Health Industry Washington Watch : Washington DC Healthcare Industry Law Firm : Reed Smith : Health Industry Washington Watch : Regulations, Medicare/Medicaid, Governmental Organizations

The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Legislative Developments.  President Obama convened a bipartisan health reform summit. The House of Representatives has approved a bill to temporarily extend current physician fee schedule payments and extend the Medicare outpatient therapy cap exceptions process, along with legislation to repeal the antitrust exemption for health insurance companies. A number of recent hearings have focused on health policy issues.
• Other HHS Developments.  CMS has released its Advance Notice of 2011 Medicare Advantage/Part D payments, extended a Medicare Secondary Payer (MSP) reporting deadline, issued guidance on DME telemarketing, delayed its PECOS enrollment requirement for ordering physicians, and announced an organizational realignment. FDA has issued a proposed rule on reporting information on falsification of data, announced an initiative with NIH to speed patient access to new therapies, and updated its listing of specific drugs that are being evaluated for potential safety issues. HHS has announced relief for state Part D drug cost expenses, released the names of entities reporting certain breaches of protected health information, and has addressed enforcement of the HITECH business associate requirement.
• Health Industry Events. CMS is holding meetings/educational calls on DMEPOS competitive bidding, the PQRI and E-prescribing, Part D data, and HCPCS code applications. The FDA is hosting meetings on clinical trial requirements and reducing radiation exposure. HHS is hosting a workshop on the HIPAA Privacy Rule’s de-identification standard.
• OIG & GAO Reports. The OIG has issued reports on RAC fraud referrals and ASP reporting and pricing. The GAO has reported on electronic personal health information exchange.

 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• President Obama Releases FY 2011 Budget Request. The Obama Administration has released its proposed federal budget for FY 2011. In its budget documents, the Administration reaffirms its commitment to enacting health reform legislation, and it addresses a number of other health policy initiatives.
• Legislative Developments.  In an effort to jump-start progress on stalled health reform legislation, President Obama has invited Democratic and Republican lawmakers to a half-day, televised health reform summit on February 25, 2010. Separately, Congress has approved “PAYGO” budget rules that include funding for a Medicare physician fee schedule fix, and a bipartisan Senate jobs bill would extend a variety of expiring health policy provisions.
• Regulatory Developments. The Obama Administration has released regulations implementing the Paul Wellstone and Pete Domenici Mental Health Parity and Addiction Equity Act of 2008. HHS published a notice announcing the adjusted Federal Medical Assistance Percentage rates for the first quarter of FY 2010.
• Other HHS Developments. Reed Smith reports on the National Summit on Health Care Fraud sponsored by HHS.   CMS has rescinded its controversial DMEPOS "consignment closet" policy. CMS also has released new data on health spending growth in 2009, along with information on physician enrollment, off-label cancer drug use, and DMEPOS competitive bidding, and it is accepting recommendations for technical expert panel on ESRD quality measures.  FDA has issued a number of guidance documents involving clinical trials and prescription drugs, and the agency has announced an initiative to protect patients from unnecessary radiation exposure associated with medical imaging.
• OIG & GAO Developments. The GAO has issued a report assessing early implementation of the Patient Safety and Quality Improvement Act of 2005. The OIG has released several reports on Medicare reimbursement for Part B prescription drugs.
• Health Industry Events. CMS is holding educational calls and/or meetings on provider enrollment issues, DMEPOS competitive bidding, HOPPS Ambulatory Payment Classification groups, and the Part D prescription drug program. The FDA is hosting a meeting on clinical trial requirements.

 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Health Reform Update. After devoting much of the last year to crafting comprehensive health reform legislation, the election of Republican Scott Brown in the Massachusetts special election to fill the late Senator Edward Kennedy’s seat has thrown into doubt the fate of these efforts. A number of options are under consideration to potentially advance health reform legislation, each of which has political challenges. 
• President Obama Delivers State of the Union Address.   On January 27, 2010, President Obama delivered his State of the Union address to Congress, in which he reaffirmed his commitment to enacting health reform legislation. 
• Other Legislative Developments. On February 1, 2010, President Obama is scheduled to deliver his proposed federal budget for fiscal year 2011, which is likely to include proposals impacting federal health care policies. Several Congressional panels have scheduled hearings on the budget, including a hearing focusing on the health policy provisions.
• HHS Developments. CMS has announced its approval of three accreditation organizations for imaging suppliers, and it has released a transmittal highlights program integrity issues for Medicare contractors. HHS and DOJ are convening a “National Summit on Health Care Fraud.” HHS has released a variety of reports on state health information laws and policies. HRSA has published a final rule on National Practitioner Data Bank adverse action reporting
• OIG & GAO Developments. The HHS OIG has issued reports on documentation requirements for DME claims and Medicaid drug payment issues. A GAO report examines how CMS handles violations of Medicare Advantage marketing rules.
• Odds & Ends. MedPAC has voted on recommendations it will make to Congress regarding Medicare payment updates for 2011. The Federal Trade Commission has released a “staff study” entitled “Pay for Delay: How Drug Company Pay-Offs Cost Consumers Billions.”
• Health Industry Events. CMS is holding meetings on DMEPOS competitive bidding, applications for IPPS/HOPPS new medical service and technology payments, and HOPPS Ambulatory Payment Classification groups. The FDA is hosting meetings on incorporating new science into CDRH regulatory decisionmaking, and clinical trial requirements.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Health Reform Update. The House has returned from its winter break to start the second session of the 111^th Congress, and the Senate returns to business next week. At the top of the Congressional agenda is reconciling the differences between the separate health reform bills approved by the House and Senate late last year. While the overarching goals of the two bills are the same – to expand access to high-quality, affordable health care and reduce health care costs – there are numerous differences in the approaches the two chambers take. 
• Regulatory Developments. HHS has released two health information technology (HIT) rules: an interim final rule with comment period on HIT standards, implementation specifications, and certification criteria, and a proposed rule implementing the American Recovery and Reinvestment Act electronic health record incentive payment provisions. CMS has published a notice correcting errors in the final 2010 HOPPS/ASC rule, including corrections to ASC payment rates. CMS is seeking comments on voluntary children's health care quality measures. The OIG has published its annual safe harbor/fraud alert solicitation. The FDA is proposing amending its informed consent regulations to inform subjects of potential disclosures of information to the NIH clinical trials database. CMS has withdrawn a proposed Medicaid rehabilitation coverage rule and further delayed final Medicaid benefits and cost-sharing flexibility rules. CMS also has released the Federal Medical Assistance Percentages for FY 2011. 
• Other HHS Developments. CMS has issued guidance on the processing of Medicare claims in light of a two-month freeze in physician fee schedule payments, along with information regarding the expiration of certain Medicare payment policies (including the therapy cap exceptions process). CMS also has issued instructions on the implementation of a new home health outlier payment policy. In addition, CMS has posted the 2010 Medicare clinical laboratory fee schedule. CMS has announced national health spending growth figures for 2008, and HHS has released a new National Health Security Strategy. The FDA has issued guidance to encourage the contingency production plans for the manufacture of medically-necessary drug products during emergencies.
• OIG & GAO Developments. The OIG has updated its 2003 Special Fraud Alert on telemarketing by DME suppliers.   Recent OIG reports address disclosure of hospital adverse events and enteral nutrient pricing for Medicare beneficiaries in non-Part A nursing home stays. The GAO has reported on Medicaid outpatient prescription drug pricing, brand-name prescription drug products with "extraordinary" price increases, nursing home quality, and uncompensated hospital care costs.
• Health Industry Events. CMS is holding educational calls and/or meetings on the Physician Quality Reporting Initiative (PQRI) and Electronic Prescribing (eRx) Incentive Programs, applications for IPPS/HOPPS new medical service and technology payments, and HOPPS Ambulatory Payment Classification groups. The FDA is hosting meetings on genetic toxicology, medical device interoperability, incorporating new science into CDRH regulatory decisionmaking, and clinical trials.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Legislative Developments. The Senate is considering Majority Leader Harry Reid’s "manager's amendment" to the pending Senate health reform bill. Congress has cleared a short-term delay in a scheduled 21.2% Medicare physician fee schedule payment cut. The House has approved a temporary extension of enhanced Medicaid matching funds, and the HHS appropriations bill for FY 2010 has been signed into law. 
• Regulatory Developments. CMS has published a notice correcting the 2010 Medicare physician fee schedule rule, which further decreases the 2010 conversion factor.   HHS has published its semiannual regulatory agenda, along with rules regarding Medicare appeals and federal Medicaid matching payments. 
• Other HHS Developments.  CMS has released the first quarter 2010 Medicare Part B Drug average sales price amounts. HHS has announced the latest expansion of the Medicare Fraud Strike Force, and HHS HIT panels continue to work on developing meaningful use criteria. The FDA has issued guidance on the use of patient-reported outcome measures to support labeling claims. 
• OIG & GAO Reports. The GAO has issued reports on DMEPOS competitive bidding and FDA’s postmarket drug safety oversight. The OIG has reported on Medicare home health outlier payments and Part D plan formulary changes. 
• Looking Ahead. CMS is hosting events on the 2010 PQRI/electronic prescribing requirements; applications for IPPS/OPPS new medical service/technology payments, and ambulatory payment classification groups. The FDA is hosting meetings on genetic toxicology guidance, incorporating new science into CDRH regulatory decisionmaking, and clinical trial requirements.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Legislative Developments. The Senate has begun debate on its major health reform package, while a CMS Office of the Actuary report raises questions about the House-approved plan’s potential to control health care spending. The House has approved Medicare physician payment reform legislation, along with a bill to create a new loan guarantee program to help small health care practices purchase of certain health information technology. A number of Congressional committees have held hearings on health policy issues, and a hearing is scheduled next week on drug pricing.  
• Regulatory Developments. CMS has withdrawn a proposed Medicaid rehabilitation coverage rule and further delayed final Medicaid benefits and cost-sharing flexibility rules. CMS also has released the Federal Medical Assistance Percentages for FY 2011. 
• Other CMS Developments. Among other things, CMS has: posted the 2010 Medicare DMEPOS fee schedule; solicited quality measure suggestions for the 2011 Physician Quality Reporting Initiative (PQRI); issued guidance on home health outlier payments; delayed certain requirements for ordering providers on DMEPOS and other Part B claims; and announced 2009 Medicare and Medicaid improper payment rates.
• OIG & GAO Reports. The HHS OIG has issued its Semiannual Report to Congress for the second half of FY 2009, along with its summary of Top Management and Performance Challenges in the Department of Health and Human Services for FY 2009. The OIG also releases a report on NIH grantees’ financial conflicts of interest policies. The GAO has issued a report on deficiencies in CMS contract management internal controls.
• FDA Developments. The FDA has announced the Safe Use Initiative for drug products and has issued warning letters regarding certain medical products sold via the internet. The agency also is examining the promotion of FDA-regulated medical products using the internet and social media tools. The FDA also has released a number of final and draft guidance documents.
• Odds & Ends. President Obama has issued an Executive Order on “Reducing Improper Payments and Eliminating Waste in Federal Programs.” MedPAC has released a report to Congress on “Measuring Regional Variation in Service Use,” and the Congressional Budget Office has issued an Economic and Budget Issue Brief on "Promotional Spending for Prescription Drugs." HHS has announced a restructuring of the Office of the National Coordinator for Health Information Technology.
• Health Industry Events. CMS is holding educational calls and meetings on OASIS-C , the 2009 PQRI, and applications for IPPS/OPPS new medical service and technology payments. HIT Policy and Standards Committee meetings also have been scheduled.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Legislative Developments. The House of Representatives has approved major health reform legislation, and attention now shifts to the Senate. The Ryan White HIV/AIDS Extension Act has been signed into law, medical isotope product legislation has passed the House, and several Congressional panels have held hearings on health policy issues. 
• Regulatory Developments. CMS has issued the final Medicare physician fee schedule, hospital outpatient prospective payment system (PPS), ambulatory surgical center payment system, and home health agency PPS rules for calendar year 2010. HHS has published an interim final rule with comment period strengthening HIPAA enforcement provisions, along with guidance documents addressing institutional review board review of research. The FTC has announced it is further extending the enforcement date for its Red Flag identity theft rules
• Other HHS Developments. CMS has posted the 2010 update to the HCPCS code set, and the agency is accepting applications for the 2011 HCPCS update. CMS also is instituting new requirements related to the ordering/referring provider on a DMEPOS claim. In addition, CMS is hosting a provider conference call on the ICD-10-CM/PCS MS-DRG Conversion Project. AHRQ has released a "Horizon Scan" on the impact of third-party payment on clinical trials. The HHS OIG has issued reports on Part D fraud and abuse, reassignment of Medicare benefits, and renal dialysis facility ESA policies. 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Legislative Developments. Yesterday House Democratic leaders unveiled the Affordable Health Care for America Act, which House leaders hope to bring to the House floor for a vote next week. The Senate failed on a procedural vote to allow consideration of a bill to avert an upcoming Medicare physician fee schedule cut, while House members have released their plan to fix the Medicare fee schedule formula. Legislation also is moving through Congress to: exempt certain small health practices from identity theft “Red Flags” rule; promote generic drug competition; end insurance anti-trust protections; reauthorize the Ryan White HIV/AIDS program; and support U.S. medical isotopes production. A number of Congressional committees have held hearings on health policy issues, including strategies to prevent health care fraud.
• Regulatory Developments. CMS has updated its inpatient rehabilitation facility (IRF) services coverage rules and manual provisions to conform to policies adopted in the August 7, 2009 IRF PPS rule; a provider education call also has been scheduled on the new policies. CMS has proposed further delaying two rules regarding Medicaid benefit packages and beneficiary cost-sharing. In addition, CMS has announced Medicare Part A and Part B premium and deductible levels for 2010.  
• Other HHS Developments. CMS has officially opened the bidding window for the Round 1 Rebid of the Medicare DMEPOS competitive bidding program and announced various upcoming deadlines for participation in the program. AHRQ is seeking comments on a draft technology assessment regarding off-label uses of cancer therapies. The FDA has issued a number of guidance documents for industry along with a report on new molecular entity postmarketing safety.
• OIG & GAO Reports. The OIG has issued reports on Medicare Part D e-prescribing, adverse event reporting for medical devices, and beneficiary appeals in Medicare Advantage. The OIG also has issued the Health Care Fraud and Abuse Control Program Annual Report and released tips on preventing medical identity fraud. The GAO has issued reports on physician resource use, oversight of clinical investigators, and drugs approved on the basis of surrogate endpoints.   
• Looking Ahead. Upcoming health industry events include CMS meetings and educational calls on DMEPOS competitive bidding, physician resource use measurement, and the Physician Quality Reporting Initiative, and the second meeting of the FDA Transparency Task Force.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Congressional Update. The Senate Finance Committee has approved the “America’s Healthy Future Act,” representing the last step in the committee process before health reform legislation can move to the full Senate for a vote. Legislation also has been enacted to delay Medicare DME accreditation requirements for pharmacies, and Congressional panels have had votes and hearings on a variety of health policy issues.
• Regulatory Developments. CMS has proposed new rules for Medicare Advantage and Part D drug plans. New regulations also have been issued to implement the Genetic Information Nondiscrimination Act of 2008. The FDA has published a proposed rule clarifying postmarketing safety reporting requirements for combination products.  The OIG is seeking information from organizations with the capability to be monitors of health care entities under quality-of-care corporate integrity agreements. 
• Other HHS Developments. CMS has provided an update on the timing for bidding under the DMEPOS competitive bidding program, and it has issued a transmittal to contractors highlighting OIG reports with recommendations to address Medicare’s vulnerability to questionable claims. CMS also is accepting applications for the 2011 HCPCS update. The FDA has issued its “Strategic Plan for Risk Communication,” which outlines how the agency intends to communicate information about the risks and benefits of FDA-regulated products, and it has issued a variety of guidance documents for industry.
• OIG & GAO Reports. The OIG has released its FY 2010 Work Plan, and the GAO has issued reports on nursing home quality of care and utilization of physician services. 
• Odds & Ends. The Office of the National Coordinator for Health Information Technology has released its Consumer Preferences Draft Requirements Document for public comment. The Agency for Healthcare Research and Quality is soliciting applications for $100 million in Recovery Act funding for comparative effectiveness grants. MedPAC recently met to discuss Medicare policy issues.
• Looking Ahead. Upcoming health industry events include meetings and educational calls regarding health information technology policy, the DMEPOS competitive bidding program, the proposed end-stage renal disease prospective payment system, Medicare coverage issues, the OASIS-C home health data set, pediatric clinical trials, transparency in FDA activities, and Medicare physician resource use.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Legislative Developments. Congressional panels continue to debate health reform legislation, with the Senate Finance Committee scheduled to resume markup of its proposal on September 29, 2009. Congressional committees have held hearings recently on other health policy issues, with additional hearings scheduled this week. A Senate committee vote on legislation to promote access to generic drugs also is set for this week.
• Regulatory Developments. CMS has issued a proposed rule to implement a prospective payment system for Medicare end-stage renal disease services, and the agency is hosting a town hall meeting on the rule next month. CMS also has published a final rule on recoupment of overpayments, along with regulations addressing certain Medicare appeals threshold amounts, corrections to the SNF PPS final rule, and state CHIP allotments. The FDA has issued a proposed rule on current good manufacturing practice requirements for combination products, along with a notice on promotion of medical products using the internet and social media and several draft and final guidance documents.
• Other HHS Developments. Under new Medicare Secondary Payer enforcement rules, certain entities that are considered primary payers under the MSP statute and that meet the definition of a responsible reporting entity must register with CMS by September 30, 2009 and comply with certain reporting requirements that begin April 1, 2010. The White House has announced a $25 million HHS patient safety and medical liability reform demonstration. CMS has issued guidance on local coverage determination exceptions, hospice conditions of participation, and surety bond and accreditation requirements for optometrists. CMS also has released the October 2009 Medicare Part B drug ASP update and announced an advanced primary care demonstration project. AHRQ has issued two reports that examine when comparative effectiveness reviews should be updated.
• OIG Reports. The OIG has issued reports on Medicare hospice care for beneficiaries in nursing facilities, Medicare Part D reconciliation payments, beneficiary utilization of albuterol and levalbuterol, and pandemic influenza preparedness.  
• Looking Ahead. Upcoming health industry events include CMS meetings and educational calls on DMEPOS competitive bidding, the Medicare Imaging Demonstration Project, the Medicare Physician Resource Use Measurement Reporting Program, and other Medicare provider and coverage issues; FDA meetings on prescription drug risk information and pediatric clinical trials; and an HHS meeting on gene patents and licensing.

 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:    

• Health Reform Update. Congress returns next week from its August recess, starting a critical period for the fate of health reform legislation. After a turbulent summer of town hall meetings and public wrangling regarding the scope of reform, President Obama will address a joint session of Congress on September 9, 2009 to discuss in more detail his vision for the legislation.
• Regulatory Developments. HHS and the FTC have issued rules on notification of health information breaches. The FDA has issued proposed rules that would require manufacturers and other covered entities to report adverse drug, biological, and device events electronically. The FDA also has reopened its public comment period on ways the agency can enhance the transparency of FDA activities and decisionmaking. HHS has adjusted for inflation the maximum civil money penalty amounts for violations of the confidentiality provisions of the Patient Safety and Quality Improvement Rule. HRSA has published a final notice on how certain children’s hospitals can participate in the 340B program.
• Other HHS Developments.  The White House has announced almost $1.2 billion in funding to help hospitals and other providers use electronic health records, and CMS has issued guidance to states on Recovery Act funding for electronic health records. CMS has delayed implementation of a controversial new policy on DMEPOS “consignment closets” or “stock and bill” arrangements. CMS has made announcements on Medicare coverage for H1N1 vaccine and on value-based purchasing demonstrations. Guidance has been issued on surety bonds for DMEPOS suppliers. AHRQ is seeking public comment on a series of white papers on patient registries. 
• OIG & GAO Reports. The OIG has issued reports on Medicaid fraud data, Medicare payment for power wheelchairs, and ambulance transportation for SNF residents. The GAO has reported on Medicare physician payments for services provided together. 
• Looking Ahead. Upcoming health industry events include FDA meetings on medical device post-approval studies and prescription drug risk information, CMS educational events regarding DMEPOS competitive bidding, an HHS meeting on gene patents and licensing, and CMS meetings on Medicare coverage issues.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:    

• Regulatory Developments -- The FDA has issued two final rules designed to expand access to investigational drugs for treatment use and clarify when patients can be charged for investigational drugs. The FDA also has announced a program setting deadlines for companies to respond to certain inspectional observations for those responses to be considered by the FDA when deciding whether to issue warning letters. CMS has corrected a number of recent Medicare payment rules. HHS is delegating to the Office for Civil Rights the authority to administer and enforce the HIPAA Security Rule. HHS also has announced how it calculating the higher federal matching funds available under the American Recovery and Reinvestment Act of 2009 (ARRA). 
• Other CMS Developments -- CMS has opened registration to all suppliers interested in participating in the Round 1 Rebid of the Medicare DMEPOS Competitive Bidding Program. CMS also has issued guidance on compliance standards for DMEPOS “consignment closets” or “stock and bill” arrangements," along with guidance to state survey agencies and Medicaid directors on a number of issues. CMS also has made a number of announcements regarding the Medicare Part D drug program and Medicare Advantage plans. 
• Other FDA Developments -- The FDA has announced steps it is taking to prevent non-compliant investigators and others from participating in new product development. The FDA also has announced FY 2010 drug and device user fee rates, and it is soliciting comments on draft guidance on genomic biomarkers.  
• Legislative Developments – Lawmakers continue to work to develop health reform legislation. In other areas, the Senate has confirmed the NIH Director, and panels have taken action on funding for HHS, along with whistleblower protection legislation and a bill to strengthen requirements for federal agencies to report and correct overpayment errors. 
• Odds & Ends -- The HHS OIG has issued reports on State Medicaid Fraud Control Units, nonphysicians performing physician services, DME in nursing homes, and pressure-reducing support surfaces. The Federal Trade Commission is delaying until November 1, 2009 enforcement of its Identify Theft Red Flags Rule. The Agency for Healthcare Research and Quality has announced plans to solicit contracts for comparative effectiveness research projects and has updated its "Methods Guide for Comparative Effectiveness Reviews."
• Looking Ahead --Upcoming health industry events include a national provider conference call on the 2009 Physician Quality Reporting Initiative, an FDA Workshop on prescription drug risk information, a series of events to help suppliers prepare for the upcoming Medicare DMEPOS competitive bidding program, and a meeting of the HHS Secretary’s Advisory Committee on Genetics, Health, and Society.

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The Centers for Medicare & Medicaid Services (CMS) recently issued a number of major Medicare payment rules. These include final fiscal year 2010 rules regarding Medicare payment for inpatient hospital, long-term care hospital, skilled nursing facility, inpatient rehabilitation facility, and hospice services, along with a proposed calendar year (CY) 2010 rule updating Medicare payments for home health services. CMS also has announced a detailed timeline for the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive bidding program Round One Rebid. These developments are summarized below.   

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:

• Legislative Developments. Three Congressional panels have now approved versions of comprehensive health reform bills, although delays in Senate Finance Committee and House Energy and Commerce Committee consideration have pushed back the schedule for floor votes. In other health policy legislative news, the House of Representatives has approved the HHS funding bill for FY 2010, and a number of Congressional panels have scheduled hearings and markups, including Senate committee vote on whistleblower protection legislation.
• Regulatory Developments. CMS has issued a proposed rule on improper Medicaid and CHIP payments, and the agency is considering changes to the hospital cost report. CMS also is soliciting proposals for private, for-profit Program of All-Inclusive Care for the Elderly demonstration projects.
• Other HHS Developments. CMS has expanded the information on its Hospital Compare Web site, and it has released an educational article identifying steps suppliers should take in preparation for the upcoming Medicare DMEPOS competitive bidding. The FDA has published a final rule on new drug application reporting requirements, along with a number of draft and final guidance documents and “frequently asked question” documents.
• Odds & Ends. The OIG has issued reports on power wheelchair claims, ultrasound services, Part D drug information, and clinical laboratory payments. The GAO has issued a report on FDA medical product program funding. MedPAC has released its June 2009 Data Book, and the AHRQ has announced the availability of funding for the development of a clinical registry of orthopedic devices, drugs, and procedures.
• Looking Ahead. Upcoming health industry events include a meeting of the Advisory Panel on Ambulatory Payment Classification Groups and an FDA Workshop on prescription drug risk information.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Regulatory Developments. CMS has released major proposed rules that would update the Medicare physician fee schedule, the hospital outpatient prospective payment system, and the ambulatory surgical center payment system for 2010. CMS also has delayed enforcement of a 2008 Medicaid provider tax rule and rescinding three controversial Bush Administration Medicaid rules that also had been blocked by Congress. The NIH has published its final “Guidelines for Human Stem Cell Research,” and the FDA is seeking public input on implementation of the Family Smoking Prevention and Tobacco Control Act.
• Other HHS Developments. CMS has announced an evaluation report on a nursing home survey process. The OIG has issued a report on Medicare Part B chemotherapy administration. AHRQ has released reports on state quality of care and on off-label drug use.
• Legislative Developments. The Senate Health, Education, Labor, and Pensions Committee has released additional details on its health reform package, and the Congressional Budget Office has released cost estimates for two draft reform plans. Congressional committees continue to hold hearings on health reform and other health policy issues. 
• Odds & Ends. Two panels have issued reports on comparative effectiveness research priorities under the American Recovery and Reinvestment Act. The Federal Trade Commission has issued an interim report on the impact of authorized generic drugs on competition in the prescription drug marketplace.
• Looking Ahead. Upcoming health industry events include a CMS meeting on HCPCS codes for negative pressure wound therapy devices, an H1NI Flu Preparedness Summit, meetings on federal health information technology efforts, a CMS meeting on clinical laboratory test payments, and a meeting of the Advisory Panel on Ambulatory Payment Classification Groups.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Legislative Developments: Major health reform legislation has been proposed in the House and Senate, including provisions to expand access to insurance coverage while controlling Medicare and Medicaid costs. The White House also has endorsed additional Medicare and Medicaid cuts. President Obama has signed into law legislation to give the FDA authority to regulate tobacco products. Congressional committees have held a number of hearings on health policy issues, including a hearing on a new FTC report on follow-on biologic drug competition.
• Regulatory Developments. CMS is seeking comments on plans to amend its rules regarding Medicaid home and community-based services waivers, and the FDA is seeking comments on a study on how to present quantitative effectiveness information in direct-to-consumer advertising. 
• Other HHS Developments. HHS is soliciting comments on what constitutes "meaningful use" of electronic health records under the American Recovery and Reinvestment Act (ARRA). CMS has issued guidance on nursing home surveys and state use of civil money penalty funds, ARRA Medicaid and CHIP provisions, and unannounced surveys. CMS also has released the July 2009 Medicare Part B drug average sales price files and announced the availability of funds for states to survey ambulatory surgical centers regarding infection control practices. The agency also is warning of a new scam targeting physician offices. 
• Odds & Ends.  The OIG has posted its Semiannual Report to Congress for October 1, 2008–March 31, 2009. MedPAC has issued a report to Congress on “Improving Incentives in the Medicare Program." AHRQ is seeking comments on a draft technology assessment on the use of Bayesian techniques in randomized clinical trials.
• Looking Ahead. Upcoming health industry events include an HHS meeting on healthcare-associated infections, a CMS meeting on HCPCS codes for negative pressure wound therapy devices, and a CMS meeting on Medicare clinical laboratory test payments.

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The Reed Smith Health Industry Washington Watch blog includes news on Congressional health reform developments, including the following:

• Senate HELP Health Reform Draft Legislation, House Outline Released
• CBO Estimates $1 Trillion Price Tag for HELP Health Reform Bill Without Key Features
• House Chairmen Outline Draft Physician Fee Schedule/SGR Reforms

The blog also reports that the federal Health Information Technology (HIT) Policy Committee is soliciting comments on what constitutes "meaningful use" of electronic health records (EHRs) under the American Recovery and Reinvestment Act. Other recent postings address White House Medicare cut proposals, follow-on biologicals, Part B drug pricing, and MedPAC recommendations for Medicare policy changes.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:

• Regulatory Developments. CMS has published two regulations impacting Medicare payments under the long-term care hospital prospective payment system. The Office of the National Coordinator for Health Information Technology has published a notice regarding regional extension centers to assist providers seeking to adopt and become meaningful users of health information technology.
• Other HHS Developments. CMS has announced additional details on its timeline for implementing the Medicare DMEPOS competitive bidding program, including a January 2011 implementation date. CMS also has released a white paper on "Potential Conflict of Interest in the Production of Drug Compendia." The FDA has formed a transparency task force, and it has released several draft and final guidance documents for industry.
• OIG & GAO Developments. The HHS OIG has audited HHS calculations of Federal Medical Assistance Percentages under the Recovery Act. The OIG also has released its annual compendium of unimplemented OIG recommendations, and has issued reports on Medicare Part D payments for SNF beneficiaries and state Medicaid nonemergency medical transportation services. The GAO has issued reports on privacy and security issues under the FDA Sentinel system and emergency department crowding.
• Legislative Developments. Congressional panels are considering legislation to promote consumer access to generic drugs. A number of Congressional panels have held hearings recently on health policy issues, including health reform and long-term care insurance. Additional hearings are scheduled this month on health reform, follow-on biogicals, whistleblower protections, and medical device regulation.
• Health Industry Events. Upcoming events will focus on HIPAA version 5010, comparative effectiveness, HCPCS codes, health information technology, FDA transparency, healthcare-associated infections, clinical laboratory payments, and Medicare coverage evidence.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:    

• Regulatory Developments. HHS has published its semiannual regulatory agenda, outlining planned regulatory initiatives in a number of health policy areas. CMS has released its draft bidding forms for the DMEPOS competitive bidding program. FDA is soliciting comments on a draft guidance document on risk information in drug and device promotion.” The Department of Defense is implementing an outpatient hospital prospective payment system for the TRICARE program.
• Other HHS Developments. The Obama Administration has established the HHS Office of Health Reform, and it has released details on its plans for implementation of American Recovery and Reinvestment Act (ARRA) provisions. HHS and DOJ have launched a joint initiative to combat Medicare fraud. CMS is seeking to educate DMEPOS suppliers on what to do if they choose not to become accredited. The Federal Comparative Effectiveness Research Coordination Council is seeking comment on its draft definition of comparative effectiveness research (CER) and CER prioritization criteria. CMS has released a draft version of the Minimum Data Set (MDS) 3.0 resident assessment instrument item set for nursing home residents.   The FDA has issued guidance on FDA-industry meetings and on labeling over-the-counter human drug products.
• Legislative Developments.  The Senate Finance Committee has released a policy paper on options for financing health reform. A new law makes significant changes to the federal False Claims Act. A Senate panel has approved legislation to authorize the FDA to regulate tobacco products. A number of Congressional panels have held hearings recently on health policy issues.
• Odds & Ends. The Social Security and Medicare Boards of Trustees released their annual assessment of the financial condition of the Social Security and Medicare trust funds. The OIG has issued a report on inappropriate Medicare payments for chiropractic services, and the GAO has examined the implications of the upcoming ESRD bundled payment system on home dialysis.
• Health Industry Events. Upcoming events will focus on comparative effectiveness, DMEPOS competitive bidding, HCPCS codes, physician issues, cardiovascular devices, medical device post-approval studies, HIPAA version 5010, clinical laboratory payments, and Medicare coverage evidence.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Obama Budget Proposal. On May 7, 2009, the Obama Administration released additional details on its proposed federal budget for FY 2010, which would provide $879 billion for HHS in FY 2010. The Administration continues to advocate the establishment of a $635 billion reserve fund over 10 years to finance health reform, funded by Medicare and Medicaid savings in addition to new revenues. 
• Regulatory Development. CMS has issued a number of significant proposed Medicare payment updates, including rules affecting inpatient prospective payment system hospitals, long-term care hospitals, skilled nursing facilities, inpatient rehabilitation facilities, and inpatient psychiatric facilities. Other HHS agency rules block several Bush Administration Medicaid rules, solicit comments on objectivity in Public-Health Service funded research, and address FDA procedures for revocation of biologics licenses. 
• Other HHS Developments. Kathleen Sebelius has been confirmed as HHS Secretary. HHS has released reports on its progress in the first 100 days of the Administration and on rural health care, and it has established the Emergency Care Coordination Center (ECCC) and a new HHS database for ARRA lobbying contacts. CMS has issued the 2011 HCPCS update application and instructions. The FDA has released draft guidance on injectors for drugs and biologicals, and label comprehension studies for nonprescription drugs. 
• Legislative Developments.  The Finance Committee has released an options paper discussing options for health care delivery system reform, and the panel is working on other aspects of health reform.   Legislation is moving through the House and Senate that would make sweeping changes to the federal False Claims Act.   A number of Congressional panels have held hearings recently on health policy issues. 
• Odds & Ends. The Federal Trade Commission (FTC) has announced a delay in enforcement of certain identity theft prevention program requirements under the FTC's Identify Theft Red Flag Rule. The HHS OIG has issued a report on how it is safeguarding ARRA funding. The Institute of Medicine has endorsed voluntary and regulatory measures to prevent financial conflicts of interest in medicine.
• Health Industry Events. Upcoming events will focus on health information technology, comparative effectiveness, ICD-10-CM/PCS implementation, HOPPS imaging efficiency measures, HCPCS codes, physician issues, cardiovascular devices, medical device post-approval studies, and Medicare coverage evidence.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:    

• Legislative Developments: Key lawmakers have announced their commitment to marking-up comprehensive health care reform legislation in early June. The Senate Finance Committee has approved the nomination of Kansas Governor Kathleen Sebelius to be HHS Secretary. A number of Congressional panels have held a hearings recently health policy issues.
• Regulatory Developments. Regulatory Development. CMS has released its proposed FY 2010 Medicare hospice wage index rule, and announced that it is not further delaying an interim final rule with comment period making changes to the Medicare DMEPOS competitive bidding program. HHS and the FTC have issued guidance on health information breach notification requirements. NIH is requesting public comment on draft guidelines regarding human stem cell research, and HHS has announced revised Federal Medical Assistance Percentages (FMAPs) for the first two quarters of FY 2009.
• Other HHS Developments.  Among other things, CMS has announced its plans to implement the Minimum Data Set (MDS) 3.0 SNF patient assessment instrument, and it has issued guidance related to billing routine cost of clinical trials, exceptions to the three-year moratorium on long-term care hospitals, and DMEPOS accreditation. The FDA has issued guidance documents related to submission of summary bioequivalence data for ANDAs and integrated summaries of effectiveness and safety, and it has published a notice regarding safety and effectiveness data for class III medical devices. The HHS OIG has issued reports on Medicaid payments for outpatient clinical diagnostic laboratory services, Medicare Part B drug prices, nursing home corporate integrity agreements, and inhalation drugs.
  Odds & Ends.  President Obama has signed an Executive Order establishing a White House Office of Health Reform. The NIH is highlighting a new funding opportunity for high-impact health research projects. Nominees are being solicited for the U.S. Preventive Services Task Force (USPSTF).
• Health Industry Events. Upcoming events will focus on updates to HCPCS codes, Medicare provider and supplier enrollment, the Recovery Audit Contractor program, FDA’s risk communication strategic plan, genetic testing, ICD-10-CM, and coverage developments. 

 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:

• Legislative Developments: The House and Senate approved separate budget resolutions with health policy provisions. The House has approved a tobacco regulation bill, along with a number of bills addressing public health and insurance policies, and several Congressional panels have held hearings on health policy issues.
• Regulatory Developments. Among other things, CMS has delayed Bush Administration regulations on Medicaid benefit package flexibility and cost sharing. The FDA is holding a public meeting and seeking comments on economically motivated adulteration, and the agency has announced generic animal drug user fees and updates to FDA regulations.
• Other HHS Developments. Dr. Joshua M. Sharfstein, President Obama's pick for FDA principal deputy commissioner, is now serving as Acting Commissioner for Food and Drugs. CMS has released its 2010 “Call Letter” and payment policies for Medicare Advantage and Part D drug plan sponsors. In addition, CMS has updated its supplier enrollment application, launched a Nursing Home Value-Based Purchasing demonstration, and requested Physician Quality Reporting Initiative measure suggestions. HHS has released a report entitled “The Costs of Inaction” to build the case for health reform this year.
• OIG & GAO Developments. The HHS OIG has announced changes to its self-disclosure protocol and announced “Recovery Act Fund Oversight” activities. The OIG also has released reports on negative pressure wound therapy pump prices, and hospital quality. The GAO is requesting the public’s help in identifying waste, fraud, abuse, or mismanagement associated with Recovery Act funds, and it has released reports on state survey system weaknesses, health-care associated infections in ambulatory surgical centers, and behind-the-counter drugs.
• Odds & Ends. The Federal Trade Commission has issued guidance on identity theft rules that could apply to health care entities. The GAO has announced the appointment of 13 members to the Health Information Technology Policy Committee.
• Health Industry Events. Upcoming events will focus on the Recovery Audit Contractor program, the Physician Quality Reporting Initiative, comparative effectiveness, HCPCS codes, FDA’s risk communication strategic plan, genetic testing, and coverage developments. MedPAC also is meeting to discuss a variety of Medicare payment and policy issues, including the impact of physician self-referral on use of imaging services and potential Medicare savings from follow-on biologics.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Legislative Developments: Congressional leaders have announced an ambitious timetable for passing comprehensive health reform. Legislation also has been signed into law funding HHS agencies for FY 2009, and a number of Congressional panels have held hearings on health reform and other health policy issues.
• Obama Administration Announcements. President Obama has named Dr. Margaret Hamburg as Commissioner of the FDA and Dr. Joshua Sharfstein as the Principal Deputy Commissioner. Dr. David Blumenthal has been named as the Administration's choice for National Coordinator for Health Information Technology. President Obama also has signed an Executive Order lifting the ban on federal funding for embryonic stem cell research, along with a Presidential Memorandum directing the White House Office of Science and Technology Policy to develop recommendations to “guarantee scientific integrity throughout the executive branch.”
• Regulatory Developments. HHS has proposed rescinding a controversial Bush Administration rule that implements certain federal nondiscrimination statutes protecting the conscience rights of health care providers.  However, the Obama Administration has decided not to block Bush Administration rules that mandate the use of updated diagnosis and procedure codes (the ICD-10-CM rule) and updated standards for electronic health care and pharmacy transactions under HIPAA. The Department of Defense has published a final rule to modify payment for drugs under the TRICARE Retail Pharmacy Program. The FDA is seeking comments on draft guidance documents on premarket approval applications and documenting statistical analysis related to new animal drug applications. 
• Other HHS Developments. HHS has announced the creation of the Office of Recovery Act Coordination to manage distribution of $137 billion in American Recovery and Reinvestment Act funds managed by HHS. HHS also announced the members of the Federal Coordinating Council for Comparative Effectiveness Research to coordinate federal comparative effectiveness research efforts. CMS has posted the April 2009 update to the Medicare Part B average sales price files.
• Odds & Ends. The HHS OIG has issued reports on Medicare post-acute care transfers and managed care payments for deceased enrollees, and the GAO has issued a report on improper home health payments. The Medicare Payment Advisory Commission (MedPAC) recently met to discuss a number of Medicare policy issues.
• Health Industry Events. Upcoming events will focus on hospital-acquired pneumonia and ventilator-associated pneumonia, comparative effectiveness, Medicare coverage evidence, hospital-acquired conditions, DMEPOS surety bonds, Medicaid dental care for children, HCPCS codes, FDA’s risk communication strategic plan, and genetic testing. 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of health policy developments, including the following:  

• Obama Budget Proposal. The Obama Administration has released its proposed federal budget for FY 2010, which includes a reserve fund of $633.8 billion over 10 years to finance health reform. While half of the reserve funds would come from tax increases on higher-income individuals, the rest would come from health system savings impacting a wide range of providers, health plans, and manufacturers. 
• Legislative Developments. President Obama has signed into law the American Recovery and Reinvestment Act, which includes a number of health policy provisions, including health information technology funding, strengthened federal health information privacy and security provisions, increased Medicaid funding, and expanded federal comparative effectiveness research efforts. MedPAC also has recommended that Congress make major changes in Medicare payment policy. The House of Representatives has approved funding for HHS for the remainder of FY 2009. Congressional panels have passed health policy bills and legislation to modify the False Claims Act, and they have been holding hearings to examine health reform policies.
• Regulatory Developments. The OMB is developing recommendations for a new Executive Order on Federal Regulatory Review. CMS has published a notice delaying the effective date of a rule on the Medicare durable medical equipment, prosthetic, orthotics and supplies competitive bidding program. CMS also is continuing a 2005 interim final rule on Medicare claims appeal procedures. The FDA has published a rule confirming the effective date of a rule on civil money penalties under the Food and Drug Administration Amendments Act of 2007. The FDA also is seeking comments on several draft guidance documents, and has announced the availability of information on a software program used to review proposed proprietary drug and biologic names. 
• Other CMS Developments. CMS has released documents regarding the 2010 Medicare Advantage and Part D prescription drug plan programs. CMS also has issued guidance on enforcement of physician-owned hospital disclosure requirements, and has released a Medicare fraud and abuse fact sheet for providers. In addition, CMS has announced new health care expenditure data.
• OIG & GAO Reports. The OIG has issued reports on the Part D coverage gap, Part B drug prices, Part D/Medicaid pharmacy reimbursement, and DME claims without valid physician identifiers.  The GAO has issued a report on dietary supplements.
• Odds & Ends. The Obama Administration has released health reform resources and convened a health reform summit. The White House also has announced that Kansas Governor Kathleen Sebelius is the President's choice for HHS Secretary and Nancy Ann DeParle has been chosen to be Director of the White House Office for Health Reform. The White House also has ordered changes in federal contracting practices. The Internal Revenue Services has issued a final report on tax-exempt hospitals.
• Health Industry Events. Upcoming events will focus on physician services, ICD-9-CM codes, Medicare coverage, hospital-acquired conditions, Medicaid dental care for children, HCPCS codes, FDA’s risk communication strategic plan, and genetic testing. 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and other developments impacting health policy. New postings address the following issues, among others:    

• Legislative Developments. The House and Senate have announced agreement on economic stimulus legislation that includes a number of health care provisions, including increased funding for state Medicaid programs, health information technology, and comparative effectiveness research. Moreover, President Obama has signed into law a bill to expand the Children's Health Insurance Program, the House has approved the Elder Abuse Victims Act of 2009, and several Congressional panels have held hearings on health policy issues.
• Regulatory Developments: As part of a broader Obama Administration regulatory review, CMS has published a notice soliciting comments on a potential delay in a recent rule on the Medicare DMEPOS competitive bidding program, along with a notice delaying implementation of a rule that provides states with increased flexibility to define the scope of covered Medicaid services. Likewise, the Department of Defense has delayed the effective date of a final rule implementing a prospective payment system for TRICARE hospital outpatient services. 
• Other CMS Developments. CMS is accepting suggestions for measures to be included 2010 Physician Quality Reporting Initiative (PQRI).  The agency also has announced that a bid protest regarding the award of Recovery Audit Contractors (RAC) has been settled. In addition, CMS has provided guidance to states on certain public health testing issues. 
• Odds & Ends. Former Senator Tom Daschle has withdrawn his nomination to be HHS Secretary.   The FDA posted updated listings of specific drugs that are being evaluated for potential safety issues. The HHS Office of Inspector General has issued reports on Medicaid and Medicare home health payments and on the operations of the Office of Medicare Hearings and Appeals. 
• Health Industry Events. Upcoming events will focus on new technologies under the  Medicare inpatient prospective payment system, outpatient hospital ambulatory payment classifications, genetic testing, physician services, Medicare coverage, and dental care for Medicaid eligible children. 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and other developments impacting health policy. New postings address the following issues, among others:  

• Regulatory Developments: The Obama Administration is conducting a review of regulations approved or pending at the end of the Bush Administration, which has delayed the effective date of a recent final Medicaid cost sharing rule and which could impact other recent rulemakings. Other regulatory developments include rules addressing DMEPOS competitive bidding under Medicare, protected classes of drugs under the Medicare Part D prescription drug benefit; implementation of ICD-10 coding and updated HIPAA electronic transaction standards; cytology proficiency testing; and institutional review board registration requirements. 
• Other CMS Developments. CMS has rescinded its previously-issued draft Part D/MA 2010 call letter, announced national Medicare noncoverage determinations for certain preventable surgical errors; announced evidence requirements for reopening Medicare claims, and issued guidance on the responsibility of Medicaid providers to screen employees for excluded persons.
• Other FDA Developments. The FDA has published a final rule on the submission of bioequivalence data. The agency also has launched the Secure Supply Chain pilot program and its soliciting comments on increasing clinical trial enrollment. In addition, the FDA has issued a number of recent final and draft guidance documents, including guidance on good reprint practices, good importer practices, current good tissue practice, standardized numerical identification for prescription drug packages, certifications of clinical trial registry/results submissions, and submission of laboratory packages by accredited laboratories. 
• Legislative Developments. The House and Senate currently are drafting major economic stimulus legislation that include a number of health care provisions, including increased funding for state Medicaid programs, health information technology, and comparative effectiveness research. Congress also is considering legislation to expand the Children's Health Insurance Program, including restrictions on physician investments in hospitals in the House version. 
• Odds & Ends. The HHS OIG has issued a report on the FDA’s oversight of clinical investigators' financial information, and the GAO has reported on high-risk government programs (including Medicare, Medicaid, and FDA programs) and on FDA approval of medical devices. HHS also has issued a report on medical identity theft.
• Health Industry Events.   Upcoming events will focus on Medicare inpatient rehabilitation facility classification criteria, establishment of a unique device identification system, new technologies under the IPPS, outpatient hospital ambulatory payment classifications, genetic testing, physician services, Medicare coverage, and dental care for Medicaid eligible children. 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and other developments impacting health policy, including the following:  

• Regulatory Developments -- CMS has issued a final rule requiring certain Medicare DMEPOS suppliers to furnish CMS with a surety bond. CMS also has released a final Medicare Part D rule that, among other things, that revises Medicare’s definition of Part D negotiated prices. The agency also has proposed revisions to the Retiree Drug Subsidy program regulations. In addition, CMS has issued corrections to the final 2009 Medicare physician fee schedule and inpatient hospital rules. HHS is seeking comments on a draft scientific agenda regarding vaccine safety. 
• Other CMS Developments –CMS has announced: enforcement efforts targeting certain DMEPOS suppliers and home health agencies, the sites for its Acute Care Episode demonstration; the final five Medicare Administrative Contractors; Hospice Interpretive Guidance; and the first results of the Hospital Outpatient Quality Data Reporting Program.
• FDA Developments – The FDA has issued draft guidance documents regarding registration of certain clinical trials under the Food and Drug Administration Amendments Act of 2007 (FDAAA), substantiation of dietary supplement claims, labeling of over-the-counter drug products, and assay migration studies for in vitro diagnostic devices. Moreover, the FDA is inviting pharmaceutical companies to participate in the FDA’s Regulatory Project Management Site Tours and Regulatory Interaction Program, and it is soliciting comments its plan to require drug establishment registration and drug listing submissions in electronic format. 
• Legislative Developments – The House of Representatives has suspended a Medicare “trigger” provision that requires expedited consideration of Medicare funding legislation in certain cases. The Senate Health, Education, Labor and Pensions Committee held a hearing on the nomination of former Senate Majority Leader Tom Daschle to be HHS Secretary, and the panel has scheduled a hearing on health information technology.
• Other Federal Developments – HHS has released its “Action Plan to Prevent Healthcare-Associated Infections.” The HHS OIG has issued a report on HHS management and performance challenges, along with a report on Medicare Part B drug prices. AHRQ is seeking comments on a report on how third-party payment policies affect clinical trial participation. MedPAC met recently to discuss a variety of Medicare payment and policy issues.
• Upcoming Health Care Events – CMS is sponsoring events to discuss the 2009 Physician Quality Reporting Initiative (PQRI) and applications for Medicare inpatient hospital add-on payments for new medical services and technologies. The Advisory Panel on Ambulatory Payment Classification (APC) Groups will meet to review the hospital outpatient hospital APC groups and their associated weights. The Medicare Evidence Development & Coverage Advisory Committee (MedCAC) will meet to discuss genomic testing. 

For details on these and other health industry developments, please visit healthindustrywashingtonwatch.com.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and other developments impacting health policy, including the following: 

• Regulatory Developments -- CMS has published regulations regarding Medicaid disproportionate share hospital payments, Medicaid non-emergency medical transportation services, and Medicare home health agency rates. HHS has published a final rule designed to protect the conscience rights of health care providers. The OIG has published its annual solicitation of ideas for new anti-kickback safe harbor provisions. The FDA is seeking comments on a planned study regarding coupons used in direct-to-consumer prescription drug print advertisements, and it has announced grants to support the clinical development of “orphan products.” Finally, and IRS proposed rule would require government entities to withhold income tax when making certain payments, including certain Medicare payments.
• Other CMS Developments -- CMS has posted first quarter 2009 Medicare Part B drug and biological average sales price amounts; released details on the 2009 Physician Quality Reporting Initiative; posted nursing home quality ratings; and announced medical necessity reviews of long term care hospital stays. CMS also has provided guidance on accreditation of durable medical equipment suppliers, requirements for entities providing mobile diagnostic testing services; and how the HIPAA Privacy Rule can facilitate electronic health information exchange in a networked environment. 
• FDA Guidance Documents -- The FDA has issued a number of guidance documents dealing with such issues as labeling of nonprescription human drug products and dietary supplements, genotoxic and carcinogenic impurities in drugs, modification of devices subject to premarket approval, and orally disintegrating tablets. 
• Obama Transition -- President-elect Barack Obama has nominated former Senator Tom Daschle as HHS Secretary and Director of a new White House Office on Health Care Reform.  Obama’s transition team also is calling on individuals to hold “Health Care Community Discussions” this month to make recommendations on health care policy.  In addition, President-elect Obama has named Eric Holder as his Attorney General.  
• OIG & GAO Reports -- The HHS OIG has issued reports on adverse events in hospitals, Medicare drug prices, and special needs plans.   The GAO has reported on Medicare Part D enrollment issues, Medicare Advantage plan profits and expenses, and characteristics of private fee-for-service plans.
• Odds & Ends -- The Congressional Budget Office hasreleased major reports on health care system reform and insurance reform. Congress has approved technical corrections to the new mental health parity law. The Agency for Healthcare Research and Quality (AHRQ) is seeking participation in a symposium on clinical and comparative effectiveness research methods.
• Looking Ahead -- CMS is hosting meetings in February on applications for Medicare inpatient prospective payment system new technology add-on payments, hospital outpatient ambulatory payment classification groups, and genomic testing.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and other developments impacting health policy, including the following:

• Regulatory Developments. CMS has issued rules providing states with increased flexibility to define the scope of covered Medicaid services and revising Medicare hospital wage indices. HHS has published the federal medical assistance percentages and enhanced federal medical assistance percentages for FY 2010. In addition, HHS is requesting public comments on its draft “Guidance on Important Considerations for When Participation of Human Subjects in Research is Discontinued,” and the FDA has issued related guidance on “Data Retention When Subjects Withdraw from FDA-Regulated Clinical Trials.” The FDA also is accepting comments on a planned FDA study examining consumer comprehension of inclusion of a toll-free number to report side effects in direct-to-consumer prescription drug television advertisements.
• Other CMS Developments. CMS has released an “Issues Paper” on its Medicare value-based purchasing program for physician and other professional services; proposed three national coverage determinations to ensure that Medicare does not cover certain types of preventable surgical errors; announced the technical specifications for a new incentive program to promote electronic prescribing; updated physicians on the suspension of the Medicare Part B drug competitive acquisition program for 2009; and released the 2009 Medicare durable medical equipment, prosthetics, orthotics, and supplies fee schedule.
• Other FDA Developments. The FDA has released guidance documents on “Cooperative Manufacturing Arrangements for Licensed Biologics” and “Submission of Patent Information for Certain Old Antibiotics.” In addition, the FDA has announced that it is teaming with WebMD to expand consumer access to FDA safety alerts and other public health information.
• OIG Developments. The HHS OIG has released the Health Care Fraud and Abuse Control (HCFAC) Program Annual Report for FY 2007 and its Semiannual Report to Congress for the second half of FY 2008. The OIG also has issued an “early alert memo” on “Payments to Medicare Suppliers and Home Health Agencies Associated With ‘Currently Not Collectible’ Overpayments.”
• Health Industry Events. CMS is hosting listening sessions on electronic prescribing, the Physician Quality Reporting Initiative, hospital-acquired conditions, and Medicare inpatient PPS add-on payments for new medical services and technologies. AHRQ is hosting a meeting on kidney disease education.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of legislative and regulatory developments, including the following:

• Regulatory Developments. HHS has published a final rule to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). In addition, HHS has published its semiannual regulatory agenda, outlining planned regulatory initiatives in a number of health policy areas. CMS has issued an interim final rule with comment period making technical changes to the methodology used to compute each state's preliminary and final allotments available to pay the Medicare Part B premiums for qualifying individuals, along with a separate final rule on Medicaid premiums and cost sharing requirements. The FDA has published draft guidance documents on “Contents of a Complete Submission for the Evaluation of Proprietary Names” and “Process Validation: General Principles and Practices.”
• Legislative Developments. Key lawmakers have released for public comment a discussion draft of legislation that would establish a value-based purchasing program for Medicare inpatient hospital care. In addition, the Senate Finance Committee has held a hearing on health care reform, and the Senate has approved technical corrections to the new mental health parity law.
• Other CMS & DOJ Developments. CMS is accepting comments on a preliminary set of outpatient imaging efficiency measures. CMS also has released a document entitled “Medicare’s Practical Guide to the E-Prescribing Incentive Program.” In addition, CMS has announced the improper payment rate for the Medicare, Medicaid and SCHIP for FY 2008. The U.S. Department of Justice also has released updated statistics on federal False Claims Act recoveries, including a discussion of significant health care fraud enforcement activities.
• Health Care Industry Events. CMS is holding forums on the Part B drug competitive acquisition program, value-based purchasing for physician and other professional services, hospital-acquired conditions, and IPPS new technology applications. The HHS Secretary's Advisory Committee on Genetics, Health, and Society is meeting to discuss whether gene patents and certain licensing practices are affecting patient access to genetic tests, and the Practicing Physicians Advisory Council is holding its quarterly meeting to discuss Medicare policy changes related to physicians’ services. AHRQ is hosting a meeting on kidney disease education.

For details on these and other health industry developments, please visit healthindustrywashingtonwatch.com.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of legislative and regulatory developments, including the following: 

• Legislative Developments. Senate Finance Committee Chairman Max Baucus has released a white paper entitled "Call to Action: Health Reform 2009," which details Senator Baucus’ goals for health care reform in the broad areas of coverage, quality, and cost. The broad scope of the Baucus white paper suggests that Congress intends to focus beyond access to insurance or the immediate problem of fixing the Medicare physician fee schedule and examine fundamental policy questions concerning how to promote quality and value throughout the health system at a time of limited federal resources.
• Regulatory Developments.   CMS has published an interim final rule with comment period revising marketing requirements for Medicare Advantage plans and Medicare Part D prescription drug plans in order to limit incentives for brokers to switch beneficiaries between plans. CMS also has published a final rule clarifying the definition of outpatient hospital services under Medicaid to align it more closely with the Medicare definition of such services. The FDA has issued regulations to adjust for inflation the maximum civil money penalty amounts under certain FDA authorities, and it has published a notice regarding nonvoting industry representatives on Center for Biologics Evaluation and Research public advisory committees.  
• Other HHS Developments. CMS has announced the chronic conditions certain Medicare Advantage special needs plans must use to identify the beneficiary populations eligible for enrollment, beginning in 2010. CMS also has released the 2009 update of the Healthcare Common Procedure Coding System (HCPCS) code set, and has updated the Medicare Benefit Policy Manual to reflect CMS policy regarding medically-accepted indications of drugs and biologicals used off-label in an anti-cancer chemotherapeutic regimen. In addition, CMS has released information for state officials regarding the refunding of the federal share of state Medicaid recoveries under state False Claims Acts, and regarding the upcoming “Medicare Nursing Home Value-Based Purchasing" demonstration. Moreover, the HHS Secretary has submitted to Congress the Department's annual report on national Medicare coverage determinations.
• GAO & OIG Reports.  The HHS OIG has issued reports on CMS enforcement of the HIPAA security rule, and appeals of DME supplier revocations. Both the OIG and GAO also have issued reports regarding the Medicare Part D drug program. 
• Health Care Industry Events. CMS is holding forums on electronic prescribing, the Part B drug competitive acquisition program, value-based purchasing for physician and other professional services, and hospital-acquired conditions. The HHS Secretary's Advisory Committee on Genetics, Health, and Society is meeting to discuss whether gene patents and certain licensing practices are affecting patient access to genetic tests, and the Practicing Physicians Advisory Council is holding its quarterly meeting to discuss Medicare policy changes related to physicians’ services.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and legislative developments, including the following:

Regulatory Developments. CMS has released major final rules on Medicare payments for physicians, outpatient hospital services, ambulatory surgical center services, and home health agencies for 2009. The FDA also has published a final rule requiring a statement to be included on certain human drug product labeling that provides a toll-free number for reporting drug side effects, and HHS has issued a final rule on insurance coverage for hospital care for mothers and newborns following childbirth.

Other CMS Developments. CMS has updated its quality standards for Medicare DMEPOS suppliers, issued Medicare Part D Marketing Guidance, and released new Medicaid spending projections.

Odds & Ends. The GAO has issued reports on FDA's foreign drug inspection program and on perimeter security at the biosafety level 4 laboratories, and the HHS OIG has issued a report Medicaid-funded personal care services provided in excess of 24 hours per day. The FDA is opening offices overseas to improve import safety. HHS also has issued “Guidance on Engagement of Institutions in Human Subjects Research.”'

Health Care Industry Events. CMS is holding forums on Medicare Part D payments for Indian Health Service & tribal facilities, kidney disease patient education services for individuals with stage IV chronic kidney disease, value-based purchasing for physician and other professional services, the adoption of the ICD-10 coding system, and hospital-acquired conditions. MedPAC is meeting to address a variety of Medicare payment and policy issues. The HHS Secretary's Advisory Committee on Genetics, Health, and Society is meeting to discuss whether gene patents and certain licensing practices are affecting patient access to genetic tests, and the Practicing Physicians Advisory Council is holding its quarterly meeting to discuss Medicare policy changes related to physicians’ services.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and legislative developments, including the following:

• Regulatory Developments:  The Agency for Healthcare Research and Quality (AHRQ) and the HHS Office for Civil Rights have announced the availability of an interim guidance document entitled “Implementing the Patient Safety and Quality Improvement Act of 2005, Including How to Become a Patient Safety Organization.'' The Centers for Medicare & Medicaid Services (CMS) has published a notice soliciting comments on the Medicare Part D/Medicare Advantage Calendar Year (CY) 2010 Bid Pricing Tool and the CY 2010 Plan Benefit Package software and formulary submission.
• Other CMS Developments:  CMS has released details on the scoring methodology it uses to identify those nursing homes that become candidates for the “Special Focus Facility” (SFF) initiative by virtue of their more serious history of severe and persistent quality of care problems. CMS also is soliciting comments regarding an interim study of options for revising geographic location adjustments under the Medicare physician fee schedule. In addition, CMS has posted Medicare Part D prescription drug plan and Medicare Advantage health plan information for 2009 online.
• Legislative Developments:  President Bush recently signed into law a number of health bills, including legislation to restrict internet pharmacy sales, increase funding for health centers, and expand disease research, among others.
• Odds & Ends:  The Food and Drug Administration (FDA) has released a draft guidance document on “Potency Tests for Cellular and Gene Therapy Products.” The Government Accountability Office (GAO) has issued reports examining the FDA’s advisory committee processes and how nonprofit hospitals meet community benefit requirements. The AHRQ's Technology Assessment Program will be posting draft report on its website, including an upcoming report on "Potential Conflict of Interest in the Production of Drug Compendia." CMS is encouraging hospitals and other health care providers to review a new publication, “Community Pan-Flu Preparedness: A Checklist of Key Legal Issues for Healthcare Providers."
• Upcoming Events:  CMS is hosting a Special Open Door Forum for physicians on the Medicare Medical Home Demonstration project. The agency also is hosting a Prescription Drug Event Symposium at CMS headquarters in Baltimore for researchers and other interested parties. In addition, CMS will host a series of national provider calls regarding issues associated with the adoption of the ICD-10 coding system.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and legislative developments, including the following:

• Regulatory Developments: Revised FY 2008 Medicare hospital inpatient PPS rates; solicitation of members for the DMEPOS competitive bidding advisory committee; a final rule on Medicaid self-directed personal assistance services; a final rule revising the Medicaid definition of "multiple source drug"; and FDA reporting requirements for authorized generics.
• Other CMS Developments: A new CMS initiative to combat Medicare DMEPOS and home health fraud and abuse; CMS guidance on Medicare payment of certain routine costs associated with clinical trials; CMS release of “Medically Unlikely Edits” used by Medicare contractors to prevent payment for excessive services; and waiver of certain hospital quality reporting requirements in hurricane areas.
• Legislative Developments: President Bush signed into law mental health parity legislation and funding for HHS and other federal agency programs through March 6, 2009. Congress also has cleared online pharmacy and organ transplant bills that now await the President's signature.
• OIG and GAO Developments: The OIG has released its FY 2009 Work Plan, supplemental compliance program guidance for nursing facilities, and reports on nursing home deficiencies. The GAO has issued reports on trends in Medicare imaging services and hospital-associated infections.
• Upcoming Events: CMS is hosting a conference on DMEPOS supplier accreditation and provider calls on adoption of the ICD-10 coding system.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss a variety of regulatory and legislative developments, including the following:

• A wide range of health care legislation approved by one or both houses of Congress in the waning days of the session, including legislation addressing mental health parity requirements, FDA drug and device approvals, internet pharmacy regulation, and medical research, among many others.
• Final CMS rules on MIPPA Medicare Part D drug plan/Medicare Advantage marketing requirements.
• A series of CMS rules on contracting requirements under the Medicaid Integrity Audit program, the criteria for terminating a provider or supplier from non-random prepayment complex medical review, and the 2009 “amount in controversy” threshold for Medicare appeals.
• CMS announcements regarding Medicare Part A and Part B premium and deductible levels for 2009, Medicare PDP and MA plan options for 2009, preliminary Medicare payment determinations for certain new clinical laboratory codes, and October 2008 Medicare Part B prescription drug average sales price pricing files.
• FDA notices regarding animal drug user fee rates and guidance on genetically-engineered animals.
• HIPAA privacy rule guidance regarding when a health care provider may share a patient’s health information with the patient’s family, friends, or others involved in the patient’s care.
• Upcoming health industry events, including a MedPAC meeting, a CMS E-Prescribing conference, a DMEPOS supplier accreditation conference, and CMS conference calls on the adoption of the ICD-10 coding system.

 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss: new FDA initiatives; Medicare DMEPOS accreditation requirements; the Medicare Part B drug CAP program; Congressional hearings and markups; OIG and GAO reports; upcoming health care industry events; and other policy developments. For details, please visit healthindustrywashingtonwatch.com.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss: FDA drug and device labeling requirements, HIPAA code set and electronic transaction standards, provider conscience rights, Medicare Part D and Medicare Advantage developments, OIG and GAO reports, upcoming events, and other health policy developments. For details, please visit healthindustrywashingtonwatch.com.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss: new Medicare regulations impacting hospitals (including hospital ownership/physician self-referral provisions), skilled nursing facilities, hospices, and inpatient rehabilitation facilities; recent FDA initiatives; CMS Medicare coverage reviews; OIG and GAO reports; and other health policy developments. For details, please visit healthindustrywashingtonwatch.com. 

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss implementation of the new Medicare payment law (MIPPA), Congressional hearings and markups, new CMS and FDA regulations, recent GAO reports, upcoming health industry events, and other health policy developments. For details, please visit http://www.healthindustrywashingtonwatch.com/.

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The Reed Smith Health Industry Washington Watch blog has been updated to discuss: major Medicare legislation approved by Congress (including increased physician payments and delay in the DMEPOS competitive bidding program); CMS proposed rules updating Medicare physician, hospital outpatient PPS, and ambulatory surgical center payments; a moratorium on several Medicaid rules; Congressional hearings; upcoming health industry events; and many other health policy developments. For details, please visit http://www.healthindustrywashingtonwatch.com/.

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The Reed Smith Health Industry Washington Watch blog provides an update on Medicare payment legislation, DMEPOS competitive bidding, a moratorium on several Medicaid rules, Congressional hearings, CMS nursing home initiatives, OIG reports, upcoming health industry events, and other health policy developments. For details, please visit healthindustrywashingtonwatch.com.

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The Reed Smith Health Industry Washington Watch blog reports on major Medicare payment legislation introduced, Congressional hearings, federal health information technology strategy, OIG reports, upcoming health industry events, and other health policy developments.  For details, please visit healthindustrywashingtonwatch.com. 

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The Reed Smith Health Industry Washington Watch blog has been updated to report on new regulations affecting hospices, Medicare Part D claims data, Medicare appeals policies, and FDA drug labeling requirements.  The blog also reports on a voluntary HHS moratorium on certain Medicaid rules, Medicare DMEPOS competitive bidding, a new FDA medical product safety surveillance initiative, health provisions in the pending emergency supplemental bill, upcoming hearings, and a recent FTC report on drug company settlement agreements, among other developments.  For the full reports, please visit healthindustrywashingtonwatch.com.

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Reed Smith launched Washington Watch as an email newsletter in February 2003 in order to update clients and others on federal policy developments impacting health care providers, manufacturers, and others in the health industry.  The publication has provided brief reports on legislative and regulatory developments affecting such areas as Medicare and Medicaid reimbursement, new benefits such as Medicare prescription drug coverage, and fraud and abuse developments.

 

After more than 100 email issues, we have decided to take advantage of a blog format for Washington Watch, which we hope will make our content more accessible (including search features and archives) and allow us to deliver our reports in a more efficient and timely manner. 

 

Please note that Reed Smith can provide clients with more in-depth information about any of these developments, or furnish targeted analyses as needed.  Reed Smith is one of the 15 largest law firms in the world, with more than 1,600 lawyers in 23 offices throughout the United States, Europe, Asia and the Middle East.  The firm’s Life Sciences and Health Industry (LSHI) Group is comprised of 200 professionals across numerous practice areas who are dedicated to our clients who help save patients’ lives and preserve their health, whether through biotechnology, pharmaceutical, medical device, life sciences or delivering health care.   As part of the LSHI team, I have been specializing in health care policy at Reed Smith since 1991, after five years working in professional staff positions for the US House of Representatives. 

 

We hope you will check our site often, and we welcome your feedback.

 

Sincerely,

 

Debra McCurdy
Senior Health Policy Analyst
Reed Smith LLP

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