and expand coverage for
all Americans,” the lawmakers wrote to Majority Leader Mitch McConnell and
committee chairmen Lamar Alexander and Orrin Hatch. “But Republicans need
to set aside their current partisan efforts and work with us to get this
Democrats outlined a number of areas of improvement in health care. They
said they want to work on reducing drug prices, decreasing premium and
out-of-pocket costs, stabilizing the insurance market and increasing
coverage for families and small businesses.
Sen. Wyden Asks FDA to Delay Opioid Workshop Due to Conflicts of
Democratic Sen. Ron Wyden, concerned about conflicts of interest at an FDA
workshop on opioids last week, asked HHS Secretary Tom Price to delay the
meeting until a more thorough review of meeting participants can be
conducted. The meeting went on as planned.
letter to Price sent May 5, Wyden detailed the
connections to drugmakers of six groups participating in the workshop on
May 9 and 10. The meeting looked at ways to improve health care provider
training in pain management and safe opioid use.
Wyden said the financial relationships between opioid manufacturers and the
pain advocacy groups raise “concerns that could undercut efforts to curb
over-prescribing.” Pain groups funded by opioid companies “have worked,
oftentimes in concert with other industry-funded groups, to steer state and
federal policy toward favoring opioids as a treatment for pain,” Wyden
The letter discusses the drug industry connections of the American Academy
of Integrative Pain Management, the American Chronic Pain Association, the
American Pain Society, the National Fibromyalgia and Chronic Pain
Association, the Pain Action Alliance to Implement a National Strategy and
CMS Releases Checklist for Stakeholders for High-Risk Pool/Section 1332 Waivers
On May 11, CMS and the U.S. Department of the Treasury released a checklist
to help states interested in pursuing Section 1332 waivers. CMS believes
this checklist will be particularly helpful for 1332 waivers implementing a
high-risk pool/state-operated reinsurance program. The agency is
encouraging states interested in applying for Section 1332 waivers to reach
out promptly for assistance in formulating an approach that meets the
requirements of Section 1332.
The final checklist can be found
Sen. Grassley, Rep. Chaffetz Argue HHS Memo Restricting Staff Communication With Congress Is Illegal
Key GOP lawmakers allege a memo by HHS Secretary Tom Price’s chief of staff
restricting his agency’s communications with Congress is potentially
illegal and unconstitutional, and they demand HHS quickly make all
department staff aware of their right to communicate directly and
independently with Congress. The HHS memo tracks with White House
regulatory affairs-nominee Neomi Rao’s past calls for all contact between
lawmakers and agency staff to be documented.
The May 3 memo by Price’s chief of staff, Lance Leggitt, states all HHS
communication with lawmakers and congressional staff needs to go through
the department’s legislative affairs shop to “help us avoid unnecessary
problems in our relationships with Congress.”
The memo drew criticism from Senate Judiciary Chair Charles Grassley (R-IA)
and House Oversight Chair Jason Chaffetz (R-UT), who ask HHS to promptly
provide all agency staff with specific, written guidance laying out their
right to communicate with lawmakers. The guidance should inform agency
staff of whistleblower protections and make it clear that the agency won’t
retaliate against those who exercise their right to communicate with
Congress, the lawmakers say.
“Absent such a clear communication from you, agency management may seek to
intimidate whistleblowers from providing information to Congress. We will
not allow that to happen and trust that nor will you. Protecting
whistleblowers is crucial to effective government and the oversight
process,” Grassley and Chaffetz wrote to Price on May 4.
The lawmakers say the HHS memo would force HHS staff to expose
communications with Congress to agency management, which would necessarily
subject them to an increased risk of reprisal, and the effect of the memo
would be to “substantially chill those communications.” Leggitt states in
the memo, which he says he wrote on behalf of Price, that the restrictions
restate longstanding department policy.
The lawmakers ask for all documents and communication referring or relating
to the directive no later than May 18.
CMS Issues New Guidance to States and Manufacturers
CMS recently released guidance to states and manufacturers through State
Release #180 and Manufacturer Release #104 to provide clarification on
Medicaid reimbursement and rebates for drugs purchased through the Federal
Supply Schedule (FSS).
These releases are now available for download
President Trump Announces Four Additional Members of Opioids Commission
On May 10, President Donald Trump officially designated New Jersey Gov.
Chris Christie to be head of the White House commission on opioids and
named four other members to the group:
North Carolina Gov. Roy Cooper, a Democrat
Massachusetts Gov. Charlie Baker, a Republican
- Former Democratic Rep. Patrick J. Kennedy, who was addicted to opioids
for several years and is now a leader of the Advocates for Opioid Recovery
- Bertha Madras, a Harvard biopsychologist and former deputy director in
the White House’s Office of National Drug Control Policy
The White House’s commission is poised to play a key role in the
administration’s effort to confront the opioid epidemic. Trump also
announced that he would appoint Rich Bagger, a former chief of staff to
Christie and an executive at the biopharmaceutical company Celgene, as a
member of the Commission on White House Fellowships. Bagger was part of
Trump’s transition team until being dismissed along with Christie in
November when Vice President Mike Pence took over the effort.
Randy Pate Named Director of CCIIO
Randy Pate is now director of CCIIO, the agency that oversees the Obamacare
marketplaces. Pate previously served as vice president of public policy for
Health Care Service Corporation, which operates Blue Cross Blue Shield
plans in five states, including Texas and Illinois. Prior to that, Pate was
a health policy fellow at the conservative Heritage Foundation.
He replaces Jeff Wu, who had been serving as acting director during the
transition to the Trump administration. The agency spokeswoman did not
immediately respond to a question about Wu’s current duties.
CCIIO is charged with overseeing the Obamacare insurance markets, which
face an uncertain future under unified Republican control of the federal
government. The biggest looming question is whether the Trump
administration will continue paying cost-sharing subsidies, which insurers
rely on to reduce costs for their poorest Obamacare customers.
Aetna Withdrawing From Obamacare Marketplaces
Aetna recently announced it will not sell coverage in individual
marketplaces in Nebraska or Delaware, marking the company’s complete
withdrawal from the Obamacare exchanges.
Both states will potentially be left with just one remaining insurer in
2018. Further, Nebraska’s lone insurer, Medica, has already warned it would
leave Iowa after becoming the sole option in that state’s marketplace.
Aetna cited losses totaling $700 million in the individual market in the
last three years as the reason for its withdrawal. The company expects to
lose an additional $200 million despite shedding almost three-quarters of
its individual market members since last year. The insurer had 255,000
individual members at the end of March.
Aetna is now the second-largest national insurer to completely withdraw
from the exchanges. Humana announced its total exit in February.
Despite the big losses in the Obamacare markets, Aetna continues to see
revenue growth in other government programs, primarily Medicare and
Medicaid. Roughly half of its premium revenues came from government
programs last year, up from 38 percent prior to full implementation of the
Affordable Care Act.
Pence, Price Meet With Biotech Industry at the White House
During a recent meeting with industry representatives, Vice President Mike
Pence, HHS Secretary Tom Price and other administration officials sketched
out how NIH and other agencies can maintain U.S. preeminence in
biotechnology. The White House meeting included: Cori Bargmann, president
of the Chan Zuckerberg Initiative; Bill Ford, General Atlantic CEO; and
Craig Thompson, president and CEO of the Memorial Sloan Kettering Cancer
Center. Officials from Celgene, Royalty Pharma, Vertex Pharmaceuticals and
Regeneron represented the industry. President Donald Trump later greeted
attendees in the Oval Office.
White House press secretary Sean Spicer told reporters that the meeting
reinforced the cooperation necessary for the industry to succeed.
MSF Argues Exclusive DOD License for Zika Vaccine Violates Bayh-Dole
Doctors Without Borders (MSF) alleges the Department of Defense may have
violated the Bayh-Dole Act by issuing Sanofi Pasteur an exclusive license
to a DOD-developed Zika vaccine without ensuring the vaccine is accessible
to patients. However, DOD says the exclusive license is warranted given the
capital needed to bring the drug through FDA approval, and says the
department has no means or authority to make determinations on vaccine
affordability or access.
“The deal gives Sanofi a blank check to charge high prices for the vaccine
and contains no known guarantee that the vaccine will be developed in a
timely and appropriate manner and made available in the US and all
countries where it is needed,” MSF
writes in a press release. Instead, MSF calls on DOD to make the vaccine candidate available for an
open non-exclusive patent license. Such a license, the group says, should
include terms that ensure further development of the vaccine prioritizes
all health needs and offers affordable access to any resulting product.
The doctors group says the exclusive license may violate Section 209 of the
Bayh-Dole Act. The law requires that exclusive licenses be granted by the
government only in cases where the exclusivity is a “a reasonable and
necessary incentive to call forth the investment capital needed to bring
the invention to practical application; or otherwise promote the
invention’s utilization by the public,” MSF argued in comments to DOD.
But DOD told MSF that the license is in accordance with federal law, and
that exclusivity is “a reasonable and necessary incentive to call forth the
substantial investment capital, exercise, and capabilities required to
bring our nascent and unproven technology through FDA licensure to
practical application for public use.”
Comey Pledged New Approach to Cybersecurity in Hospitals
The FBI needs much deeper collaboration with the private sector to mitigate
the threats posed by criminals and nation-states to hospital networks,
then-director James Comey said in a speech to the American Hospital
“A vast majority of intrusions are not shared with law enforcement,” Comey
said, and hospitals hacked with ransomware often pay up and hope that
solves the problem. “I understand that instinct, but it is horribly
short-sighted,” he said.
The FBI needs to be more effective at sharing information related to
cyber-borne threats, and industry needs to share more. It does not have to
be an onerous process, he said.
Comey also said the FBI needs to recruit more private-sector tech talent,
and to practice deterrence against criminals and other malicious actors by
arresting them or otherwise disrupting their schemes.
Anthem Appeals $54B Cigna Merger Case to Supreme Court
In a last-ditch effort to save its troubled $54 billion merger with Cigna,
Anthem asked the U.S. Supreme Court to review a circuit court ruling siding
with the government in its challenge to the deal.
The D.C. Circuit in its April 28 split ruling relied on outdated,
decades-old case law and the court did not adequately take into account
more than $2 billion in cost savings the merger would unleash, Anthem said.
“Anthem urges that 1960s-era merger precedents relied upon by the courts
below must be updated to reflect the modern understanding of economics and
consumer benefit,” the company said in a statement.
The health insurance giant cited a dissenting opinion penned by Circuit
Judge Brett M. Kavanaugh in the case, who said the deal would be beneficial
for the merged company’s customers. The D.C. Circuit’s ruling is evidence
of a circuit split on the question of how merger efficiencies should factor
into an analysis of a transaction’s effects on competition, Anthem said.
The suit presents the high court with the opportunity to take up its first
merger case in several decades and provide much-needed guidance on
efficiencies, Anthem argued in its petition for certiorari. Since 1967’s FTC v. Procter & Gamble Co., when the Supreme Court said
economies could not be used as a defense against illegality in merger
cases, economic thinking in the area has progressed, and courts are
confused on how to interpret that precedent, the company said.
On May 11, a Delaware chancery judge rejected Anthem’s bid for a 60-day
block on Cigna’s declared intent to terminate the merger of the two health
insurers, saying Anthem’s prospects for overcoming multiple challenges to
the deal are slim.
PhRMA Sheds 22 Companies After Approving New Membership Criteria
05/09/2017 01:33 PM EDT
On May 9, PhRMA said 22 companies are no longer members after the drug
lobby formally approved new criteria requiring companies to devote a
portion of their resources to research and development.
The new requirements may allow one of the most recognizable industry
lobbying groups to reduce negative headlines from members’ contributing to
the high cost of prescription drugs.
The list of departing companies includes five that have voluntarily left
the organization since Jan. 1. That includes Marathon Pharmaceuticals,
which was widely criticized for its initial price tag of $89,000 for a drug
treating Duchenne muscular dystrophy.
Fifteen of the companies were associate members, which will still have the
opportunity to apply for full membership under the new rules.
PhRMA’s revised membership criteria require companies to spend at least 10
percent on research and development based on a three-year average of total
global sales. That spending must be at least $200 million per year.
The seven former full members are: AMAG Pharmaceuticals, Horizon Pharma,
Jazz Pharmaceuticals, Leadiant Biosciences, Mallinckrodt Pharmaceuticals,
Orexigen Therapeutics and The Medicines Company.
The former 15 associate members are: ACADIA Pharmaceuticals, Aerie
Pharmaceuticals, Avanir Pharmaceuticals, BioMarin Pharmaceutical, CSL
Behring, Esperion Therapeutics, Ferring Pharmaceuticals, Grifols USA, Ipsen
Biopharmaceuticals, Marathon Pharmaceuticals, Shionogi Inc., Sucampo
Pharmaceuticals, Theravance Biopharma, Vifor Pharma and VIVUS.
5. State Activities
California: Gov. Brown Releases New Proposed Budget
California Gov. Jerry Brown’s
revised 2017-18 budget
continues to rely on Obamacare and Medicaid as they now exist. The new
proposed budget, which he released May 11, indicates the Medicaid shortfall
has been reduced by $620 million, largely due to savings from drug rebates
in managed care and slower-than-expected caseload growth.
But the Medicaid program still has a deficit, and there is ongoing tension
between Brown and Medi-Cal providers. The governor still plans to use funds
from the state’s new $2-per-pack tobacco tax to close the Medicaid deficit
instead of boosting provider rates, restoring services—such as adult dental
care—or extending coverage to undocumented young adults. The Legislature
has until June 15 to approve the budget.
Illinois: Illinois Senate Approves Abortion Access Bill
The Illinois Senate approved a bill that allows state Medicaid dollars to
be used for elective abortion services and protects abortion access in the
event that the Supreme Court overturns Roe v. Wade. The bill, which
passed the House last month, now heads to Republican Gov. Bruce Rauner’s
Rauner, who has previously claimed to support abortion rights, has vowed to
veto the bill—putting him in a tough political position ahead of his
reelection effort next year.
Four other states already allow state Medicaid dollars to be used for
elective abortions. Federal Medicaid dollars are prohibited from covering
abortion, with narrow exceptions including rape, incest or threats to a
mother’s life. There are currently 15 states that pay for medically
necessary abortion, according to the Guttmacher Institute.
Louisiana: Department of Health Seeking Comment on Drug Pricing
Louisiana’s Department of Health is seeking comment on
for the federal government to help lower prices for drugs treating
hepatitis C, which affects more than 70,000 people in the state. The first
idea is for HHS to strike a voluntary licensing agreement with drug makers
to make discounted treatments available to Louisianans. The second idea is
to use an existing federal patent law to obtain medications at a
much lower cost.
In an interview, Health Secretary Rebekah Gee said there are roughly 35,000
Louisianans with hepatitis C who are uninsured or enrolled in Medicaid, but
the state is only able to treat around 320 patients per year because of the
exorbitant cost of medications.
Gee argues that these approaches could benefit the state for a wide range
of treatments, including medications to prevent premature births and a Zika
New Jersey: Lawmakers Introduce Bills to Preserve ACA Provisions
Democratic state lawmakers recently introduced three bills meant to
preserve Affordable Care Act provisions if the federal health care law is
repealed. Two of the bills aim to prohibit New Jersey from applying for
certain waivers included the MacArthur amendment, such as the prohibition
on charging sicker people higher premiums and coverage of essential health
benefits. The third bill would establish a publicly funded and state-run
health insurance plan known as the “New Jersey Public Option Health Care
Act.” New Jersey law already requires protections for pre-existing
conditions, including guaranteed issue and community rating, in the
individual and small group insurance markets.
Oregon: Lawmakers Considering Raising Health Care Taxes
Oregon Gov. Kate Brown and state lawmakers are considering raising health
care taxes to close a Medicaid budget shortfall that threatens the state’s
Obamacare Medicaid expansion. The revenue boost would come from two places:
raising an existing provider tax on hospitals and creating a new tax on
insurance premiums. A joint legislative committee had
ending the Medicaid expansion to help plug a $1.6 billion budget gap, along
with several other potential options. Expansion covers roughly 350,000
people in Oregon.
6. Regulations Open for Comment
FDA Considers Establishing New Office of Patient Affairs
The FDA is considering establishing a new Office of Patient Affairs that
would centralize its work on patient involvement in the review and approval
of drugs and medical devices, according to a
March 14 notice
in the Federal Register.
Comments on the new office are due by June 12, 2017.
FDA Proposes 1,000 Medical Devices to Exempt From Premarket
On March 14, FDA took one of its first actions to begin implementing the
21st Century Cures Act, by
more than 1,000 medical devices it will exempt or partially exempt from the
premarket review process. The devices on the list are sufficiently well
understood and do not present risks that require premarket notification to
provide a reasonable assurance of safety and effectiveness, FDA said. The
agency will finalize the list after a 60-day public comment period.
Comments are due by May 15, 2017.
FDA Extends Comment Period on Biosimilar Interchangeability Guidance
FDA is extending the public comment period for its
outlining how biosimilar sponsors can demonstrate that their products are
interchangeable with other biologics, following extension requests from top
The agency laid out in a January 2017 draft guidance its first attempt at
codifying the requirements that sponsors must satisfy to demonstrate
interchangeability. The agency said it would make case-by-case
determinations of interchangeability, but indicated it would require
studies measuring the impact of switching on clinical pharmacokinetics and
The Biotechnology Innovation Organization (BIO), Pharmaceutical Research
and Manufacturers of America and Covington & Burling all requested
comment period extensions, according to documents posted on
The comment period, which was set to close on March 20, will be extended 60
days until May 19.
FDA Submits Interim Final Rule on Long-Delayed Menu Labeling Rule
On April 27, FDA submitted an
interim final rule
to the White House Office of Management and Budget concerning a
long-delayed menu labeling rule. By submitting an interim final rule to OMB
they are delaying its existing final rule, slated to take effect May 5. The
apparent change in course follows a
by the National Association of Convenience Stores and the National Grocers
Association asking FDA to push back the final rule’s effective date.
The move to submit the interim final rule follows years of controversy and
debate about the menu labeling requirements, which stem from a
little-noticed provision in the Affordable Care Act that calls for
mandatory calorie disclosure on menus at chains that have 20 or more
The agency’s notice to OMB offers no detail about whether it is seeking
other changes to the rule, but says FDA will be taking comments.
CMS Releases Proposed Hospital Pay Rule
In a new proposed
2018 Medicare payment rule, CMS
says it will look to cut hospital industry regulations and streamline
oversight, and it’s asking hospitals themselves for help. The agency is
soliciting ideas for changes to rules and procedures governing acute-care
and long-term care hospitals. The initiative aims to “relieve regulatory
burdens for providers,” as well as promote flexibility and innovation, CMS
said in a statement.
The new proposed rule would suspend for one year a provision penalizing
long-term care hospitals that receive more than 25 percent of patients from
a single acute-care hospital. It would also reduce certain quality
reporting requirements for hospitals that have implemented electronic
CMS projects the rule would increase Medicare spending on inpatient
hospital services by $3.1 billion in 2018, with operating payments to
hospitals increasing 2.9 percent. Long-term care hospitals’ Medicare
payments are projected to decrease by $173 million, or 3.75 percent, over
the same period.
Comments on the rule must be submitted no later than 5 p.m. EDT on June 13,
CMS Proposes 2018 Payment and Policy Updates for Medicare Hospital
CMS is offering hospitals a 90-day meaningful use reporting period in 2018,
according to a
proposed payment rule
released April 14.
The first major payment regulation released under HHS Secretary Tom Price
marks a change from the back-and-forth over electronic health records
meaningful use requirements seen under the Obama White House. The previous
administration would typically propose a yearlong reporting period, then
scale it back at the last minute after intense lobbying pressure. As a
Republican congressman from Georgia, Price often pushed the Obama
administration hard for 90-day meaningful use reporting periods.
In connection with the 21st Century Cures Act, CMS also is
to remove from meaningful use clinicians who see most of their patients at
ambulatory surgery centers.
Price and CMS are also changing previously finalized requirements from
electronic clinical quality measures. Under the proposed rule, hospitals
can select six measures and report on them for the first three quarters of
For more information,
CMS is Accepting Measure Submissions for the Advancing Care Information
Performance Category until June 30
CMS is still accepting measures for the Advancing Care Information
performance category of the Merit-based Incentive Payment System (MIPS).
The Annual Call for Measures and Activities ends June 30, 2017.
CMS encourages providers to identify and submit measures for the MIPS
Advancing Care Information performance category. To be considered,
proposals must include specific criteria including, but not limited to,
measure description, measure type and numerator and denominator
CMS requests that stakeholders consider outcome-based measures, patient
safety measures and cross-cutting measures that use certified EHR
technology to support the improvement activities and quality performance
categories of MIPS.
Advancing Care Information Submission Form
to propose measures for inclusion, and send the form to
To learn more about the process for submitting measures, please visit the
Call for Measures
webpage, and review the
Call for Measures and Activities fact sheet.
CMS Looks to Boost Medicare Payments to Rehab Hospitals, Nursing
Facilities and Hospices
CMS could boost Medicare payments to a swath of rehabilitation hospitals,
nursing facilities and hospices under a trio of new proposed rules.
On April 27, the agency floated a
$390 million bump
in federal payments to skilled nursing facilities in 2018—or roughly 1
percent higher than this year. Hospices, meanwhile,
a 1 percent increase worth $180 million.
to increase reimbursement to rehab hospitals by $80 million for 2018, in
addition to eliminating a penalty on facilities that don’t submit certain
data to the federal government on time.
proposed payment rules for other
providers, CMS is asking the industries for input on regulations it should
overhaul or eliminate. CMS Administrator Seema Verma and HHS Secretary Tom
Price have pledged to review all of the agency’s rules in a bid to cut
unnecessary or burdensome regulations.
Comments on the trio of rules must be received no later than 5 p.m. on June
CMS Seeking Comments on Data Elements in IMPACT Act
CMS has contracted with the RAND Corporation to develop standardized
patient/resident assessment data elements in alignment with the Improving
Medicare Post-Acute Care Transformation Act of 2014 (IMPACT Act).
CMS seeks comments from stakeholders on data elements that meet the IMPACT
Act domains of cognitive function and mental status; medical conditions and
co-morbidities; impairments; medication reconciliation; and care
preferences. The public comment period opens on April 26, 2017, and closes
on June 26, 2017.
For more information, view the
CMS Issues 2018 IPPS Proposed Rule
CMS issued the FY 2018 Inpatient Prospective Payment System (IPPS) and Long
Term Acute Care Hospital (LTCH) rule on April 14, which proposes a number
of changes to the Medicare and Medicaid Electronic Health Record (EHR)
The proposals include:
For CY 2018, modifying the EHR reporting period from the full calendar
year to a minimum of any continuous 90-day period for new and returning
participants in the Medicare and Medicaid EHR Incentive programs.
Adding a new exception from the Medicare payment adjustments for
Eligible Professionals (EPs), Eligible Hospitals and Critical Access
Hospitals (CAHs) that demonstrate through an application process that
complying with the requirement for being a meaningful EHR user is not
possible because their certified EHR technology has been decertified
under ONC’s Health IT Certification Program.
Implementing a policy in which no payment adjustments will be made for
EPs who furnish “substantially all” of their covered professional
services in an ambulatory surgical center (ASC); applicable for the
2017 and 2018 Medicare payment adjustments.
Using Place of Service (POS) code 24 to identify services furnished in
an ASC as well as requesting public comment on whether other POS codes
or mechanisms should be used to identify sites of service in addition
to or in lieu of POS code 24.
Comments must be submitted by 5 p.m. on June 13, 2017.
To learn more, review the
CMS Publishes Post-Acute Care Proposed Rules
On May 11, CMS published the following proposed rules:
GAO Reviews USDA Actions to Reduce Risks of Avian Influenza
new report, GAO reviewed several issues related to avian influenza. GAO found that
the U.S. Department of Agriculture (USDA) has taken actions to address
lessons learned from its responses to the outbreaks, such as encouraging
states to form response teams. However, it does not have a plan to evaluate
the effectiveness of its efforts. GAO recommended that USDA develop such a
Avian influenza is an extremely infectious and potentially fatal disease in
poultry. In 2014 and 2016, outbreaks in the U.S. led to the death of more
than 50 million chickens, turkeys and other birds, and cost billions of
dollars. Controlling avian influenza viruses in poultry is crucial to
preventing those viruses from evolving to infect people.
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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