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Health

With a Trump win and Republicans maintaining control of
the House and Senate, the health agenda promises to be
one of the greatest policy areas of change in the next
Congress.

ACA Repeal/Replace. In January, following a 240-181
vote, the House sent to the President H.R. 3762,
Restoring Americans' Healthcare Freedom Reconciliation
Act -a piece of legislation which dismantled key
provisions of the Affordable Care Act (ACA). The same
legislation was approved in the Senate on a vote of 52 to
47. Although the President ultimately vetoed the
legislation, it represents a blueprint for Congressional
action in 2017 to repeal core components of the ACA.

The reconciliation process allows leaders to call up
legislation and pass it with a simple majority vote in the
Senate-avoiding a potential filibuster. Reconciliation
rules in the Senate are complex, enforced by the Senate
Parliamentarian, and constrained by CBO scoring rules
and conventions-which combine to determine what can
and cannot be included in a reconciliation bill.
Reconciliation is a powerful tool but its use is limited to
policy changes that have a direct impact on taxing or
spending levels. Because they have used this process
before, Republicans have a road map of the changes that
will be possible through the use of reconciliation in a
closely divided Senate. Find a link to a summary of the
Reconciliation bill that passed in 2015 here. Donald
Trump has been less prescriptive in terms of the specifics
of the ACA replace plan that he supports. But generally,
he has called for a special session of Congress to
completely repeal the ACA and replace it with a plan that
allows consumers to buy insurance across state lines,
allow individuals to deduct the cost of health care on their
federal tax returns, expand Health Savings Accounts
(HSAs) and block grant Medicaid. Speaker Paul Ryan and
the House GOP introduced a proposal to replace the ACA
that can be found here. Because the Senate GOP did not
introduce their own ACA replace plan, negotiations
between the chambers will be required before a strategy
is developed.

User Fee Legislation. The Senate HELP Committee and
the House Energy and Commerce Committee are tasked
with the reauthorization of the Prescription Drug User Fee
Act (PDUFA), the Generic Drug User Fee Act (GDUFA), the
Biosimiliar User Fee Act (BsUFA), the Medical Device User
Fee and Modernization Act (MDUFMA). These programs
must be reauthorized in 2017 to ensure that sufficient
industry fees are available for the FDA to continue to
consider the applications of drugs and devices.

EY

The Food and Drug Administration (FDA) and relevant
industries have reached draft agreements on the user fee
proposals. The proposals are historically bipartisan
priorities and are expected to be approved by Congress
next year. Some of the drug pricing issues raised by
Democrats in 2016 could potentially become embroiled in
the FDA user fee legislation negotiations. Even though
Donald Trump has voiced some populist concerns about
the increasing cost of prescription drugs, the risk of drug
pricing policy changes being enacted next year are less
likely given that Hillary Clinton did not win the White
House and the GOP continues to control the House and
Senate. But Democrats are likely to continue to highlight
the issue and seek policy changes to address it.

Mental Health/ Opioids. Currently, discussions are
ongoing to find a compromise that can be enacted on
mental health legislation in the lame duck Congress and
possible further action to address the opioid addiction
crisis that was such a big issue in so many election
campaigns. But disagreements over funding levels, gun
issues and the privacy of medical records persist. It
remains to be seen if negotiators can reach agreement on
these issues in the lame duck session of Congress or if the
issue will be revisited in the next Congress.

MACRA Oversight. Congressional oversight of the
Centers for Medicare & Medicaid Services' (CMS)
implementation of the Medicare Access and CHIP
Reauthorization Act of 2015 (MACRA) is expected to
continue following several House and Senate hearings
held over the past several months and recent publication
of a final rule on the matter.

In 2015 Congress passed MACRA which overhauls how
Medicare pays for physician services. The legislation
repealed the Medicare physician sustainable growth rate
(SGR) formula and instead moves to a new two-track
payment system called the Quality Payment Program
(QPP). The two tracks of the QPP seek to tie an increased
percentage of physicians' Medicare fee-for-service
payments to outcomes through the Merit Based Incentive
Payment System (MIPS) and also to encourage the
adoption of alternative payment models (APMs).

At recent House and Senate hearings, members from
both parties expressed concern about MACRA's potential
adverse impact on smaller independent and rural
physician practices. While the final rule attempts to
address these concerns, it is expected that Congress will
continue to utilize its oversight power to monitor
implementation.

17 | Election 2016

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