Transcript Dykema Gossett Presentation Template
2011 FEDERAL REGULATORY HOT TOPICS
HFMA-Western Michigan Chapter Maria B. Abrahamsen Dykema Gossett PLLC 248.203.0818
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-provider based 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 provider based 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