Value Based Purchasing and Health Care Reform

CRS Report: Accountable Care Organizations and the Medicare Shared Savings Program

For additional information, see the Congressional Research Services (CRS) report at the link below:

Accountable Care Organizations and the Medicare Shared Savings Program (David Newman) (11/4/2010)

 

American Medical Association Submits ACO Comments to CMS in Response to Request for Information

For additional information, see the following:

AMA says physicians should lead ACO development (Health Care Finance) (12/3/2010)

AMA to CMS: Physician-Led New Models of Care Benefit Patients and Health System (AMA News Release) (12/2/2010)

See the AMA Letter to CMS (12/2/2010)

Additional Medicare, Medicaid and CHIP Screening Requirements Published in Federal Register

As mentioned in the September 21st post below, the CMS proposed rule relating to additional screening requirements for provider and supplier enrollment in Medicare, Medicaid and CHIP was published in the Federal Register today, September 23rd.  Click on the link below to view the proposed rule: 

Medicare, Medicaid, and Children's Health Insurance Programs; Additional Screening Requirements, Application Fees, Temporary Enrollment Moratoria, Payment Suspensions and Compliance Plans for Providers and Suppliers; Proposed Rule (75 FR 58203).

CMS Proposes New Program Enrollment Requirements

Yesterday, the Centers for Medicare & Medicaid Services (CMS) released a Proposed Rule that would, among other things, “implement provisions of the Patient Protection and Affordable Care Act (the “Affordable Care Act”) that “establish procedures under which screening is conducted for providers of medical or other services and suppliers in the Medicare program, providers in the Medicaid program, and providers in the Children’s Health Insurance Program (CHIP).”  As stated in the Proposed Rule, the Affordable Care Act makes a number of changes to these programs that "enhance the provider and supplier enrollment process to improve the integrity of the programs to reduce fraud, waste, and abuse.”  The Proposed Rule proposes the use of additional screening tools, including unannounced site visits, fingerprinting, and criminal background checks, depending on the "risk level" assigned to a provider or supplier seeking enrollment.  The Proposed Rule (link below) is scheduled to be published in the Federal Register on Thursday (September 23^rd) and comments in response to the Proposed Rule are due by November 16th.

The enhanced enrollment and screening requirements in the Proposed Rule demonstrate the government's commitment to ensuring the integrity of federal health programs and increasing enforcement efforts.  The Proposed Rule reflects the testimony by Daniel Levinson (Inspector General of the U.S. Department of Health and Human Services) before the House Committee on Energy and Commerce (September 15th), which focused on the government’s efforts to combat health care fraud, waste, and abuse in regard to durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS), as well as the recent testimony of the U.S. Government Accountability Office before the House Committee on Ways and Means (June 15, 2010) recommending stricter enrollment processes and standards. 

Download the Proposed Rule

Agencies Set September 27th Deadline for ACO Questions or Comments

As mentioned in the September 17^th post below, the FTC, CMS and OIG (the “Agencies”) published a notice (the “Notice”) in the Federal Register announcing a public workshop regarding Accountable Care Organizations (ACOs) to be held on October 5th at the CMS Headquarters.  In addition to setting forth the workshop format and discussion topics, the Notice solicits comments concerning the types of contractual and financial relationships under various ACO business models that might trigger or implicate the antitrust laws, the physician self-referral prohibition (the "Stark Law") and/or the anti-kickback statute, as well as payment arrangements that might implicate the civil monetary penalties law.

Further, the Notice requests comments relating to how current Stark Law exceptions and anti-kickback statute safe harbors might be inadequate to address the types of financial arrangements that will be created by ACOs and ways existing exceptions and safe harbors might be tailored to further address integration.  The Notice also solicits recommendations for how a "new meaningful exception and safe harbor for incentive payments related to the newly created ACOs could be crafted."

Citing a May 2010 Policy Brief entitled, "Implementing Accountable Care Organizations," the Notice recognizes the complexity associated with integrating health care delivery among independent providers.  The Notice states that because of the "substantial commitment of health care providers' resources and time," providers may be "more likely to integrate their care delivery Medicare and Medicaid beneficiaries if they also use the same delivery system for patients covered by health care insurance in the private market.  The potential for ACOs to operate in both public and private markets further supports the need to explore the application to ACOs of these laws and regulations, as well as the Agencies' enforcement responsibilities."

There are a substantial number of potential ACO models under development at present.  The opportunity to submit questions prior to the issuance of draft regulations for ACOs may be the best time to influence the direction that the regulations will take. 

The Notice sets out certain requirements for written comments.  Written comments or statements should not include any sensitive personal information, such as an individual’s Social Security number; date of birth; driver’s license number or other State identification number or foreign country equivalent; passport number; financial account number; or credit or debit card number.  Comments also should not include any sensitive health information, such as medical records and other individually identifiable health information.  Written comments or statements will be accepted and considered for discussion at the workshop if they are received by the September 27^th deadline.

I will be attending the workshop in person.  If you would like to provide me with a copy of your comments to the Agencies in advance of the workshop or if you are interested in additional information regarding any specific topics relating to the workshop, please feel free to contact me at the email address below.  I can assume no responsibility for assisting in the advancement your comments, but it would be helpful for my preparation for the meeting and future posts regarding the workshop.  You may send comments to me by email at VBPBlog@gmail.com.

Health Policy Brief: Accountable Care Organizations

Beginning in 2009, Health Affairs and the Robert Wood Johnson Foundation (RWJF) have published multiple Policy Briefs discussing health reform topics relating to the Medicare program, elements of the proposed health reform bills, and the new health reform law.  Each Policy Brief provides a concise discussion of the background and various perspectives regarding the respective topic.  

Accountable Care Organizations (ACOs) are the focus of the July 27, 2010 Policy Brief.  Health Affairs and RWJF provide a 5-page overview of the health reform law establishing ACOs and the "challenges and opportunities facing health systems, physicians, administrators, insurers, patients, and policy makers as ACOs take shape."  The Brief also highlights various items to watch for as the program evolves, including addressing potential legal hurdles, private insurer recognition of ACOs, and encouraging widespread provider participation in the ACO program.

For additional information:

See the ACO Health Policy Brief (Health Affairs/Robert Wood Johnson Foundation) (7/27/2010)

See other articles included in the Health Affairs/Robert Wood Johnson Foundation Health Policy Brief Series.

Commonwealth Fund Releases ACO Survey Results

Last month, the Commonwealth Fund released a Data Brief entitled, "Health Care Opinion Leaders' Views on Delivery System Innovation and Improvement".  The 10-page brief provides a glimpse into some of the primary considerations, according to health care and health policy experts, in regard to the development of a shared saving program through accountable care systems or organizations (ACOs). 

The survey highlights experts' opinions on barriers and strategies for the implementation of delivery innovation provisions in the Patient Protection and Affordable Care Act.  The survey results reflect responses related to organizational considerations and the potential effectiveness of ACOs, as well as priorities in "facilitating delivery system innovation and improvement in the coming years."  Survey respondents highlight various aspects of implementing the program that will need to be addressed in future rule-making, such as:

• the need for financial incentives or special payment arrangements to encourage participation in accountable care systems;
• the development of proper ACO performance metrics;
• establishment of the Innovation Center within the Centers for Medicare & Medicaid Services (CMS);
• quality and cost reporting and transparency; and
• eligibility and regulation of ACOs.

According to a recent CMS Open Door Forum, proposed regulations relating to ACOs and the shared savings program may be published as early as this fall.

President Obama Appoints Berwick CMS Administrator

On Wednesday (July 7), President Obama appointed Dr. Donald M. Berwick to oversee the Centers for Medicare & Medicaid Services (CMS), which has been without a permanent administrator since October 2006.  The appointment during a congressional recess allows Dr. Berwick to serve through 2011 without Senate confirmation.  For more information, see the articles below:

Obama to Bypass Senate to Name Health Official - New York Times (7/6)

Obama Bypasses Senate by Appointing Medicare Chief - The Washington Post (7/7)

Healthcare Leaders Applaud Berwick's Quality, Fiscal Approach - Healthcarefinancenews.com (7/8)

President Obama Signs Medicare Payment Fix

Today, President Obama signed into law The Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010.  The legislation delays the 21 percent cut in physician Medicare payments until November 30, 2010.

See the New York Times article.

See the text of The Preservation of Access to Care for Medicare Beneficiaries and Pension Relief Act of 2010.

Affordable Care Act Adds Disclosure Requirement to Stark Law Exception

    On March 23, 2010, President Obama signed the Patient Protection and Affordable Care Act (“PPACA”) into law.  One regulatory change included in PPACA is the addition of certain disclosure requirements to the in-office ancillary services (“IOAS”) exception to the federal physician self-referral law, commonly known as the Stark Law.

  

 

    Briefly, the Stark Law prohibits a physician from making referrals for designated health services (“DHS”) payable by Medicare or Medicaid to an entity with which the physician (or an immediate family member) has a financial relationship, unless an exception applies.  The Stark Law also prohibits the DHS entity from filing a claim for those referred services unless an exception applies.  The Stark Law is a strict liability statute and each element of an exemption must be satisfied.  In general terms, the IOAS exception mandates: (1) who can provide the DHS; (2) where the DHS can be provided; and (3) who can bill for the DHS.  As a result of PPACA, physicians must also meet certain disclosure requirements to meet the requirements of the IOAS exception.

  

    Section 6003 of the PPACA amends the IOAS exception by adding the requirement that referring physicians provide notice to their Medicare patients in writing, at the time of a referral for magnetic resonance imaging (MRI), positron emission tomography (PET), and computed tomography (CT) (and other imaging services that the Secretary of Health and Human Services determines appropriate): (1) that the patient may obtain such services from a provider other than the referring physician or a member of the referring physician’s group practice; and (2) provide the patient with a list of other providers who furnish the service in the area where the patient resides.  Under Section 6003, the disclosure requirements apply to MRI, PET, and CT services furnished on or after January 1, 2010.