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POWERS Health Care Reform Resource
Center
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reform implementation.
Health Care News
Congressional Activity
Senate Panel Releases
Compounding Legislation, Schedules Hearing
Senator Tom Harkin
(D-IA) introduced a controversial bipartisan Senatedrug
compounding bill on Wednesday, May 15,
that would "clarify" that some compounding pharmacies are subject
to direct federal oversight by the Food and Drug Administration (FDA). The
Senate Health, Education, Labor and Pensions (HELP) Committee, which released
drafts of the bill over the past several weeks, is scheduled to take up the
legislationWednesday.
Representative Ed Markey (D-MA) introduced a compounding bill in the House of
Representatives last year.
House GOP Votes to
Repeal Health Care Law
The House voted 229-195 on Thursday, May 16, to repeal the
Affordable Care Act. It marked the 37 time the GOP-led House voted either to
repeal or eliminate funding for the 2010 legislation designed to provide
health coverage for millions of uninsured Americans. The vote is the third
time House Republicans voted for a full repeal. The vote was largely along
party lines, with all 227 Republicans voting for the repeal and all but two
Democrats voting against the repeal.
New CBO Budget Projections Show Slower Growth in Health Care
Spending
In updated
budget figures released by the
Congressional Budget Office (CBO) on Tuesday, May 14, CBO analysts projected a deficit this year of $642 billion,
about $200 billion less than the agency predicted in February. CBO explained
that the lower projection was based upon unexpected increases in revenues and
payments from Fannie Mae and Freddie Mac. For the 10-year period from 2014 to
2023, CBO projects a cumulative deficit that is $618 billion less than its $7
trillion projection in February. The decrease is largely a result of outlay
reductions for Medicare, Medicaid and Social Security, according to the CBO.
Regulatory Activity
CMS Announces Open
Period for Model of Bundling Demonstration
The Centers for
Medicare and Medicaid Services (CMS) announced
an opportunity for additional
organizations to apply for Model 1
of the Bundled Payments for Care Improvement (BPCI). Under Model
1of the BPCI demonstration, CMS will pay the participating hospitals a
bundled Medicare payment for episodes of care in an acute care hospital.
Earlier this year, CMS announced that over 450 health care organizations wereparticipating
in the BPCI demonstration overall.
However, the New Jersey Hospital Association's group of providers is the only
participating group of providers in Model 1 thus far. The open period ends on July 31.
CMS Offers $1 Billion
in Grants for Second Round of Health Care Innovation
CMS announced on Wednesday, May 15, a funding
opportunity that will award up to
$1 billion in grants to test service delivery models for Medicaid, Medicare,
and the Children's Health Insurance Program. The second round of grant
funding under the Health
Care Innovation Awardswill go to applicants who can demonstrate
they will improve quality of care and decrease costs within three years.
CMS Issues Proposed
Rule for Reductions in Payment to Disproportionate Share Hospitals
On May 13, CMS issued
a proposed
rule for hospitals that
serve a disproportionate number of low-income and uninsured populations. CMS
will cut $11 billion in payments to Disproportionate Share Hospitals (DSH),
beginning with a $500 million reduction in FY 2014. Cuts would increase to
$1.8 billion in FY 2017 and $5 billion in FY 2018. Comments are due July 12.
CMS Releases Hospital Charge Data for the First Time
For the first time, CMS released data this month on variations in hospital charges
for common inpatient services paid under Medicare in 2011. The data collected
represent almost 7 million discharges or 60 percent of total Medicare
Inpatient Prospective Patient System discharges.
State Activity
CMS Expecting States to Enforce Standards in Federal Marketplace
As the agency mentioned in previous releases, CMS will look to states
participating in the federal exchange to enforce standards mandated under the
ACA, according to guidance issued Tuesday, May 14. Where states fail to adequately
enforce the new standards, CMS proposes to enforce the standards through civil
money penalties and decertification of plans. The marketplace open for
enrollment October 1.
CMS Caps Funding for
Last Months of High-Risk Pools
CMS recently announced revised
CMS contract terms that it would cap the
amount of funding ACA high-risk pools receive through the end of the year. The
agency requested state Pre-existing Condition Insurance Plans (PCIP) propose
a contract amount for the last seven months. Where states choose to close
PCIPs, the enrollees will be allowed to move into the federal PCIP. The PCIP
program is a temporary program intended to ensure those with pre-existing
conditions can access insurance coverage prior to implementation of new
health insurance reforms in 2014.
Court Rulings
Judge Grants Temporary Restraining Order against Phoebe Putney/Palmyra
Merger
A federal judge issued a temporary restraining order (TRO) blocking any further
consolidation between Phoebe Putney Health System and Palmyra Medical Center,
both in Albany, GA, and prohibiting any price changes to existing health-plan
contracts. This action comes after the U.S. Supreme Court overturned the
Eleventh Circuit in a decision allowing the Federal Trade Commission (FTC) to
challenge the hospital merger. The order is expected to remain in effect
until there is a ruling following a June 14 hearing on the FTC's Motion for
Preliminary Injunction.
Company Petitions
SCOTUS to Review Preemption Device Case
Medical technology
company Medtronic is petitioning the Supreme Court to determine whether the
Medical Device Amendments to the Food, Drug and Cosmetic Act preempt state
laws related to requirements for companies to report adverse advents to the
FDA. Richard Stengel, a man who became paralyzed after having a Medtronic
device implanted,alleges that Medtronic was negligent under Arizona
state law because the company didn't file information on certain adverse
events to the FDA. The 9th Circuit Court of Appeals ruled in January that
federal law does not preempt state law in this case. Medtronic is appealing
the case to the Supreme Court as a result.
Potential Supreme
Court Class Action Ruling May Impact Health Care Manufacturers
Two cases pending
before the U.S. Supreme Court could have implications for drug and device
companies. The Supreme Court will decide later this month if it will hear
cases regarding whether lawsuits brought by state attorneys general on behalf
of residents should be heard in state court or federal court. Typically,
cases such as these have been heard at the state level, but the Class Action
Fairness Act allows cases to be moved to federal court if the case involves
more than 100 people. Because there is a clear split between the circuit
courts, the Supreme Court is expected to hear the case. Both cases involve alleged
price fixing of liquid crystal displays, but attorneys said the
question at issue in the cases will have far reaching implications. State
attorneys general have increasingly brought lawsuits against pharmaceutical,
device, tobacco and other FDA-regulated industries for violations of state
consumer protection laws. These types of actions could be affected by the
high court's decision.
Generic Drug
Manufacturer Settles False Claims and FDA Allegations
In the largest
drug safety settlement to date with a generic drug manufacturer, the company Ranbaxy
USA Inc. pleaded guilty to felony charges relating to the manufacture and
distribution of adulterated drugs. The manufacturer also settled civil claims
to resolve allegations that it caused false claims to be submitted to
government health care programs as a result of the adulterated claims.
Other Health Care News
Muscular Dystrophy Group Urges FDA to Make Orphan Drug Changes
Advocacy group Parent Project Muscular Dystrophy published a white
paper detailing suggestions on how the group thinks the Food and
Drug Administration (FDA) could improve its review process of drugs for
serious and life-threatening diseases that currently lack treatments. The
group recommends that the FDA accelerate approval for therapies to treat rare
diseases; issue clear guidance regarding the level of evidence required to
approve the treatments; use existing authority to pilot adaptive approval for
serious and life-threatening disorders with significant unmet medical need;
and weigh more seriously the patient's and caretaker's benefit and risk
preferences when making risk benefit determinations.
Powers in the
News
Publications,
Appointments & Speaking Engagements
POWERS Co-Founder and Principal Jim Pyles authored an article at the request
of the American Bar Association on the class action lawsuit against the IRS
for seizing 60 million health records. "If the allegations are true, the
IRS is in trouble," wrote Jim Pyles in a statement toHealthcare
IT News. "[Under] both constitutional law and HIPAA, then I
think we have a problem." Pyles added that the Fourth Amendment was
drafted in response to the General Warrants issued by the King of England
under which his officers could search for any evidence of crime without
showing probable cause. "The drafters expressly sought to curb that
practice in the 4th Amendment which guarantees the 'right of the people to be
secure in their persons, houses, papers, and effects against unreasonable
searches and seizures,'" he added. If the allegations are true,
"they way overstepped the limits of the search warrant." "The
Right to Obtain Restrictions under the HIPAA/HITECH Rule: A Return to the
Ethical Practice of Medicine," will be available in an upcoming
publication of the ABA.
POWERS Associate Amita
Sanghvi was re-appointed to serve on theAmerican
Health Lawyers Associations' Advisory Council on Diversity for fiscal year 2014. AHLA's Advisory Council
on Diversity serves as a resource to AHLA in achieving its goal of diverse
and inclusive participation of its members and leaders by advising,
recommending, and developing programs and initiatives that will encourage
members from diverse backgrounds to become more involved in the Association's
activities.
POWERS Principal Bobby
Silverstein will deliver the keynote speech at the first annual Nancy
Crewe Memorial Symposium - Future Directions in Disability Policy and
Strategies to Impact Employment of People with Disabilities: A Call to Action on May 22 in Lansing, MI. The symposium
provides an opportunity for Michiganders of varied experiences to participate
in a dialogue on disability policy and employment with national leaders in
the field. The full-day event is sponsored by Michigan State University's
Office of Rehabilitation and Disability Studies and Peckham Inc. Limited
seating is available, registration required.
POWERS Principal
Robert M. Portman will lead a live, 90-minute CLE - Strafford Legal Webinar
with interactive Q&A on Wednesday, May 22, 2013 at 1PM EST, entitled: Concierge
Medicine Legal Considerations - Complying With Medicare Regulations,
Insurance Laws and the Anti-Kickback Statute.
POWERS Co-Founder and
Principal Jim Pyles will lead three Clearwater Compliance 3-hour sessions,
entitled: HIPAA
Virtual Audit Prep BootCamp on May 29, June 5 & 19. Additionally, Clearwater Compliance
is offering several complimentary HIPAA-HITECH
Compliance Webinars.
POWERS Principal William von Oehsen is slated to participate in
several upcoming SNHPA
340B Regional Roundtables, dates will be announced shortly for TN,
LA, IA, and WI. SNHPA is hosting a series of complimentary, three-hour
regional roundtables throughout the country. These events, facilitated by
SNHPA 340B experts, are a great way to keep updated on current developments
within the 340B program and learn how to utilize and ensure compliance with
this complex federal program. Roundtables are open to both current and
prospective hospital members and SNHPA Corporate Partners. Due to their
smaller size, they also offer a valuable opportunity for networking and
dialogue.
For More
Information
For further information on any topics
discussed or publications listed, or to get copies of the alert, please call
(202) 466-6550 and ask for Sara Rosta of the Legislative Practice Group.
Powers Pyles Sutter & Verville (POWERS) P.C. is a full service law firm
specializing in health care and education law and located at 1501 M St., NW 7th Floor, Washington DC 20005
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Verville P.C.
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