GAO calls CMS’ Medicare Advantage encounter data into query

The Centers for Medicare and Medicaid Services (CMS) has made insufficient development in validating the completeness and precision of Medicare Advantage encounter data, a crucial component for administering accurate payments for the program, in accordance to a Government Accountability Office audit.

CMS gathers Medicare Advantage encounter data, detailed data about the care and health status of Medicare Advantage enrollees, to evaluate payments. Although, despite GAO’s 2014 suggestions that CMS completely assess data quality before use, auditors discovered that the agency has yet to take critical measures to make sure the encounter data is right and complete, making the Medicare Advantage program susceptible to improper payments and wasted taxpayer dollars.

“CMS has still to undertake tasks that fully deals Medicare Advantage encounter data precision, like reviewing medical records,” states the audit report. “Moreover, few health insurance and provider trade associations GAO interviewed voiced concerns about CMS’s capability to accurately identify diagnoses utilized for risk adjustment…To the extent that CMS is making payments deployed on data that haven’t been completely validated for completeness and accuracy, the soundness of billions of dollars in Medicare expenditures sustains to be unsubstantiated.”

A CMS spokesperson refused to particularly comment on the GAO’s findings and suggestions, and instead referred to the agency’s official written responses released in the audit report. Among those responses, CMS officials pointed out that they are working with Medicare Advantage agencies to refine how the methodology used to gain diagnoses data is applied.

Additionally, the agency claimed that it has started compiling basic statistics on the volume and consistency of data submissions and preparing automated summary reports for Medicare Advantage agencies demonstrating diagnosis information used for risk adjustment.

Specifically, CMS started phasing in patient diagnosis data from Medicare Advantage encounter data in its risk adjustment process in the year of 2015 and told the GAO it intends to depend completely on those data by the year of 2020.

Because it has primarily concentrated on collecting comprehensive encounter data for risk adjustment purposes, CMS officials also informed auditors that the agency has highly deferred planning for extra uses of the data.

Nevertheless, in accordance to the GAO, few stakeholder agencies have objected to the risk adjustment transition time frame, compelling that it does not permit sufficient time for a victorious transition. Still, CMS asserts that the multiyear transition time frame is reasonable.

Provided the agency’s limited progress, auditors claimed that they continue to believe that CMS should execute GAO’s July 2014 suggestion that the agency completely develop plans for the extra uses of Medicare Advantage encounter data.

“This latest GAO research proves once again that the encounter data system isn’t ready for full implementation,” stated House Ways and Means Committee Chairman Rep. Kevin Brady (R-Texas) in a written statement. “While the system was developed to ensure right payments for the millions of seniors who depend on Medicare Advantage, it won’t work with incomplete and inaccurate data and could lead to higher premiums or decreased benefits down the road. CMS must ensure this significant system is based on the right information so taxpayer dollars are going to Medicare recipients who require them most.”

Likewise, House Energy and Commerce Committee Chairman Rep. Greg Walden (R-Ore.) claimed in a written statement that the GAO report “raises more uncertainties about the encounter data system and either it is ready to perform its duties.”

While applauding that few improvements have been made since GAO’s 2014 report, Walden noted that “key suggestions from the government watchdog have still to be implemented” and voiced his support for the “GAO’s asserting that CMS should completely assess its data quality before implementing” the Medicare Advantage encounter data system.

 

The Act would offer professional development Services to rural providers

The U.S. Senate on a 97-0 vote has approved the Expanding Capacity for Health Outcomes Act to expand Project ECHO, a step to offer professional development services and other support to healthcare rural providers in remote and underserved regions.

Project ECHO is modeled after a step at the institute of University of New Mexico that connects rural patients to rural providers through telemedicine. Project ECHO previously concentrated on care for patients with hepatitis C.

Under the legislation, which moves to the U.S. House that has a companion bill, Project ECHO now will extend across the rural areas of nation to serve a wide variety of healthcare requirements. Senators Orrin Hatch (R-UT) and Brian Schatz (D-HI) sponsored the bill.

Project ECHO will utilize videoconferencing technology to link specialists with rural primary care providers or rural providers. Weekly “teleECHO clinics” will combine didactic teaching (ways to better manage work) with mentoring and case-based learning, in accordance to a statement from Hatch.

These clinics, or lectures, could cover such areas as treatments for several diseases, offering behavioral health treatment in rural areas, and making improvements in public health interventions like HIV and tuberculosis.

The aim, in accordance to Hatch, is to increase expert knowledge among rural providers while giving a network of assistance, helping the provider retention rate, decreasing isolation and offering more access to specialists.

The legislation needs the Department of Health and Human Services to assess if Project ECHO improves the quality of care, and calls for the Government Accountability Office to assess increased efficiencies and cost savings via the program.

“We are now one step closer to supporting new ways to train health providers and deliver health care,” Sen. Schatz stated in a statement. “Technology is modifying and changing the way medical professionals connect with each other and their sufferers. Our bill capitalizes on this technology to give health experts in hard-to-reach areas the specialized training they need and assist them to reach more patients.

 

FDA Plans to Extend Its Global Regulatory Reach

June 20, 2011 — The US Food and Drug Administration (FDA) plans to take a more global approach to ensure the safety and quality of regulated drugs and medical devices, the agency's commissioner announced during a media briefing today.

One prong of the new 4-pronged approach will involve partnering with counterparts worldwide and creating global coalitions of regulators intent on ensuring and improving global product safety and quality, said FDA Commissioner Margaret Hamburg, MD.

"This is a long-term strategy," Dr. Hamburg said. "It cannot be accomplished immediately and will probably take many years to implement, depending upon resources."

One part of the new approach will mean regulators no longer regard borders the same way. "The border can no longer be the nation's primary line of defense against unsafe imported products," she said. "Instead, the border must serve as a final checkpoint on preventive controls throughout the supply chain."

An FDA report, Pathway to Global Product Safety and Quality, describes the new strategy. Most notably, it calls for the agency to change how it conducts business and to take a more global approach to promote and protect the health of US consumers. Highlights of the report include 3 other prongs of the 4-pronged approach:

• The coalitions of regulators will develop international data information systems and networks and increase the regular and proactive sharing of data and regulatory resources across world markets.


• The FDA will build in more information gathering and analysis, with an increased focus on risk analytics and information technology.


• The FDA increasingly will leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk.

Such coalition-type models do not exist in the world of FDA-regulated products, said John Taylor, JD, acting principal deputy commissioner of the FDA, and the FDA does not already have a coalition in place. However, many peer regulators have expressed interest in working more closely together to ensure the safety and integrity of products moving through the global supply chain.

Current Regulatory Authority Outdated

When asked whether the FDA would need new authority from Congress to proceed with the project, Taylor said the agency would move ahead with the strategy regardless of whether it needs new authority to do so. He also noted that the agency's authority relating to medical products is outdated. In 1938, the authority given to the FDA largely grew out of a world where manufacturers of regulated products were based in the United States.

"We've been a domestic agency that works in an international world," he said. "What we need to do is transform ourselves into a global agency that is able to work all around the world and address product issues that arise all over the world."

Taking a more global approach will enable the FDA to better monitor companies in far-flung areas that might otherwise escape regulatory scrutiny as more FDA-regulated products are produced overseas.

Global production of FDA-regulated goods has exploded over the past 10 years, according to Dr. Hamburg. Manufacturers increasingly use imported materials and ingredients in their US production facilities, "making the distinction between domestic and imported products outdated, to say the least," she said.

Products regulated by FDA, Dr. Hamburg said, reflect the globalization of today's economy:

• 10% of all imports into the United States consist of products FDA regulates,


• 80% of active pharmaceutical ingredients in the drugs Americans use come from overseas,


• 40% of drugs themselves are imports, and


• about half of all medical devices used in this country are imported.

Yet the FDA does not have the resources to keep pace with demands created by globalization, according to the report issued today that describes the FDA's new plan. In 2008, the Government Accountability Office recommended that the FDA increase inspections of foreign drug companies, but at current rates, it would take 9 years for the agency to inspect every high-priority pharmaceutical facility just once.

The new strategy would build on changes already made by the FDA. Between 2007 and 2009, the FDA increased the number of foreign drug manufacturing inspections by 27% and opened international offices in several key locations around the world.

The FDA has also collaborated with counterparts in the European Union and Australia on drug inspections, and it has joined an organization of drug manufacturing inspectorates from 39 countries. The FDA and other global leaders are also creating an expanded global regulators forum for medical devices.

More information on the new strategy is available on the FDA Web site.