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 report on recent health policy developments, including the following:

• Regulatory Developments. CMS has published several major proposed rules that would update FY 2014 Medicare payment policy for acute inpatient hospitals and long-term care hospitals, skilled nursing facilities, inpatient rehabilitation facilities, and hospices. CMS also has published rules addressing rewards to Medicare fraud tipsters and provider enrollment rules, along with a notice on the ACA Early Retiree Reinsurance Program. HHS is considering HIPAA Privacy Rule amendments to allow reporting of mental health data to the National Instant Criminal Background Check System. The IRS has published regulations to implement certain ACA insurance premium tax credit and medical loss ratio provisions. 
   
• Other HHS Developments. Recent CMS policy announcements have addressed Independent Payment Advisory Board (IPAB) reductions, Quality Improvement Organization service areas, ordering and referring denial edits, hospital charge data, Physician Payment Sunshine Act implementation, sequestration guidance for state surveyors and Medicare Part C & D plans, gapfill payments for new molecular pathology codes, draft Medicaid Federal Upper Limit files, and potential Physician Quality Reporting System measures. HHS has released enhanced National Standards for Culturally and Linguistically Appropriate Services (CLAS) in Health Care, and it has highlighted enforcement efforts in this area. HHS has provided an update on the status of efforts to promote health information technology.
   
• OIG Developments. The OIG has released an updated Provider Self-Disclosure Protocol and an updated Special Advisory Bulletin on the Effect of Exclusion from Participation in Federal Health Care Programs.
   
• Legislative Developments. Current legislative efforts are focusing on drug distribution security and Medicare physician fee schedule reform, and recent Congressional hearings and markups have addressed a number of health policy issues.
   
• Health Industry Events. Upcoming events include meetings/calls on the Data.Medicare.Gov data portal, the “Sunshine Act”/National Physician Payment Transparency Program, and HCPCS code applications.

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The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

• Proposed FY 2014 Budget. The Obama Administration has released its proposed federal budget for fiscal year 2014, which includes proposals that would save $401 billion from federal health programs over 10 years. A Reed Smith alert on the proposal is available here.
   
• Regulatory Developments. Recent CMS regulations have addressed federal funding for Medicaid expansion under the Affordable Care Act, Health Insurance Exchange “Navigators,” electronic health record (EHR) donation protections, and oversight rules for accreditation organizations. Reed Smith has issued a special alert regarding recent CMS policies on hospital Part B inpatient billing. The IRS has published hospital community health needs assessment regulations, and a HRSA rule addresses reporting to the Healthcare Integrity and Protection Data Bank and the National Practitioner Data Bank.
   
• Other HHS Developments. CMS has: announced the winners of the Medicare DMEPOS competitive bidding round 2/national mail order competition; announced 2014 rates and policies for Medicare Advantage and Part D prescription drug plans; provided resources on EHR incentive program audits; released guidance on participation in Federally-Facilitated and State Partnership Exchanges; and launched a “Medicare Chronic Conditions Dashboard.” FDA has issued draft guidance on biosimilar product development.
   
• Legislative Developments. Recent Congressional hearings have addressed a number of health policy issues; a Senate panel has approved the Mental Health Awareness and Improvement Act; and House committee leaders have released additional details on their Medicare physician fee schedule reform proposal.
   
• OIG Developments. The OIG has issued reports on Medicare supplier surety bonds, private insurer reporting to the HealthCare.Gov plan finder portal, and the Medicaid Integrity Program.
   
• Health Industry Events. Upcoming events include meetings/calls on EHR billing and coding, the Medicare ESRD low-volume payment adjustment, transitioning to ICD-10, HCPCS code applications, the comparative effectiveness data infrastructure, and medical device labeling.

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The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

• CMS Developments. CMS has issued regulations on hospital Part B inpatient billing policy, nursing facility closure notification rules, insurance waiting periods under the Affordable Care Act (ACA), and technical corrections to Medicare inpatient hospital regulations. CMS also has provided more details on sequestration cuts impacting Medicare.
   
• Legislative Developments. The President has signed a government funding bill that maintains FY 2013 Medicare sequestration cuts. Recent Congressional hearings have addressed a number of health policy issues, and a Senate panel has approved organ transplant and animal drug user fee bills.
   
• OIG Developments. The OIG has issued a Special Fraud Alert on physician-owned distributors (PODs), and it has updated guidelines for evaluating state false claims laws.
   
• Other Policy Developments. MedPAC has released its annual report to Congress on Medicare payment policy, and MACPAC has released its annual report to Congress on Medicaid and CHIP. Also, in case you missed them, Reed Smith attorneys have recently prepared client alerts on major regulatory issues, including the Physician Payment "Sunshine Act" Final Rule, ACA Insurance Exchanges and Qualified Health Plans, and the HITECH Final Rule.
   
• Health Industry Events. Upcoming events include meetings/calls on the Medicare Shared Savings Program, the Physician Quality Reporting System, transitioning to ICD-10, HCPCS code applications, and medical device labeling.

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The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

• Regulatory Developments. The Obama Administration has issued several rules to implement Affordable Care Act insurance provisions, including the essential health benefits framework and insurance market reforms. CMS also is requesting comments on forms to disclose DMEPOS competitive bidding contract supplier ownership changes, and has announced hospital payment adjustments. HHS is inviting comments on advancing interoperability and health information exchange.
   
• Other HHS Developments. CMS has released its first guidance on the impact of sequestration on Medicare. CMS has extended the 2013 Medicare participation enrollment period for DMEPOS suppliers, and has updated Medicare drug files and offered tips on ICD-10 implementation. HHS has suspended enrollment in the ACA Pre-Existing Condition Insurance Plan, and FDA has issued new guidance documents.
   
• Legislative Developments. Congress has cleared the Pandemic and All-Hazards Preparedness Reauthorization Act, and Congressional panels have held hearings on various health policy issues.
   
• GAO & OIG Developments. Recent OIG reports address DME infusion drugs, long-term care hospital reporting of co-location status, conflict-of-interest oversight for Medicare Part D pharmacy and therapeutics committees, Part B drug pricing, and skilled nursing facility care planning/discharge planning. GAO reports have focused on pharmacy services administrative organizations, risk adjustment for Medicare Advantage plans, and the Medicare low-volume payment adjustment for dialysis facilities.
   
• Health Industry Events. Upcoming events include meetings/calls on the Physician Quality Reporting System (PQRS) and Electronic Prescribing (eRx) Incentive Program, Medicare hospital outpatient payment policy, HCPCS code applications, medical device labeling, hospital value-based purchasing, and implementation of Medicare ordering/referring provider edits.

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The Reed Smith Health Industry Washington Watch blog (http://www.healthindustrywashingtonwatch.com) has been updated to report on recent health policy developments, including the following:

• Regulatory Developments. The Obama Administration has proposed reforms to reduce provider regulatory burdens, ACA “shared responsibility” payment rules, and ACA contraceptive coverage requirements. CMS has proposed updates to Medicare Advantage and Part D drug policies. CMS also is seeking input on use of clinical quality measures for Medicare physician quality reporting, and it has published its ACA “Physician Payment Sunshine Act” final rule (as previously reported). 
   
• Other CMS Developments. President Obama has renominated Marilyn Tavenner to be CMS Administrator. CMS is seeking applications for a new ESRD care model, moving forward with the ACA Bundled Payments for Care Improvement initiative, and cutting Medicare reimbursement for certain DMEPOS items under the competitive bidding program.
   
• Legislative Developments. House panels are inviting comments on Medicare SGR/physician fee schedule reform. The House has approved GME, pediatric research, and EMT bills, and Congressional panels have held hearings and markups on health policy issues. The Finance Committee has released a compilation of public recommendations to address health care fraud and abuse.
   
• Fraud & Abuse Developments. The Obama Administration has released reports on the Health Care Fraud and Abuse Control Program and Medicare and Medicaid recovery auditing.
   
• Health Industry Events. Upcoming events include meetings/calls on the Physician Quality Reporting System (PQRS) and Electronic Prescribing (eRx) Incentive Program, Medicare hospital outpatient payment policy, HCPCS code applications, accessible standardized medical device labeling, and ICD-9-CM and ICD-10-CM/PCS updates.

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The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

• Regulatory Developments. CMS has proposed changes to Medicaid eligibility, benefits, and appeals rules. The agency also is seeking suggestions for surveys on hospice and hospital outpatient surgery department/ambulatory surgery center care. The FDA has issued a final rule on current good manufacturing practice requirements for combination products and has announced 2013 generic drug active pharmaceutical ingredient and finished dosage form facility user fee rates. As discussed in our recent special alert, HHS has published its long-awaited omnibus final rule modifying the HIPAA Privacy, Security, Breach and Enforcement Rules.  
• Other HHS Developments. CMS has issued revised Medicare enrollment applications, and it has previewed a core set of Medicaid health home quality Measures. FDA has issued draft guidance on combination product postapproval modification submissions. PCORI is seeking nominations for four advisory panels. 
• Legislative Developments. The House has passed the Pandemic and All-Hazards Preparedness Reauthorization Act, and a House panel has approved graduate medical education, pediatric research, and emergency medical technician bills. The Senate HELP Committee has held health policy hearings. Reed Smith has posted an analysis of a new law making changes to Medicare Secondary Payer policy.
• OIG & GAO Developments. Recent OIG reports have addressed Medicare fraud in community mental health centers, Medicare Parts C & D benefit integrity activities, state Medicaid third-party liability collection, and Medicare payments for unlawfully present or incarcerated beneficiaries. The GAO has offered recommendations for the Medicare physician value modifier program.
• Health Industry Events. Upcoming events include a CMS meeting on Medicare hospital outpatient payment policy and an FDA workshop on accessible standardized medical device labeling.

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The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

• Regulatory Developments. The Obama Administration has published its latest semiannual regulatory agenda, which points to a busy 2013 for HHS. CMS also published a request for information regarding hospital readiness for electronic quality reporting, and the OIG is soliciting proposals for anti-kickback statute safe harbors and special fraud alerts. The IRS has proposed Affordable Care Act employer “shared responsibility” requirements for employee health coverage.
   
• Other HHS Developments. CMS has announced a 90-day enforcement discretion period for HIPAA eligibility and claim status operating rules, and it has released updated draft Medicaid drug pricing files. HHS is seeking comments on a draft “Health IT Patient Safety Action and Surveillance Plan.
   
• OIG & GAO Developments. Recent OIG reports have addressed Medicare rates for back orthoses, Medicare Part B drug pricing, DMEPOS competitive bidding, and Medicare oversight of home health agencies. Recent GAO reports have examined Medicaid supplemental payments and consumer protections for Medicare/Medicaid dual eligible.
   
• Legislative Developments. A new law establishes an IVIG demonstration project and makes Medicare Secondary Payer (MSP) program policy revisions. Also, in case you missed our earlier posting, the recent “fiscal cliff” deal -- the American Taxpayer Relief Act of 2012 -- includes numerous Medicare payment provisions.
   
• Health Industry Events. Upcoming events including calls/meetings on Medicare/Medicaid electronic health record incentives, medical diagnostic equipment access standards, Medicare hospital outpatient payment policy, Medicare inpatient hospital new technology add-on applications, and an FDA workshop on accessible standardized medical device labeling.

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The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

• Regulatory Developments. The IRS has issued several regulations on Affordable Care Act (ACA) provisions, including the medical device tax, a fee on insurers to fund comparative outcomes research, and guidance on the branded prescription drug fee, and an Office of Personnel Management proposed rule addresses the ACA Multi-State Plan Program. HHS has issued a proposed rule on ACA benefit and payment parameters for 2014 and a notice on FY 2014 Federal Medical Assistance Percentage amounts. CMS rules and notices address electronic health record (EHR) certification criteria and incentive program specifications, provider application fees, and patient experiences with emergency department care.
   
• Other HHS Developments.CMS has made announcements regarding the 2013 Medicare DMEPOS fee schedule, supervision levels for select outpatient services, outpatient therapy limits and coding policy for 2013, Medicare Part B drug ASP files, hospice data collection, and ACA Medicaid and insurance provisions. FDA has issued draft guidance on the conduct of clinical trials and product safety/risk minimization.
   
• Fraud & Abuse Developments. The Justice Department reports nearly $5 billion in False Claims Act recoveries for FY 2012. Recent OIG reports have addressed home and community-based services, Medicare Part B drug prices, the Medicare EHR incentive program, and unimplemented OIG recommendations. Recent GAO reports have reviewed Medicaid EHR incentive payments, Medicare prepayment edits, Medicaid program integrity efforts, and Medicare dialysis reimbursement.
   
• Legislative Developments. Congressional hearings have focused on health policy issues.
   
• Health Industry Events. CMS has announced calls/meetings on ACA disproportionate share hospital payment provisions, hospital outpatient payment policy, and inpatient hospital new technology add-on applications.

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The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

• Regulatory Developments. The Obama Administration has issued proposed rules on Affordable Care Act (ACA) standards for essential health benefits, actuarial value, and accreditation, along with insurance market reforms and wellness program rules. HHS is requesting comments on ACA exchange health plan quality management and Stage 3 meaningful use policy. In addition, CMS has announced 2013 Medicare deductible and coinsurance amounts, and it is seeking final clearance for its final rule implementing the ACA’s “Physician Payment Sunshine Act” provisions.  FDA documents address implementation of the Food and Drug Administration Safety and Innovation Act.
   
• Other CMS Developments. CMS has announced the 2012 Medicare improper payment rate, potential Medicare national coverage determination topics, and proposed revisions to the Medicare coverage with evidence development policy. CMS also has taken steps to implement an ACA Medicare data sharing provision, and has posted information on the ACA branded prescription drug fee program.
   
• OIG & GAO Reports. The HHS OIG has issued its Semiannual Report, which announces approximately $6.9 billion in expected audit and investigative recoveries, along with reports on HHS management challenges, least costly alternative drug policy, personal care services, the Medicare appeals process, and hospital present on admission indicator reporting. A GAO report assesses CMS fraud prevention system implementation.
   
• Odds & Ends. The Massachusetts Public Health Council finalized amendments to the State’s policy restricting certain payments by pharmaceutical and medical device manufacturers to Massachusetts health care practitioners and imposing other related disclosure requirements.
   
• Health Industry Events. CMS has announced meetings on hospital outpatient payment policy and IPPS new tech add-on applications. FDA is hosting a meeting on pharmacy compounding. Other upcoming events will address IRS proposed rules for charitable hospitals, Patient-Centered Outcomes Research Institute research topics, and medical diagnostic equipment accessibility standards.

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The Reed Smith Health Industry Washington Watch blog has been updated to report on recent health policy developments, including the following:

• Regulatory Developments. CMS has issued several major final 2013 Medicare payment rules, including final rules updating Medicare payment policies for hospital outpatient departments, ambulatory surgical centers, physician fee schedule policies (including a new face-to-face encounter requirement for Medicare DME orders), home health agencies (including hospice quality reporting provisions), the end-stage renal disease PPS, and Medicare bad debt reimbursement. CMS also has issued a final rule boosting Medicaid primary care payments and vaccine administration fees as required by the ACA, and several other major ACA implementation rules are awaiting final regulatory clearance.
   
• Other CMS Developments. CMS has released the 2013 HCPCS update and final 2013 Medicare clinical lab payment determinations.
   
• OIG & GAO Reports. Recent HHS OIG reports have addressed the impact of the Medicare DMEPOS competitive bidding program on billing for diabetes test strips and Medicare payments to skilled nursing facilities. The GAO has issued reports on Medicare costs from self-referrals of advanced imaging services and high-expenditure Medicare Part B drugs.
   
• Legislative Developments. Committee panels have examined meaningful use rules and the recent outbreak of fungal meningitis.
   
• Health Industry Events. Upcoming meetings will address IRS proposed rules for charitable hospitals, Patient-Centered Outcomes Research Institute research topics, and medical diagnostic equipment accessibility standards.

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As has been widely reported, today the U.S. Supreme Court ruled that the Affordable Care Act’s (ACA) individual health insurance mandate does not violate the Constitution because it may be viewed as a permissible tax on individuals who do not obtain health insurance. The only provision of the law that the Court invalidated is a Medicaid provision that threatened states with the loss of existing Medicaid funding if they decline to comply with the ACA’s Medicaid coverage extension. By preserving the vast majority of the landmark health reform law, the Court avoided the policy chaos that would have resulted from striking down the ACA in its entirety. There is now legal certainty for state and federal governments, health care providers and suppliers, drug and device manufacturers, employers and individuals. As discussed below, the focus in Washington will return to continuing implementation of the law. Nevertheless, although the legal battle is over, the political fight will continue and likely reverberate through the coming Presidential and Congressional election campaigns.  See our report below.

In other news, the Reed Smith Health Industry Washington Watch blog reports on the following recent health policy developments:

• Regulatory Developments. CMS is considering using its “inherent reasonableness” authority to establish special Medicare payment limits for retail diabetic testing supplies, and several other Medicare payment rules are awaiting final regulatory clearance. The IRS has proposed regulations to implement ACA standards for charitable hospitals.
• Other HHS Developments. HHS has announced that health insurers will pay $1.1 billion in rebates under the ACA’s medical loss ratio provision, and the Department has launched prescription drug monitoring pilot projects. CMS has outlined conditions for provider use of certain repackaged medications.
• Legislative Developments. Congress has approved the Food and Drug Administration Safety and Innovation Act, and the House of Representatives approved the Counterfeit Drug Penalty Enhancement Act.
• GAO & OIG Developments. The GAO has issued reports on the privacy and security of prescription drug data and home and community-based services (HCBS) waiver programs. Recent OIG reports address Medicare claims for diabetic testing supplies, physician electronic health record use, and HCBS programs.
• Odds & Ends. MACPAC released a report to Congress on Medicaid and CHIP policy.
• Health Industry Events. Upcoming events include meetings/calls on hospital value-based purchasing, the Medicare Shared Savings Program/Advance Payment Model, the Medicare clinical lab fee schedule, and Medicare hospital outpatient payment policy. 

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