Holland & Knight Health Dose: November 29, 2022 – Healthcare & More Trending News

LEGISLATIVE UPDATES

Congress Returns for Lame-Duck Push

Democrats will management the U.S. Senate in 2023 by a margin of
one or two votes, which the Georgia run-off election will decide
on Dec. 6, 2022. Republicans have management of the U.S. House of
Representatives, however with a slim majority. Until the brand new Congress
is sworn in on Jan. 3, 2023, Democrats will proceed to manage
each chambers.

Congress has lower than three weeks earlier than the present persevering with
decision (CR) expires on Dec. 16, 2022. However, it’s thought of
more and more seemingly that Congress will move a brief-time period CR to
present extra time to discover a compromise and solidify finish-of-the-12 months
priorities. Congress could stay in session up till Dec. 23, 2022.
In the healthcare area, a number of gadgets which are thought of
should-move throughout the lame duck embrace extending Medicaid funding
for the U.S. territories; addressing the approaching 4 p.c
Medicare PAYGO lower; expiring Medicare low-quantity and
Medicare-Dependent Hospital Program cost changes; and
reauthorizing the Maternal, Infant, and Early Childhood Home
Visiting Program. The looming query is whether or not Congress will
tack on extra healthcare gadgets such because the U.S. Food and Drug
Administration (FDA) insurance policies disregarded of the person payment
reauthorization package deal handed earlier this 12 months, Medicare
doctor cost points, longer-time period telehealth flexibilities,
increasing entry to psychological well being companies and pandemicrelated
investments. Much of what may make it right into a probably massive
legislative 12 months-finish deal remains to be in flux largely because of the
incontrovertible fact that prime-line spending figures are nonetheless being negotiated. In
quick, Congress is operating out of time to perform a prolonged
to-do checklist.

House Democrats to Vote on Leadership, Caucus Rules This
Week

House Democrats are contemplating a proposal to institute time period
limits for committee management. The caucus’ guidelines will probably be
voted on throughout the get together’s management elections for the 118th
Congress on Nov. 30, 2022. An modification from Rep. Bill Foster
(D-Ill.) would permit members to serve six years on the prime of a
committee. Following that interval, they would want caucus approval
to stay within the management submit. Democrats are additionally contemplating an
modification to the principles from Reps. Suzan DelBene (D-Wash.) and Mark
Pocan (D-Wis.) that may make caucus management chargeable for
appointing the chair of the Democratic Congressional Campaign
Committee (DCCC).

Medicare Prior Authorization Transparency Bill Introduced in
Senate

Sens. Roger Marshall (R-Kan.) and Maggie Hassan (D-N.H.)
launched laws (S. 5117) to require the inclusion of
data on prior authorization necessities and different
utilization administration methods within the “Medicare &
You” handbook and annual discover academic supplies despatched to
seniors throughout the annual Medicare Open Enrollment interval. The
Medicare & You Handbook Improvement Act would require the
Centers for Medicare & Medicaid Services (CMS) to incorporate
data on the outline of utilization administration
methods, together with prior authorization and step remedy, and the way
a beneficiary can discover which methods apply beneath a particular
Medicare Advantage (MA) plan or prescription drug plan. It would
additionally embrace an outline explaining that seniors who swap to an
MA plan and later swap again to their authentic Medicare plan could
be prohibited from buying supplemental protection or should pay
considerably increased premiums. Reps. Mike Kelly (R-Pa.) and Tom
O’Halleran (D-Ariz.) have launched companion laws. The
invoice’s sponsors are pushing for its inclusion within the 12 months-finish
package deal.

ARPA-H Launches Website and Twitter Account

The Advanced Research Projects Agency for Health (ARPA-H)
formally launched its web site final week. Authorized by Congress in
March 2022, the brand new company will carry collectively business, academia
and authorities by way of public-non-public partnerships for prime-threat,
excessive-reward endeavors supposed to drive breakthroughs in
biomedicine and well being. The webpage highlights the brand new company’s
focus areas of accelerating higher well being outcomes and supporting
the event of excessive-affect options to well being issues.
ARPA-H’s Twitter account will present common updates on
its present initiatives. The program is at the moment funded at $1
billion, however that is thought of a “down payment.”
Additional funding is being pursued within the fiscal 12 months 2023 funds
package deal that’s at the moment being negotiated by Congress.

HHS Plan to Fund New COVID-19 Vaccine Initiative; GOP Leaders
Oppose

The U.S. Department of Health and Human Services (HHS) introduced
a $350 million initiative for Health Resources and Services
Administration (HRSA)-supported well being facilities to extend COVID-19
vaccines of their communities, particularly specializing in underserved
populations. The administration’s public schooling initiative
contains a further $125 million for organizations serving the
aged and disabled. All HRSAfunded well being facilities, in addition to
well being facilities that acquired American Rescue Plan funding, will probably be
eligible for the Expanding COVID-19 Vaccination initiative.

Ranking House Energy and Commerce Committee Republican Cathy
McMorris Rodgers (R-Wash.) and Rep. Tom Cole (R-Okla.) publicly
slammed the administration for taking $475 million from the
Provider Relief Fund to pay for the initiative with out offering a
clear image of the reduction fund’s present standing.

CMS additionally issued new steerage emphasizing that payers and
suppliers are required to make sure sufferers have entry to essentially the most
current COVID-19 vaccines and coverings. The guiding memo implores payers to evaluate billing
practices for monoclonal antibodies and antiviral medication and asks
nursing properties particularly to evaluation all related steerage.

Senators Move to Advance Legislation to Improve Dual-Eligible
Care

A bipartisan group of U.S. senators who sit on the Senate
Finance Committee are working to develop laws to enhance how
people dually enrolled in Medicare and Medicaid are cared for
and coated. The group of lawmakers, led by Sen. Bill Cassidy
(R-La.), not too long ago despatched a letter to healthcare and affected person
communities in search of data that may assist Congress craft a
invoice to repair the structural issues plaguing the
“dual-eligible” inhabitants.

REGULATORY UPDATES

HHS Proposes Changes to Substance Use Disorder Patient Record
Protections

HHS issued a proposed rule on Nov. 28, 2022, that may
make adjustments regarding confidentiality of affected person data for
Substance Use Disorder (SUD) beneath 42 CFR half 2. The rule goals to
take away boundaries to care coordination and enhance affected person privateness
protections by aligning Part 2 data disclosure necessities extra
carefully with the Health Insurance Portability and Accountability
Act (HIPAA) privateness rule. Proposed adjustments embrace permitted future
use and disclosure of Part 2 data based mostly on a one-time affected person
consent; permitted redisclosure of Part 2 data in any method
permitted by the HIPAA Privacy Rule (with sure exceptions); new
affected person rights to acquire an accounting of disclosures and request
restrictions; expanded prohibitions on the use and disclosure of
Part 2 data in authorized proceedings; new civil cash penalties for
Part 2 violations; up to date breach notification necessities; and
up to date HIPAA Privacy Rule Notice of Privacy Practices necessities
to particularly tackle Part 2 data. Public feedback are due 60
days after the rule is printed within the Federal Register. A reality sheet is obtainable with extra data
on the rule.

HHS Overhauls 340B Administrative Dispute Resolution
Process

HHS issued one other main proposed rule that goals to overtake and
simplify the 340B administrative dispute decision course of, which
is designed to help coated entities and producers in
resolving disputes relating to overcharging, duplicate reductions or
diversion. In this rule, HHS goals to make the method extra
accessible by making it “extra expeditious and fewer
formal.” Among different adjustments, the Biden Administration
proposes to take away the present minimal threshold of $25,000. Any
claims which are already in course of can be mechanically
transferred to the brand new course of. Public feedback are due 60 days
after the rule is printed within the Federal Register.

Monkeypox Renamed “Mpox” in Effort to Reduce
Stigma

Monkeypox has been formally renamed “mpox” by the
World Health Organization (WHO). The title change is meant to
scale back stigma related to the illness, notably amongst
minority teams, and was advocated for by the Biden
Administration.

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