By: Michelle Duncan

 

DMEPOS providers and suppliers may soon be required to pass stringent compliance reviews, disclose information about their business in a national database and make details about their relationships with physicians public. That is, if a proposed healthcare reform policy released by Senate Finance Committee Chairman Max Baucus (D-Mont.) and Ranking Member Charles Grassley (R-Iowa) becomes law.

 

Entitled Transforming the Health Care Delivery System: Proposals to Improve Patient Care and Reduce Health Care Costs, the policy is “the first of three sets of potential option papers” that will be discussed and debated by Finance Members as they work to create a comprehensive proposal for healthcare reform, according to a Committee on Finance press release, issued April 28, 2009.

 

Note: Throughout this article, page numbers have been included to cite the location of quotes within the proposed healthcare reform policy. A full copy of the 48-page policy may be downloaded here.

 

Public comment on any of the policy’s suggested reform options may be directed to: Health_Reform@finance-dem.senate.gov. The deadline for comments is May 15, 2009.

 

Guilty until Proven Innocent

Among the reform options in senators Baucus and Grassley’s healthcare policy, is a proposal to grant the Secretary of Health and Human Services (HHS) the power to utilize various screening techniques – including criminal background checks and even requiring fingerprint submissions – to evaluate an enrolling Medicare provider’s risk of noncompliance.

 

As part of the evaluation, all prospective providers would be required to disclose to the Secretary any “previous affiliations with enrolled entities that have uncollected Medicare or Medicaid debt,” potential grounds for the Secretary to deny their enrollment applications (p. 42).

 

Furthermore, the proposed reform option grants the Secretary the ability “to require surety bonds of up to $500,000 (commensurate with the size of the business) and to impose moratoria on the enrollment of new providers as determined to be necessary to prevent or combat fraud” (p. 43).

 

Upon passing their evaluations, new providers and suppliers would be required to go through a “provisional participation” period of 6-to-12 months. During this time, some providers may be subject to “enhanced oversight, such as prepayment review[s] and payment limitations” (42.)

 

The two senators propose covering the costs of screenings by charging Medicare enrollment application fees. Monetary penalties would also be imposed on those omitting or providing false information on their applications.

 

One PI: Big Brother is Watching

If you have any skeletons in your DME closet, they may soon be available for all of Big Brother to see.

 

The implementation of a new “One PI” healthcare database is another reform option proposed in senators Max Baucus (D-Mont.) and Charles Grassley’s (R-Iowa) policy.

 

The new database would potentially consolidate multiple healthcare databanks, including the HHS Office of the Inspector General’s (OIG) Healthcare Integrity and Protection Data Bank (HIPDB), into one comprehensive data source, One PI.

 

The current HIPDB contains information on providers such as:

• Civil Judgments
• Federal or State Criminal Convictions
• Actions Taken by Federal or State Licensing Agencies
• Exclusions from Medicare and Medicaid 

According to the proposal, the One PI database would combine the HIPDB with other provider databanks into a national “sanctions data system,” able to be accessed by “state licensure boards and federal and state law enforcement agencies” (p. 44).

 

Along with the above information, One PI would also contain the following about each Medicare provider: 

• Provider Ownership
• Provider Business Relationships
• History of Adverse Actions
• Results of Site Visits and Other Monitoring
• Fraud Settlement Data

One of the ideas behind developing One PI is to give agencies such as the OIG and Department of Justice (DOJ) the ability to investigate potential fraud and abuse via a centralized data source. If voted into law, Medicare applicants would need to be verified in the One PI database, “prior to [receiving] provider/suppler numbers” (p. 44).

 

Physician Relationships Exposed

The creation of a new policy aimed at making physician relationships transparent is also among the reforms proposed in the healthcare policy draft.

 

Under the subheading “Physician Payment Sunshine,” senators Baucus and Grassley propose amending “part A (General Provisions) of title XI of the Social Security Act” to require manufacturers of a covered drug, device, biological, or medical supply, to make public any relationships in which they provide “payments and other transfers of value” to a physician (p. 26).

 

The proposed policy would require those manufacturers to report the following information electronically to the Secretary of HHS on an annual basis beginning March 31, 2012, and on the 90^th day of each year thereafter: 

• The name and address of all physicians paid
• Amount/value of each payment
• Dates of payment
• A description of the form of payment
• The reason for payment (i.e. marketing, education, research)
• The name of any covered drugs, devices, biological or medical supplies related to the reason for payment
• National Provider Identifier
• The name of any entities or individual the payment was transferred to at the physician’s request 

Some payments and transfers would be excluded from the reporting requirement. Those transfers not required to be reported to the Secretary include: 

• Payments or transfers of $10 or less
• Samples intended for patient use
• Patient educational materials
• Short-term loan of a covered device
• Discounts and rebates
• In-kind items used for charity care
• Profit distributions from publicly traded companies 

Under the newly proposed policy, the above listed manufacturers would also be required to provide the Secretary with electronic, annual reports of “any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member)” (p. 26).

 

Beginning September 30, 2012, electronic reports submitted to the Secretary would be compiled and made available via “an Internet website” (p. 26). In addition to compensation information, the website would include the following: 

• Enforcement actions during the preceding year
• Background information on physician-industry relationships
• A separate listing of payments related to clinical research 

To ensure payments are reported, Baucus and Grassley suggest imposing a civil monetary penalty (CMP) of $1,000 to $10,000 for each unreported payment, with a maximum total annual CMP of $150,000. For those who “knowingly fail to submit information,” an increased CMP of $10,000 to $100,000 per purposely withheld payment would apply. In this case, the maximum total annual CMP would be $1,000,000 (p. 26).