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 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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