The CMS rule cites its own concerns about the potential for abuse, and the OIG’s concerns relating to the potential for laboratories and other ancillary services providers to abuse its safe harbor. Such abuses have caused both CMS and OIG to consider narrowing the scope of protected donors to those who have “a direct and primary patient care relationship and a central role in the health care delivery infrastructure.”
“The OIG has received comments suggesting that abusive donations are being made under the electronic health records safe harbor,” the CMS proposed rule states, adding that “(some responses) allege that donors are using the safe harbor to provide referral sources with items and services that appear to support the interoperable exchange of information on their face, but, in practice, lead to data and referral lock-in.”
Indeed CAP has also heard of numerous cases of unfair business practices and abuse of the exception/safe harbor, and strongly advocates removing laboratories from the exception. CAP has advocated with CMS and the OIG several times and shared information regarding abuses.
Currently, laboratories are permitted to donate electronic health record software and training to health care providers as long as the software is interoperable and the organization/group/practice that receives the donation contributes 15% to the cost of the donated technology.
The proposed rules seek comments on removing laboratories from among the protected donors covered by the EHR donation exception to the physician self-referral law and the safe harbor in the anti-kickback law. They are also seeking comments new or modified conditions that could be added to prevent the misuse of the exception resulting in data and referral lock-in but also allow and encourage the free exchange of data, and possibly retain the current scope of permissible donors.
The EHR donation exception went into effect in August 2006 to stimulate adoption of electronic health records among physicians, and is due to sunset on December 31, 2013.
The proposed rules invites comments on extending the exception through December 31, 2016 or later, and other provisions, including:
limiting the scope of protected donors under the electronic health records exception to hospitals, group practices, prescription-drug-plan sponsors and Medicare Advantage organizations;
updating the provision under which EHR software is deemed interoperable to make the rules consistent with Office of National Coordinator for Health Information Technology requirements;
removing the requirement for software to have electronic prescribing capability;
adding or modifying conditions to limit the risk of data and referral lock-in as an alternative or additional means of preventing donations that subvert the intent of the exception.
The proposed rules were published in the Federal Register on April 10, 2013. Comments are due by June 10, 2013.
President’s Budget Repeals Sequester, Averts SGR, but Labs See Cuts
President Obama’s budget proposal this week would retire the Sustainable Growth Rate (SGR) formula, undo the 2% cut from sequestration, and maintain physician pay at its current level, but it also cuts funding to clinical labs and continues to forecast billions in savings through other cost-cutting programs such as the Independent Payment Advisory Board (IPAB).
In terms of SGR, the administration supports several years of fee-for-service payment stability to allow CMS time to develop and test a variety of pay-for-performance models that would eventually replace the SGR in determining physician pay. The goal is to “provide predictable payments that incentivize quality and efficiency in a fiscally responsible way,” the budget says. Physicians currently face a 24.4% pay cut under the Medicare SGR formula in 2014 unless action is taken to address the current SGR system.
Clinical laboratories would not fare as well. The President’s budget projects saving $9.46 billion over 10 years by “modernizing payments for clinical laboratory services by more closely aligning payment levels with the private sector and granting the Secretary authority to adjust payment rates under the CLFS in a budget-neutral manner as well as supporting policies to encourage electronic reporting of laboratory results.” This represents a 1.75% cut to CLFS payment rates every year from 2016-2023. The budget would also “expand the availability of Medicare data released to physicians and other providers for performance improvement, fraud prevention, value-added analysis and other purposes. Savings would start in 2016.”
The budget predicts saving Medicare $4.1 billion from strengthening IPAB, a board created to recommend Medicare reductions to Congress, which Congress is bound to adopt. CAP opposed creation of the IPAB and supports legislation to repeal it. Savings would also come from reducing graduate medical education funding by nearly $11 billion to “better align GME payments with patient care costs,” a cut CAP also would oppose in light of pathologist shortages predicted within the next few years.
Another provision projects saving $6.1 billion by excluding certain services, but not anatomic pathology, from the in-office ancillary services (IOAS) exception to the Stark law. CAP and the other members in the Alliance for Integrity in Medicare (AIM)—a broad coalition of laboratory, radiation oncology, physical therapy and medical imaging medical societies and groups committed to ending the practice of inappropriate physician self-referral, have pressed lawmakers on the Hill and at CMS to remove anatomic pathology as well as other services from the IOAS exception. The Administration proposal follows recommendations made by the Medicare Payment Advisory Committee (MEDPAC). It does not explicitly exclude anatomic pathology services. CAP and the AIM coalition are already advocating for increased savings by removing AP services from the exception.
Overall, the Administration proposed $3.8 trillion budget for fiscal 2014, with a deficit next year of $744 billion, down from $973 billion this year. Medicare would be cut $370 billion over 10 years, with nearly half coming from hospitals (-$30 billion) and drug companies (-$140 billion). In addition, $35 billion would come from increasing Medicare premiums for wealthy beneficiaries.
Supreme Court Hears Oral Arguments on Gene Patents Next Week
Oral arguments over whether genes can be patented will be made at the Supreme Court next week, as attorneys from both sides present arguments in the high stakes case No.12-398, Association for Molecular Pathology et. al. v. Myriad Genetics, Inc.
The Court granted the plaintiff’s petition filed by the American Civil Liberties Union (ACLU), requesting review of a Federal Appeals Court’s 2–1 ruling upholding patents on two human genes (BRCA1 & BRCA2) associated with hereditary breast and ovarian cancer. The ACLU represented plaintiffs, including the College and other geneticists, patients, and scientific organizations in a suit challenging Myriad Genetics’ patent claims on BRCA 1 and BRCA 2 genes.
The Court’s ruling, expected sometime in June, will help shape the burgeoning field of genetic testing and treatment by defining how far gene patent holders’ rights go, and if genes can in fact be patented at all. An estimated 6000 genes have already been patented by private companies, the government, or individuals. The total number of human genes is estimated to be about 30,000.
Patent holders and investors in genetic and biomedical research companies argue the patents are necessary in order to recoup the investment required to isolate and analyze genes. Patient groups and physicians argue that patients are hurt by the patents because gene patent holders can effectively deny patients access to life saving genetic tests by limiting availability or charging exorbitant fees to have the tests. Patent holders have also restricted researcher access to the isolated genes and its mutations, impeding medical innovation by controlling who can and cannot conduct further study or develop alternative tests on/for patented genes.
During the Supreme Court oral arguments set for April 15, 2013, the Justices will focus on one question: are human genes patentable? According to court documents, the case will be heard in the morning on April 15, with 25 minutes allotted for petitioners’ arguments, 10 minutes allotted for the Solicitor General arguing as amicus curiae, and 30 minutes for respondents. An audio recording of the oral arguments can be replayed or downloaded from the SCOTUS website by Friday, April 19.
See the SCOTUS docket 12-398 for the complete list of proceedings for this case, as well as the list of amicus curiae briefs filed for both sides.
Statline will be following this important story with continued coverage and analysis.
CAP Asks CMS to Clarify Details on PT Referral Exception
As previously reported in Statline, CMS proposed a number of changes to the laboratory proficiency testing (PT) requirements under CLIA as part of a larger effort to help health care providers operate more efficiently by getting rid of regulations that the agency claims are out of date or no longer needed.
Most important for pathologists, CMS said it would consider a referral improper but not intentional, and therefore not subject to automatic revocation of their CLIA license, if the PT referral meets all of the following criteria:
it is a result of reflex or confirmatory testing;
it is not a repeat referral;
it is in full conformance with written laboratory protocols.
CAP has advocated for modernizing CLIA in a way that protects the public without stifling innovation, as this exception would do.
“The CAP believes that the proposed rule clarifying PT sample treatment and providing CMS with enforcement discretion is an important initial step in modernizing the PT referral regulations,” CAP wrote.
However, the CAP also expressed concern about the narrow exception, implications on laboratory directors, and the program’s transparency and possible variability related to enforcement.
CAP asked for clarification on exactly how and under what circumstances the exception will be applied given the different possible scenarios for PT referral to accidentally occur or go undetected. The comment letter also asked whether the exception would cover the directors of laboratories that have referred PT specimens and meet the above criteria, and whether the Agency would share the guidance it will provide to the CMS regional offices and state surveyors in determining and enforcing the rule.
New Meaningful Use Audits Announced
The Centers for Medicare and Medicaid Services (CMS) announced it will conduct “pre-payment audits” as well as “post-payment audits” on about 5-10% of participants of the Electronic Health Record (EHR) Meaningful Use (MU) program recently to ensure participants are properly attesting to meaningful use of EHRs.
As reported in the last Statline, the CAP has already secured a hardship exception in 2015 for pathologists, and it actively supports legislation introduced in the House to exempt pathologists from earning incentives or facing penalties from the MU program.
According to data released by CMS earlier this month, 1.8% of pathologists have attested to MU and received payment. However, the CAP believes that only a small fraction of pathologists will actually be able to participate due to the unique way pathologists practice medicine. Also, it is unclear whether pathologists that have received MU incentive money in Stage 1 where it’s easier to use others’ data to meet MU, will find MU Stage 2 more difficult to meet.
Physicians selected for an audit will receive a letter from Figliozzi & Co., an accounting firm based in Garden City, N.Y., contracted to conduct the audits. CMS issued a set of FAQs for providers about the audits.
Attestation information submitted for the EHR incentive program can be updated, changed, cancelled, or withdrawn, even after successful submission in the EHR Registration and Attestation System, according to CMS. The attestation amendment form or the withdrawal form must be completed and returned to CMS with any incentive payments already received.
According to CMS, nearly 207,000, or almost half of the 520,000 health care professionals eligible to participate in the MU program have been paid an EHR meaningful use bonus.
CAP Explains Problems with PQRS and EHR Incentive Programs
While some pathologists have participated in CMS’s PQRS program and earned incentives, many others have been unable to participate in CMS’s PQRS and EHR incentive programs. Despite five CAP-developed PQRS measures, measures that accurately and completely reflect pathologists’ roles and capture pathologists’ value still do not exist in CMS’s program, CAP informed CMS in new comments submitted this week.
Metrics linking individual patients to individual physicians through ICD-9/10 and CPT codes cannot be easily applied to pathologists because “much of what many pathologists do to improve patient quality and impact patient safety is focused on Part A activities that cannot be linked to individual patients but have wide reaching impact,” CAP wrote.
Also, pathologists’ long history of meeting regulatory requirements under CLIA and participating in CAP accreditation programs that go beyond CLIA have allowed fewer gaps in quality and care compared to other medical specialties not subjected to such a high level of regulatory scrutiny, according to CAP.
Sub-specialization within pathology is another factor preventing some pathologists from qualifying for PQRS incentives as CAP’s current PQRS measures do not cover all of pathology.
CAP’s chief recommendations to improve the programs and increase participation were:
allow metrics that clearly advance quality patient care and enhance patient safety
don’t penalize physician specialties for failing to meet requirements that do not fit in their scope of practice or are beyond their control
build new pathways for developing quality measures that are flexible enough to account for variability among physician specialties
accept quality improvement activities developed by specialty societies that measure performance as quality measures
allow performance credit for quality activity in a variety of settings
CAP provided input to a CMS Request for Information (RFI) on “the Use of Clinical Quality Measures (CQMs) Reported Under the Physician Quality Reporting System (PQRS), the Electronic Health Record (EHR) Incentive Program, and Other Reporting Programs”. See CAP’s full comments.
ONC Reminds Laboratories to Weigh in on Health Information Exchange Policy
Over 2000 labs have already participated in a nationwide study by the Office of the National Coordinator for Health IT (ONC) on the current and potential use of health information exchanges (HIE) for sending lab results to ordering clinicians.
ONC’s focus is to determine the percentage of laboratories that are able to send structured lab results electronically to ordering physicians, and the percentage of lab results that are currently being sent electronically in coded format to ordering physicians.
CAP encourages it members to complete the survey and send it in as soon as possible. The survey period ends on May 10, 2013.
The survey findings will be used to establish a baseline level of laboratory information exchange in order to inform the HIE program’s activities and provide targeted assistance to states and territories in developing their laboratory information exchange strategies.
Notice of the study was published in the Federal Register in October 2012, and has support from both the CAP and the College of Healthcare Information Management Executives (CHIME). Surveys were sent out to all clinical laboratories in January and February this year.
ONC hopes to receive completed surveys from 4000 or more hospital-based and independent labs. Results of the survey will be posted on the ONC website this summer.