Saturday, July 27, 2013

The Centers for Medicare and Medicaid Services has added three new Frequently Asked Questions relating to clinical quality measure specifications under the electronic health records meaningful use program:

QUESTION: When new versions of clinical quality measure (CQM) specifications are released by the Centers for Medicare and Medicaid Services (CMS), do developers of Electronic Health Records (EHR) technology need to seek retesting/recertification of their certified complete EHR or certified EHR module in order to keep its certification valid?

ANSWER: No. The minimum version required for 2014 Edition certification is the version of CQM specifications released by CMS in December 2012.  EHR technology that has been issued a certification based on the December 2012 version will remain certified even when CMS releases new versions of CQM specifications.
We strongly encourage EHR technology developers to update to the newest CQMs specifications as they become available since those updates include new codes, logic corrections and clarifications. We also recommend EHR technology developers consider that other CMS programs (beyond the EHR Incentive Programs) and other private sector programs generally update CQMs on an annual basis.  Thus, not updating EHR technology to the newest CQM version specifications creates the potential that providers may not be able to participate and report in those other programs for which they are eligible because the CQM data generated by their EHR technology is based on older specification versions and therefore may not be accepted by the other programs. Please see FAQ 8898 and 8900 for additional information pertaining to the relationship between EHR certification and the CQM specification updates.

QUESTION: If the Electronic Health Records (EHR) technology is already certified to the “version 1” clinical quality measure (CQM) specifications, can it be updated to include the Center for Medicare and Medicaid Service’s (CMS) updated “version 2” specifications without seeking retesting/recertification?

ANSWER: Yes, you can update your EHR technology to the new version of the CQM specifications without seeking additional testing and certification.
If you change your certified EHR technology’s version when you update it to include the new version of CQM specifications you will also need to contact your Office of the National Coordinator - Authorized Certification Body (ONC-ACB) and, at a minimum, submit an inherited certified status request to get this new version certified and listed on the Certified Health IT Product List (CHPL) for selection by your customers. The ONC-ACB would have discretion to require additional testing in relation to your request for inherited certified status. Please see FAQ 8896 and 8900 for additional information pertaining to the relationship between EHR certification and the CQM specification updates.

QUESTION: If Electronic Health Records (EHR) technology has not yet been certified to the criteria related to clinical quality measure (CQM) capabilities (45 CFR 170.314(c)(1) through (3)), can the EHR technology be tested and certified to just the newest available version of the CQM specifications?

ANSWER: Yes.  We strongly encourage EHR technology developers to test and certify to the newest CQMs specifications as they become available since those updates include new codes, logic corrections and clarifications.  In addition, other CMS programs (beyond the EHR Incentive Programs) and other private sector programs generally update CQMs on an annual basis.  Updating EHR technology to the newest CQM version specifications enables providers to participate and report in those other programs for which they are eligible as well. Please see FAQ 8896 and 8898 for additional information pertaining to the relationship between EHR certification and the CQM specification updates.

All meaningful use FAQs are available here.

China state media says 18 more detained in GSK probe

BEIJING (Reuters) - At least 18 more people have been detained in China in connection with a corruption scandal involving British drugmaker GlaxoSmithKline, state media reported, giving more details on a probe which has rocked the company.
State radio reported late on Friday on its website that police in the central city of Zhengzhou had "recently held, in accordance with the law, 18 GlaxoSmithKline (China) employees and some medical personnel".
It provided no details of the detentions.
The Zhengzhou police news department, reached by telephone, said they were "unaware of the situation" and declined to comment further.
GSK did not immediately respond to a request for comment.
Chinese police have previously announced the detention of four Chinese GSK executives in connection with allegations that the drugmaker funneled up to 3 billion yuan ($489 million) to travel agencies to facilitate bribes to doctors and officials.
GSK has admitted that some Chinese executives appeared to have broken the law but Chief Executive Andrew Witty said on Wednesday that head office had no knowledge of the alleged wrongdoing.
The official Xinhua news agency said that certain GSK employees are "suspected of offering bribes to doctors, asking them to prescribe more drugs in order to grow sales volume, and in the meantime pushing up drug prices".
Xinhua cited an interview with a man surnamed Li, who it said was a regional sales manager for GSK responsible for selling respiratory drugs to more than 10 hospitals in Zhengzhou, who detailed how the corruption worked.
"They invited doctors to join high-end academic conferences to help the practitioners increase influence in their fields. They also established good personal relations with doctors by catering to their pleasures or offering them money, in order to make them prescribe more drugs," Xinhua said.
"A 35-year-old female medical representative surnamed Wang, working under Li, said she entered doctors' offices to act as their assistant, and meet their needs as much as possible, even their sexual desires," the report added.
"Wang said GSK China's executives already knew this, and some executives gave clear directives to the sales department to offer bribes to doctors with money or opportunities to attend academic conferences."
However, many doctors got money even when the lectures did not actually exist, Xinhua said.
"Wang just forged lecture materials in order to obtain reimbursements from the company," it added.
"According to Li and Wang, the company set the target of raising drug sales by 30 percent annually in the last two years, and the target can only be achieved by pushing doctors to prescribe more if there are no increases in the number of patients," Xinhua reported.
GSK this week appointed one of its top European executives as the new head of operations in China.
(Reporting by Ben Blanchard and Fang Yan; Editing by Michael Perry)

United States: False Claims Act Whistleblowers Continue to Collect Large Settlements

Last Updated: July 26 2013
Article by Breanne M. Sheetz

Two recent settlements emphasize the high cost of Medicare/Medicaid fraud allegations and the incentive for healthcare industry whistleblowers to come forward. These types of lawsuits continue to increase, resulting in large settlements that benefit individual whistleblowers and federal and state governments.
In one case, pharmaceutical manufacturer Mallinckrodt settled a False Claims Act (FCA) lawsuit for $3.5 million in the Northern District of California. The Department of Justice alleged that the company improperly paid kickbacks in the form of consulting fees to "shady doctors" who were willing to prescribe high volumes of certain medications for insomnia, pain, and depression, and who submitted false Medicare and Medicaid claims. A whistleblowing former employee claimed that he first learned of the allegedly illegal program in a sales meeting. As a result of his whistleblowing efforts, he will receive $603,000 from the settlement. The remainder will be allocated to the federal government and eight states to fund Medicare and Medicaid programs.
In a second recent matter, Park Avenue Medical Associates, a practice with more than 120 facilities in three states, settled a FCA lawsuit with the U.S. Attorney's Office for $1 million in the Southern District of New York. In a consent judgment, the medical practice acknowledged that it billed Medicare for psychotherapy services provided to nursing home and assisted living residents without proving they "had the capacity" to benefit from the treatment. The practice also admitted to charging Medicare for psychiatric diagnostic examinations without adequate documentation. A former employee of the practice's billing and collections department brought the lawsuit, and he will likely receive 15-25% of the settlement amount.
These settlements follow the heightened whistleblowing incentives trend we have been reporting over the past few months. Legislation has been proposed in Congress, the Preventing and Reducing Improper Medicare and Medicaid Expenditures Act of 2013 (the PRIME Act) (H.R. 2305S. 1123), which would create stronger penalties for Medicare and Medicaid fraud. In addition, the Department of Health and Human Services recently proposed a rule that would raise the ceiling for whistleblower payouts to nearly $10 million.  The Corporate Whistle Blower Center has also unveiled a website dedicated to encouraging healthcare industry whistleblowers to come forward. With these developments on the horizon, healthcare employers should expect to see even more whistleblowing lawsuits and larger settlements.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

Feds ban new home healthcare agencies in Miami to fight Medicare fraud - Miami-Dade -


Citing Miami’s ignominious status as a national Medicare fraud “hot spot,’’ federal health officials Friday said they will temporarily ban new home health agencies in Miami-Dade and Monroe counties from enrolling in Medicare and Medicaid, in an effort to stem scams and abuse.
The six-month moratorium, invoked under the Affordable Care Act for the first time, begins Tuesday. It will freeze new and pending applications for home health agencies in the two South Florida counties and Chicago, and for ambulance providers in Houston.
During the moratorium, officials with the federal Centers for Medicare & Medicaid Services will continue to monitor home health billing from enrolled providers to root out fraud, according to the agency’s announcement.
“We are putting would-be fraudsters on notice that we will find and stop them before they can attempt to bill Medicare, Medicaid’’ and other programs, CMS Administrator Marilyn Tavenner said in a statement.
The unprecedented action was welcomed by elected officials and industry groups.
Three Republican U.S. senators issued statements applauding the move but criticizing federal health officials for taking so long to act on their new powers, granted in 2010.
Calling the moratorium “better late than never,’’ Sen. Orrin Hatch, R-Utah, the ranking member of the Senate Finance Committee — which oversees the Medicare program — issued a statement saying: “It’s unfortunate that it took CMS three years to use the tools it’s had to protect seniors, who rely on Medicare, from fraud and abuse.”
Val J. Halamandaris, president of the National Association for Home Care & Hospice, which helped lobby to ensure moratorium power was included under the Affordable Care Act, said in a statement that “we fully support the action taken by CMS.”
Home health agencies provide nursing, physical therapy and other services to Medicare and Medicaid beneficiaries who are confined to their homes because of a disability or illness. The new moratorium also will apply to providers seeking reimbursement from the Children’s Health Insurance Program, known as CHIP.
It is unclear how many new providers will be excluded from the taxpayer-funded insurance programs for the poor and elderly, but The Associated Press reported that 662 home health agencies operated in Miami-Dade in 2012. The moratorium does not apply to existing home health providers.
CMS found that there were a disproportionate number of home health agencies relative to beneficiaries in Miami and Chicago. The ratio ranged from 327 percent higher in Chicago, to 1,960 percent higher in Miami.
The Miami area, where schemes involving home health care, diabetic care, mental health and physical therapy fraud have flourished for years, has stood out as the nation’s epicenter of Medicare corruption.
The U.S. Attorney’s Office routinely prosecutes high-profile cases of Medicare fraud.
In May, federal prosecutors announced the arrest of Roberto F. Marrero, an actor who played bit parts in shows such as Miami Vice and who more recently launched a cable station featuring Cuban cultural programs. Authorities allege he also led a con man’s life as the owner of a Medicare-licensed home health agency that fleeced $15 million from the government program.
In May, a patient recruiter for a Miami home health agency was sentenced to 37 months in prison for his role in a $20 million Medicare fraud scheme. And in February, the owners and operators of two Miami home health agencies were sentenced to prison and ordered to pay millions in restitution for perpetrating a $48 million fraud on Medicare by billing for unnecessary services.
Given the large number of elderly Medicare beneficiaries who live in South Florida, it’s not a surprise that the region is home to a large number of home health agencies. But because homebound patients are dispersed across a wide geographic area, the healthcare providers who serve them can be difficult to monitor, said Steven Ullmann, a professor and director of health policies at the University of Miami School of Business Administration.
Ullmann described a market in South Florida whereby fraudulent healthcare providers buy Medicare numbers from beneficiaries in exchange for a financial or in-kind bribe, such as a new television.
“When you have a Medicare number,’’ Ullmann said, “then you can start billing.’’
Because federal law requires Medicare to deliver prompt payment for services without verification, fraudulent claims often are not discovered until well after the fact. Fly-by-night operators open up a storefront, bill Medicare for fraudulent services, then disappear by the time federal investigators come looking for them.
“That seems to be something that occurs here with greater prevalence than you would find in other parts of the country,’’ Ullmann said.
In 2009, the Justice and Health and Human Services departments expanded criminal “strike forces’’ targeting the fraud from Miami, Los Angeles and Houston to include Detroit, Brooklyn, Baton Rouge and Tampa. They also committed about half a billion dollars to fraud-prevention efforts.
Still, the fight to stamp it out is a constant struggle, despite convictions of more than 1,000 defendants in South Florida alone. The region accounts for one-third of all healthcare fraud prosecutions in the nation.
In 2008, Medicare paid $520 million to Miami-Dade home healthcare agencies for treating diabetic patients — more than what the agency spent on diabetics in the rest of the country combined, according to federal authorities.
Federal officials identified Miami, Chicago and Houston as fraud “hot spots’’ by mining data that showed these cities as significant outliers compared to other areas of the country when it comes to home health providers and ground ambulance services.

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Feds ban new home healthcare agencies in Miami to fight Medicare fraud - Miami-Dade -