Provider Information
CMS Issues Final Rule Giving Access to Medicare Claims Data (December 2011)CMS announced a final rule on December 7 providing access to Medicare claims data by qualified entities. The purpose of the access is to facilitate the aggregation of Medicare claims data to provide healthcare provider and supplier performance reports. The final rule is a result of provisions contained in the PPACA drafted to advance improved transparency to assist consumers. The final rule takes effect January 6. CMS Expands Coverage for Preventive Care Services (December 2011)
The Centers for Medicare and Medicaid Services (CMS) announced two new preventive care services covered under Medicare to address cardiovascular disease and obesity. One face-to-face cardiovascular disease risk reduction visit each year will be now be covered for Medicare beneficiaries. In addition, Medicare will be adding coverage for preventive services to reduce obesity.
According to a statement released by CMS, a beneficiary who screened positive for obesity with a body mass index (BMI) greater than or equal to 30 kg/m2, can receive one face-to-face counseling visit each week for one month and one face-to-face counseling visit every other week for an additional five months. A beneficiary may receive one face-to-face counseling visit every month for an additional six months (for a total of 12 months of counseling) if he or she has achieved weight reduction of at least 6.6 pounds during the first six months of counseling. The new covered services are intended to advance the Million Hearts initiative led by CMS and the Centers for Disease Control and Prevention. The initiative is aimed at preventing one million heart attacks and strokes in the next five years. You can learn more about the Million Hearts initiative by visiting http://millionhearts.hhs.gov/. Call on Congress to Repeal the Medicare SGR Formula (November 2011)
A bipartisan group of U.S. senators and representatives was named in August to serve on the Joint Select Committee on Deficit Reduction. These 12 members of Congress have a unique opportunity to permanently repeal the SGR formula. The Committee is intended to avoid the historical policy and political challenges that have impeded the attainment of permanent solutions in the past.
To reach the goal of SGR repeal, the ACOI in conjunction with the AOA and others, launched a campaign entitled EveryPatientCounts. The campaign features a petition that calls on Congress to enact a permanent solution to the SGR formula. Through this petition, physicians, medical students, patients, healthcare administrators and concerned citizens collectively can express their support for a permanent solution to this ongoing problem.
While correcting the SGR formula is not easy, the next three months hold great potential to solve this ongoing problem. We urge you to join this campaign by signing the petition. Once you sign, urge your colleagues, family and friends to do the same. It is as easy as visiting www.everypatientcounts.org. Womens Preventative Services Rule Issued (August 2011)
The Centers for Medicare and Medicaid Services (CMS), the Department of Labors Employee Benefits Security Administration and the Internal Revenue Service issued an interim final rule on womens preventive services August 1. The guidelines were recommended by the Institute of Medicine on July 19. As a result of the new rules, group and individual plans with plan years beginning after August 1, 2012 will have to cover a wide-range of preventive services for women. The new services include: contraception; well-woman visits; breastfeeding supplies and support; domestic violence screening; and human papillomavirus DNA testing for women 30 years of age or older, among other things. The rule issued on August 1 implements provisions of the Patient Protection and Affordable Care Act (ACA, Pub. L. 111-148). Plans that began before the ACA was enacted and that meet certain Health and Human Services requirements may be exempted from having to provide the new preventive services. It is estimated that nearly 88 million women will be in non-grandfathered plans by 2013. New Study Reveals Cost of Physicians Dealing with Insurers (August 2011)
According to a new study entitled, U.S. Physician Practices Versus Canadians: Spending Nearly Four Times as Much Money Interacting with Payers, the annual cost per U.S. physician to interact with payers is $82,975. Conversely, the annual cost per physician in Ontario, Canada is $22,205. Other findings of the study include: U.S. physicians spend an additional 1.2 hours per week interacting with health plans; nurses and medical assistants spend nearly 10 times more time on administrative tasks related to health plans per week; and U.S. clerical staff spend an additional 37.2 hours per week per physician more than their Canadian counterparts. The study estimates that these discrepancies cost the U.S. at least $31 billion per year. The study, which was partially funded by the Commonwealth Fund, is available at www.commonwealthfund.org. New Free Health Information Available through the National Library of Medicine (July 2011)
The National Library of Medicine (NLM) announced a new free service called MedlinePlus Connect. MedlinePlus Connect is a service of the NLM, the National Institutes of Health (NIH) and the Department of Health and Human Services (HHS) that allows health organizations and health information technology providers to link patient portals and electronic health record systems to MedlinePlus, an authoritative up-to-date health information resource for patients, families and healthcare providers.
MedlinePlus Connect is available as a Web application or a Web service. According to the NLM, Medline Plus has hundreds of health topic pages that bring together information from NIH, other government agencies and reputable health information providers. Additional information is available at www.nlm.nih.gov/medlineplus/connect/overview.html. CMS Proposes Rule on Release of Claims Data (July 2011)
The Centers for Medicare and Medicaid Services (CMS) released a proposed rule to give qualified entities access to Medicare claims data for the purpose of creating healthcare provider and supplier performance reports. The reports are to be made available to the public. The proposed rule is in response to a provision contained in the Patient Protection and Affordable Care Act (ACA, Pub. L. 111-148). According to CMS Administrator Donald Berwick, MD, Performance reports that include Medicare data will result in higher quality and more cost effective care. Under the proposed rule, providers and suppliers are required to receive a copy of the report prior to its release to ensure its accuracy. Additional information on this proposed rule will be provided as it becomes available. Limitation of Red Flag Rules Signed Into Law (February 2011)
The President signed into law the Red Flag Program Clarification Act of 2010 (S.3987, Pub.L. 111-319) on December 18. The legislation was approved by the Senate on November 30 and the House on December 7. The enactment of this important legislation prevents the Federal Trade Commission (FTC) from applying its red flag rule to physicians and attorneys. Application of the rule to physicians would have required physicians to put in place identity theft prevention programs to identify, detect and respond to specific activities that could indicate identity theft. The ACOI and others challenged the FTCs interpretation that physicians fell under the definition of creditors. Enactment of this legislation brings this matter to a favorable conclusion. 1099 Reporting Requirement Repeal Fails in the Senate (October 2010)
The Senate failed to approve two separate amendments to the Small Business Jobs Act and Credit Act (S. 5297)(Pub. L. 111-240) that would have repealed Form 1099 reporting requirements created under the ACA. Specifically, the ACA requires all businesses to report to the Internal Revenue Service (IRS) any payments to vendors that are greater than $600 starting in 2012.
The provision was added to the ACA as a means to increase tax revenue by decreasing the occurrence of businesses that fail to report income. A great deal of concern has been raised with regard to the additional paperwork burdens that will be placed on small businesses and others. The amendments to S. 5397, S. Amdt. 4595 and S. Amdt. 4596, would have raised the reporting threshold and would have repealed the reporting requirement, respectively. While there is concern on both sides of the aisle that the current reporting requirement may be overly burdensome, there is little agreement on how best to address the matter. The ACOI will continue to work on this matter over the upcoming months in order to ensure members are not adversely impacted by the rule. New Physician Shortage Estimates Released (October 2010)
The Association of American Medical Colleges (AAMC) Center for Workforce Studies released new physician shortage estimates on September 30. According to the new estimates released by the AAMC, the current physician shortage will be exacerbated by an additional 32 million Americans having access to healthcare coverage combined with an ever-expanding pool of Medicare enrollees. The AAMC estimates that there will be a shortage of over 36,000 physicians by 2015. In the release announcing the new estimates the AAMC stated, Unless Congress supports at least a 15 percent increase in residency training slots (adding another 4,000 physicians a year to the pipeline), access to healthcare will be out of reach for many Americans. Physician-shortage concerns remain an important issue for Congress to address. The ACOI continues to work to promote the expansion of residency training slots and the availability of healthcare services. House Advances Legislation to Reduce Fraud in Medicare (October 2010)
The House approved the Strengthening Medicare Anti-Fraud Measures Act of 2010 (H.R. 6130) by voice-vote on September 22. The legislation authorizes the Secretary of Health and Human Services (HHS) to exclude from participation in any federal healthcare program entities affiliated with a sanctioned entity, as well as any officer or managing employee of an affiliated entity, if the affiliated entity was affiliated at the time of any of the conduct that lead to the conviction or exclusion of the sanctioned entity. Currently, executives can leave a company before it is convicted of fraud and keep participating in federal healthcare programs. H.R. 6130 would essentially give the HHS inspector generals office greater power to weed out fraud and abuse within the Medicare program. To date, action on this legislation has not been scheduled in the Senate. IRS Announces Tax Incentive for Those Who Work in Underserved Areas (July 2010)
The Internal Revenue Service (IRS) announced efforts to strengthen the healthcare workforce in underserved areas on June 16. The IRS announced that, “Under the Affordable Care Act healthcare professionals who received student loan relief under state programs that reward those who work in underserved communities may qualify for refunds on their 2009 federal income returns as well as an annual tax cut going forward.” Prior to the enactment of the “Patient Protection and Affordable Care Act,” only amounts received under the National Health Service Corps Loan Repayment and Forgiveness Program were eligible for the tax benefit. As a result of this legislation, the tax exclusion applies to any state loan repayment or loan forgiveness programs intended to increase the availability of healthcare services in underserved or health professional shortage areas. Additional information is available from the IRS at www.irs.gov/newsroom/article/0,,id=224387,00.html . Prevention and Public Health Council Created by Executive Order (July 2010)
The President created the National Prevention, Health Promotion and Public Health Council by Executive Order on June 10. The Council, comprised of Cabinet members and other top officials, is charged with developing and making public a national prevention, health promotion and public health strategy that is to be reviewed annually. The Surgeon General serves as the Chair of the Council which is housed within the Department of Health and Human Services. Patient Bill of Rights Released (July 2010)
Interim final rules implementing certain consumer protections contained in the “Patient Protection and Affordable Care Act” were issued on June 22. The rules are effective August 27. Under the new “Patient Bill of Rights” insurance companies are prohibited from imposing pre-existing condition exclusions on children, prevention policy rescissions for unintentional mistakes on an application for insurance coverage, may not set lifetime limits on coverage and the use of annual limits on coverage, is restricted, among other things. You may view a fact sheet on the “Patient Bill of Rights” at www.whitehouse.gov/sites/default/files/Consumer%20reg%20Fact%20Sheet.pdf. FTC “Red Flag” Rule Delayed (July 2010)
The Federal Trade Commission (FTC) announced that it was delaying, for the fifth time, enforcement of the “Red Flag” rules from June 1, 2010 to December 31, 2010. The delay preceded an agreement by the FTC to temporarily exempt physicians from application of the “Red Flag” rules until the U.S. Court of Appeals for the District of Columbia settles questions over the scope of the Commission’s rule. Under the rules, financial institutions and creditors must put in place identity theft prevention programs to identify, detect and respond to specific activities that could indicate identity theft. The ACOI and others have challenged the FTC’s interpretation that physician’s fall under the definition of “creditors.” Additional information will be provided in upcoming newsletters. President Appoints Head of CMS (July 2010)
President Obama appointed Donald Berwick, MD, as Administrator of the Centers for Medicare and Medicaid Services on July 7. Dr. Berwick was previously nominated on April 7 for the position. Dr. Berwick is a pediatrician by training and was most recently the president and CEO of the Institute for Healthcare Improvement. He was also a professor at Harvard Medical School and the Harvard School of Public Health. A recess appointment is used from time-to-time to place an individual into a position in a more expeditious fashion. The appointment expires at the end of the Congressional session, which will be the end of calendar year 2011. President Obama re-nominated Dr. Berwick for confirmation by the Senate on July 19. Dr. Berwick will be responsible for overseeing much of the implementation of the “Patient Protection and Affordable Care Act” (PPACA, Pub.L. 111-148). Dr. Berwick is a recognized expert in health system reform. “Meaningful Use” Rule Released (July 2010)
CMS announced a final rule defining “meaningful use” of electronic health records (EHR). Physicians and hospitals that attain meaningful use of certified EHR’s may qualify for federal bonus payments. The final rule implements provisions contained in the American Recovery and Reinvestment Act of 2009 (ARRA, Pub. L. 111-6). A companion rule was released by the Office of the National Coordinator for Health Information Technology (ONCHIT) to delineate the rules for technology to be certified. The final meaningful use rule is more flexible than the original proposed rule. This is accomplished by dividing Stage 1 meaningful use adoption objectives into “core” objectives and “optional” objectives that can be deferred in 2011 or 2012. Overall, the final rule relaxed the threshold requirements for meeting Stage 1 criteria. According to a fact sheet released by CMS, “Eligible professionals can receive as much as $44,000 over a five-year period through Medicare. For Medicaid, eligible professionals can receive as much as $63,750 over six years. A table that outlines the maximum EHR incentive payment for Medicare eligible professionals appreas on page 4. CMS Expected to Cover Newly-Approved Prostate Drug (June 2010)
The Centers for Medicare and Medicaid Services (CMS) is expected to cover a newly-approved prostate cancer drug that will cost approximately $93,000 for three infusions. The new drug, Provenge, is designed to use a patient’s immune system to fight prostate cancer. According to a Food and Drug Administration press release, “The median survival for patients receiving Provenge treatments was 25.8 months as compared to 21.7 months for those who did not receive the new treatment.” Coverage for the drug will be provided under Medicare Part B. Medicare patients would still be required to cover 20 percent of the drug’s cost. You can read more about the FDA’s approval of Provenge at www.fda.gov. House Approves Legislation to Repeal Antitrust Exemption for Insurers (April 2010)
The House approved the “Health Insurance Industry Fair Competition Act” (H.R. 4626) by a vote of 406-19 on February 24. The legislation would repeal the federal antitrust exemption enjoyed by health and medical liability insurers provided for under the McCarran-Ferguson Act. The legislation is intended to promote greater competition, support administrative simplification reforms and improve efficiency within the insurance industry. To date, the legislation has not been scheduled for consideration in the Senate. MedPAC Recommends Increase in Physician Fees (April 2010)
The Medicare Payment Advisory Commission (MedPAC) released its semiannual report to Congress entitled, “Report to Congress: Medicare Payment Policy” on March 1. The report recommends rate adjustments in fee-for-service Medicare. Specifically, in its report MedPAC recommended physicians and other Part B providers receive a one percent increase in their fees in 2011. In a news release announcing the report MedPAC stated, “These updates are based on an assessment of payment adequacy taking into account beneficiaries’ access to care, supply of providers, the quality of the care they receive, and Medicare margins.” You may view the entire report at www.medpac.gov. Medicare to Cover HIV Screening (January 2010)
The Centers for Medicare and Medicaid Services (CMS) announced it will cover Human Immunodeficiency Virus (HIV) infection screening for Medicare beneficiaries who are at increased risk for the infection, including women who are pregnant and Medicare beneficiaries of any age who voluntarily request the service. The decision is effective immediately and will cover both standard and US Food and Drug Administration-approved HIV rapid screening tests. The decision to expand coverage for HIV testing is result of a provision contained in the “Medicare Improvements for Patients and Providers Act of 2008” (MIPPA), which allows CMS to add to the list of covered preventive services, if certain requirements are met. H1N1 Flu Emergency Declared (November 2009)
President Obama declared the H1N1 flu outbreak a national emergency on October 23. The declaration will allow the temporary waiver of certain federal requirements allowing local hospitals to carry out emergency plans. Under federal law, the Secretary of Health and Human Services may grant waivers only after the President declares a national emergency and the Secretary has declared a public health emergency. Regulations that may be waived are those related to Medicare, Medicaid and the Children�s Health Insurance Program, among others. Waivers were last used during Hurricane Katrina, flooding in North Dakota and the 2009 presidential inauguration. Is Your National Provider Identifier Information Up to Date? (August 2009)
The National Plan and Provider Enumeration System (NPPES) has issued nearly three million National Provider Identifiers (NPIs) since 2005. More than 700,000 NPIs have been assigned to physicians. Certain information in the NPPES is made available to the public. As such, it is essential to keep your information up to date. Medicare regulations require that any changes be reported within 30 days. The Centers for Medicare and Medicaid Services is encouraging all physicians to review their data and up date it where necessary. If you have not already established an NPPES user id and password you may obtain assistance by contacting the NPI Enumerator at 1-800-465-3203. ACOI Supports Coverage of Preventive Vaccines Under Medicare (July 2009)
The ACOI joined other physician associations in calling on Kathleen Sebelius, Secretary of the U.S. Department of Health and Human Services, to direct CMS to include all recommended preventive vaccines within the �additional preventive services� eligible for coverage under Medicare Part B. Section 101 of the �Medicare Improvement for Patients and Providers Act of 2008� (MIPPA)(Pub. L. 110-275) granted CMS the authority to cover �additional preventive services� under Medicare Part B. Medicare beneficiaries currently have access to the influenza, pneumococcal and Hepatitis B vaccines under Medicare Part B. While other recommended preventive vaccines are available under Medicare Part D, there are barriers that make it difficult for certain beneficiaries to receive the vaccinations. Consolidation of all vaccines under Medicare Part B will promote the interests of Medicare beneficiaries by advancing Medicare�s focus on prevention. Medicare Issues Fraud Alert (July 2009)
The Centers for Medicare & Medicaid Services (CMS) has become aware of a scam where perpetrators are sending faxes to physician offices posing as the Medicare carrier or Medicare Administrative Contractor (MAC). The fax instructs physician staff to respond to a questionnaire to provide an account information update within 48 hours in order to prevent a gap in Medicare payments. The fax may have the CMS logo and/or the contractor logo to enhance the appearance of authenticity. Medicare fee-for-service providers, including physicians, non-physician practitioners, should be wary of this type of request. If you receive a request for information in the manner described above, please check with your contractor before submitting any information. Medicare providers should send information to a Medicare contractor using only the address found in the download section of the CMS.gov website found at www.cms.hhs.gov/MLNGenInfo or www.cms.hhs.gov/MedicareProviderSupEnroll. Health and Human Services and Office of the
Attorney General Confront Medicare Fraud (June 2009)
Health and Human Services (HHS) Secretary Kathleen Sebelius and Attorney General Eric H. Holder, Jr. announced the creation of an interagency team devoted to combating Medicare fraud on May 20. It is estimated that Medicare fraud costs the federal government billions of dollars each year. The Health Care Fraud and Prevention and Enforcement Action Team (HEAT) will allow for the coordination of efforts by the two agencies. The team will be made up of law enforcement agents, prosecutors and staff members from HHS and the Department of Justice. The new interagency team will meet bi-weekly. According to Secretary Sebelius, �For every dollar we invest in fraud prevention and oversight at least $1.55 comes back for the taxpayer.�
Healthcare Reform Package Continues To Develop (June 2009)
The House and Senate continue to develop legislation to reform the health care system. To date, the House Committees on Ways and Means, Energy and Commerce and Education and Labor have held or scheduled hearings on multiple facets of health care reform. The Senate Committees on Finance and Health, Education, Labor and Pensions (HELP) have also conducted hearings. It is expected that legislative language will be released in the next few weeks with committee mark-ups occurring shortly thereafter. The ACOI will be certain to share information as it becomes available. For additional information on health care reform efforts, you may contact Tim McNichol at tmcnichol@acoi.org or by calling toll-free 1-800-327-5183.
CMS Announces Coverage of Bariatric Surgery (April 2009)
CMS has announced that Medicare will provide coverage for bariatric surgery when it is used to treat morbidly obese Type 2 diabetics. Coverage will be provided only if the surgery is performed at a CMS-approved facility. The four types of bariatric surgeries that will be covered are: Gastric bypass, open and laparoscopic Roux-en-Y gastric bypass, laparoscopic adjustable gastric banding, and an open and laparoscopic biliopancreatic diversion with duodenal switch. You may obtain additional information on CMS� website at www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=219
�Sunshine� Act Introduced (February 2009)
Senators Charles Grassley (IA) and Herb Kohl (WI) introduced a bill entitled the �Physician Payments Sunshine Act of 2009� (S. 301) on January 22. The legislation would require pharmaceutical companies and device manufactures to publicly disclose any gifts to doctors that in the aggregate exceed $100 per year. S. 301 also would require that any applicable manufacturer or group purchasing organization disclose ownership or investment interests by physicians or immediate family members in publicly traded securities or mutual funds. The legislation would provide for civil penalties for those who fail to file required reports. Product samples not intended for sale, educational materials that directly benefit patients and discounts, among other items, would be exempted from reporting requirements. S. 301 has been referred to the Senate Finance Committee where no further action has been taken. The ACOI will continue to analyze and monitor this legislation.
Court Issues Ruling Protecting Physician Privacy (February 2009)
The District of Columbia Circuit Court issued a ruling protecting the privacy of physicians on January 30. In Consumers� Checkbook v. Department of Health and Human Services, the Court held that certain Medicare claims data for physicians are not subject to Freedom of Information Act (FOIA) requests. Specifically, Consumers� Checkbook requested data including diagnosis, course of treatment and the physician identifying number, among other items, for all Medicare claims. The court found that while there was no substantial public interest for the data, there was a substantial privacy interest for physicians. The Court reasoned that the information requested along with already publicly available data would make it possible to calculate an individual physician�s personal salary. As a result, the Court held that HHS could not be required to release the data requested.
House Republicans Establish Healthcare Reform Task Force (February 2009)
House Minority Leader John Boehner (OH) announced the formation of a task force to develop health care reform options. The task force is led by representative Roy Blunt (MO). The 16 member task force was developed to look at options to reduce the cost of care while increasing accessibility through market-based strategies. While the task force will be able to produce legislative initiatives, the rules of the House in conjunction with the minority status of the task force members makes it unlikely that they will be able to develop bills that will be considered by the full House. It may provide the minority with new policy positions, however, that could be used in future negotiations of healthcare reform legislation advanced by the majority.
$1.12 Billion Recovered in Healthcare Fraud Settlements and Judgments in 2008 (January 2009)
The Department of Justice (DOJ) recently announced the recovery of $1.12 billion in healthcare fraud settlements and judgments in fiscal year (FY) 2008. A majority of the recoveries, 78 percent, stemmed from actions brought by individuals under the False Claims Act. According to a statement released by the DOJ, healthcare accounted for the majority of the total $1.34 billion in total fraud and abuse claims recoveries in FY 2008. The largest area of healthcare fraud recoveries involved pharmaceutical companies and related entities.
CMS Set to Recalculate 2007 PQRI Data (January 2009)
CMS announced that it is recalculating the data on the 2007 Physician Quality Reporting Initiative (PQRI). According to a representative at CMS, a number of technical issues have been identified that could result in a larger instance of �valid reporting.� One example that was given was the improper removal of national provider identifiers (NPIs) by electronic claims clearinghouses. CMS believes that the review will result in additional payments being made to participants in the 2007 PQRI program. Eligible providers will receive payments in late 2009.
CMS Releases Quality Ratings for Long-Term Care Facilities (January 2009)
The Centers for Medicare and Medicaid Services (CMS) released a new five-stare quality rating system for long-term care facilities on December 18. The new system rates 15,800 Medicare and Medicaid participating facilities. According to Kerry N. Weems, Acting Administrator, the five-star system is based on data derived from annual health inspections, quality measures reported by nursing homes and staffing information reported by nursing homes. The top facilities are given a rating of four or five stars, while the lowest performing facilities are rated one star. You can learn more about the rating system at www.Medicare.gov.
"Medicare Trigger� Removed Under House Rules Package (January 2009)
Following the convening of the 111th Congress, the House adopted the rules that will govern the operation of the legislative body for the next two years by a vote of 242-181. Included in the rules package (H Res 5) is a line stating that the Medicare trigger �shall not apply.� A trigger was created under the 2003 �Medicare Modernization Act� (MMA)(Pub. L. 108-173) requiring the President to submit, and congress must consider, legislation to curb spending under the Medicare program if 45 percent or more of Medicare�s funding comes from general tax revenues for two years in a row. The rule change does not amend the law in that the President may still have to put forth a proposal. As a result of the rule change, the House would not have to consider legislation proposed in response to the trigger.
Implementation of �Red Flag� Rule Delayed (December 2008)
The Federal Trade Commission (FTC) issued �Red Flag Rules� in a final rule on November 9, 2007. The final rule requires financial institutions and creditors to put in place identity theft prevention programs to identify, detect and respond to specific activities that could indicate identity theft. The FTC suggested recently that that the term �creditor� defined as, �any entity that regularly extends, renews or continues credit�,� is applicable to physicians. In response to concerns raised by the physician community, the FTC announced a delay in implantation of the rule until May 1, 2009. The ACOI will continue to monitor this situation closely.
FDA Publishes Final Rule on Adverse Event Reporting (December 2008)
The Food and Drug Administration (FDA) published a final rule entitled, �Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products� in the Federal Register on October 28. The final rule confirms the interim final rule issued on January 3, 2008. Under the rule, certain human drug products will require labeling that includes a toll-free number for reporting side effects. The statement must also note that the number is not intended for medical advice. The final rule implements provisions of the Best Pharmaceuticals for Children Act (Pub. Law 107-109) and the Food and Drug Administration Amendments Act of 2007 (Pub. Law 110-85). The final rule is to be effective on November 28 and compliance must be achieved by July 1, 2009.
PhRMA Issues Updated Code of Conduct (September 2008)
Pharmaceutical Research and Manufacturing of America (PhRMA) recently announced the adoption of an updated Code of Interactions with Healthcare Professionals for its member companies that will take effect in January, 2009. While companies who violate the new code of conduct will not face any penalties, it is expected that public scrutiny and pressure by competitors will drive compliance. Specifically, the updated code will place a ban on restaurant meals for physicians and will prohibit PhRMA member companies from paying for entertainment and recreation. This includes tickets to the theatre, sporting events, sporting equipment and leisure or vacation trips. The new code of conduct does not prohibit in-office or in-hospital meals for physicians or staff if the meal is part of an �educational presentation.� In addition, the code addresses payments for speeches, continuing medical education, consulting arrangements and scholarships. All of PhRMA�s member companies have endorsed the code and will publicly certify compliance. You may view the code in its entirety at www.phrma.org.
FDA Finalizes Label Change Rules (September 2008)
The Food and Drug Administration (FDA) finalized a rule amending when a pharmaceutical company can change the labeling of an already-approved drug, biologic, or medical device. The rule takes effect on September 22, 2008. Under the final rule, there are a few instances when a supplemental application should be submitted to amend labeling for an approved product to reflect newly obtained information. While concerns have been expressed that the rule will make it more difficult to alter labels, the FDA in the rule stated that, �This rule will not make it more difficult to provide appropriate warnings regarding hazards associated with medical products.� Some trade organizations have expressed continued concerns with the final rule and its potential impact on patient safety.
CMS Announces PQRI Bonus Payments (August 2008)
The Centers for Medicare and Medicaid Services (CMS) announced the release of more than $36 million in bonus payments under the Physician Quality Reporting Initiative (PQRI). According to CMS, over 56,700 providers satisfactorily reported quality information under the 2007 PQRI. According to a statement released by CMS on July 15, individual participants averaged $600 in incentive payments while group practices averaged payments of over $4,700. One group practice received a payment totaling $205,700. CMS stated that payments should be received by the end of August. For additional information on the PQRI program, you may visit www.cms.hhs.gov/PQRI.
CMS Issues E-Prescribing Regulations (May 2008)
The Centers for Medicare and Medicaid Services (CMS) issued a final rule for electronic prescribing standards under the Medicare prescription drug benefit on April 2. While physicians are not currently required to use electronic prescribing, those who do so will have to follow the new standards when electronically transmitting prescriptions and prescription information for covered drugs for Medicare beneficiaries under the Medicare prescription drug program or Medicare Part D.
The final rule establishes the following requirements: give prescribers information about which drugs are covered by a Medicare beneficiary�s prescription drug benefit plan; provide prescribers with information about medications a beneficiary is already taking, including those prescribed by other providers, to help reduce the number of adverse drug events; and allow prescribers to receive an electronic notice from the pharmacy telling them that a patient�s prescription has been picked up, not picked up, or has been partially filled, to help monitor medication adherence in patients with chronic conditions, among other things. In announcing the final rule, Department of Health and Human Services (HHS) Secretary Michael O. Leavitt stated, �Establishing standards for e-prescribing under Medicare�s prescription drug program will help pave the way for widespread adoption of e-prescribing throughout the medical community. The final rule is effective April 1, 2009.
Legislation Introduced to Require Reporting of Gifts to Physicians (May 2008)
U.S. House of Representative Ways and Means Health Subcommittee Chairman Fortney �Pete� Stark and Representative Peter DeFazio introduced the �Physician Payment Sunshine Act of 2008� (H.R. 5605) on March 13. The legislation was introduced to require the disclosure of certain information by prescription drug and medical device manufacturers. Under the bill, the manufactures would be required to report any gift to a physician with a value of $25 or more. The reported information is to be made publicly available to help ensure marketing by drug and medical device manufacturers does not adversely impacting the health care delivery system. H.R. 5605 is a companion bill to S. 2029 introduced by U.S. Senators Charles Grassley and Herb Kohl. Both bills await action by their respective chambers of Congress.
HHS Announces EHR Demo (March 2008)
The Department of Health and Human Services (HHS) announced on February 20, a demonstration project that will provide Medicare incentive payments to physicians for the use of certified electronic health records (EHRs) to improve patient care. The demonstration project is directed at small and medium-sized primary care physician practices with the intent of reducing medical errors and improving the quality of care. The program is intended to impact the delivery of care for approximately 3.6 million Americans. According to HHS, total payments under the demonstration for all five years may be as much $58,000 per physician or $290,000 per practice. The application period is open through Mid-May. For more information on the demonstration program, you may visit www.cms.hhs.gov.
Medicare Spending Experiences Largest Annual Increase in 25 Years (January 2008)
A report examining the annual healthcare spending in the United States was published recently in the journal Health Affairs. According to the released findings, healthcare expenditures in 2006 totaled about $2.1 trillion. This amounts to spending about $7,026 per person and is a 6.7 percent increase over 2005 levels. Also included in this data is a finding that Medicare spending rose to about $401.3 billion in 2006 from $338 billion the previous year. While a large part of the Medicare increase from 2005 levels is attributed to the first full year of the Medicare prescription drug benefit ($41 billion), the 18.7 percent increase in Medicare outlays was the largest in 25 years. In light of this and other data contained in the report, the cost and availability of healthcare services is certain to remain a hot topic in healthcare policy circles.
CMS Releases List of Poor Performing Nursing Homes (December 2007)
The Centers for Medicare and Medicaid Services (CMS) recently released the first list of the nation�s poor-performing nursing homes. According to CMS, �Nearly three million Americans, most of who are enrolled in Medicare or Medicaid, depend on the nation�s 16,000 nursing homes at some point during each year to provide life saving care.� The list was released in an effort to provide consumers with valuable information and to promote improvements in the quality care provided to nursing home residents. The list of the 52 worst-performing special focus facilities (SFF), as designate by CMS, can be viewed at www.hhs.gov/.
New Preventive Services Guide Made Available by CMS (October 2007)
CMS announced the availability of the 2nd Edition of �The Guide to Medicare Preventive Services for Physicians, Providers, Suppliers, and Other Health Care Professionals.� The guide provides fee-for-service physicians and others with coverage, coding, billing and reimbursement information for preventive services and screenings covered by Medicare. You can obtain a copy of the guide by visiting the Medicare Learning Network (MLN) at www.cms.hhs.gov/MLNGenInfo/.
CMS Issues Final Physician Self-Referral Rules (October 2007)
The Centers for Medicare and Medicaid Services issued final regulations prohibiting physicians from referring Medicare patients for certain designated health services (DHS) provided by businesses in which they or their immediate family members have a financial interest, unless an exception applies. This regulation is Phase III of the physician self-referral law which is often referred to as the Stark Law. According to CMS, �The rule does not establish any new exceptions to the physician self-referral prohibition, but rather makes certain refinements that could permit or, in some cases, require restructuring of some existing arrangements.� In order to obtain more information on the physician self-referral law, you may visit www.cms.hhs.gov/physicianselfreferral/.
Final NCD for Use of Anemia Drugs in Cancer Treatments Issued by CMS
(August 2007)
The Centers for Medicare and Medicaid Services (CMS) released a final national coverage decision (NCD) to limit Medicare coverage of Erythropoiesis Stimulating Agents (ESAs) on July 30. Under the final NCD, which is effective immediately, CMS limited Medicare coverage of ESAs for certain cancers and related neoplastic conditions. The final coverage decision was issued after reviewing and including comments provided by the ACOI and others. In its comments, the ACOI raised concerns with CMS�s one-size-fits all approach to cancer care and suggested further review of additional data. You may view the final NCD www.cms.hhs.gov/mcd/viewdecisionmemo.asp?id=203.
Physician Quality Reporting Initiative Underway (July 2007)
Reporting is underway for the 2007 Physician Quality Reporting Initiative (PQRI) on claims for dates of service as of July 1. Physicians who participate in the PQRI may qualify for bonus payments totaling 1.5 percent by reporting the appropriate quality measure data on claims submitted to their Medicare claims processing contractor. Links to additional information and materials, including the PQRI Tool Kit and frequently asked questions (FAQs), are available at http://www.acoi.org/GovRelationsLinks.html.
CMS Addresses Looming NPI Compliance Deadline (April 2007)
The Centers for Medicare and Medicaid Services (CMS) has announced a mechanism to address non-compliance with the National Provider Identifier (NPI) final rule. All covered entities must utilize NPIs and replace �legacy identifiers� by May 23, 2007, except for small plans, which must be in compliance by May 23, 2008. Recognizing that covered entities may not be able to be in full compliance by May 23, 2007, CMS has announced a contingency plan. CMS has announced that it will rely on voluntary compliance and utilize a complaint driven process after May 23, 2007 for covered entities that fall under the earlier deadline. If a complaint is registered for non-compliance, the covered entity accused of failure to comply with the NPI provisions will have the option to demonstrate compliance, document its good faith efforts to comply with the standards and/or submit a corrective action plan. CMS has stated that it will review non-compliance complaints on a case-by case basis. According to CMS, contingency plans may not extend beyond May 23, 2008. To this end, you are encouraged to obtain and utilize your NPI as soon as possible. Additional information on the NPI can be found at the Centers for Medicare and Medicaid Services� webpage at www.cms.hhs.gov/.
Preventive Services Covered by Medicare Expanded for 2007 (January 2007)
The number of preventive and screening services under the Medicare program has expanded as a result of a series of legislative enactments. The additional services, a �Welcome to Medicare� physical exam, cardiovascular screening, additional cancer tests and more, are available to beneficiaries who are enrolled in Medicare Part B. For additional information on these and other benefits, visit www.medicare.gov/Health/Overview.asp.
CMS Launch Medicare Preventive Services Outreach (June 2006)
Building on efforts to educate Medicare beneficiaries and providers about the Medicare Part D drug benefit, Centers for Medicare and Medicaid Administrator Mark McClellan, MD announced efforts to conduct outreach to promote the use of preventive services. According to McClellan, Medicare screening benefits are used by 50 percent or fewer of beneficiaries. Current statistics show the utilization rate for pap tests and pelvic exams is 36.3 percent; prostate cancer screening is 54.2 percent; screening mammograms is 54.7 percent; obtaining a pneumonia and flu shot is 65.2 percent and 68 percent respectively; and, cardiovascular screening is 82.6 percent. It is believed that greater utilization of these and other preventive services could save billions of dollars in medical expenses and preventable medical conditions.
Utilization of National Provider Identifiers Approaching (May 2006)
All health care providers must begin using National Provider Identifiers (NPIs) in Health Insurance Portability and Accountability Act (HIPAA) transactions by May 23, 2007. Failure to do so could result in the denial of claims. If you have not applied for your NPI, you may do so by doing one of the following:
- Accessing the web-based National Plan and Provider Enumeration System (NPPES);
- Filling out a paper NPI application/update form and mailing it to the NPI Enumerator; or
- Having your NPI application information, along with the application information submitted to NPPES through the Electronic File Interchange (EFI) by an organization on your behalf.
CMS Releases Physician Voluntary Reporting Program Information (April 2006)
The Centers for Medicare and Medicaid Services (CMS) released additional information on how to participate in the Physician Voluntary Reporting Program (PVRP). Under the program, CMS will ask physicians to voluntarily report information to CMS about the quality of care they provide to Medicare beneficiaries.
Through participation in the program, physicians will help gather data about the quality of care provided to Medicare beneficiaries and will help identify the most effective ways to use quality measures in practice to improve quality of care. In addition, physicians who participate in the PVRP will begin to receive data feedback on the measures. This will allow participants to compare the quality of care they provide with that of their peers. The program is starting with 16 quality measures; seven are primary care measures, two are for emergency physicians, two are for nephrologists and five are for surgeons. Detailed information about the PVRP may be obtained at www.cms.hhs.gov/PVRP/01_Overview.asp. Physicians may register to participate in the program by visiting www.quality.net.prg/pvrpintent.
HHS Issues Final Rule on Imposition of Penalties for HIPAA Violations (April 2006)
The Department of Health and Human Services (HHS) released its final rule on the imposition of civil monetary penalties for violating the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The final rule, which took effect March 16, 2006, clarifies the investigation process, bases for liability, determination of the penalty amount, grounds for a waiver, conduct of the hearing and the appeals process. Under the final rule, a civil monetary penalty may not exceed more than $100 per violation and $25,000 per calendar year. In addition, the rule sets forth safeguards to prevent imposition of a penalty even if a violation of the HIPAA rules occurred. Detailed information on the final rule may be viewed at www.hhs.gov/ocr/hipaa/.
CMS Releases Medicare Remit Easy Print Software (March 2006)
The Centers for Medicare and Medicaid Services (CMS) announced the availability of Medicare Remit Easy Print (MREP) software. The software is available from your Medicare carrier or Durable Medical Equipment Regional Carrier�s (DMERC) website. MREP software allows physicians to view and print Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant 835s. The software allows physicians to print, view and search remittance information, among other things. Additional information on the MREP software can be obtained at www.cms.hhs.gov/MedlearnMattersArticles/downloads/se0611.pdf.
CMS Announces Oncology Demonstration Project (February 2006)
The Centers for Medicare and Medicaid Services (CMS) has announced implementation of the Medicare Oncology Demonstration Project for 2006. The one-year demonstration project is to identify and assess office-based oncology practices and services to improve upon the efficient and effective delivery of oncological services to Medicare beneficiaries in thirteen diagnostic categories.
Participation in the project is voluntary and limited to physician specialists in the areas of hematology, medical oncology, and hematology/oncology. For additional information, you may contact Tim McNichol at tmcnichol@acoi.org or by calling toll-free 1-800-327-5183.
Medicare Prescription Drug Formularies Available (February 2006)
The President signed into law the �Medicare Prescription Drug and Modernization Act of 2003� (MMA) (P.L. 108-173) on December 8, 2003. Included in the MMA was a provision establishing Part D of the Medicare program to provide prescription drug benefits to Medicare beneficiaries. The benefit took effect January 1 and enrollment continues until May 15.
In order to assist in patient care and determine whether specific drugs are covered under a plan�s formulary, there are several resources that may be of assistance. Epocrates, Inc. has provided their comprehensive formulary through its free Epocrates Rx� software. The software can be downloaded at www.epocrates.com. In addition, the Centers for Medicare and Medicaid Services (CMS) created a web-based formulary finder at http://formularyfinder.medicare.gov/formularyfinder/selectstate.asp.