von Briesen Health Law Blog

March 13, 2012

HHS Releases Final Rule on Affordable Insurance Exchanges

Filed under: Legislation Watch — Scott Thill @ 1:51 pm

The Department of Health and Human Services (HHS) has released a Final Rule (644 pages) to implement Affordable Insurance Exchanges (Exchanges), which must become operational by January 1, 2014. Exchanges will provide marketplaces where individuals and small employers can compare private health insurance options (e.g. based on price and quality). The Final Rule combines proposed rules issued on July 15, 2011 and August 17, 2011 relating to Exchange establishment and eligibility.

As described by HHS, the Final Rule includes:

Minimum standards that states must satisfy if they elect to establish an Exchange (e.g. standards for individual and employer eligibility in an Exchange);
Minimum standards that health insurance issuers must satisfy to participate in an Exchange and offer qualified health plans; and
Standards that employers must satisfy to participate in the Small Business Health Options Program.

A number of the provisions in the Final Rule are interim rules, open to public comment. HHS is accepting comments on interim provisions relating to the following, among others:

The ability of agents and brokers to assist individuals in applying for advance payment of the premium tax credit and cost-sharing reductions for qualified health plans;
Options for conducting eligibility determination;
Eligibility standards for cost-sharing reductions;
Timeliness standards for Exchange eligibility determinations;
Verification for applicants with special circumstances; and
Agreements between agencies administering insurance affordability programs.

November 4, 2011

CMS Releases its CY 2012 OPPS Final Rule

CMS has released its CY 2012 Outpatient Prospective Payment System (OPPS) Final Rule, effective January 1, 2012. Notable provisions of the Final Rule include:

A market basket update of 1.9%.
Adjustment to payment rates for certain cancer hospitals.
A process for the APC Panel to evaluate requests for alternative supervision levels for hospital outpatient therapeutic services and issue recommendations to CMS on the same.
The addition of three quality measures for hospital outpatient departments to report for purposes of the CY 2014 and CY 2015 payment determinations. The new measures include: (i) a measure relating to cardiac rehabilitation patient referrals; (ii) a measure relating to the use of a safe surgery checklist; and (iii) a measure relating to hospital outpatient department volume for selected surgical procedures.
A reduction in the number of randomly selected hospitals (from 800 to 450) for validating hospital outpatient quality reporting data for the CY 2013 payment determination.
Revisions to the hospital value-based purchasing program.
A process for physician-owned hospitals to apply for an exception to the federal prohibition on expanding facility capacity in physician-owned hospitals.

You may review a display copy of the Final Rule here or CMS’ summary here.

September 15, 2011

WellPoint and IBM Partner to Use Watson Technology in Health Care

Filed under: Medicare/Medicaid Compliance — Scott Thill @ 8:45 am

WellPoint and IBM have partnered to develop applications using IBM’s Watson technology to assist physicians in diagnosing and treating patients. Watson is the computer system that won $1 million on Jeopardy in February 2011. In its new role, Watson technology will help achieve an evidence-based approach to medicine. Watson-based technology could process information on a patient and a database of medical knowledge to produce diagnoses and treatments options for a specific patient. WellPoint plans to initiate a pilot program for the technology in 2012.

You may access WellPoint’s press release here or learn more about Watson here.

August 31, 2011

CMS Announces its Bundled Payments Initiative

Filed under: Billing and Payment, Hospital and Physician Relationships — Scott Thill @ 2:35 pm

CMS Announces its Bundled Payments Initiative

CMS has announced its bundled payments initiative aimed at improving health and quality, while lowering health care costs. The initiative is based on the idea that bundling payments across a single episode of care will encourage doctors, hospitals and other providers to work to together to coordinate both pre- and post-discharge care. Under the bundled payments initiative, CMS is testing and developing four bundling models. As described further below, CMS is imposing deadlines for submitting a letter of intent and application.

Bundling Models

Three of the bundling models involve retrospective payment bundling, while the fourth bundling model involves prospective bundling. A summary of the four models follows:

Model 1 (retrospective): An episode of care would be the inpatient stay in the general acute care hospital. Medicare would pay the hospital and physicians separately. Medicare would pay hospitals under the Inpatient Prospective Payment System, but at a negotiated discount, and physicians under the Physician Fee Schedule. The hospital and physicians could share in any savings resulting from better care coordination.

Model 2 (retrospective): An episode of care would include the inpatient stay and post-acute care for a minimum of 30 days or 90 days after discharge. Providers would propose clinical conditions to target based on MS-DRGs. CMS and providers would identify a target payment amount for an episode of care, bundling hospital services, physician services, post-acute care, related admissions and other proposed services (e.g. clinical laboratory services). Participants would receive separate payment for their services at the usual rates. Medicare would compare the amount of total payments to the target price and pay the participants any “savings” (the difference between total payments and the target price) to share among themselves.

Model 3 (retrospective): An episode of care would begin at discharge from the inpatient stay and continue for a minimum of 30 days after discharge. Like Model 2, providers would propose clinical conditions, receive separate payments and share in any savings.

Model 4 (prospective): An episode of care would be the inpatient stay at the general acute care hospital. Providers would propose clinical conditions to target based on MS-DRGs. The hospital would receive a single, pre-determined bundled payment covering all services furnished during the inpatient stay, including physician/practitioner services. Physicians/practitioners would submit no-pay claims to Medicare and receive payment directly from the hospital.

Letter of Intent/Application Deadline

Applicants may participate in more than one of the four models. CMS has established the following deadlines for applicants to submit a LOI and application.

Model 1: The LOI is due by September 22, 2011. The application is due by October 21, 2011.

Models 2-4: The LOI is due by November 4, 2011. The application is due by March 15, 2012.

You may access more information and the application by clicking here.

June 14, 2011

Comments to CMS’ 2011 IPPS Proposed Rule are due by June 20th

Filed under: Billing and Payment, Medicare/Medicaid Compliance — Scott Thill @ 11:30 am

Just a reminder, comments to CMS’ 2011 Inpatient Prospective Payment System Proposed Rule are due by June 20, 2011. Several notable provisions in the Proposed Rule include:

Policies for several hospital quality initiatives, including policies related to the Hospital Readmissions Reduction Program and the Hospital Value-Based Purchasing Program.
The addition of contrast-induced acute kidney injury as a hospital acquired condition.
The removal of excisional debridement cases from the current MS-DRG and assignment of them to three new MS-DRGs that would provide more accurate, but lower, payment.
The creation of two new MS-DRGS for autologous bone marrow transplants. One MS-DRG would apply to such transplants with complications or comorbidities, while another MS-DRG would apply to such transplants without any complication or comorbidity.
Revisions to the rules for determining pension costs for Medicare cost-finding and wage index purposes.
Clarification that Medicare’s 3-day/1-day payment window policy applies to both preadmission diagnostic and non-diagnostic services furnished at a physician practice wholly owned or wholly operated by the admitting hospital.
The exclusion of patient days and bed days for inpatient hospice services from the Medicare disproportionate share adjustment and indirect medical education adjustment.
Clarification of CMS’ “under arrangements” requirements.

You may access the Proposed Rule here.

A summary of the Proposed Rule is available from CMS here.

May 18, 2011

The OIG Has Provided Compliance Training Materials Online

Filed under: Fraud and Abuse, Hospital and Physician Relationships, Medicare/Medicaid Compliance — Scott Thill @ 8:59 am

The Office of Inspector General has provided compliance training materials online at: http://compliance.oig.hhs.gov/webcast.html. The OIG intends to post a video of a webcast relating to the compliance training online by the end of the month.

April 6, 2011

CMS/OIG, FTC/DOJ and IRS Weigh In on ACOs

Filed under: Legislation Watch — David Edquist, Lisa Gingerich, John Hintz, Jeff Mark and Scott Thill @ 12:04 pm

“The Administration has led an unprecedented, collaborative effort among all of the agencies responsible for developing guidance for ACOs,” said FTC Chairman Jon Leibowitz. “This guidance will help ensure that ACOs meet their goals of improving quality and lowering costs while minimizing the regulatory burden on healthcare providers.”

As the Chairman notes, the agencies responsible for development and oversight of Accountable Care Organizations (“ACOs”) issued on March 31, 2011 guidance regarding qualification and implementation of Medicare Shared Savings Programs. This Update provides summaries of the proposed rules offered by the Centers for Medicare & Medicaid Services (“CMS”)/Department of Health and Human Services Office of Inspector General (“OIG”) and Federal Trade Commission (“FTC”)/Antitrust Division of the Department of Justice (“DOJ”) and the notice issued by the Internal Revenue Service (“IRS”) all of which address ACOs. The agencies will accept public comments until May 31, 2011.

CMS’ Proposed Rules for ACOs: A Summary

Filed under: Legislation Watch — David Edquist, Jeff Mark, John Hintz, Lisa Gingerich, Scott Thill and Meghan O'Connor @ 11:03 am

On March 31st the Centers for Medicare and Medicaid Services (“CMS”) released its proposed rule to establish the Medicare Shared Savings Program (the “Shared Savings Program”). The rule will be published in the Federal Register in the next few days. CMS will accept comments on the proposed rule for a period of 60 days after publication in the Federal Register, and will respond to comments in a final rule to be issued later this year. At the heart of the Shared Savings Program is the development of Accountable Care Organizations (“ACOs”) to bring together providers and suppliers in an effort to coordinate care for Medicare fee-for-service (“FFS”) beneficiaries. To participate in the Shared Savings Program, ACOs must submit an application, and if approved, enter into a three year agreement with CMS to be accountable for the quality, cost and overall care of at least 5,000 traditional FFS Medicare beneficiaries who may be assigned to it. The Shared Savings Program will begin operating on January 1, 2012.

Proposed Rule Key Concepts and Issues

• Proposed regulations will be published in the Federal Register on April 7.

• Participation requires 3 year agreement with early termination forfeiture.

• Proportionate representation and 75% control of governance required for ACO participants which may include hospitals, physicians and other providers.

• Involvement of Medicare beneficiaries and community stakeholders required.

• Detailed and potentially onerous application, operation and reporting requirements.

• Retrospective and prospective assignment of beneficiaries based on primary care physician.

• Beneficiaries may opt out of data sharing, but quality of services and coordination of care may not decline.

• Two track shared savings model to encourage early participation in program.

• Comments to proposed rule due by Monday, June 6.

January 4, 2011

The Department of Justice Announces Settlements Totaling in the Millions

Filed under: Billing and Payment, Fraud and Abuse, Hospital and Physician Relationships, Medicare/Medicaid Compliance — Scott Thill @ 2:56 pm

In the last week, the Department of Justice (DOJ) announced a number of settlements relating to health care, totaling in the millions of dollars. The settlements included allegations under the False Claims Act, among other laws, and are described below.

Detroit Medical Center

The DOJ announced last week that Detroit Medical Center agreed to pay $30 million to settle allegations that it violated the False Claims Act, the Anti-kickback Statute and the federal self-referral law (Stark). The allegations involved improper relationships between Detroit Medical Center and referring physicians, including office lease agreements and independent contractor relationships that were inconsistent with fair market value or not in writing. The relationships were self-disclosed by Detroit Medical Center after it discovered the relationships while preparing for a sale of its facilities.

Kyphoplasty

The DOJ announced today that seven additional hospitals have agreed to pay a total of more than $6.3 million to settle allegations relating to the False Claims Act and kyphoplasty. The settlements relate to allegations that the hospitals overcharged Medicare when performing kyphoplasty (a procedure used to treat certain spinal fractures). The government alleged that the hospitals inappropriately classified the procedures as inpatient, rather than outpatient. According to the DOJ, the procedure can often be performed safely as a less-expensive outpatient procedure.

The seven hospitals are located in Florida, Mississippi, Texas, South Carolina, North Carolina and Alabama. The government had already reached settlements with 18 other hospitals and with Medtronic Spine LLC (a corporate successor to Kyphon Inc.) relating to kyphoplasty. Two employees of Kyphon named the settling hospitals as defendants in a qui tam suit under the False Claims Act.

November 16, 2010

CMS Releases its CY 2011 OPPS/ASC Final Rule

Filed under: Billing and Payment, Fraud and Abuse, Hospital and Physician Relationships, Medicare/Medicaid Compliance — Scott Thill @ 11:20 pm

CMS has released its CY 2011 final rules for hospital outpatient and ambulatory surgery center payment (the “Final Rule”). As described by CMS, notable provisions of the Final Rule relate to:

CMS’s application of a 2.35% update to the OPPS for CY 2011.

CMS’s application of a 0.2% update to the ASC payment system for CY 2011.

Waiver of the Part B deductible and coinsurance for certain preventive services paid under the hospital outpatient prospective payment system (including the initial preventive physical examination) and certain preventive services paid under the ambulatory surgery center payment system.

CMS’s decision not to finalize a payment adjustment for cancer hospitals for 2011. The health care reform legislation (PPACA) requires CMS to make a budget neutral payment adjustment if outpatient costs incurred by certain cancer hospitals exceed the outpatient costs incurred by other OPPS hospitals.

Additional quality measures for hospital outpatient departments to report. CMS is adding four quality measures (including a health information technology measure and three imaging efficiency measures) for the CY 2010 payment determination and eight new measures for the CY 2013 payment determination. Six of the new measures for the CY 2013 payment determination relate to the emergency department.

CMS’s efforts to validate whether hospitals accurately report quality measures using chart-abstracted data. CMS will validate data from 800 randomly selected hospitals for the 2012 payment determination.

Revisions to CMS’s supervision requirements for outpatient therapeutic services.

The addition of six surgical procedures to the list of procedures that Medicare will cover in an ASC.

A prohibition on the use of Stark’s “rural provider” and “whole hospital” exception by new physician-owned hospitals and limiting the ability of existing physician-owned hospitals to expand their capacity.

Implementation of the direct and indirect graduate medical education provisions of PPACA. CMS must reallocate unused residency slots to certain hospitals with qualified residency programs. CMS also must reallocate residency slots from hospitals that will close down to other teaching hospitals. The new regulatory provisions also relate to how hospitals should count hours a resident spends in training and research activities and in patient care activities in a non-provider setting (e.g. in a physician’s office).

You can review the entire Final Rule here or CMS’s summary here.

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