Transcript Dykema Gossett Presentation Template

2011 FEDERAL REGULATORY HOT TOPICS
HFMA-Western Michigan Chapter
Maria B. Abrahamsen
Dykema Gossett PLLC
248.203.0818
[email protected]
November 17, 2011
California | Illinois | Michigan | North Carolina | Texas l Washington, D.C.
www.dykema.com
Fraud & Abuse Advisory Opinions

“Yes” to free local transportation by hospital
from nearby physician offices.

“Yes” to tertiary hospital assuming expense
of furnishing emergency consultations with
stroke neurologists via telemedicine
technology to community hospitals.

“Yes” to vaccine manufacturer’s vaccine
reminders to patients who have received
only a portion of recommended number of
doses.
Fraud & Abuse Advisory Opinions

Three opinions on outsourcing
components of hospital sleep lab
• “Yes” to per-use fee without marketing
• “Yes” to flat fee with marketing
• “No” to per-use fee with marketing
Fraud & Abuse Advisory Opinions

“No” to a “contractual joint venture”
between existing LTC pharmacy and a
new pharmacy created by SNF owners.

“No” to referring physician investment in a
pathology lab management company.

“No” to below-cost ambulance services
and medical supplies/equipment to SNF.
Fraud & Abuse Advisory Opinions

“No” to DMEPOS supplier’s contracts with
IDTFs to perform CPAP-related services
for supplier’s customers.

“No” to an online referral service, funded
by fees paid by post-acute care providers,
covering referral requests from hospitals
for post-discharge services.
Fraud and Abuse

“Waivers” of anti-kickback, Stark and
gainsharing rules published for those ACO’s
seeking, or party to, Shared Savings
contract with CMS.
Stark Developments

“Whole Hospital” and “Rural Hospital”
Exceptions
• Grandfathered if physician-owned, with
provider agreement, on 12/31/10
• No increase in aggregate ORs,
procedure rooms and beds after 3/23/10
• No increase in % physician ownership
after 3/23/10
• Disclosures to patients, CMS and public
required
• Bona fide investment safe guards
• Regulations implement exceptions to
limits effective 1/1/12
Stark Developments

Physician imaging disclosure requirements
• Apply if rely on IOAS exception
• MR, CT, PET
• Effective 1/1/11
• List of “suppliers”
• Within 25 mile radius of physician’s
office
• Minimum 5 choices
• Neither signature nor file copy required
Stark Developments

Voluntary Stark Self-Disclosure Protocol
• Only one federal self-disclosure
• No guarantee of leniency
• Provider must “open its books” to CMS
for verification

CMS Stark Advisory Opinion
• Hospital recruitment of physician to an
existing practice; non-compete in
recruit’s employment contract with
practice is okay.
Medicare “Under Arrangements”
Principle

Effective 10/1/11 “routine services” (e.g.
room, board and nursing) may not be
furnished to hospital inpatient outside the
hospital.
• Therapeutic and diagnostic services
still okay outside hospital
• CMS cites ICU/excluded hospital
abuses
• Don’t confuse with outpatient services
Medicare 3 - Day
Payment Window
• Effective DOS beginning 6/25/10
• Outpatient non-diagnostic services within 3
days prior to admission = bundled if
“related” to admission
• Prior policy: “related” = identical principal
diagnosis
• New: “related” unless hospital shows not
related
• New: “related” = “clinically associated”
• New: “unrelated” = “clinically distinct or
independent from reason for admission”
• Condition Code 51
• No change re pre-admission diagnostic
services
Medicare 3 - Day
Payment Window

CMS “clarifies” application to non-providerbased physician offices “wholly owned” or
“wholly operated” by hospital
• Same principles as pre-admission
services furnished at the hospital
• Change in 2010 to definition of “related”
will increase application of principle to
office services
• Professional services will be paid at
facility rate; if split into TC/PC, only PC
will be paid; new modifier will be
developed; effective 7/1/12.
Medicare Value Based
Purchasing

Effective discharges beginning 10/1/12

Add-on to DRG payments for hospitals that
score well
• Funded by overall decrease in DRG
payments
• Score based on greater of
“achievement” or “improvement” points
• Initial score measured 7/1/11 – 3/31/12,
and compared to 7/1/09 – 3/31/10
• 100% score required on half of patient
care measures to get full points
Medicare Value Based
Purchasing (continued)
• 12 clinical process of care measures
(70% weight)
• 8 patient experience of care measures
(30% weight)
• FY 2014 – will include relative spending
per Medicare beneficiary (Parts A & B
combined) in scoring
Medicare Hospital Readmission
Reduction Program

Effective discharges beginning 10/1/12

Payment reduction for excess readmission
rate (i.e. readmit within 30 days) for 3
diagnoses
Physician Supervision of
Hospital Outpatient “Incident
to” Services - 2011

General rule – “direct” physician
supervision required throughout hospital
therapeutic services
• exception for 16 “nonsurgical
extended duration services”
– “direct” supervision at initiation
– thereafter “general” supervision
– examples – observation, infusion,
injections
Physician Supervision of
Hospital Outpatient “Incident
to” Services - 2011

Supervisor must be “immediately
available”
• Still not defined
• No location-specific requirement

No longer an on/off-campus distinction

Supervising MD or NPP must be qualified
to “perform” the supervised service

CAHs and small rural hospitals – no
enforcement in 2011
Physician Supervision of
Hospital Outpatient Services 2012

Direct physician supervision required for all
hospital outpatient therapeutic services paid
under OPPS, except cardiac rehab, intensive
cardiac rehab, pulmonary rehab, and
“nonsurgical extended duration services.”

N/A to services paid outside OPPS, e.g. PT,
OT, ST and clinical lab

The same therapeutic services must be
furnished in the hospital or in a providerbased department of hospital
• Example: Not covered as hospital services
if performed in certified ASC.
Physician Supervision of
Hospital Outpatient Services 2012

New review process to assign supervision
level (general, direct, personal) to specific
therapeutic outpatient services.

CMS will exempt small rural hospitals and
CAHs again in 2012.
Medicare – Hospital
Conditions of Participation

Training re administration of blood
transfusions and IV meds
• OK if part of general orientation
• Document individual competency

Immediate Reporting of Drug Errors
• Immediate reporting if known or
potential harm
• Notice to physician
• Contrast to routine reporting
Medicare – Hospital
Conditions of Participation

Patient Visitation Rights
• Substance of policy
• Notice to patients
• Non-discrimination
Medicare – Hospital
Conditions of Participation

Revised Anesthesia CoP
• Need a policy to define “anesthesia”
• Qualifications of practitioners and
director must be specified

Life Safety Code Compliance
• December 2010 CMS guidance
• Michigan enforcement
Medicare – 2011 Practitioner
Payment Changes

10% bonus for primary care

10% bonus for general surgeons in HPSAs

CMS nibbling away at Practice Expense
RVUs
Medicare – Practitioner Payment
Changes - 2012

SGR estimated to reduce professional fees
as of 1/1/12 by 27.4%

Every 5 years CMS recalibrates wRVUs
• Must be budget neutral
• Proposed changes published 6/11:
– Reduce value of observation services
– Reduce value of codes typically billed
with an E & M service

CMS “expects” AMA to review ½ E & M
codes by 7/1/12 and remainder by 7/1/13,
and review highest non-E & M codes per
specialty
Medicare – ASCs

2011 = 100% “New” ASC rates

Proposed ASC Quality Reporting System:
• reporting begins 2012
• payment consequences 2014

CMS guidance re ASC H&Ps, similar to
Hospital CoPs

Patient rights information: okay to deliver
prior to start of procedure, rather than
before date of procedure
Medicare LTAC Moratoria

In 2007 Congress enacted moratoria on (a)
new LTACs and (b) bed increases in
existing LTACs.

Health Reform extended moratoria through
12/31/12.

Certain “in the works” LTACs exempt from
moratoria.
• Exempted LTACs may not increase bed
size after 9/30/11. Loophole closed.
Medicare Inpatient
Rehab Facilities

Revised regulations, effective 10/1/11:
• “New” rehab unit = not paid under IRF
PPS for at least 5 calendar years.
• Excluded status not affected by a
CHOW, if new owner assumes provider
agreement
• Changes in bed size and square feet of
an IRF no longer limited to beginning of
cost reporting year; once during year
permitted with 30 days notice to CMS
Regional Office.
• A unit may still be excluded only as of
the start of cost reporting year.
Medicare - Diagnostic
Testing

CMS backs down on required physician
signature on lab requisition forms

CERT program focuses on missing and
insufficient signatures on orders for
diagnostics (and injections)
• No retroactive orders; use attestation
instead
• Dated
• Legible signature
• No signature stamps
Medicare - Diagnostic
Testing

CMS will reduce professional fee for
multiple advanced imaging services in
single session, effective 1/1/12

CMS invites comments on similar reductions
for TC & PC of all imaging and TC of all
diagnostic tests

OIG resurrects issue of EKGs and imaging
in ED; CMS continues to state that
interpretation need not occur while patient is
in ED
Medicare - ESRD

New payment system as of 1/1/11
• Broader bundling
• Patient-specific adjustments
• 4-year phase-in

ESRD Quality Incentives
• As of 1/1/12
• Reduction of up to 1% to 2% based on
care delivered
Medicare - DME

New definition of “durable” =
minimum 3-year lifetime
Medicare - General

Provider/supplier enrollment is effective no
earlier than date on which CMS
determines all federal requirements are
satisfied

Medicare enrollment forms updated July
2011
• More extensive reporting
• New 855O
• Must be used after October, 2011
Medicare – General

New Enrollment Procedures
• Risk categories
• Application fees
• Moratoria & suspensions authorized
• Compliance plans = future rulemaking

By March 2015 all providers and suppliers
will be required to revalidate enrollment, if
enrolled before 3/26/11. (CMS granted
itself a 2-year extension in Nov. 2011)

When provider/supplier enrolls, changes
enrollment info, or revalidates – must agree
to be paid electronically.
Medicare – General

Reduced Payment for Multiple Therapies on
Same Day
• applies if paid under MPFS
• greater reduction for institutional
providers
Federal Medicaid Developments

Medicaid RAC audit regulations published
9/16/11

CMS requires states to deny increased
payments for provider-preventable
conditions

No federal match for Medicaid payments to
provider under investigation for a “credible
allegation of fraud”
Drug Resales

FTC Advisory Opinion to University of
Michigan
• Pharmaceuticals for U-M employees and
dependents
• NPIA discount confirmed
• If University’s NPIA price < pharmacy’s
“cost,” pharmacy is paid its margin and
University replenishes inventory