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31 posts from February 2012

February 29, 2012

Physician Payment Sunshine: Over 100 Organizations ask CMS to Scrap the Current Dispute Resolution Process

Scrap the current system
As we have noted over the past few weeks, many health care groups and organizations have been submitting comments on the proposed regulations that would implement Section 6002 of the Patient Protection and Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act. 

As reported by, almost 100 groups last week submitted comments expressing their concern about the proposed regulations and the impact they will have on practicing physicians.  These groups, including the American Medical Association (AMA) and the Society for Vascular Surgery pushed back against the current format of the Sunshine Act, “warning that the rule doesn't do enough to protect the reputations of physicians in case of a dispute.”   

These groups urged the Centers for Medicare and Medicaid (CMS) to make changes to the provision, which requires drug and device manufacturers to begin reporting gifts or payments worth more than $10. The reporting will begin at a time determined once CMS publishes the final rule.  The result, a searchable database containing the names and addresses of each recipient and the details of the payments, will be made publicly available sometime in 2013.


The act also mandates stiff penalties for companies that fail to comply. Companies found to inadvertently omit reports could ring up civil fines of between $1,000 and $10,000 "for each payment or other transfer of value or ownership or investment interest not reported," according to the act.  Companies found to knowingly skirt the reporting rules could be slapped with fines of $10,000 to $100,000.  The total amount of fines can't exceed $1 million, or 0.1 percent of total annual revenues, in a single year. 

While AMA and other health groups supported the intention of the act, “they warned that physicians need better safeguards and pathways to challenge payments.”  The proposed rule excludes CMS from involvement in any disputes between manufacturers and physicians, a hands-off approach that has industry groups worried.  Instead, CMS noted that it would basically put an asterisk (*) next to a doctors name for the specific payment, indicating that the physician or teaching hospital had challenged the payment.  Not many other details were provided or proposals indicating a formal or administrative grievance process to challenge such mistakes. 


"False, misleading, and inaccurate information could be publicly posted on a government website while denying physicians basic due process rights to challenge such information," according to the letter, signed by groups including the American College of Cardiology, the American Assn. of Orthopedic Surgeons and the Society of Thoracic Surgeons. 

The groups urged rule-makers to establish an independent arbiter to mediate disagreements and provide physicians with an avenue to dispute entries in the public database with a written response in the interest of protecting a physician's good name.


"A few disputes between a manufacturer and a handful of physicians are unlikely to ruin a manufacturer/GPO's standing or even subject the manufacturer/GPO to civil money penalties," the groups wrote. "In contrast, physicians may have their careers and professional reputations damaged as a result of one disputed report, and physicians may incur significant expenses to resolve a dispute with a manufacturer/GPO." 

"We strongly urge CMS to re-structure the process the agency has outlined," the health groups wrote. "The proposed rule opens the door to the real possibility that a large number of physicians could become the victims of false, inaccurate, or misleading reporting and suffer significant damages including investigation by government and private entities, potential disciplinary actions, public censure, ridicule, and destruction of professional reputation and livelihood."


The full list of co-signers of the letter includes: 

American Medical Assn.
Aerospace Medical Assn.
American Academy of Dermatology Assn.
American Academy of Family Physicians
American Academy of Neurology
American Academy of Ophthalmology
American Academy of Physical Medicine and Rehabilitation
American Assn. of Clinical Endocrinologists
American Assn. of Clinical Urologists
American Assn. of Neurological Surgeons
American Assn. of Neuromuscular and Electrodiagnostic Medicine
American Assn. of Orthopaedic Surgeons
American College of Cardiology
American College of Chest Physicians
American College of Emergency Physicians
American College of Mohs Surgery
American College of Osteopathic Family Physicians
American College of Osteopathic
American College of Osteopathic Surgeons
American College of Phlebology
American College Radiology
American College of Surgeons
American Congress of Obstetricians and Gynecologists
American Gastroenterological Assn.
American Medical Group Assn.
American Osteopathic Academy of Orthopedics
American Osteopathic Assn.
American Society for Clinical Pathology
American Society for Gastrointestinal Endoscopy
American Society for Pediatric Nephrology
American Society for Radiation Oncology
American Society of Cataract and Refractive Surgery
American Society of Echocardiography
American Society of Hematology
American Society of Nuclear Cardiology
American Society of Plastic Surgeons
American Thoracic Society
American Urogynecologic Society
American Urological Assn.
College of American Pathologists
Congress of Neurological Surgeons
Heart Rhythm Society
Joint Council of Allergy, Asthma and Immunology
Medical Group Management Assn.
Renal Physicians Assn.
Society for Cardiovascular Angiography and Interventions
Society for Vascular Surgery
Society of Gynecologic Oncology
The Endocrine Society
The Society of Thoracic Surgeons
Medical Assn. of the State of Alabama
Alaska State Medical Assn.
Arkansas Medical Society
California Medical Assn.
Connecticut State Medical Society
Medical Society of Delaware
Medical Society of the District of Columbia
Florida Medical Assn. Inc
Hawaii Medical Assn.
Idaho Medical Assn.
Illinois State Medical Society
Iowa Medical Society
Kansas Medical Society
Kentucky Medical Assn.
Louisiana State Medical Society
Maine Medical Assn.
MedChi, The Maryland State Medical Society
Massachusetts Medical Society
Michigan State Medical Society
Minnesota Medical Assn.
Mississippi State Medical Assn.
Missouri State Medical Assn.

Montana Medical Assn.
Nebraska Medical Assn.
Nevada State Medical Assn.
New Hampshire Medical Society
Medical Society of New Jersey
New Mexico Medical Society
Medical Society of the State of New York
North Carolina Medical Society
North Dakota Medical Assn.
Ohio State Medical Assn.
Oregon Medical Assn.
Pennsylvania Medical Society
Rhode Island Medical Society
South Dakota State Medical Assn.
Tennessee Medical Assn.
Texas Medical Assn.
Utah Medical Assn.
Vermont Medical Society
Medical Society of Virginia
West Virginia State Medical Assn.
Wyoming Medical Society

Physician Payment Sunshine: Association of Clinical Researchers and Educators asks CMS to Reevaluate the Proposed Regulations

CMS Sunshine
The Association of Clinical Researchers and Educators (ACRE), recently submitted its comments regarding Section 6002 of the Patient Protection Affordable Care Act (PPACA)—also known as the Physician Payment Sunshine Act.   

ACRE, founded in 2009, is a non-profit organization of medical professionals who recognize that physician-industry collaborations and relationships benefit patients and advance science.  ACRE provides a forum for physicians and industry partners to further such collaborations, and to advocate on behalf of better patient care. ACRE is lead by a steering committee of physicians from major medical institutions.  

ACRE members include active practitioners of diverse medical specialties and subspecialties, medical society leaders and distinguished educators and researchers at academic centers and others in industry, who are engaged in promoting excellence in medical service, education, and innovation with substantive records of accomplishment in these endeavors. 

Comments on Sunshine 

ACRE requested that CMS consider the manifest benefits Americans have received from physician-industry collaboration and the threats the proposed regulations pose for these relationships.  They urged CMS more vividly to envision the important and necessary collaboration that physician, academia and industry must have in order to produce new life saving medicines and the chilling effects of this Act on collaboration. 

ACRE asked that CMS reevaluate the proposed regulations, particularly in light of the significant disproportion between their manifest costs and their uncertain, remote and speculative benefits. 

They noted how the “Regulatory compliance will consume resources that would be better directed to enhancing the value of care physicians provide to patients through development of better medicines and devices.”  It is ACRE’s view “that these regulations will impose undue regulatory burdens on medical products companies, discourage research, severely discourage scientific progress, and deny patients of benefit from the innovations that would be slowed down or eliminated as a result of the increased scrutiny and focus on administration over reaseach.” 

ACRE noted that, “The intimidating and burdensome consequences of implementing the Sunshine Act will be detrimental to the speed of the process and in many instances may curtail it entirely. Furthermore, the evidence that there is harm in these collaborations is nil to nonexistent, while the benefits are large and easily demonstrable.” 

They explained how, “Very few people and especially patients come even close to having the experience or training to comprehend the minute and complex information that will accumulate under the Sunshine regulations.” 

Accordingly, ACRE’s concern “is that companies and physicians will spend countless hours ensuring the accuracy of information that has not been shown to have any benefit to patients. Literally billions will be spend to Sunshine compliance that will never be utilized by patients. The likelihood is just like the computer software, the vast majority of American’s will simply ignore the information even if presented at their point of care as no one really cares.” 

The maintained that, “the most destructive aspect of Sunshine is its flawed premise that every payment presents a conflict of interest. The fact is that payment information can serve either good or bad purposes.” 

The “good” outcome “sunshine” advocates claim is that “transparency” will rein in medical care costs based on the absolutely unproven and arguably false premise that industry payments to physicians drive overprescribing of unnecessary and overly expensive brand products.  ACRE noted how products constitute less than 10% of health care spending and practitioners prescribe generics over 75% of the time.”  In addition, third party payers routinely limit payment and reimbursement to those medical products which have demonstrated both safety and efficacy in the diseases for which they are prescribed. More importantly, “innovative medical products, acquired through paid collaborations between physicians and industry, help prolong life and improve life quality, considerations as or more important than costs.” 

ACRE also recognized how “Payment data of the kind that will be published under the Sunshine Act has already been published for several years under various corporate integrity agreements that manufacturers have negotiated with the Office of the Inspector General (OIG) for the Department of Health and Human Services (HHS). However, ACRE said it was “not aware of any study showing that patients have benefited in any way, nor have savings in health care costs been achieved.” 

For example, they noted how payment data have been published in Massachusetts for two years now however, “There has been no research or evidence indicating that patients have benefited from the publication of such payments or the State has reduced its medical costs or improved health outcomes.”  More to the point – there have been negative effects of these regulations as relates to innovation and physician education – see Wolf DW

ACRE maintained that, “How these data are to be taken in the context of analyzing scientific research is unknown and merely will serve the interests of fascinated individuals (certainly not patients or researchers). Without context, these data cannot be interpreted; intentionality, influence, alleged corruption and causality cannot be defined by the data alone.” 

ACRE also expressed its concern, “that the tremendous burden of additional work that manufacturers, physicians, and teaching hospitals will have to do, and the amount of money and time they will have to allocate to compliance is an immense diversion of already limited and diminishing resources better spent on innovation and education. Money spent on implementing Sunshine regulations will not improve patient or clinical outcomes or reduce health care system costs, and will unnecessarily divert resources away from more productive activities.” 

They noted further how “the publication of such payments without any context will discourage physicians from productive collaborations with industry. This will only further accelerate clinical research leaving the U.S.” 

ACRE also provided specific comments, echoing many of the same concerns that other organizations have expressed, with regard to exempting third parties and accredited CME providers from reporting; providing adequate context on the public website; etc. 

Ultimately, ACRE noted that, “The academic and scientific return on investment for sunshine is negative. The evidence of risk or harm is nil but the bureaucratic consequences of implementation will lead to diversion of increasingly limited resources for these new reporting requirements.”  They concluded by noting that, “Americans need jobs today, and current clinicians and researchers need to maintain the relationships they have with industry to ensure that new scientific advances and technological breakthroughs continue.”

February 28, 2012

CMS: Electronic Medical Records Meaningful Use Round 2

Health and Human Services (HHS) Secretary Kathleen Sebelius announced the next steps for providers who are using electronic health record (EHR) technology and receiving incentive payments from Medicare and Medicaid.  These proposed rules, from the Centers for Medicaid & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC), will govern stage 2 of the Medicare and Medicaid Electronic Health Record Incentive Programs.

“We know that broader adoption of electronic health records can save our health care system money, save time for doctors and hospitals, and save lives,” said Secretary Sebelius.  “We have seen great success and momentum as we’ve taken the first steps toward adoption of this critical technology.  As we move into the next stage, we are encouraging even more providers to participate and support more coordinated, patient-centered care.”

Under the Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009, eligible health care professionals and hospitals can qualify for Medicare and Medicaid incentive payments when they adopt certified EHR technology and use it in a meaningful way. What is considered “meaningful use” is evolving in three stages:

  • Stage 1 (which began in 2011 and remains the starting point for all providers): “meaningful use” consists of transferring data to EHRs and being able to share information, including electronic copies and visit summaries for patients.
  • Stage 2 (to be implemented in 2014 under the proposed rule): “meaningful use” includes new standards such as online access for patients to their health information, and electronic health information exchange between providers.
  • Stage 3 (expected to be implemented in 2016): “meaningful use” includes demonstrating that the quality of health care has been improved.

CMS’ proposed rule (455 pages) specifies the stage 2 criteria that eligible providers must meet in order to qualify for Medicare and/or Medicaid EHR incentive payments. It also specifies Medicare payment adjustments that, beginning in 2015, providers will face if they fail to demonstrate meaningful use of certified EHR technology and fail to meet other program participation requirements. 

In a November 2011 “We Can’t Wait” announcement, the Department outlined plans to provide an additional year for providers who attested to meaningful use in 2011.   Under the proposed rule, stage 1 has been extended an additional year, allowing providers to attest to stage 2 in 2014, instead of in 2013.

The proposed rule (184 pages) announced by ONC identifies standards and criteria for the certification of EHR technology, so eligible professionals and hospitals can be sure that the systems they adopt are capable of performing the required functions to demonstrate either stage of meaningful use that would be in effect starting in 2014.  ONC provided a fact sheet summary of the rule.  ONC also provided a link to a recent presentation discussing these recent changes.

“Through the Medicare and Medicaid EHR Incentive Programs, we’ve seen incredible progress as over 43,000 providers have received $3.1 billion to help make the transition to electronic health records,” said CMS Acting Administrator Marilyn Tavenner. “There is great momentum as the number of providers adopting this technology grows every month.  Today’s announcement will help ensure broad participation and success of the program, as we move toward full adoption of this money-saving and life-saving technology.”

“The proposed rules for stage 2 for meaningful use and updated certification criteria largely reflect the recommendations from the Health IT Policy and Standards Committees, the federal advisory committees that operate through a transparent process with broad public input from all key stakeholders. Their recommendations emphasized the desire to increase health information exchange, increase patient and family engagement, and better align reporting requirements with other HHS programs,” said Farzad Mostashari, MD, ScM, National Coordinator for Health Information Technology.

“The proposed rules announced today will continue down the path stage 1 established by focusing on value-added ways in which EHR systems can help providers deliver care which is more coordinated, safer, patient-centered, and efficient.”

The number of hospitals using EHRs has more than doubled in the last two years from 16 to 35 percent between 2009 and 2011.  Eighty-five percent of hospitals now report that by 2015 they intend to take advantage of the incentive payments.

Stage 2 Criteria for Meaningful Use 

In the proposed rule, CMS proposes to specify Stage 2 criteria that eligible providers (EPs), eligible hospitals, and CAHs must meet in order to qualify for an incentive payment, as well as introduce changes to the program timeline and detail payment adjustments.  These proposed criteria were substantially adopted from the recommendations of the Health IT Policy Committee (HITPC), a Federal Advisory Committee that obtains industry and provider input regarding the Medicare and Medicaid EHR Incentive Programs, as well as through consideration of current program data for the Medicare and Medicaid EHR Incentive Programs. 

The proposed Stage 2 criteria for meaningful use focus on increasing the electronic capturing of health information in a structured format, as well as increasing the exchange of clinically relevant information between providers of care at care transitions.

The proposed Stage 2 criteria for meaningful use are based on a series of specific objectives, each of which is tied to a proposed measure that all EPs and hospitals must meet in order to demonstrate that they are meaningful users of certified EHR technology. This approach is similar to the objective and measure approach used in Stage 1. 

In their July 28, 2010, rule outlining Stage 1 criteria, CMS finalized a separate set of core objectives and menu objectives for both EPs and eligible hospitals and CAHs. In Stage 1, EPs and hospitals must meet or qualify for an exclusion to all of the core objectives and 5 out of the 10 menu measures in order to qualify for an EHR incentive payment under these Stage 1 requirements. 

In this proposed rule, CMS proposes to maintain the same core and menu structure for the program for Stage 2. We propose for Stage 2 that EPs must meet or qualify for an exclusion to 17 core objectives and 3 of 5 menu objectives. We propose that eligible hospitals and CAHs must meet or qualify for an exclusion to 16 core objectives and 2 of 4 menu objectives. 

Each objective/measure was evaluated for its applicability to all EPs and eligible hospitals. In cases where there are situations that make it impossible for an EP or eligible hospital to meet the measure, an exclusion was defined in the final rule. If an exclusion applies, then the EP or eligible hospital would not have to meet that objective/measure in order to be deemed a meaningful user. 

Nearly all of the Stage 1 core and menu objectives have been retained for Stage 2. The “exchange of key clinical information” core objective from Stage 1 was eliminated in favor of a more robust “transitions of care” core objective in Stage 2, and the “provide patients with an electronic copy of their health information” objective was eliminated because it has been replaced by an “electronic/online access” core objective. 

There are also multiple Stage 1 objectives that have been combined into more unified Stage 2 objectives, with a subsequent rise in the measure threshold that providers must achieve for each objective that has been retained from Stage 1. This eliminates unnecessary accounting and reporting burden for providers by recognizing that, for providers who have been Stage 1 meaningful users for multiple years, recording these data in structured form has become a normal part of care delivery. 

Changes to Stage 1 Criteria for Meaningful Use 

In this proposed rule, CMS proposes several changes to existing Stage 1 criteria for meaningful use. Some of these changes would be optional for use by providers in Stage 1 but would be required for use in Stage 2. Other changes would not take effect until providers have to meet the Stage 2 criteria. An overview of these proposed changes includes: 

  • Changes to the denominator of computerized provider order entry (CPOE) (Stage 1 Optional, Stage 2 Required)
  • Changes to the age limitations for vital signs (Stage 1 Optional, Stage 2 Required)
  • Elimination of the “exchange of key clinical information” core objective from Stage 1 in favor of a “transitions of care” core objective that requires electronic exchange of summary of care documents in Stage 2 (Effective Stage 2)
  • Replacing “provide patients with an electronic copy of their health information” objective with a “view online, download and transmit” core objective. (Effective Stage 2) 

Greater Applicability to Specialists 

The NPRM proposes new objectives that have greater applicability to many specialty providers. The addition of these objectives recognizes the leadership role that many specialty providers have played in the meaningful use of health IT for quality improvement purposes with respect to: 

  • Imaging results and information accessible through certified EHR technology
  • Capability to identify and report cancer cases to a State cancer registry, except where prohibited, and in accordance with applicable law and practice
  • Capability to identify and report specific cases to a specialized registry (other than a cancer registry), except where prohibited, and in accordance with applicable law and practice 

Stage 2 Reporting of Clinical Quality Measures 

Just as in Stage 1, CMS proposes that EPs, eligible hospitals, and CAHs be required to report on specified clinical quality measures (CQMs) in order to qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs. 

For EPs, CMS is proposing a set of measures that align Stage 2 CQMs with existing quality programs by aligning measures with the Physician Quality Reporting System (PQRS), Medicare Shared Savings Program, and National Council for Quality Assurance (NCQA) for medical home accreditation, as well as measures proposed under the Children’s Health Insurance Program Reauthorization Act (CHIPRA) and under section 1139A of the Social Security Act (as added by Section 2701 of the Affordable Care Act). 

For eligible hospitals and CAHs, CMS is proposing to align Stage 2 CQMs with the Inpatient Quality Reporting (IQR) and the Joint Commission’s hospital quality measures.   The proposed rule would require EPs to report 12 CQMs and eligible hospitals and CAHs to report 24 CQMs in total. CMS recognizes that for clinical quality reporting to become routine, the administrative burden of reporting must be reduced.    

This proposed rule outlines a process by which EPs, eligible hospitals, and CAHs beyond their first year of Stage 1 participation would submit CQM data electronically, thereby reducing the associated burden of reporting on quality measures for providers.  CMS is soliciting public comment on two mechanisms of electronic CQM reporting: aggregate-level electronic reporting as a group, or through existing quality reporting systems (for Medicare providers). Within these and States’ mechanisms of reporting, CMS has proposed different approaches to CQM reporting that offer flexibility to EPs, eligible hospitals, and CAHs. 

Payment Adjustments and Exceptions 

Medicare payment adjustments are required by statute to take effect in 2015. In this NPRM, CMS proposes that any Medicare EP or hospital that demonstrates meaningful use in 2013 would avoid payment adjustment in 2015. Also, any Medicare provider that first demonstrates meaningful use in 2014 would avoid the penalty if they meet the attestation requirement by July 3, 2014 (eligible hospitals) or October 3, 2014 (EPs). 

Meaningful use attestations to State Medicaid Agencies by EPs who are eligible for either Medicare or Medicaid but opted for Medicaid, will be accepted to avoid the Medicare penalty. However, it is important to note that the receipt of Medicaid EHR Incentive Program payments for one kind of Medicaid incentive payment (the adopt, implement or upgrade, the criteria for the first year of Medicaid EHR Incentive Program payments), is not the same as meeting the meaningful use criteria. Therefore, those providers may be subject to Medicare payment adjustments if they do not otherwise demonstrate meaningful use. 

CMS is proposing exceptions to these payment adjustments. This proposed rule outlines three categories of exceptions based on: 

  • Availability of internet access or barriers to obtaining IT infrastructure;
  • A time-limited exception for newly practicing EPs who would not otherwise be able to avoid payment adjustments; and
  • Unforeseen circumstances such as natural disasters that would be handled on a case-by-case basis. 

CMS is also soliciting comment on additional criteria for exceptions. 


Thus far CMS has spent less than 10% or $3.1 billion of the $36.3 billion allocated for electronic health records in the stimulus package.  Thus far only 43,000 healthcare providers at a cost of $72,500 per provider have entered the meaningful use program.   This is far short of goal to have at least ½, 600,000 of the 1.2 million eligible providers participate in EHR. 

A major policy selling point for the adoption of EHR is the ability for systems to share information.  This week at a major healthcare IT conference it was regularly discussed that even providers using the same version of a EHR software package cannot share records due to customization by one or both parties.   CMS is funding information exchanges for each state but they are doing so on a pittance compared to the rest of the budget and the complexity of the task.  Unfortunately this has all the makings of a failed government program. 

The proposed rules with 443 pages for the stage 2 criteria and 184 pages for standards and criteria for certification are overwhelming for both the system developers and health care providers.  This type of consuming regulations will only work against more providers jumping in and implementing EHR systems.    It is hard to imagine how a regulation with over 600 pages will meet the Presidents executive order calling for agencies to reduce and not create burdensome regulations.  The combined total of just this section of the regulation is 1/4th in length of the entire affordable care act..

Hospitals with IT infrastructure and concern about the penalties eventually increasing to 5% of their Medicare billings will implement this rule despite its complexity. 

Several other factors are weighing in against the adoption of EHR for small practices include;

  • Small providers which account for roughly 75% of healthcare delivered in this country and many don’t believe they have the technical skills or IT infrastructure to implement EHR.  Think about a provider’s office where the providers spouse or other relative is the receptionists and also keeps the books and does the billing, this is not as uncommon as you may first think.  
  • As long as Medicare and Medicaid reimburse using the fee for service model anything that slows down throughput, seeing patients quickly will cut into their eventual reimbursement and will not be adopted with any speed.   Even with CMS penalizing the provider, it may not make economic sense for them to reduce their patient throughput to implement EHR.
  • Many of these smaller providers are also seeing other local practices bought up by local hospitals; this is also a disincentive as they may delay purchase of an EHR system knowing that they will make the transition to EHR with their new employer’s software.  As one physician shared with me there is no sense in learning two systems and it takes time to sell your practice.
  • A major obstacle to purchasing EHR has been the conversion in less than two years to ICD 10 a system of billing codes that is uniquely different and significantly more complex than the current ICD 9 system.  Now that HHS has permanently delayed its implantation, many offices may now go in and purchase a record system. 

In the end the rush to EHR is proving to be more elusive than originally projected and the calls for simplification may be coming sooner rather than later.


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